An exploratory analysis of the cost-effectiveness of insulin glargine 300 units/mL versus insulin glargine 100 units/mL over a lifetime horizon using the BRAVO diabetes model.

BACKGROUND: This analysis assessed the cost-effectiveness of insulin glargine 300 units/mL (Gla-300) versus insulin glargine 100 units/mL (Gla-100) in insulin-naïve adults with type 2 diabetes (T2D) inadequately controlled with oral antidiabetic drugs (OADs). METHODS: Costs and outcomes for Gla-300 versus Gla-100 from a US healthcare payer perspective were assessed using the BRAVO diabetes model. Baseline clinical data were derived from EDITION-3, a 12-month randomized controlled trial comparing Gla-300 with Gla-100 in insulin-naïve adults with inadequately controlled T2D on OADs. Treatment costs were calculated based on doses observed in EDITION-3 and 2020 US net prices, while costs for complications were based on published literature. Lifetime costs ($US) and quality-adjusted life-years (QALYs) were predicted and used to calculate incremental cost-effectiveness ratio (ICER) estimates; extensive scenario and sensitivity analyses were conducted. RESULTS: Lifetime medical costs were estimated to be $353,441 and $352,858 for individuals receiving Gla-300 and Gla-100 respectively; insulin costs were $52,613 and $50,818. Gla-300 was associated with a gain of 8.97 QALYs and 21.12 life-years, while Gla-100 was associated with a gain of 8.89 QALYs and 21.07 life-years. This resulted in an ICER of $7522/QALY gained for Gla-300 versus Gla-100. Thus, Gla-300 was cost-effective versus Gla-100 based on a willingness-to-pay threshold of $50,000/QALY. Compared with Gla-100, Gla-300 provided a net monetary benefit of $3290. Scenario and sensitivity analyses confirmed the robustness of the base case. CONCLUSION: Gla-300 may be a cost-effective treatment option versus Gla-100 over a lifetime horizon for insulin-naïve people in the United States with T2D inadequately controlled on OADs.

Real-World Persistence, Adherence, Hypoglycemia, and Health Care Resource Utilization in People With Type 2 Diabetes Who Continued With the Second-Generation Basal Insulin Analog Insulin Glargine 300 Units/mL or Switched to a First-Generation Basal Insulin (Insulin Glargine 100 Units/mL or Detemir 100).

People with type 2 diabetes receiving a second-generation basal insulin (BI) analog may be switched to a first-generation formulation for financial reasons or changes in health insurance. However, because second-generation BI analogs have more even pharmacokinetic profiles, longer durations of action (>24 vs. ≤24 hours), and more stable action profiles than first-generation BI analogs, such a change may result in suboptimal treatment persistence and/or adherence. This study compared treatment persistence, treatment adherence, rates of hypoglycemia, and health care resource utilization outcomes in people with type 2 diabetes who either continued treatment with the second-generation BI Gla-300 or switched to a first-generation BI. The study showed that continuing with Gla-300 was associated with a lower risk of discontinuing therapy, fewer emergency department visits, and lower hypoglycemia event rates than switching to a first-generation BI.

Cost-effectiveness analysis of once-daily insulin glargine 300 U/mL versus insulin degludec 100 U/mL using the BRAVO diabetes model.

AIMS: A cost-effectiveness analysis was conducted to compare insulin glargine 300 U/mL (Gla-300) versus insulin degludec 100 U/mL (IDeg-100) in insulin-naïve adults with type 2 diabetes (T2D) sub-optimally controlled with oral anti-diabetic drugs (OADs). METHODS: The BRAVO diabetes model was used to assess costs and outcomes for once-daily Gla-300 versus once-daily IDeg-100 from a US healthcare sector perspective. Baseline clinical data were based on BRIGHT, a 24-week, non-inferiority, randomised control trial comparing Gla-300 and IDeg-100 in adults with T2D sub-optimally controlled with OADs (with or without glucagon-like peptide-1 receptor agonists). Treatment costs were based on doses observed in BRIGHT as well as net prices. Costs associated with complications were based on published literature. Lifetime costs (US$) and quality-adjusted life-years (QALYs) were predicted and used to calculate incremental cost-effectiveness ratio estimates; extensive scenario and sensitivity analyses were conducted. RESULTS: Overall lifetime medical costs were estimated to be $327,904 and $330,154 for people receiving Gla-300 and IDeg-100, respectively; insulin costs were $43,477 and $44,367, respectively. People receiving Gla-300 gained 8.024 QALYs and 18.55 life-years, while people receiving IDeg-100 gained 7.997 QALYs and 18.52 life-years. Because Gla-300 was associated with a cost-saving of $2250 and 0.027 additional QALYs, it was considered to be dominant compared with IDeg-100. Results of the scenario and sensitivity analyses confirmed the robustness of the base case results. CONCLUSION: Gla-300 was the dominant treatment option compared with IDeg-100 based on the willingness-to-pay threshold of $50,000/QALY. Results remained robust against a wide range of alternative assumptions on key parameters.

Real-world outcomes of addition of insulin glargine 300 U/mL (Gla-300) to glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy in people with type 2 diabetes: The DELIVER-G study.

AIMS: To provide real-world data on the addition of basal insulin (BI) in people with type 2 diabetes mellitus (PWD2) suboptimally controlled with glucagon-like peptide-1 receptor agonist (GLP-1RA) therapy. However, real-world data on the addition of BI to GLP-1RA therapy are limited. MATERIALS AND METHODS: We used a US electronic medical record data source (IBM® Explorys®) that includes approximately 4 million PWD2 to assess the real-world impact of adding the second-generation BI analogue insulin glargine 300 U/mL (Gla-300) to GLP-1RA therapy. Insulin-naïve PWD2 receiving GLP-1RAs who also received Gla-300 between March 1, 2015 and September 30, 2019 were identified; participants were required to have data for ≥12 months before, and ≥6 months after, addition of Gla-300. RESULTS: The mean (standard deviation [SD]) age of participants (N = 271) was 57.9 (10.8) years. Baseline glycated haemoglobin (HbA1c) was 9.16% and was significantly reduced (-0.97 [SD 1.60]%; P < 0.0001) after addition of Gla-300; a significant increase in the proportion of PWD2 achieving HbA1c control was observed after addition of Gla-300 (HbA1c <7.0%: 4.80% vs. 22.14%, P < 0.0001; HbA1c <8.0%: 19.56% vs. 51.29%, P < 0.0001). The incidence of overall (8.49% vs. 9.59%; P = 0.513) and inpatient/emergency department (ED)-associated hypoglycaemia (0.37% vs. 0.74%; P = 1.000), as well as overall (0.33 vs. 0.46 per person per year [PPPY]; P = 0.170) and inpatient/ED-associated hypoglycaemia events (0.01 vs. 0.04 PPPY; P = 0.466) were similar before and after addition of Gla-300. CONCLUSIONS: In US real-world clinical practice, adding Gla-300 to GLP-1RA significantly improved glycaemic control without significantly increasing hypoglycaemia in PWD2. Further research into the effect of adding Gla-300 to GLP-1RA therapy is warranted.

Real-world persistence, adherence, health care resource utilization, and costs in people with type 2 diabetes switching from a first-generation basal insulin to a second-generation (insulin glargine 300 U/mL) vs an alternative first-generation basal insulin.

BACKGROUND: People with type 2 diabetes (T2D) who change their basal insulin (BI) may have variable persistence with therapy. Compared with first-generation (long-acting) BI analogs (insulin glargine 100U/mL [Gla-100]; insulin detemir [IDet]), second-generation (longer-acting) BI analogs (insulin glargine 300U/mL [Gla-300]; insulin degludec) have similar glycated hemoglobin (HbA1c) attainment and lowered hypoglycemia risk, which could impact treatment persistence. OBJECTIVE: To compare persistence, adherence, health care resource utilization (HRU), and costs for individuals switching from neutral protamine Hagedorn insulin or a first-generation BI analog with either the second-generation BI, Gla-300, or an alternative first-generation BI analog (Gla-100 or IDet). METHODS: We used Optum Clinformatics claims data from adults (aged ≥ 18 years) with T2D who had received BI (neutral protamine Hagedorn, Gla-100, IDet) in the 6-month baseline period, and switched to either Gla-300 or an alternative first-generation BI (Gla-100 or IDet; treatment switch = index date) between April 1, 2015, and August 31, 2019. Participants were followed for 12 months, until plan disenrollment, or until death, whichever occurred first. Cohorts were propensity score matched (PSM) on baseline characteristics. The primary outcome was the proportion who were persistent with therapy at 12 months. Secondary outcomes were adherence (proportion of days covered); change in HbA1c; and all-cause, diabetes-related, and hypoglycemia-related HRU and costs. RESULTS: PSM generated 3,077 participants/group (mean age: 68 years, 52% female). Cohorts were well balanced except for hospitalization, which was adjusted in models as a covariate. During the 12-month follow-up period, participants who received Gla-300 vs first-generation BI had greater persistence with (45.5% vs 42.1%; adjusted P = 0.0001), and adherence to (42.8% vs 38.2%; adjusted P = 0.0006), BI therapy and a statistically larger reduction in HbA1c at 12 months (-0.65% vs -0.45%; adjusted P = 0.0040). The proportion of participants achieving HbA1c less than 8% (47.2% vs 40.9%; P < 0.0001), but not less than 7% (21.2% vs 20.8%), was significantly higher for Gla-300 vs first-generation BI. All-cause (45.3 vs 65.9 per 100 patient-years [P100PY]) and diabetes-related (21.5 vs 29.1 P100PY), but not hypoglycemia-related, hospitalizations (1.0 vs 1.5 P100PY) were significantly (P < 0.0001) lower for Gla-300 vs first-generation BI. Similarly, all-cause (111.9 vs 148.8 P100PY), diabetes-related (54.8 vs 74.2 P100PY), and hypoglycemia-related (2.9 vs 5.7 P100PY) emergency department (ED) visits were significantly lower for Gla-300 (all P < 0.0001). Costs for all-cause hospitalizations and hypoglycemia-related ED visits were significantly lower for Gla-300 vs first-generation BI. Although pharmacy costs were significantly higher for Gla-300 vs first-generation BI, all-cause total health care costs were not significantly different: $41,255 vs $45,316 per person per year, respectively. CONCLUSIONS: In this claims-based analysis of people with T2D receiving BI, switching to Gla-300 was associated with significantly better persistence, adherence, and HbA1c reduction compared with switching to an alternative first-generation BI analog. All-cause HRU was significantly lower; despite significantly higher pharmacy costs, total health care costs were similar. DISCLOSURES: This study was funded by Sanofi US. Medical writing support was provided by Helen Jones, PhD, CMPP, of Evidence Scientific Solutions and funded by Sanofi US. Dr Wright is on the speakers' bureau and sits on the advisory boards for Abbot Diabetes, Bayer, Boehringer Ingelheim, Eli Lilly, and Sanofi; sits on the advisory board for Medtronic; and is a consultant for Abbot Diabetes, Bayer, Boehringer Ingelheim, and Eli Lilly. Dr Malone is on advisory boards for Novartis and Avalere and consults for Pear Therapeutics, Sarepta, and Strategic Therapeutics. Dr Trujillo sits on advisory boards for Novo Nordisk and Sanofi. Drs Gill, Zhou, and Preblick and Mr Li are employees and stockholders of Sanofi. Mr Huse is an employee of Evidera and a contractor for Sanofi. Dr Reid is a speaker and consultant for Novo Nordisk and Sanofi-Aventis and is a consultant for AstraZeneca and Intarcia.

Post Hoc Analysis Evaluating the Impact of Antihyperglycemic Background Therapies on Attainment of A1C Targets Without Hypoglycemia in the ACHIEVE Control Pragmatic, Real-Life Study.

BACKGROUND: ACHIEVE Control, a prospective, open-label, randomized, pragmatic, real-life study in insulin-naive people with type 2 diabetes (A1C 8.0-11.0%), demonstrated superiority of insulin glargine 300 units/mL (Gla-300) versus first-generation standard-of-care basal insulin (SOC-BI; glargine 100 units/mL or insulin detemir) in achieving individualized A1C targets without documented symptomatic (glucose ≤3.9 mmol/L [≤70 mg/dL] or <3.0 mmol/L [<54 mg/dL]) or severe hypoglycemia (American Diabetes Association level 3) at 6 months. Noninsulin antihyperglycemic background therapies are commonly used; however, sulfonylureas may increase hypoglycemia risk. This post hoc analysis assessed outcomes according to background therapy. METHODS: Subgroup analyses were performed per concomitant use/nonuse of sulfonylureas, glucagon-like peptide-1 receptor agonists, dipeptidyl peptidase 4 inhibitors, or sodium-glucose cotransporter 2 (SGLT2) inhibitors. End points (6 and 12 months) included A1C target attainment without documented symptomatic or severe hypoglycemia, A1C target attainment, and absence of documented symptomatic or severe hypoglycemia. RESULTS: Odds ratios (ORs) at 12 months mostly favored Gla-300 versus SOC-BI across subgroups except in analysis of SGLT2 inhibitors, in which ORs were similar. Among sulfonylurea users, ORs at 12 months strongly favored Gla-300 versus SOC-BI for all end points, particularly A1C target achievement without documented symptomatic hypoglycemia (glucose ≤3.9 mmol/L [≤70 mg/dL]; OR 1.25, 95% CI 1.02-1.53) or severe hypoglycemia and achievement of no documented symptomatic hypoglycemia (glucose <3.0 mmol/L [<54 mg/dL]; OR 1.25, 95% CI 1.02-1.52) or severe hypoglycemia. CONCLUSION: The results suggest that, in insulin-naive people with type 2 diabetes, Gla-300 is effective with a risk of hypoglycemia that is lower than or similar to that of SOC-BI regardless of background medication. Individuals receiving concomitant sulfonylureas were more likely to remain without symptomatic or severe hypoglycemia with Gla-300.

Target attainment in insulin-naive patients at high risk for hypoglycemia: Results from ACHIEVE Control.

AIMS: To better understand outcomes in people with type 2 diabetes at high risk of hypoglycemia, we conducted post hoc analyses in subgroups of participants from the real-world ACHIEVE Control study (NCT02451137) with ≥1 hypoglycemia risk factor. METHODS: Insulin-naive adults with type 2 diabetes and A1c ≥8% were randomized 1:1 to insulin glargine 300 U/mL (Gla-300) or standard-of-care basal insulin (SOC-BI). Participants had documented history of ≥1 risk factors for hypoglycemia: chronic kidney disease, cardiovascular disease, dementia or blindness, age ≥65 years, or history of hypoglycemia. Outcomes included individualized A1c target attainment without documented symptomatic hypoglycemia (blood glucose [BG] ≤3.9 mmol/L or <3.0 mmol/L) or severe hypoglycemia, A1c target attainment, and absence of documented symptomatic or severe hypoglycemia at 6 and 12 months. RESULTS: Within subgroups, odds ratios generally showed trends favoring Gla-300 versus SOC-BI, particularly for hypoglycemia avoidance in participants ≥65 years of age (BG ≤3.9 mmol/L; odds ratio, 1.52; 95% confidence interval, 1.14-2.03) and those with chronic kidney disease (BG ≤3.9 mmol/L; odds ratio, 2.28; 95% confidence interval, 1.26-4.12). Results were consistent with the overall population. CONCLUSIONS: These data suggest potential benefit of Gla-300 versus SOC-BI for avoiding hypoglycemia in participants with ≥1 hypoglycemia risk factor.

A pragmatic randomized clinical trial of insulin glargine 300 U/mL vs first-generation basal insulin analogues in insulin-naïve adults with type 2 diabetes: 6-month outcomes of the ACHIEVE Control study.

AIMS: To compare the safety and efficacy of insulin glargine 300 U/mL (Gla-300) versus first-generation standard-of-care basal insulin analogues (SOC-BI; insulin glargine 100 U/mL or insulin detemir) at 6 months. METHODS: In the 12-month, open-label, multicentre, randomized, pragmatic ACHIEVE Control trial, insulin-naïve adults with type 2 diabetes (T2D) and glycated haemoglobin (HbA1c) 64 to 97 mmol/mol (8.0%-11.0%) after ≥1 year of treatment with ≥2 diabetes medications were randomized to Gla-300 or SOC-BI. The composite primary endpoint, evaluated at 6 months, was the proportion of participants achieving individualized HbA1c targets per Healthcare Effectiveness Data and Information Set (HEDIS) criteria without documented symptomatic (blood glucose ≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycaemia at any time of the day at 6 months. RESULTS: Of 1651 and 1653 participants randomized to Gla-300 and SOC-BI, respectively, 31.3% and 27.9% achieved the composite primary endpoint at 6 months (odds ratio [OR] 1.19, 95% confidence interval [CI] 1.01-1.39; P = 0.03 for superiority); 78.4% and 75.3% had no documented symptomatic or severe hypoglycaemia (OR 1.19, 95% CI 1.01-1.41). Changes from baseline to month 6 in HbA1c, fasting plasma glucose, weight, and BI analogue dose were similar between groups. CONCLUSIONS: Among insulin-naïve adults with poorly controlled T2D, Gla-300 was associated with a statistically significantly higher proportion of participants achieving individualized HEDIS HbA1c targets without documented symptomatic or severe hypoglycaemia (vs SOC-BI) in a real-life population managed in a usual-care setting. The ACHIEVE Control study results add value to treatment decisions and options for patients, healthcare providers, payers and decision makers.

Insulin glargine 300 U/mL versus first-generation basal insulin analogues in insulin-naïve adults with type 2 diabetes: 12-month outcomes of ACHIEVE Control, a prospective, randomized, pragmatic real-life clinical trial.

AIM: To report the effectiveness and safety of insulin glargine 300 U/mL (Gla-300) versus standard-of-care basal insulin analogues (SOC-BI) at 12 months in the ACHIEVE Control trial, which is a prospective pragmatic randomized real-life study in insulin-naïve adults with type 2 diabetes (T2D). METHODS: A total of 3304 insulin-naïve adults with T2D and glycated haemoglobin (HbA1c) concentration of 64 to 97 mmol/mol (8.0% to 11.0%) after ≥1 year of treatment with two or more antihyperglycaemic agents were randomized to Gla-300 or SOC-BI. Key secondary endpoints included HbA1c target attainment without documented symptomatic (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycaemia at 12 months. RESULTS: At 12 months, 26.1% (Gla-300) and 23.7% (SOC-BI) of adults achieved HbA1c targets without documented symptomatic (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycaemia (odds ratio [OR] 1.14, 95% confidence interval [CI] 0.97-1.35); 33.0% and 29.5%, respectively, achieved HbA1c targets without documented symptomatic (<3.0 mmol/L [<54 mg/dL]) or severe hypoglycaemia (OR 1.19, 95% CI 1.02-1.38). The OR for HbA1c target achievement was 1.15 (95% CI 0.99-1.34), and favoured Gla-300 versus SOC-BI for absence of documented symptomatic or severe hypoglycaemia at 12 months for both ≤3.9 mmol/L (≤70 mg/dL; OR 1.21, 95% CI 1.05-1.40) and < 3.0 mmol/L (<54 mg/dL; OR 1.26, 95% CI 1.07-1.48). CONCLUSION: Gla-300 tended to be associated with lower hypoglycaemia risk than SOC-BI in real-world clinical practice during the 12-month follow-up.

Efficacy and safety of a morning injection of insulin glargine 300 units/mL versus insulin glargine 100 units/mL in adult patients with type 1 diabetes: A multicentre, randomized controlled trial using continuous glucose monitoring.

Video abstract: View a video abstract for this article. AIMS: This multicentre (N = 104), randomized controlled phase 4 study compared the efficacy and safety of insulin glargine 300 units/mL (Gla-300) with insulin glargine 100 units/mL (Gla-100) in patients with type 1 diabetes (T1D). MATERIALS AND METHODS: Patients were randomized 1:1 to self-perform morning Gla-300 or Gla-100 injections daily for 16 weeks. The primary endpoint was percentage of time blood glucose remained in the target range (70-180 mg/dL) during Week 15/16, measured by blinded continuous glucose monitoring. Secondary endpoints included incidence and rate of nocturnal symptomatic hypoglycaemia (≤70 mg/dL), glycaemic variability parameters and safety assessments. Exploratory analyses were performed in patients with glycated haemoglobin (HbA1c) <7.5% at Week 16. RESULTS: Overall, 638 patients with T1D were included (Gla-300, n = 320; Gla-100, n = 318). In the modified intent-to-treat (mITT) population, no differences between Gla-300 and Gla-100 were observed in time in range, in glycaemic variability, or in incidence or rates of nocturnal symptomatic hypoglycaemia. In exploratory analyses of patients with HbA1c <7.5% at Week 16, Gla-300 recipients had greater improvement in time in range over 24 hours, during the day and at night compared with Gla-100 recipients (P < 0.05), with small increases in overall hypoglycaemia. CONCLUSIONS: Time in range and glycaemic variability were similar for Gla-300 and Gla-100 recipients at the end of study in the mITT population of relatively well-controlled patients with T1D. In patients with end-of-study HbA1c <7.5%, exploratory analyses suggested that Gla-300 provided improvements in time in range compared with Gla-100.

Improved Treatment Engagement Among Patients with Diabetes Treated with Insulin Glargine 300 U/mL Who Participated in the COACH Support Program.

INTRODUCTION: Persistence with basal insulin therapy can be suboptimal, despite recent improvements in insulin formulations and delivery systems. Patient support programs may help increase adherence. This study evaluated the impact of the Toujeo® COACH support program, which provides patients with continuing and individualized education and advice on lifestyle changes, by assessing its effect on number of refills and days on therapy. METHODS: The study population included 1724 patients with diabetes who filled a first prescription for insulin glargine 300 U/mL (Gla-300) between April and December 2015 and received a welcome call from a Guide, and 1724 matched control patients from the Symphony Health Integrated Dataverse® prescription claims database. Control patients received Gla-300 but did not enroll in the program. These patients were matched based on age, gender, location, prior use of insulin, insulin dose, number of concomitant drugs, and copay tier. RESULTS: The COACH and control groups comprised 52% men and 48% women; 22% were aged 18-47 years, 23% were 48-55 years, 27% 56-61 years, and 28% ≥ 62 years. Most (99%) had used insulin in the year before receiving the welcome call. At 6 months, patients in the COACH group had refilled their prescription 3.2 times on average, compared with 2.4 times for control patients (P < 0.0001); at 9 months, the average number of refills was 4.7 and 3.6, respectively (P < 0.0001). The average number of days on therapy at 6 months was 102.2 days in the COACH group and 81.5 days in the control group (P < 0.0001); at 9 months, the average number of days on therapy was 151.9 and 121.6, respectively (P < 0.0001). CONCLUSION: Patients in the COACH program were significantly more likely to refill their prescriptions and stay on therapy. Patient support programs such as the COACH program could be an effective way to help improve diabetes care. FUNDING: Sanofi US, Inc. and McKesson Corporation.

INSULIN GLARGINE 300 U/ML IS ASSOCIATED WITH LESS WEIGHT GAIN WHILE MAINTAINING GLYCEMIC CONTROL AND LOW RISK OF HYPOGLYCEMIA COMPARED WITH INSULIN GLARGINE 100 U/ML IN AN AGING POPULATION WITH TYPE 2 DIABETES.

OBJECTIVE: Assess efficacy, hypoglycemia, and weight gain in patients with type 2 diabetes (T2D) treated with insulin glargine 300 U/mL (Gla-300) or 100 U/mL (Gla-100) across different age groups. METHODS: Pooled data were generated for patients randomized to Gla-300 or Gla-100 in the EDITION 2 (NCT01499095) and 3 (NCT01676220) studies. In 4 age groups (<55, ≥55 to <60, ≥60 to <65, ≥65 years), glycated hemoglobin A1C (A1C), percentage of patients reaching A1C <7.5% (58 mmol/mol), weight change, confirmed hypoglycemia (blood glucose ≤70 mg/dL), and/or severe hypoglycemia (events requiring third-party assistance) were analyzed with descriptive statistics and logistic, binomial, and analysis of covariance regression modeling. RESULTS: A1C reductions from baseline and proportions of patients at target were similar for Gla-300 and Gla-100 across all age groups at 6 and 12 months, but hypoglycemia incidence and event rate were lower with Gla-300 at 6 (both P<.001) and 12 months ( P<.001 and P = .005, respectively). Patients on Gla-300 gained less weight than those on Gla-100 at 6 ( P = .027) and 12 months ( P = .021). Changes in weight and daily weight-adjusted insulin dose decreased with increasing age at 6 ( P<.001 and P = .017, respectively) and 12 months ( P<.001 and P = .011, respectively). CONCLUSION: Older patients with T2D may benefit from treatment with Gla-300, which is associated with a lower hypoglycemia rate and less weight gain with similar efficacy compared with Gla-100. ABBREVIATIONS: A1C = glycated hemoglobin A1C BMI = body mass index Gla-100 = insulin glargine 100 U/mL Gla-300 = insulin glargine 300 U/mL OAD = oral antidiabetes drug T2D = type 2 diabetes.

Clinical and Economic Outcomes Associated With the Timing of Initiation of Basal Insulin in Patients With Type 2 Diabetes Mellitus Previously Treated With Oral Antidiabetes Drugs.

PURPOSE: In patients with type 2 diabetes mellitus (T2DM) not achieving glycemic targets using oral antidiabetes drugs (OADs), studies suggest that timely insulin initiation has clinical benefits. Insulin initiation at the early versus late stage of disease progression has not been explored in detail. This retrospective database analysis investigated clinical and economic outcomes associated with the timing of insulin initiation in patients with T2DM treated with ≥1 OAD in a real-world US setting. METHODS: This study linked data from the Truven Health MarketScan(®) Commercial database, Medicare Supplemental database, and Quintiles Electronic Medical Records database. A total of 1830 patients with T2DM were included. Patients were grouped according to their OAD use before basal insulin initiation (1, 2, or ≥3 OADs) as a proxy for the timing of insulin initiation. Clinical and economic outcomes were evaluated over 1 year of follow-up. FINDINGS: During follow-up the 1 OAD group, compared with the 2 and ≥3 OADs groups, had a greater reduction in glycosylated hemoglobin A1c (-1.7% vs -1.0% vs -0.9%, respectively; P < 0.0001), greater achievement of glycemic target (38.2% vs 26.7% vs 19.6%, respectively; P < 0.0001), and a lower incidence of hypoglycemia (2.7% vs 6.6% vs 5.0%, respectively; P = 0.0002), with no difference in total health care costs ($21,167 vs $21,060 vs $20,133, respectively). IMPLICATIONS: This study shows that early insulin initiation (represented by the 1 OAD group) may be clinically beneficial to patients with T2DM not controlled with OADs, without adding to costs. This supports the call for timely initiation of individualized insulin therapy in this population.

Health Outcomes Associated with Initiation of Basal Insulin After 1, 2, or ≥ 3 Oral Antidiabetes Drug(s) Among Managed Care Patients with Type 2 Diabetes.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is a progressive disease. Despite starting with single oral antidiabetes drug (OAD) therapy and then adding OAD(s), most patients eventually require insulin therapy to achieve and maintain glycemic control. The timely initiation of insulin therapy could help patients with T2DM whose glycemic control is not adequately maintained using OADs alone. OBJECTIVE: To describe and compare baseline characteristics and assess real-world health outcomes associated with initiating basal insulin after 1 OAD, 2 OADs, or ≥ 3 OADs among T2DM patients. METHODS: Data were analyzed from adult T2DM patients in a U.S. managed care claims database (IMPACT) who initiated a basal insulin (from January 1, 2001, to December 31, 2011) with continuous health plan enrollment for 6 months before (baseline) and 12 months after (follow-up) insulin initiation and who had at least 1 OAD prescription. Outcome measures according to the number of OADs used were (a) treatment discontinuation, (b) glycated hemoglobin (A1c) levels, (c) proportion of patients experiencing hypoglycemia, (d) health care resource utilization, and (e) costs. RESULTS: Data from 71,988 patients were included (1 OAD: 19,168 patients [26.6%]; 2 OADs: 29,112 [40.4%]; and ≥ 3 OADs: 23,708 [32.9%]). All baseline characteristics, except nephropathy, were significantly different across the 3 groups. At baseline, when compared with the 1 OAD or 2 OADs groups, the ≥3 OADs group was less likely to be female or have macrovascular disease and had experienced fewer hypoglycemic events and hospitalization as well as lower costs. At follow-up, treatment discontinuation rates were 36.0%, 27.6%, and 21.4% for the 1 OAD, 2 OADs, and ≥ 3 OADs groups, respectively. A1c reduction was -1.33%, -1.05%, and -0.86%, respectively. The proportion of patients experiencing any hypoglycemia was 4.7%, 3.8%, and 3.3% at baseline; and 3.7%, 3.5%, and 3.1% at follow-up for the 1 OAD, 2 OADs, and ≥3 OADs groups, respectively. In all 3 groups, health care costs decreased compared with baseline, particularly in the 1 OAD and 2 OADs groups, with decreased inpatient costs offsetting increased drug costs. CONCLUSIONS: This real-world analysis shows that there are significant baseline differences in patients with T2DM on 1 OAD, 2 OADs, or ≥3 OADs when adding insulin therapy. All 3 groups had significant improvements in clinical and economic outcomes compared with baseline, yet at different magnitudes. These data contribute to a growing body of evidence supporting the timely initiation of insulin therapy for T2DM patients not maintaining glycemic control with OADs.

Much ado about nothing? A real-world study of patients with type 2 diabetes switching Basal insulin analogs.

INTRODUCTION: Type-2 diabetes mellitus (T2DM) is a progressive disease, and many patients eventually require insulin therapy. This study examined real-world outcomes of switching basal insulin analogs among patients with T2DM. METHODS: Using two large United States administrative claims databases (IMPACT(®) and Humana(®)), this longitudinal retrospective study examined two cohorts of adult patients with T2DM. Previously on insulin glargine, Cohort 1 either continued insulin glargine (GLA-C) or switched to insulin detemir (DET-S), while Cohort 2 was previously on insulin detemir, and either continued insulin detemir (DET-C) or switched to insulin glargine (GLA-S). One-year follow-up treatment persistence and adherence, glycated hemoglobin (HbA1c), hypoglycemia events, healthcare utilization and costs were assessed. Selection bias was minimized by propensity score matching between treatment groups within each cohort. RESULTS: A total of 5,921 patients (mean age 60 years, female 50.0%, HbA1c 8.6%) were included in the analysis (Cohort 1: IMPACT(®): n = 536 DET-S matched to n = 2,668 GLA-C; Humana(®): n = 256 DET-S matched to n = 1,262 GLA-C; Cohort 2: n = 419 GLA-S matched to n = 780 DET-C), with similar baseline characteristics between treatment groups in each cohort. During 1-year follow-up, in Cohort 1, DET-S patients, when compared with GLA-C patients, had lower treatment persistence/adherence with 33-40% restarting insulin glargine, higher rapid-acting insulin use, worse HbA1c outcomes, significantly higher diabetes drug costs, and similar hypoglycemia rates, health care utilization and total costs. However, in Cohort 2 overall opposite outcomes were observed and only 19.8% GLA-S patients restarted insulin detemir. CONCLUSIONS: This study showed contrasting clinical and economic outcomes when patients with T2DM switched basal insulin analogs, with worse outcomes observed for patients switching from insulin glargine to insulin detemir and improved outcomes when switching from insulin detemir to insulin glargine. Further investigation into the therapeutic interchangeability of insulin glargine and insulin detemir in the real-world setting is needed.

Comparing patient preferences and healthcare provider recommendations with the pen versus vial-and-syringe insulin delivery in patients with type 2 diabetes.

OBJECTIVES: This study aimed to examine healthcare provider (HCP) recommendations and patient preferences for the insulin pen versus vial-and-syringe in patients with type 2 diabetes mellitus (T2DM) and to assess clinical end points and safety outcomes. SUBJECTS AND METHODS: Using a randomized, open-label, crossover design, in total, 405 insulin-naive adults with T2DM from 60 centers received basal insulin glargine in one of two device treatment sequences (2 weeks of pen followed by 2 weeks of vial-and-syringe, or vice versa). The primary end point, patient device preference, was evaluated at Week 4 (end of the crossover period) using the Insulin Injection Preference Questionnaire. Patient preference and HCP recommendation were assessed with one global item and three subscale items (blood glucose control, reluctance to use insulin, and long-term insulin use) using a 5-point scale ranging from 1=not preferred or not recommended to 5=preferred or recommended. Patients were then re-randomized to either pen or vial-and-syringe for further observation (6, 10, and 30 weeks) to evaluate clinical end points (glycosylated hemoglobin [A1C] and fasting blood glucose levels) and safety outcomes (hypoglycemia and adverse events). RESULTS: Patients reported a significant preference for pens over vial-and-syringe, and HCPs strongly recommended pens over vial-and-syringe (both P<0.001). Consistent response patterns were observed by HCPs and patients for the three subscale items. Fasting blood glucose, A1C levels, and the incidence of hypoglycemia were comparable in the two groups. CONCLUSIONS: Patients preferred pens over vial-and-syringe, with the pen device also recommended by HCPs, when initiating basal insulin treatment in insulin-naive patients with T2DM.

Does pen help? A real-world outcomes study of switching from vial to disposable pen among insulin glargine-treated patients with type 2 diabetes mellitus.

OBJECTIVE: The study was designed to evaluate real-world data on clinical and economic outcome differences between patients with type 2 diabetes mellitus (T2DM) who use insulin glargine with vial-and-syringe delivery and those who switch to pen administration. SUBJECTS AND METHODS: This retrospective study analyzed medical and pharmacy claims information from the national managed-care IMPACT(®) database (Ingenix Inc., Salt Lake City, UT). Adults with T2DM treated with insulin glargine were evaluated. Clinical and economic outcomes over 1 year were compared between individuals who had converted from administering glargine via vial-and-syringe to the SoloSTAR(®) (sanofi-aventis U.S., Bridgewater, NJ) pen (Switchers) and patients who continued to use vial-and-syringe administration (Continuers). Patients from each cohort were matched using propensity score matching for a comparison sample. RESULTS: In total, 3,893 eligible patients were identified (665 Switchers and 3,228 Continuers), with a matched cohort with 603 patients in each group. Baseline characteristics were similar between groups. One-year treatment persistence was significantly higher with Switchers versus Continuers (65.3% vs. 49.8%; P<0.0001). Medication possession ratio was also significantly higher among Switchers (0.79 vs. 0.76; P=0.0173). Insulin use and glycemic control were similar between groups. Healthcare utilization and total costs were also similar between groups. Higher prescription costs among Switchers were offset by lower overall and diabetes-related outpatient and inpatient costs. CONCLUSIONS: Switching from insulin glargine vial-and-syringe administration to pen delivery resulted in improved treatment adherence and persistence, with comparable clinical and economic outcomes.

Comparative effectiveness of basal-bolus versus premix analog insulin on glycemic variability and patient-centered outcomes during insulin intensification in type 1 and type 2 diabetes: a randomized, controlled, crossover trial.

CONTEXT: In patients with diabetes, intraday glucose variability might predict health outcomes independently from glycosylated hemoglobin (HbA1c). OBJECTIVE: Our objective was to evaluate patient satisfaction (PS), quality of life (QoL), glycemic control, and variability during insulin intensification to HbA1c below 7.0%. PATIENTS, DESIGN, AND SETTING: Eighty-two type 1 and 306 insulin-treated type 2 diabetes patients (47% male; age 54±11 yr; HbA1c=7.8±0.7%) participated in this multicenter, randomized, crossover trial at 52 U.S. centers. INTERVENTIONS: Interventions included insulin glargine plus premeal glulisine (n=192) vs. twice-daily premix 75/25 or 70/30 analog insulin (n=196) for 12 wk and crossed to the alternate arm for 12 wk. MAIN OUTCOME MEASURES: Main outcome measures included PS and QoL questionnaires, 3-d continuous glucose monitoring (CGM), and HbA1c every 4-8 wk. RESULTS: Mean±se HbA1c change was -0.39±0.09% for glargine-glulisine and -0.05±0.09% for premix (P<0.0001). The PS net benefit scale (0-100) improved from 51.1 to 60.5±1.2 for glargine-glulisine and worsened to 45.4±1.2 for premix (P<0.0001). The PS regimen acceptance scale was comparable (P=0.33). Overall QoL favored glargine-glulisine (P<0.001), as did perceived health (P<0.0001), symptom distress (P<0.0001), general health perceptions (P<0.01), and psychosocial (P<0.02). CGM daily glucose mean, daily glucose sd (glycemic variability), and percent time over 140 mg/dl were lower for glargine-glulisine by 13.1±2.7 mg/dl, 5.9±1.4 mg/dl, and 7.3±1.6%, respectively (all P<0.0001), with no difference in CGM percent time below 70 mg/dl (P=0.09). Symptomatic hypoglycemia rates were comparable. HbA1c, mean CGM daily glucose, and glycemic variability were independent predictors of PS net benefit. CONCLUSIONS: Patient satisfaction was impacted more positively by improved QoL, reduced glucose variability, and better glycemic control with a basal-bolus regimen than negatively by the burden of additional injections, thereby facilitating insulin intensification and the ability to achieve HbA1c below 7.0%.

Outcomes associated with insulin therapy disruption after hospital discharge among patients with type 2 diabetes mellitus who had used insulin before and during hospitalization.

OBJECTIVE: To evaluate outcomes associated with insulin therapy disruption after hospital discharge in patients with type 2 diabetes mellitus who had used insulin before and during hospitalization. METHODS: In this observational, retrospective analysis of medical records obtained from a coordinated health system in the United States, patients with type 2 diabetes mellitus who had used insulin 30 days before and during hospitalization were included. Clinical and cost outcomes were compared between patients who continued insulin therapy and those who had disrupted insulin therapy after hospital discharge. RESULTS: In total, 2160 records were analyzed (851 patients with continued insulin therapy and 1309 patients with disrupted insulin therapy). Mean baseline glycated hemoglobin A1c levels were 8.56% and 7.73% in patients who continued insulin therapy and patients who disrupted insulin therapy, respectively (P<.001), suggesting that patients who discontinued insulin therapy had better glycemic control at baseline. Continued insulin therapy was associated with an expected greater reduction in glycated hemoglobin A1c (P<.001); similar hypoglycemia rates; lower risks of all-cause hospital readmission, diabetes-related readmission, and all-cause emergency department visits; and improved survival. Continued insulin therapy was associated with $3432 lower total medical service costs than disrupted therapy over the 6-month postdischarge period. CONCLUSION: Ensuring adherence to insulin therapy in patients who require insulin therapy after hospitalization should be a priority for postdischarge patient care programs. However, the clinical implications of this study are limited by the fact that it could not be determined whether all patients required insulin therapy after hospital discharge.

Outcomes associated with post-discharge insulin continuity in US patients with type 2 diabetes mellitus initiating insulin in the hospital.

AIM: Hyperglycemia in hospitalized patients is associated with adverse outcomes; treatment of hyperglycemia in the hospital improves outcomes. We investigated clinical outcomes and hospital readmissions associated with insulin continuation and discontinuation post-discharge in patients with type 2 diabetes mellitus (T2DM) who initiated insulin therapy during hospitalization. MATERIALS AND METHODS: This observational retrospective database analysis was performed using medical records obtained from a US coordinated health system. Patients with T2DM, glycated hemoglobin (HbA1c) levels ≥ 8.0%, naïve to insulin, and initiating insulin during hospitalization were included. Clinical outcomes and hospital readmissions were compared between patients who continued and discontinued insulin post-discharge. RESULTS: Of 732 patients initiating insulin during hospitalization, 180 (24.6%) continued and 552 (75.4%) discontinued insulin. Higher mean baseline HbA1c levels were observed in patients continuing insulin compared with those discontinuing insulin (11.1% vs 9.5%; P < 0.001). A significantly higher percentage of patients continuing insulin achieved target HbA1c levels (< 7.0%) compared with those discontinuing insulin (P = 0.023), with no difference in hypoglycemia rates. In patients with a baseline HbA1c of ≥ 9.0%, insulin continuation was significantly associated with lower risks of all-cause (adjusted hazard ratio, 0.58; 95% CI, 0.36-0.93; P = 0.0276) and diabetes-related (adjusted hazard ratio, 0.46; 95% CI, 0.23-0.87; P = 0.0204) hospital readmissions. CONCLUSION: Continuation of insulin post-discharge in insulin-naïve patients with T2DM is associated with better HbA1c target level achievement, no difference in hypoglycemia rates, and a reduced risk of hospital readmission in patients with baseline HbA1c levels ≥ 9.0%.