DIVE/DPV registries: benefits and risks of analog insulin use in individuals 75 years and older with type 2 diabetes mellitus.

INTRODUCTION: The aims of this study were to characterize insulin-treated individuals aged ≥75 years with type 2 diabetes using basal insulin analogs (BIA) or regular insulins (human insulin (HI)/neutral protamine Hagedorn (NPH)) and to compare the benefits and risks. RESEARCH DESIGN AND METHODS: The analysis was based on data from the DPV (Diabetes-Patienten-Verlaufsdokumentation) and DIVE (DIabetes Versorgungs-Evaluation) registries. To balance for confounders, propensity score matching for age, sex, diabetes duration, body mass index and hemoglobin A1c (HbA1c) as covariates was performed. RESULTS: Among 167 300 patients aged ≥75 years with type 2 diabetes (mean age, 80.3 years), 9601 subjects used insulin regimens with basal insulin (HI/NPH or BIA). Of these 8022 propensity score-matched subjects were identified. The mean diabetes duration was ~12 years and half of the patients were male. At the time of switch, patients provided with BIA experienced more dyslipidemia (89.3% vs 85.9%; p=0.002) and took a greater number of medications (4.3 vs 3.7; p<0.001) and depression was more prevalent (8.4% vs 6.5%; p=0.01). Aggregated to the most actual treatment year, BIA was associated with a higher percentage of patients using basal-supported oral therapy (42.6% vs 14.4%) and intensified conventional insulin therapy (44.3% vs 29.4%) and lower total daily insulin doses (0.24 IU/kg/day vs 0.30 IU/kg/day; p<0.001). The study did not reveal significant differences in efficacy (HbA1c 7.4% vs 7.3%; p=0.06), hospitalizations (0.7 vs 0.8 per patient-year (PY); p=0.15), length of stay (16.3 vs 16.1 days per PY; p=0.53), or rates of severe hypoglycemia (4.07 vs 4.40 per 100 PY; p=0.88), hypoglycemia with coma (3.64 vs 3.26 per 100 PY; p=0.88) and diabetic ketoacidosis (0.01 vs 0.03 per 100 PY; p=0.36). CONCLUSION: BIA were used in more individually and patient-centered therapy regimens compared with HI/NPH in patients with a mean age of 80 years. Both groups were slightly overtreated with mean HbA1c <7.5%. The risk of severe hypoglycemia was low and independent of insulin type. Further analyses of elderly patients with type 2 diabetes are needed to provide evidence for best practice approaches in this age group.

Type 2 diabetes in older patients: an analysis of the DPV and DIVE databases.

BACKGROUND: The clinical profile differs between old and young patients with type 2 diabetes mellitus (T2DM). We explored, based on a large real-world database, patient and disease characteristics and actual treatment patterns by age. METHODS: The analysis was based on the DIVE and DPV registries of patients with T2DM. Patients were analyzed by age groups 50-59 (middle-young), 60-69 (young-old), 70-79 (middle-old), 80-89 (old), and 90 years or more (oldest-old). RESULTS: A total of 396,719 patients were analyzed, of which 17.7% were 50-59 years, 27.7% 60-69 years, 34.3% 70-79 years, 18.3% 80-89 years and 2.0% at least 90 years. We found that (a) T2DM in old and oldest-old patients was characterized much less by the presence of metabolic risk factors such as hypertension, obesity, dyslipidemia and smoking than in younger patients; (b) the HbA1c was much lower in oldest-old than in middle-young patients (7.2 ± 1.6% versus 8.0 ± 2.2%; p < 0.001), but it was associated with higher proportions of patients with severe hypoglycemia (7.0 versus 1.6%; p < 0.001); (c) this was potentially associated with the higher and increasing rates of insulin use in older patients (from 17.6% to 37.6%, p < 0.001) and the particular comorbidity profile of these patients, for example, chronic kidney disease (CKD); (d) patients with late diabetes onset had lower HbA1c values, lower bodyweight and less cardiovascular risk factors; (e) patients with a longer diabetes duration had a considerable increase in macrovascular and even more microvascular complications. CONCLUSION: In very old patients there is a need for frequent careful routine assessment and a tailored pharmacotherapy in which patient safety is much more important than blood-glucose-lowering efficacy.

Treatment intensification strategies after initial metformin therapy in adult patients with type-2 diabetes: results of the DPV and DIVE registries.

AIMS: Our study aimed to analyse treatment strategies after failure of initial metformin mono-therapy in adult patients with type-2 diabetes (T2DM). METHODS: The DIVE and DPV databases were combined and 16,681 adult patients with T2DM and metformin mono-therapy identified. Patients were analysed depending on whether metformin was continued (MET), or whether it was combined with other oral antidiabetics (OAD), with GLP-1 antagonists (GLP-1) or with basal insulin (BOT/BOT plus). Metabolic control, body weight and hypoglycaemia, micro- and macro-vascular events were compared within 1 year. RESULTS: A total of 11,911 (71%) participants continued MET until the end of the observation period, 3334 (20.0%) were intensified using OAD, 579 (3%) started on GLP-1, and 857 (5%) were initiated on BOT/BOTplus. Predictors of OAD and BOT/BOTplus therapy were elevated HbA1c, longer diabetes duration and the presence of micro- and macro-vascular diseases, while GLP-1 therapy was predicted by younger age, female sex, higher body weight and shorter diabetes duration. Micro- and macro-vascular diseases were negative predictors of GLP-1 therapy. Effects on HbA1c were highest in the BOT/BOTplus and OAD group, while GLP-1 treatment had the best effect on body weight. CONCLUSIONS: BOT/BOTplus and OAD show good HbA1c reduction even in patients with longer diabetes duration and in older patients. GLP-1 therapy is effective concerning weight loss in overweight patients and is more often used in females and patients with shorter diabetes duration. Interestingly, despite several studies showing positive effects on micro- and macro-vascular outcomes, prevalent macro-vascular diseases are no predictors of GLP-1 use.

Characteristics of Patients with Type-1 or Type-2 Diabetes Receiving Insulin Glargine U300: An Analysis of 7268 Patients Based on the DPV and DIVE Registries.

INTRODUCTION: Insulin glargine 300 U/ml (U300) was registered based on the EDITION clinical trial program. The aim of this database analysis was to describe the profile of adult U300 recipients with type-1 (T1DM) or type-2 diabetes (T2DM). METHODS: The analysis was based on data from the German DIVE/DPV registries. Patients were sampled in May (DIVE) and in March 2018 (DPV) and divided into those who commenced U300 within the 1st year (early adopters) or 2nd year (late adopters). Patients were further compared to patients receiving U100 during the same time period. RESULTS: Among 581,519 adult patients contained in the databases, 7268 with either T1 or T2DM received U300 and 22,050 U100. Baseline characteristics of U300 and U100 recipients did not differ substantially in both types of diabetes. Patients with T2DM had many risk factors and comorbidities. The median HbA1c (both T1DM and T2DM, 8.1% for U300 and 7.9 and 8.3% for U100) and fasting blood glucose values were similar at baseline. Severe hypoglycemia was less prevalent in T2DM and among recipients of U300 (3.1 vs. 3.9%), whereas in T1DM the rate was higher (10.6 vs. 10.1%). There were minor, but clinically probably irrelevant, differences in age and BMI for T1DM and T2DM between the first and second years. Patients with T2DM being initiated in the second year had a higher HbA1c value (8.6 vs. 8.3%) than those initiated during the first year. Patients in clinical practice showed substantially higher HbA1c values in both T1DM and T2DM, and doses used were lower than those reported from the EDITION trial program. U300 patients had a longer diabetes duration (T1 and T2DM), a higher BMI and received higher basal insulin doses (T1 and T2DM) compared to U100. While HbA1c was comparable, the rate of severe hypoglycemia under U300 was reduced in T2DM but not T1DM with or without adjustment for differences in baseline characteristics in T2DM. CONCLUSION: The data confirm the clinical profile documented for U300 in the EDITION studies during the first years of its registration. In an unselected patient population, there was a lesser rate of severe hypoglycemia but at a comparable HbA1c. FUNDING: German Centre for Diabetes Research (DZD) (01GI1106), the European Foundation for the Study of Diabetes (EFSD) and the German Diabetes Society (DDG). The DIVE registry (organized as Diabetes Agenda 2010 GmbH, Berlin, Germany) received funding from Sanofi, AstraZeneca, Bayer, and Abbott and was conducted under the auspices of diabetesDE.

[Which patients from routine care use the new insulin analogue glargine U300 compared to patients with glargine U100 : A multicenter analysis of 14,123 patients with insulin glargine from die diabetes registries DPV and DIVE]. / Welche Patienten aus der Routinebetreuung verwenden das neue Insulin-Analogon Glargin U300 im Vergleich zu Patienten mit Glargin U100? : Eine multizentrische Analyse von 14.123 Patienten mit Insulin Glargin aus den Diabetesregistern DPV und DIVE.

BACKGROUND: Glargine U300 (Gla-300) is a further development of glargine U100 (Gla-100). Since 2015, Gla-300 has been available in Germany and Austria. We compared patients initiating therapy with Gla-300 with patients starting with Gla-100. Moreover, it was investigated whether patients from real-life diabetes care differ from patients participating in the EDITION clinical study program. METHODS: Data are based on the diabetes registries DPV and DIVE. Patients started/switched to Gla-100 or Gla-300 in 2015 were included. Linear regression was applied for bodyweight (BW), BMI, HbA1C, daily total and basal insulin dose/kgBW and negative binomial regression for severe hypoglycemia. Data were adjusted for age, sex, and diabetes duration. RESULTS: 14,123 patients were identified (Gla-100: 11,397; Gla-300: 2726). Gla-300 patients with T1D were older, T2D patients younger compared to subjects using Gla-100 (both p < 0.0001). In Gla-300 subjects, diabetes duration was longer (both p < 0.0001). Patients started/switched to Gla-300 had a higher BW, a higher BMI and a lower baseline HbA1C. The rate of severe hypoglycemia was comparable. Total and basal insulin doses/kgBW were higher in patients with Gla-300. DPV/DIVE subjects were older, had a lower BW, and were more frequently male compared to EDITION patients. HbA1C was higher in T1D patients from DPV/DIVE. CONCLUSION: Data from the diabetes registries DPV/DIVE indicate differences between Gla-300 and Gla-100 patients at the onset of insulin therapy. This analysis provides additional information to the EDITION clinical study program.