ABSTRACT
BACKGROUND: Derived time in range (dTIR), calculated from self-monitored blood glucose (SMBG-dTIR) profiles, has demonstrated correlation with risk of cardiovascular and microvascular complications. This post hoc analysis of the DUAL V and DUAL VIII trials aimed to compare dTIR with an insulin degludec/liraglutide fixed-ratio combination (IDegLira) versus insulin glargine 100 units/mL (glargine U100) in people with type 2 diabetes (T2D). MATERIALS AND METHODS: Nine-point SMBG profiles were taken more than 24 hours at baseline and end of trial (EOT: 26 weeks [DUAL V] and 104 weeks [DUAL VIII]) and used to derive the percentage of readings within target range (70-180 mg/dL). Estimated treatment differences (ETDs, IDegLira-glargine U100) were analyzed using analysis of covariance, with treatment as fixed effects and baseline response as a covariate. RESULTS: ETDs for change from baseline to EOT in dTIR were significantly greater with IDegLira versus glargine U100 in DUAL V (4.18%, P = .027) and DUAL VIII (5.17%, P = .001). The proportions of people achieving ≥70% dTIR at EOT with IDegLira and glargine U100, respectively, were 62% and 60% in DUAL V (P = .7541), and 50% and 26% in DUAL VIII (P < .0001). The proportion achieving a ≥5% increase in dTIR from baseline to EOT with IDegLira and glargine U100 was 63% in both groups in DUAL V (P = .9043), and 44% and 25%, respectively, in DUAL VIII (P < .0001). CONCLUSIONS: IDegLira was associated with significantly greater increases in dTIR versus basal insulin alone in people with T2D. TRIAL ID(S): ClinicalTrials.gov, NCT01952145 (DUAL V); ClinicalTrials.gov, NCT02501161 (DUAL VIII).
ABSTRACT
AIMS: To investigate the efficacy and safety of fast-acting insulin aspart (faster aspart) compared with insulin aspart (IAsp) in participants with type 2 diabetes (T2D) across different subgroups. METHODS: We report on a post hoc analysis of onset 9, a 16-week trial of participants with T2D randomised to faster aspart (n = 546) or IAsp (n = 545). Participants were grouped by baseline HbA1c (< 7.0%, ≥ 7.0%), meal test bolus insulin dose (≤ 10 units [U], > 10 U to ≤ 20 U, > 20 U), body mass index (< 30 kg/m2, ≥ 30 to < 35 kg/m2, ≥ 35 kg/m2), and age (< 65 years, ≥ 65 years). Outcomes assessed were change from baseline in HbA1c and in 1-h postprandial glucose (PPG) increment, and severe or blood glucose (BG)-confirmed hypoglycaemia. RESULTS: Faster aspart provided reductions in HbA1c comparable to IAsp across all subgroups, with improved 1-h PPG control compared with IAsp in several subgroups. Faster aspart had comparable or improved rates of severe or BG-confirmed hypoglycaemia versus IAsp, particularly in participants with good glycaemic control (HbA1c < 7.0%), the elderly (≥ 65 years old), and those with insulin resistance (> 20 U meal test bolus insulin dose). CONCLUSIONS: Faster aspart provides effective overall glycaemic control, with improved early PPG control compared with IAsp across a range of patient characteristics. CLINICAL TRIAL REGISTRATION: NCT03268005.
Fast-acting insulin aspart (faster aspart) is a type of insulin used at mealtimes to reduce the spike in blood sugar resulting from that meal. Faster aspart works in the body more quickly and more effectively than insulin aspart (IAsp), the previous version of this insulin. The properties of insulins in the body can change according to certain patient characteristics. In this study, the researchers wanted to find out if there were differences between various subgroups of patients in the effectiveness and safety of faster aspart compared with IAsp in the treatment of type 2 diabetes. Data were used from a clinical trial (onset 9), in which 546 patients were treated with faster aspart and 545 were treated with IAsp. Patients were grouped by baseline glycated haemoglobin (HbA1c), meal test actual bolus insulin dose, body mass index, and age. Faster aspart provided reductions in HbA1c comparable to IAsp across all subgroups, with improved glucose control 1 hour after a meal compared with IAsp, in several subgroups. Faster aspart had comparable or improved rates of hypoglycaemia versus IAsp, particularly in participants with good glucose control, the elderly (≥ 65 years old), and those with insulin resistance. In summary, the researchers found that faster aspart provides effective overall glucose control, with improved early mealtime glucose control compared with IAsp across patients with a range of baseline characteristics.
