Dataset Information

Effective Overall Glycaemic Control with Fast-Acting Insulin Aspart Across Patients with Different Baseline Characteristics: A Post Hoc Analysis of the Onset 9 Trial.

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.

SUBMITTER: Lane W

PROVIDER: S-EPMC8991309 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature

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Publications

Effective Overall Glycaemic Control with Fast-Acting Insulin Aspart Across Patients with Different Baseline Characteristics: A Post Hoc Analysis of the Onset 9 Trial.

Lane Wendy W Favaro Elena E Jódar Esteban E Kelkar Pranav P Oviedo Alejandra A Sivarathinasami Ramsathish R Senior Peter A PA Sesti Giorgio G Franek Edward E

Diabetes therapy : research, treatment and education of diabetes and related disorders 20220315 4

<h4>Aims</h4>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.<h4>Methods</h4>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), bo ...[more]

PMID: 35290624

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Project description:IntroductionThis study investigated glycaemic control in individuals with type 1 (T1D) or type 2 diabetes (T2D) 6 months after initiating fast-acting insulin aspart (faster aspart) in a real-world setting.MethodsThis was a single-arm, observational study using extracted patient data from the IBM® Explorys® database (USA) for individuals with T1D or T2D initiating faster aspart (at least one prescription of faster aspart) in the study period 1 January 2018 to 27 October 2020. Clinical characteristics, including age, body mass index, and baseline HbA1c, were extracted, as well as recorded events of hypoglycaemia. The primary endpoint was the change in HbA1c from baseline to 6 months.ResultsA total of 787 individuals were included; 36.6% of these individuals had T1D and 63.4% had T2D (of whom 46.9% were new users of rapid-acting insulin when initiating faster aspart [T2D new users] and 53.1% were switching from another rapid-acting insulin to faster aspart [T2D switchers]). For individuals with T1D, T2D new users, or T2D switchers, estimated mean change in HbA1c from baseline to 6 months was - 0.20% (95% CI - 0.53, 0.14; p = 0.252), - 1.00% (95% CI - 1.34, - 0.67; p < 0.0001), and - 0.70% (95% CI - 1.06, - 0.35; p = 0.0001), respectively. In the baseline HbA1c > 8.5% subgroup, there was a significant estimated decrease in HbA1c from baseline to 6 months in individuals with T1D (- 1.2% [95% CI - 1.80, - 0.60]; p = 0.0001) or T2D (- 0.6% [95% CI - 0.92, - 0.35]; p < 0.0001). Event rates of hypoglycaemia after 12 months were 0.68, 0.38, and 0.59 events/year for individuals with T1D, T2D new users, and T2D switchers, respectively.ConclusionUS IBM® Explorys® data demonstrated a clinically relevant reduction in HbA1c 6 months after initiating faster aspart treatment for individuals with T2D, but not T1D overall, although patients with baseline HbA1c > 8.5% had significant HbA1c reductions regardless of diabetes type.

Project description:INTRODUCTION:The aim of this study was to investigate the association between baseline characteristics [HbA1c and body mass index (BMI)] and the effect of mealtime fast-acting insulin aspart (faster aspart) relative to insulin aspart (IAsp) or basal-only insulin therapy on several efficacy and safety outcomes in people with diabetes. METHODS:Post hoc analysis of three randomised phase 3a trials in people with type 1 diabetes (T1D; onset 1) and type 2 diabetes (T2D; onset 2 and 3). Participants (N = 1686) were stratified according to baseline BMI (< 25 kg/m2, 25-< 30 kg/m2, ≥ 30 kg/m2) or HbA1c (≤ 58 mmol/mol, > 58-< 64 mmol/mol, ≥ 64 mmol/mol; ≤ 7.5%, > 7.5-< 8.0%, ≥ 8.0%). RESULTS:In participants with T2D, the estimated treatment difference for change in HbA1c was similar for all BMI and HbA1c subgroups. No major differences between treatments were observed in risk of overall hypoglycaemia or insulin dose across subgroups. In participants with T1D, change in HbA1c was similar across BMI and HbA1c subgroups, and no major differences between treatments were observed for severe or blood glucose-confirmed hypoglycaemia across subgroups. Total daily insulin dose (U/kg) was similar across all baseline HbA1c groups and the BMI < 25 kg/m2 and 25-30 kg/m2 groups, but was significantly lower with mealtime faster aspart compared with IAsp in the BMI > 30 kg/m2 subgroup. CONCLUSIONS:In participants with T1D and T2D, treatment differences (for change in HbA1c and overall hypoglycaemia) between mealtime faster aspart and insulin comparators were similar to the corresponding overall analysis across baseline HbA1c and BMI subgroups. The finding of a lower total daily insulin dose in participants with obesity (BMI > 30 kg/m2) and T1D treated with faster aspart, versus those treated with IAsp, may warrant further investigation. TRIAL REGISTRATION:ClinicalTrials.gov NCT01831765 (onset 1); NCT01819129 (onset 2); NCT01850615 (onset 3). FUNDING:Novo Nordisk A/S, Søborg, Denmark.

Dataset Information

Effective Overall Glycaemic Control with Fast-Acting Insulin Aspart Across Patients with Different Baseline Characteristics: A Post Hoc Analysis of the Onset 9 Trial.

Aims

Methods

Results

Conclusions

Clinical trial registration

Publications

Effective Overall Glycaemic Control with Fast-Acting Insulin Aspart Across Patients with Different Baseline Characteristics: A Post Hoc Analysis of the Onset 9 Trial.

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