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Adding fast-acting insulin aspart to basal insulin significantly improved glycaemic control in patients with type 2 diabetes: A randomized, 18-week, open-label, phase 3 trial (onset 3).

ABSTRACT: To confirm glycaemic control superiority of mealtime fast-acting insulin aspart (faster aspart) in a basal-bolus (BB) regimen vs basal-only insulin.In this open-label, randomized, 18-week trial (51 sites; 6 countries), adults (n?=?236) with inadequately controlled type 2 diabetes (T2D; mean glycosylated haemoglobin [HbA1c]?±?SD: 7.9%?±?0.7% [63.1?±?7.5?mmol/mol]) receiving basal insulin and oral antidiabetic drugs underwent 8-week optimization of prior once-daily basal insulin followed by randomization 1:1 to either a BB regimen with faster aspart (n?=?116) or continuation of once-daily basal insulin (n?=?120), both with metformin. Primary endpoint was HbA1c change from baseline after 18?weeks of treatment. Secondary endpoints included: postprandial plasma glucose (PPG) change and overall PPG increment (all meals); weight; treatment-emergent adverse events; hypoglycaemic episodes.HbA1c decreased from 7.9% (63.2?mmol/mol) to 6.8% (50.7?mmol/mol; BB group) and from 7.9% (63.2?mmol/mol) to 7.7% (60.7?mmol/mol; basal-only group); estimated treatment difference [95% confidence interval] -0.94% [-1.17; -0.72]; -10.3?mmol/mol [-12.8; -7.8]; P ?

SUBMITTER: Rodbard HW

PROVIDER: S-EPMC5637905 | biostudies-other | 2017 Oct

REPOSITORIES: biostudies-other

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Adding fast-acting insulin aspart to basal insulin significantly improved glycaemic control in patients with type 2 diabetes: A randomized, 18-week, open-label, phase 3 trial (onset 3).

Rodbard Helena W HW Tripathy Devjit D Vidrio Velázquez Maricela M Demissie Marek M Tamer Søren C SC Piletič Milivoj M

Diabetes, obesity & metabolism 20170706 10

<h4>Aim</h4>To confirm glycaemic control superiority of mealtime fast-acting insulin aspart (faster aspart) in a basal-bolus (BB) regimen vs basal-only insulin.<h4>Materials and methods</h4>In this open-label, randomized, 18-week trial (51 sites; 6 countries), adults (n = 236) with inadequately controlled type 2 diabetes (T2D; mean glycosylated haemoglobin [HbA1c] ± SD: 7.9% ± 0.7% [63.1 ± 7.5 mmol/mol]) receiving basal insulin and oral antidiabetic drugs underwent 8-week optimization of prior o ...[more]

PMID: 28345792

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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.

Dataset Information

Adding fast-acting insulin aspart to basal insulin significantly improved glycaemic control in patients with type 2 diabetes: A randomized, 18-week, open-label, phase 3 trial (onset 3).

Publications

Adding fast-acting insulin aspart to basal insulin significantly improved glycaemic control in patients with type 2 diabetes: A randomized, 18-week, open-label, phase 3 trial (onset 3).

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