Efficacy and safety of fast-acting insulin aspart in comparison with insulin aspart in type 1 diabetes (onset 1): A 52-week, randomized, treat-to-target, phase III trial.

Abstract

AIMS:

To compare the safety and efficacy of fast-acting insulin aspart (faster aspart) with conventional insulin aspart (IAsp) in adults with type 1 diabetes (T1D).

MATERIALS AND METHODS:

onset 1 was a randomized, multicentre, treat-to-target, phase III, 52-week (initial 26 weeks + additional 26 weeks) trial conducted at 165 sites across 9 countries. Adults with T1D were randomly allocated to double-blind mealtime faster aspart or IAsp, each with once- or twice-daily insulin detemir. The primary endpoint, change in glycated haemoglobin (HbA1c) from baseline after the initial 26 weeks, has been reported previously. In the present paper, we report data from the full 52-week study period.

RESULTS:

Between August 2013 and June 2015, 381 participants were assigned to double-blind faster aspart and 380 participants to IAsp. After 52 weeks, estimated mean changes from baseline in HbA1c levels were -0.08% (faster aspart) and +0.01% (IAsp); estimated treatment difference significantly favoured faster aspart (-0.10% [95% confidence interval {CI} -0.19;-0.00]; P = .0424). Changes from baseline in 1-hour postprandial plasma glucose (PPG) increment (meal test; faster aspart -1.05 mmol/L; IAsp -0.14 mmol/L) also significantly favoured faster aspart (estimated treatment difference -0.91 mmol/L [95% CI -1.40;-0.43]; -16.48 mg/dL [95% CI -25.17;-7.80]; P = .0002). There was no difference in overall severe or blood glucose-confirmed hypoglycaemic episodes or treatment-emergent adverse events between treatments.

CONCLUSIONS:

At 52 weeks, overall glycaemic control had significantly improved with faster aspart vs IAsp, consistent with the 26-week study findings. Achieving an insulin profile closer to physiological insulin secretion with faster aspart translates into lower PPG and HbA1c levels compared with those achieved with IAsp in people with T1D.

• Authors: Chantal Mathieu, Bruce W Bode, Edward Franek, Athena Philis-Tsimikas, Ludger Rose, Tina Graungaard, Anne Birk Østerskov, David Russell-Jones
• Journal: Diabetes, obesity & metabolism (Diabetes Obes Metab) Vol. 20 Issue 5 Pg. 1148-1155 (05 2018) ISSN: 1463-1326 [Electronic] England
• PMID: 29316130 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2018 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Chemical References

• Blood Glucose
• Glycated Hemoglobin A
• Hypoglycemic Agents
• hemoglobin A1c protein, human
• Insulin Detemir
• Insulin Aspart

Topics

• Adult
• Blood Glucose (analysis)
• Blood Glucose Self-Monitoring
• Diabetes Mellitus, Type 1 (blood, drug therapy)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Drug Compounding
• Drug Monitoring
• Drug Therapy, Combination (adverse effects)
• Female
• Follow-Up Studies
• Glycated Hemoglobin (analysis)
• Humans
• Hyperglycemia (prevention & control)
• Hypoglycemia (chemically induced, prevention & control)
• Hypoglycemic Agents (administration & dosage, adverse effects, therapeutic use)
• Insulin Aspart (administration & dosage, adverse effects, therapeutic use)
• Insulin Detemir (administration & dosage, adverse effects, therapeutic use)
• Male
• Meals
• Middle Aged