One-year efficacy and safety of a fixed combination of insulin degludec and liraglutide in patients with type 2 diabetes: results of a 26-week extension to a 26-week main trial.

Abstract

AIMS:

To confirm, in a 26-week extension study, the sustained efficacy and safety of a fixed combination of insulin degludec and liraglutide (IDegLira) compared with either insulin degludec or liraglutide alone, in patients with type 2 diabetes.

METHODS:

Insulin-naïve adults with type 2 diabetes randomized to once-daily IDegLira, insulin degludec or liraglutide, in addition to metformin ± pioglitazone, continued their allocated treatment in this preplanned 26-week extension of the DUAL I trial.

RESULTS:

A total of 78.8% of patients (1311/1663) continued into the extension phase. The mean glycated haemoglobin (HbA1c) concentration at 52 weeks was reduced from baseline by 1.84% (20.2 mmol/mol) for the IDegLira group, 1.40% (15.3 mmol/mol) for the insulin degludec group and 1.21% (13.2 mmol/mol) for the liraglutide group. Of the patients on IDegLira, 78% achieved an HbA1c of <7% (53 mmol/mol) versus 63% of the patients on insulin degludec and 57% of those on liraglutide. The mean fasting plasma glucose concentration at the end of the trial was similar for IDegLira (5.7 mmol/l) and insulin degludec (6.0 mmol/l), but higher for liraglutide (7.3 mmol/l). At 52 weeks, the daily insulin dose was 37% lower with IDegLira (39 units) than with insulin degludec (62 units). IDegLira was associated with a significantly greater decrease in body weight (estimated treatment difference, -2.80 kg, p < 0.0001) and a 37% lower rate of hypoglycaemia compared with insulin degludec. Overall, all treatments were well tolerated and no new adverse events or tolerability issues were observed for IDegLira.

CONCLUSIONS:

These 12-month data, derived from a 26-week extension of the DUAL I trial, confirm the initial 26-week main phase results and the sustainability of the benefits of IDegLira compared with its components in glycaemic efficacy, safety and tolerability.

• Authors: S C L Gough, B W Bode, V C Woo, H W Rodbard, S Linjawi, M Zacho, P D Reiter, J B Buse
• Journal: Diabetes, obesity & metabolism (Diabetes Obes Metab) Vol. 17 Issue 10 Pg. 965-73 (Oct 2015) ISSN: 1463-1326 [Electronic] England
• PMID: 25980900 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2015 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Chemical References

• Blood Glucose
• Glycated Hemoglobin A
• Hypoglycemic Agents
• Insulin, Long-Acting
• Thiazolidinediones
• hemoglobin A1c protein, human
• insulin degludec
• Liraglutide
• Metformin
• Pioglitazone

Topics

• Aged
• Blood Glucose (drug effects)
• Diabetes Mellitus, Type 2 (blood, drug therapy)
• Dose-Response Relationship, Drug
• Drug Therapy, Combination
• Fasting (blood)
• Female
• Glycated Hemoglobin (drug effects)
• Humans
• Hypoglycemia (chemically induced)
• Hypoglycemic Agents (administration & dosage)
• Insulin, Long-Acting (administration & dosage)
• Liraglutide (administration & dosage)
• Male
• Metformin (administration & dosage)
• Middle Aged
• Pioglitazone
• Thiazolidinediones (administration & dosage)
• Weight Loss (drug effects)