Combination therapy with liraglutide and insulin in Japanese patients with type 2 diabetes: A 36‐week, randomized, double‐blind, parallel‐group trial
Open Access
- 11 December 2015
- journal article
- research article
- Published by Wiley in Journal of Diabetes Investigation
- Vol. 7 (4), 565-573
- https://doi.org/10.1111/jdi.12457
Abstract
Aims/Introduction To assess efficacy and safety of liraglutide in combination with insulin compared with insulin monotherapy in Japanese patients with type 2 diabetes. Materials and methods This was a 36‐week, multicenter, double‐blind, parallel‐group trial, where patients on stable insulin therapy (basal/premixed/basal–bolus) were randomized 1:1 to additional liraglutide 0.9 mg/day (n = 127) or placebo (n = 130). The insulin dose was fixed for 16 weeks, and titrated based on self‐measured plasma glucose thereafter. The primary end‐point was change in glycosylated hemoglobin after 16 weeks. Results Superiority of liraglutide plus insulin versus insulin monotherapy was confirmed based on estimated mean difference in glycosylated hemoglobin after 16 weeks of −1.30% (−14 mmol/mol; 95% confidence interval −1.47 to −1.13 [−16, −12]; P < 0.0001). Statistical significance was maintained to week 36. More patients on liraglutide achieved a glycosylated hemoglobin target of P < 0.0001). Improvements in seven‐point self‐measured plasma glucose and fasting plasma glucose were significantly greater with liraglutide than the placebo at week 16. Insulin dose after 36 weeks was lower with liraglutide than the placebo (estimated treatment ratio: 0.82 [95% confidence interval 0.76–0.90; P < 0.0001]). Occurrence of adverse events was similar in the two groups (85.8 and 81.5%, respectively); most were mild in severity. There were no significant differences in the number of hypoglycemic episodes during the 36 weeks. Conclusions Adding liraglutide to insulin results in superior glycemic control compared with insulin alone in Japanese patients with type 2 diabetes, and is generally well tolerated.Keywords
Funding Information
- Novo Nordisk
This publication has 34 references indexed in Scilit:
- Efficacy and safety comparison between liraglutide as add-on therapy to insulin and insulin dose-increase in Chinese subjects with poorly controlled type 2 diabetes and abdominal obesityCardiovascular Diabetology, 2012
- Glucagon-like peptide-1 receptor agonists as add-on therapy to basal insulin in patients with type 2 diabetes: a systematic reviewDiabetes, Metabolic Syndrome and Obesity, 2012
- Management of Hyperglycemia in Type 2 Diabetes: A Patient-Centered ApproachDiabetes Care, 2012
- Relationship of Insulin Dose, A1c Lowering, and Weight in Type 2 Diabetes: Comparing Insulin Glargine and Insulin DetemirDiabetes Technology & Therapeutics, 2010
- Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomised, parallel-group, open-label trialThe Lancet, 2010
- Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trialDiabetologia, 2009
- Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6)The Lancet, 2009
- Efficacy and Safety of the Human Glucagon-Like Peptide-1 Analog Liraglutide in Combination With Metformin and Thiazolidinedione in Patients With Type 2 Diabetes (LEAD-4 Met+TZD)Diabetes Care, 2009
- Liraglutide, a once‐daily human GLP‐1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with Type 2 diabetes (LEAD‐1 SU)Diabetic Medicine, 2009
- Efficacy and Safety Comparison of Liraglutide, Glimepiride, and Placebo, All in Combination With Metformin, in Type 2 DiabetesDiabetes Care, 2009