Efficacy and safety of linagliptin as add-on therapy to basal insulin and metformin in people with Type 2 diabetes.

Abstract

AIM:

To evaluate the efficacy and safety of linagliptin in people with Type 2 diabetes inadequately controlled on basal insulin and metformin.

METHODS:

This was a post hoc subanalysis of participants who received basal insulin and metformin in a global phase III study that randomized participants (1:1) to receive linagliptin 5 mg once daily or placebo for ≥52 weeks as add-on therapy to basal insulin alone or in combination with metformin and/or pioglitazone. During the first 24 weeks, the background dose of basal insulin remained stable; thereafter, adjustments based on glucose concentrations were recommended. The primary endpoint of the subanalysis was the change from baseline in HbA1c after 24 weeks. The safety analysis incorporated data up to a maximum of 110 weeks.

RESULTS:

A total of 950 participants receiving background insulin and metformin were included in this subanalysis (linagliptin and placebo, both n = 475). At week 24, the placebo-corrected adjusted mean (±se) change from baseline in HbA1c with linagliptin was -7 (±1) mmol/mol [-0.7 (±0.1) %; 95% CI -0.8, -0.6; P < 0.0001]. The overall frequency of drug-related adverse events (linagliptin, 18.9%; placebo, 21.9%) and investigator-reported hypoglycaemia (linagliptin, 30.7%; placebo, 31.6%) were similar in both groups at the end of treatment. The frequency of severe hypoglycaemia was low (linagliptin, 1.7%; placebo, 0.8%). No meaningful changes in mean (±sd) body weight were noted in either group [week 52: linagliptin, -0.5 (±3.2) kg; placebo, 0.0 (±3.1) kg].

CONCLUSIONS:

Linagliptin added to basal insulin and metformin improved glycaemic control, without increasing the risk of hypoglycaemia or body weight gain.

• Authors: S Durán-Garcia, J Lee, H Yki-Järvinen, J Rosenstock, U Hehnke, S Thiemann, S Patel, H-J Woerle
• Journal: Diabetic medicine : a journal of the British Diabetic Association (Diabet Med) Vol. 33 Issue 7 Pg. 926-33 (07 2016) ISSN: 1464-5491 [Electronic] England
• PMID: 26605991 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2015 Diabetes UK.

Chemical References

• Glycated Hemoglobin A
• Hypoglycemic Agents
• Insulin
• hemoglobin A1c protein, human
• Linagliptin
• Metformin

Topics

• Aged
• Clinical Trials, Phase III as Topic
• Diabetes Mellitus, Type 2 (drug therapy, metabolism)
• Drug Therapy, Combination
• Female
• Glycated Hemoglobin (metabolism)
• Humans
• Hypoglycemia (chemically induced)
• Hypoglycemic Agents (therapeutic use)
• Insulin (therapeutic use)
• Linagliptin (therapeutic use)
• Male
• Metformin (therapeutic use)
• Middle Aged
• Treatment Outcome
• Weight Gain
• Weight Loss