Linagliptin improved glycaemic control without weight gain or hypoglycaemia in patients with Type 2 diabetes inadequately controlled by a combination of metformin and pioglitazone: a 24‐week randomized, double‐blind study. Issue 12 (7th July 2014)

• Record Type: Journal Article
• Authors: Bajaj, M.; Gilman, R.; Patel, S.; Kempthorne‐Rawson, J.; Lewis‐D'Agostino, D.; Woerle, H.‐J.
• Is Part Of: Diabetic medicine. Volume 31:Issue 12(2014:Dec.)
• Page Start: 1505
• Page End: 1514
• Publication Date: 2014-07-07
• Subjects: Diabetes -- Periodicals; 616.462
• DOI: 10.1111/dme.12495
• Languages: English
• ISSNs: 0742-3071

Abstract

<abstract abstract-type="main" id="dme12495-abs-0001"> <title>Abstract</title> <sec id="dme12495-sec-0001" sec-type="section"> <title>Aims</title> <p>To investigate the efficacy and safety of the dipeptidyl peptidase‐4 inhibitor linagliptin in patients with Type 2 diabetes mellitus inadequately controlled by a combination of metformin and pioglitazone.</p> </sec> <sec id="dme12495-sec-0002" sec-type="section"> <title>Methods</title> <p>This was a multi‐centre, phase 3, randomized, double‐blind, placebo‐controlled study comparing linagliptin 5 mg once daily (<italic>n</italic> = 183) and placebo (<italic>n</italic> = 89) as add‐on to metformin and pioglitazone. The primary endpoint was the change from baseline in glycated haemoglobin (HbA<sub>1c</sub>) after 24 weeks.</p> </sec> <sec id="dme12495-sec-0003" sec-type="section"> <title>Results</title> <p>The placebo‐corrected adjusted mean (<sc>se</sc>) change in HbA<sub>1c</sub> from baseline to 24 weeks was –6 (1) mmol/mol [–0.57 (0.13)%] (<italic>P</italic> < 0.0001). In patients with baseline HbA<sub>1c</sub> ≥ 53 mmol/mol (7.0%), 32.4% of patients in the linagliptin group and 13.8% in the placebo group achieved HbA<sub>1c</sub> < 53 mmol/mol (7.0%) (odds ratio 2.94; <italic>P</italic> = 0.0033). The placebo‐corrected adjusted mean (<sc>se</sc>) change from baseline in fasting plasma glucose at week 24 was –0.57 (0.26) mmol/l [–10.4 (4.7) mg/dl] (<italic>P</italic> = 0.0280). The incidence of serious adverse events was 2.2% with linagliptin and 3.4% with placebo. Investigator‐defined hypoglycaemia occurred in 5.5% of the linagliptin group and 5.6% of the placebo group. No meaningful changes in mean body weight were noted for either group.</p> </sec> <sec id="dme12495-sec-0004" sec-type="section"> <title>Conclusions</title> <p>Linagliptin as add‐on therapy to metformin and pioglitazone produced significant and clinically meaningful improvements in glycaemic control, without an additional risk of hypoglycaemia or weight gain (Clinical Trials Registry No: NCT 00996658).</p> </sec> </abstract>