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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
Author(s) -
Bajaj M.,
Gilman R.,
Patel S.,
KempthorneRawson J.,
LewisD'Agostino D.,
Woerle H.J.
Publication year - 2014
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1111/dme.12495
Subject(s) - linagliptin , medicine , metformin , pioglitazone , placebo , type 2 diabetes , clinical endpoint , diabetes mellitus , gastroenterology , randomized controlled trial , endocrinology , alternative medicine , pathology
Aims 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. Methods This was a multi‐centre, phase 3, randomized, double‐blind, placebo‐controlled study comparing linagliptin 5 mg once daily ( n = 183) and placebo ( n = 89) as add‐on to metformin and pioglitazone. The primary endpoint was the change from baseline in glycated haemoglobin (HbA 1c ) after 24 weeks. Results The placebo‐corrected adjusted mean ( se ) change in HbA 1c from baseline to 24 weeks was –6 (1) mmol/mol [–0.57 (0.13)%] ( P < 0.0001). In patients with baseline HbA 1c ≥ 53 mmol/mol (7.0%), 32.4% of patients in the linagliptin group and 13.8% in the placebo group achieved HbA 1c < 53 mmol/mol (7.0%) (odds ratio 2.94; P = 0.0033). The placebo‐corrected adjusted mean ( se ) change from baseline in fasting plasma glucose at week 24 was –0.57 (0.26) mmol/l [–10.4 (4.7) mg/dl] ( P = 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. Conclusions 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).