Premium
Efficacy and safety of linagliptin as add‐on therapy to basal insulin and metformin in people with Type 2 diabetes
Author(s) -
DuránGarcia S.,
Lee J.,
YkiJärvinen H.,
Rosenstock J.,
Hehnke U.,
Thiemann S.,
Patel S.,
Woerle H.J.
Publication year - 2016
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.13041
Subject(s) - linagliptin , metformin , medicine , placebo , insulin , basal (medicine) , type 2 diabetes , diabetes mellitus , pioglitazone , clinical endpoint , adverse effect , endocrinology , pharmacology , randomized controlled trial , alternative medicine , pathology
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 HbA 1c 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 HbA 1c 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.