The efficacy and safety of teneligliptin added to ongoing metformin monotherapy in patients with type 2 diabetes: a randomized study with open label extension

ABSTRACT

Objective: The study investigated the efficacy and tolerability of teneligliptin co-administered to patients with type 2 diabetes mellitus (T2DM) who were inadequately controlled by stable metformin monotherapy ≥ 1000 mg/day.

Methods: A total of 447 patients from 55 European centers who completed a 14-day screening and 14-day run-in phase, received randomized double-blind treatment with 5, 10, 20 or 40 mg teneligliptin or placebo once daily, for 24 weeks. 364 patients continued treatment in a 28-week open label extension during which they received teneligliptin 20 mg once daily.

Results: Co-administration of teneligliptin (5 to 40 mg) with metformin demonstrated dose-related and statistically significant reductions in HbA_1c after 24 weeks (-0.30 to -0.63% placebo adjusted) of double-blind treatment. The greatest reduction in HbA_1c was seen with teneligliptin at 40 mg (-0.63%) at Week 24. There was also a dose-dependent increase in proportion of responders achieving HbA_1c < 7.0% at this endpoint. Responses were maintained throughout 28 weeks open label treatment with 20 mg teneligliptin. Treatment was well tolerated to Week 52 and the overall incidence of hypoglycemia during 52 weeks was 2.3%.

Conclusions: Teneligliptin co-administered with metformin produced significant reductions in HbA_1c in patients with T2DM without increasing the risk of hypoglycemia.

KEYWORDS:

• Co-administration
• diabetes mellitus
• metformin
• teneligliptin
• type 2

Acknowledgement

The authors wish to thank all of the investigators and institutions involved in the study, a list of which is provided in the Appendix.

Declaration of interests

Funding for this study was provided by Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan. A. Bryson and M. Lawson are employees of Mitsubishi Tanabe Pharma Europe Ltd. which is an affiliate of Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.