Efficacy and safety of initial combination therapy with alogliptin plus metformin versus either as monotherapy in drug-naive patients with type 2 diabetes: a randomized, double-blind, 6-month study Article

Industry Collaboration

cited authors

  • Pratley, R. E., Fleck, P., Wilson, C.

funding text

  • The study was sponsored by Takeda Development Center Americas, Inc., Deerfield, IL, USA, and Takeda Development Centre Europe Ltd., London, UK. The authors wish to thank the patients and investigators at all of the sites worldwide for their participation in tins study. This study is registered with clinicaltrials.gov (NCT 01023581).

abstract

  • Aim: To evaluate the efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin plus metformin (A+M) initial combination therapy versus either as monotherapy in drug-naive T2DM patients. Methods: This international, randomized, double-blind, placebo-controlled, 26-week study involved T2DM patients with hyperglycaemia (HbA1c 7.5-10.0%) following diet/exercise therapy. Patients (N=784) received placebo, alogliptin (A, 12.5 mg BID or 25 mg QD), metformin (M, 500 or 1000 mg BID) or A+M (12.5/500 or 12.5/1000 mg BID); placebo, A25 for secondary analyses only. Endpoints: week 26 changes from baseline in HbA1c (primary), fasting plasma glucose (FPG) and 2-h postprandial glucose (PPG); incidences of clinical response and hyperglycaemic rescue. Results: Week 26 mean HbA1c reductions from baseline (8.45%) were -1.22 and -1.55% with A+M 12.5/500 and 12.5/1000 versus -0.56, -0.65, and -1.11% with A12.5, M500 and M1000 (p<0.001, A+M vs. component monotherapies). FPG reductions were -1.76 and -2.55 mmol/L with 12.5/500 and 12.5/1000 versus -0.54, -0.64 and -1.78 mmol/L with A12.5, M500 and M1000 (p<0.05, A+M vs. component monotherapies). Significantly more A+M-treated patients achieved HbA1c<7% (47.1-59.5% vs. 20.2-34.3% with monotherapy), significantly fewer required hyperglycaemic rescue (2.6-12.3% vs. 10.8-22.9% with monotherapy). A+M caused only mild/moderate hypoglycaemia (1.9-5.3%) and weight loss (0.6-1.2 kg). Conclusions: Alogliptin plus metformin initial combination therapy was well tolerated yet more efficacious in controlling glycaemia in drug-naive T2DM patients than either as monotherapy.

authors

Publication Date

  • July 1, 2014

webpage

published in

category

start page

  • 613

end page

  • 621

volume

  • 16

issue

  • 7

WoS Citations

  • 36

WoS References

  • 23