Efficacy and safety of initial combination therapy with alogliptin plus metformin versus either as monotherapy in drug‐naïve patients with type 2 diabetes: a randomized, double‐blind, 6‐month study1. Issue 7 (12th February 2014)

• Record Type: Journal Article
• Authors: Pratley, R. E.; Fleck, P.; Wilson, C.
• Is Part Of: Diabetes, obesity & metabolism. Volume 16:Issue 7(2014:Jul.)
• Page Start: 613
• Page End: 621
• Publication Date: 2014-02-12
• Subjects: Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.12258
• Languages: English
• ISSNs: 1462-8902

Abstract

<abstract abstract-type="main" id="dom12258-abs-0001"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="dom12258-sec-0002" sec-type="section"> <title>Aim</title> <p id="dom12258-para-0002">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‐naïve T2DM patients.</p> </sec> <sec id="dom12258-sec-0003" sec-type="section"> <title>Methods</title> <p id="dom12258-para-0003">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.</p> </sec> <sec id="dom12258-sec-0006" sec-type="section"> <title>Results</title> <p id="dom12258-para-0006">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).</p> </sec> <sec id="dom12258-sec-0007" sec-type="section"> <title>Conclusions</title> <p id="dom12258-para-0007">Alogliptin plus metformin initial combination therapy was well tolerated yet more efficacious in controlling glycaemia in drug‐naïve T2DM patients than either as monotherapy.</p> </sec> </abstract>