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Initial combination therapy with alogliptin and pioglitazone in drug-naive patients with type 2 diabetes.

ABSTRACT:

Objective

To assess the efficacy and tolerability of alogliptin plus pioglitazone for initial combination therapy in drug-naïve type 2 diabetic patients.

Research design and methods

This 26-week, double-blind, parallel-group study randomized 655 patients with inadequately controlled type 2 diabetes to four arms: 25 mg alogliptin (A25) q.d. monotherapy, 30 mg pioglitazone (P30) q.d. monotherapy, or 12.5 (A12.5) or 25 mg alogliptin q.d. plus pioglitazone (P30) q.d. combination therapy. Primary efficacy was A1C change from baseline with the high-dose combination (A25+P30) versus each monotherapy.

Results

Combination therapy with A25+P30 resulted in greater reductions in A1C (-1.7±0.1% from an 8.8% mean baseline) vs. A25 (-1.0±0.1%, P<0.001) or P30 (-1.2±0.1%, P<0.001) and in fasting plasma glucose (-2.8±0.2 mmol/l) vs. A25 (-1.4±0.2 mmol/l, P<0.001) or P30 (-2.1±0.2 mmol/l, P=0.006). The A25+P30 safety profile was consistent with those of its component monotherapies.

Conclusions

Alogliptin plus pioglitazone combination treatment appears to be an efficacious initial therapeutic option for type 2 diabetes.

SUBMITTER: Rosenstock J

PROVIDER: S-EPMC2963503 | biostudies-literature | 2010 Nov

REPOSITORIES: biostudies-literature

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Publications

Initial combination therapy with alogliptin and pioglitazone in drug-naïve patients with type 2 diabetes.

Rosenstock Julio J Inzucchi Silvio E SE Seufert Jochen J Fleck Penny R PR Wilson Craig A CA Mekki Qais Q

Diabetes care 20100819 11

<h4>Objective</h4>To assess the efficacy and tolerability of alogliptin plus pioglitazone for initial combination therapy in drug-naïve type 2 diabetic patients.<h4>Research design and methods</h4>This 26-week, double-blind, parallel-group study randomized 655 patients with inadequately controlled type 2 diabetes to four arms: 25 mg alogliptin (A25) q.d. monotherapy, 30 mg pioglitazone (P30) q.d. monotherapy, or 12.5 (A12.5) or 25 mg alogliptin q.d. plus pioglitazone (P30) q.d. combination thera ...[more]

PMID: 20724648

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