Sitagliptin and Pioglitazone Mechanism of Action Study in Type 2 Diabetes Mellitus (0431-061)

Phase 1 Completed 211 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

A clinical study to determine the safety, efficacy and mechanism of action of sitagliptin alone and in combination with pioglitazone, in patients with type 2 diabetes mellitus who have inadequate glycemic (blood sugar) control.

Timeline

Start: 2007-07-11
Primary completion: 2009-02-24
Completion: 2009-02-24

Outcome

Met primary endpoint

registry analysis (superiority or other test); Sitagliptin 100 mg vs Placebo; p = 0.002; Mean Difference (Net) -29.7 (95% CI -48.7 to -10.6); ANCOVA NCT00511108 ↗

registry analysis (superiority or other test); Sitagliptin 100 mg vs Placebo; p <0.001; Geometric Mean Difference 73.8 (95% CI 44.2 to 104.4); ANCOVA NCT00511108 ↗

Publications

Results Alba M, Ahren B, Inzucchi SE, Guan Y, Mallick M, Xu L, O'Neill EA, Williams-Herman DE, Kaufman KD, Goldstein BJ. Sitagliptin and pioglitazone provide complementary effects on postprandial glucose and pancreatic islet cell function. Diabetes Obes Metab. 2013 Dec;15(12):1101-10. doi: 10.1111/dom.12145. Epub 2013 Jul 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pioglitazone	Small molecule	30 mg	Oral
Subject	Sitagliptin	Small molecule	100 mg	Oral