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

• Status: Completed
• Trial end date: 2009-02-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Pioglitazone; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• Patient has type 2 diabetes mellitus

• Male

• Female that is highly unlikely to become pregnant

• Patient is not on an antihyperglycemic agent (AHA) (hemoglobin A1c [A1C] 7-10%) or on oral single AHA or low-dose combination therapy (A1C 6.5-9.0%)

Exclusion Criteria:

• Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis

• Patient has required insulin therapy within the past 12 weeks

• Patient is on or has been taking a Peroxisome Proliferator-Activated Receptor-gamma (PPAR -gamma) agent (i.e. Thiazolidinediones [TZDs]) within the prior 12 weeks of the screening visit.