Sitagliptin Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control on metformin therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Patient has type 2 diabetes mellitus

• Males

• Females who are highly unlikely to become pregnant

• Patients poorly controlled while taking one or two oral antidiabetic medications

Exclusion Criteria:

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

• Patient required insulin therapy within the prior 8 weeks

• Patient is on or has been taking Thiazolidinediones (TZDs) such as Actos® (pioglitazone) or Avandia® (rosiglitazone) or is on or has been taking Byetta® (exenatide) within the prior 12 weeks of the screening visit