At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of type 2 diabetes mellitus
- ✓Not currently taking any antihyperglycemic medication
- ✕History of type 1 diabetes mellitus
- ✕History of diabetic ketoacidosis
- ✕Insulin use within 8 weeks prior to study start
- ✕Active weight loss program (not in maintenance phase)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of MK0431 Monotherapy in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
In Brief
A Phase 3 clinical trial evaluating Sitagliptin (MK0431), Sitagliptin, and 2 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 741 participants.
Detailed Summary
The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.
Study Details
Timeline
Interventions
Phase A: Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.
Phase A: Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.
Phase A: Placebo matching Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.
Phase A: Placebo matching Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.
Phase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication.