At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial in China to Study the Safety and Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sulfonylurea Therapy, Alone or in Combination With Metformin
In Brief
A Phase 3 clinical trial evaluating Sitagliptin, Placebo, and 3 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 498 participants.
Detailed Summary
A study to compare safety and efficacy of sitagliptin and placebo therapy when added to stable sulfonylurea alone or in combination with metformin in participants with type 2 diabetes mellitus (T2DM). The primary hypothesis of this study is that after 24 weeks, the addition of sitagliptin compared with placebo provides greater reduction in hemoglobin A1C (HbA1C) in T2DM participants on sulfonylurea alone or in combination with metformin.
Study Details
Timeline
Interventions
Sitagliptin 100 mg oral tablet once daily for 24 weeks
Matching placebo to sitagliptin oral tablet once daily for 24 weeks
Participants will continue ongoing open-label therapy with gliclazide (dosed according to the China drug label) throughout the study.
Participants will continue ongoing open-label therapy with glimepiride (dosed according to the China drug label) throughout the study.
Participants will continue ongoing open-label therapy with metformin (at least 1500 mg daily) throughout the study.