At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
In Brief
A Phase 3 clinical trial evaluating Saxagliptin, Placebo, and 1 other intervention for Diabetes. Completed, enrolled 365 participants across 74 sites in 4 countries.
Detailed Summary
The purpose of this trial is to understand if saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise
Study Details
Timeline
Interventions
Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT)
Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT)
Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT)
Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT)
Coated tablets, Oral, 0mg, Daily (6 months ST, 12 months LT)
Tablets, Oral, 500-2000 mg, as needed (12 months LT)