CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 565 enrolled
Drug / intervention
Saxagliptin +5 moredrug
Likely dose
Saxagliptin 2.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00295633
NCT00295633Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase III Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS477118) in Combination With Thiazolidinedione Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Thiazolidinedione Therapy Alone

AstraZeneca·interventional·Posted Feb 24, 2006·Updated Apr 7, 2015

In Brief

A Phase 3 clinical trial evaluating Saxagliptin, Placebo, and 3 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 565 participants across 133 sites in 8 countries.

Detailed Summary

The purpose of this clinical research study is to learn whether Saxagliptin added to thiazolidinedione (TZD) therapy is more effective than TZD alone as a treatment for Type 2 diabetic subjects who are not sufficiently controlled with TZD alone

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesArgentina, Canada, India, Mexico, Peru, Philippines, Puerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 24, 2006
Enrollment StartMar 1, 2006
Primary CompletionOct 1, 2007
Study CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 20.4 years ago

Interventions

Saxagliptindrug

Tablets, Oral, 2.5 mg, Once daily (6 months ST, 12 months LT)

Saxagliptindrug

Tablets, Oral, 5 mg, once daily (6 months ST, 12 months LT)

Placebodrug

Tablets, Oral, 0 mg, Once daily (6 months ST, 12 months LT)

pioglitazonedrug

Tablets, Oral, 30 mg or 45 mg, once daily (6 months ST, 12 months LT)

rosiglitazonedrug

Tablets, Oral, 4 mg, once daily or 8 mg, either as once or twice daily (6 months ST, 12 months LT)

metformindrug

Tablets, Oral, 500-2500 mg, as needed (12 months LT)