CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 315 enrolled
Drug / intervention
Saxagliptin +3 moredrug
Likely dose
Saxagliptin 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/NCT01619059
NCT01619059Phase 3Completed

A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Triple Therapy With Saxagliptin Added to Dapagliflozin in Combination With Metformin Compared to Therapy With Placebo Added to Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin and Dapagliflozin

AstraZeneca·interventional·Posted Jun 14, 2012·Updated Apr 22, 2016

In Brief

A Phase 3 clinical trial evaluating Saxagliptin, Dapagliflozin, and 2 other interventions for Type 2 Diabetes. Completed, enrolled 315 participants across 83 sites in 9 countries.

Detailed Summary

The purpose of this study is to learn if BMS-477118 (Saxagliptin) as part of a triple combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of this treatment will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesCanada, Czechia, Hungary, Mexico, Poland, Puerto Rico, Romania, Russia, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 14, 2012
Enrollment StartJun 1, 2012
Primary CompletionJun 1, 2014
Study CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 14.0 years ago

Interventions

Saxagliptindrug

Tablets, Oral, 5 mg, Once daily, Up to 52 weeks

Dapagliflozindrug

Tablets, Oral, 10 mg, Once daily, Up to 52 weeks

Metformin IRdrug

Tablets, Oral, ≥ 1500mg, Twice daily, Up to 52 weeks

Placebo matching with Saxagliptindrug

Tablets, Oral, 0 mg, Once daily, Up to 52 weeks