CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 953 enrolled
Drug / intervention
Saxagliptin 5mg +1 moredrug
Likely dose
Saxagliptin 5mgfrom 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/NCT02104804
NCT02104804Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination With Metformin in Chinese Subjects in China With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Insulin Alone or on Insulin in Combination With Metformin

AstraZeneca·interventional·Posted Apr 4, 2014·Updated Oct 2, 2017

In Brief

A Phase 3 clinical trial evaluating Saxagliptin 5mg and Placebo for Saxagliptin for Type 2 Diabetes Mellitus. Completed, enrolled 953 participants across 11 sites.

Detailed Summary

A Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination with Metformin in Chinese Subjects in China with Type 2 Diabetes Who Have Inadequate Glycaemic Control on Insulin Alone or on Insulin in Combination with Metformin

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 4, 2014
Enrollment StartMay 7, 2014
Primary CompletionFeb 26, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.2 years ago

Interventions

Saxagliptin 5mgdrug

Saxagliptin 5mg (plus stable insulin dose), given orally once daily (24 weeks); subjects stratified by use of stable metformin dose; flexible insulin dose (as needed for rescue).

Placebo for Saxagliptindrug

Placebo tablets (plus stable insulin dose), given orally once daily (24 weeks); subjects stratified by use of stable metformin dose; flexible insulin dose (as needed for rescue).