CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,136 enrolled
Drug / intervention
Saxagliptin 5 mg +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/NCT02273050
NCT02273050Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control

AstraZeneca·interventional·Posted Oct 23, 2014·Updated Feb 5, 2018

In Brief

A Phase 3 clinical trial evaluating Saxagliptin 5 mg, Placebo 5 mg for Saxagliptin, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 1,136 participants across 17 sites.

Detailed Summary

A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination with Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects with Type 2 Diabetes who have Inadequate Glycaemic Control

Study Details

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

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 23, 2014
Enrollment StartDec 1, 2014
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 11.7 years ago

Interventions

Saxagliptin 5 mgdrug

Tablet, Oral, 5 mg, Once daily in the morning

Placebo 5 mg for Saxagliptindrug

Tablet, Oral, 5 mg, Once daily in the morning

Placebo 500 mg for metformin (with titration)drug

Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration.

Metformin 500 mg with titrationdrug

Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration.