CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 444 enrolled
Drug / intervention
Saxagliptin +3 moredrug
Likely dose
Not stated in 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/NCT02419612
NCT02419612Phase 3Completed

A 52-week International, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase 3bTrial With a Blinded 104-week Long -Term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin ≥1500 mg in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

AstraZeneca·interventional·Posted Apr 17, 2015·Updated Jun 23, 2020

In Brief

A Phase 3 clinical trial evaluating Saxagliptin, Dapagliflozin, and 2 other interventions for Diabetes. Completed, enrolled 444 participants across 84 sites in 10 countries.

Detailed Summary

This clincial trial is evaluating if the co-administration of saxagliptin and dapagliflozin, in addition to metformin, results in better glycemic control, as measured by HbA1c, over a treatment period of 52 weeks, compared to the addition of glimepiride to metformin in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on Metformin Alone. We will compare the change from baseline in HbA1c achieved with saxagliptin, in co-administration with dapagliflozin, added to current background therapy with metformin compared to glimepiride added to current background therapy with metformin ≥1500 mg at Week 52.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes
CountriesCzechia, Germany, Hungary, Mexico, Poland, Romania, Russia, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 17, 2015
Enrollment StartAug 14, 2015
Primary CompletionAug 29, 2017
Study CompletionSep 18, 2019
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 11.2 years ago

Interventions

Saxagliptindrug

Dapagliflozindrug

Glimepiridedrug

Placeboother