CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 939 enrolled
Drug / intervention
Dapagliflozin +5 moredrug
Likely dose
Dapagliflozin 10 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/NCT02471404
NCT02471404Phase 4Completed
CompareCT.gov

A 52-Week, Multi-Centre, Randomised, Parallel-Group, Double-Blind, Active Controlled, Phase IV Study to Evaluate the Safety and Efficacy of Dapagliflozin or Dapagliflozin Plus Saxagliptin Compared With Sulphonylurea All Given as Add-on Therapy to Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Monotherapy

AstraZeneca·interventional·Posted Jun 15, 2015·Updated Mar 26, 2019

In Brief

A Phase 4 clinical trial evaluating Dapagliflozin, Saxagliptin, and 4 other interventions for Type 2 Diabetes Mellitus and Inadequate Glycaemic Control. Completed, enrolled 939 participants across 173 sites in 5 countries.

Detailed Summary

This study is being carried out to see if dapagliflozin and dapagliflozin plus saxagliptin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glimepiride (sulphonylurea) as an addition to metformin treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus, Inadequate Glycaemic Control
CountriesCzechia, Germany, Hungary, Poland, Slovakia
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 15, 2015
Enrollment StartSep 21, 2015
Primary CompletionMar 13, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.0 years ago

Interventions

Dapagliflozindrug

10 mg, orally Green, plain, diamond-shaped, film-coated tablet

Saxagliptindrug

5 mg, orally Plain, yellow, biconvex, round, film-coated tablet

Glimepiridedrug

1, 2, or 4 mg, orally Opaque gray capsule

Placebo for dapagliflozindrug

Does not contain active ingredient, orally Green, plain, diamond-shaped, film-coated tablet

Placebo for saxagliptindrug

Does not contain active ingredient, orally Plain, yellow, biconvex, round, film-coated tablet

Placebo for glimepiridedrug

Does not contain active ingredient, orally. Opaque gray capsule