CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 321 enrolled
Drug / intervention
Dapagliflozin 10 mg +1 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/NCT02413398
NCT02413398Phase 3Completed
CompareCT.gov

A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase III Study to Evaluate the Glycemic Efficacy and Renal Safety of Dapagliflozin in Patients With Type 2 Diabetes Mellitus and Moderate Renal Impairment (CKD 3A) Who Have Inadequate Glycemic Control.

AstraZeneca·interventional·Posted Apr 9, 2015·Updated Oct 31, 2018

In Brief

A Phase 3 clinical trial evaluating Dapagliflozin 10 mg and Matching Placebo for Dapagliflozin for Type 2 Diabetes Mellitus. Completed, enrolled 321 participants across 87 sites in 8 countries.

Detailed Summary

The purpose of this clinical research study is to determine whether dapagliflozin can improve (decrease) blood glucose values in patients with Type 2 diabetes and moderate renal impairment.This study will be conducted at approximately 100 centres from countries across North America and European regions. It is planned to randomize a total of 302 patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesBulgaria, Canada, Czechia, Italy, Poland, Spain, Sweden, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 9, 2015
Enrollment StartJun 15, 2015
Primary CompletionNov 7, 2017
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 11.2 years ago

Interventions

Dapagliflozin 10 mgdrug

Tablets administered orally once daily for 24 weeks. Randomization will be stratified by pre-enrolment anti-hyperglycemic therapy

Matching Placebo for Dapagliflozindrug

Matching Placebo for Dapagliflozin tablets administered orally once daily for 24 weeks