CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 459 enrolled
Drug / intervention
Dapagliflozin 10 mg +2 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/NCT02547935
NCT02547935Phase 3Completed
CompareCT.gov

An Exploratory Phase II/III, Randomized, Double-blind, Placebo Controlled, Parallel Design Study to Evaluate the Efficacy, Safety and Pharmacodynamics of Dapagliflozin and Dapagliflozin in Combination With Saxagliptin in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria Treated With ACEi or ARB

AstraZeneca·interventional·Posted Sep 14, 2015·Updated Aug 21, 2019

In Brief

A Phase 3 clinical trial evaluating Dapagliflozin 10 mg, Saxagliptin 2.5 mg, and 1 other intervention for Type 2 Diabetes Mellitus, CKD and Albuminuria. Completed, enrolled 459 participants across 112 sites in 9 countries.

Detailed Summary

The purpose of this clinical research study is to determine whether dapagliflozin alone or in combination with saxagliptin can decrease albuminuria and improve glycemic control in patients with Type 2 diabetes, albuminuria and renal impairment (CKD). The study is planned to randomize a total of 450 patients (150 patients per treatment arm)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus, CKD and Albuminuria
CountriesAustralia, Canada, Japan, Mexico, South Africa, South Korea, Spain, Taiwan, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 14, 2015
Enrollment StartSep 21, 2015
Primary CompletionMay 18, 2018
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 10.8 years ago

Interventions

Dapagliflozin 10 mgdrug

Tablets administered orally once daily for 24 weeks.

Saxagliptin 2.5 mgdrug

Tablets administered orally once daily for 24 weeks.

Matching Placebo for Dapagliflozin 10 mg and Saxagliptin 2.5mgdrug

Tablets administered orally once daily for 24 weeks.