A study to evaluate the effect of dapagliflozin with and without saxagliptin on albuminuria, and to investigate the effect of dapagliflozin and saxagliptin on HbA1c in patients with type 2 diabetes and CKD
Study identifier:D1690C00023
ClinicalTrials.gov identifier:NCT02547935
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Type 2 diabetes mellitus, CKD and albuminuria
Phase
Phase 2/3
Healthy volunteers
No
Study drug
Dapagliflozin 10 mg, Saxagliptin 2.5 mg, Matching Placebo for Dapagliflozin 10 mg and Saxagliptin 2.5mg
Sex
All
Actual Enrollment
459
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 21 Sept 2015
Primary Completion Date: 18 May 2018
Study Completion Date: 18 May 2018
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Jul 2019 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Dapagliflozin 10mg Tablets administered orally once daily for 24 weeks | Drug: Dapagliflozin 10 mg Tablets administered orally once daily for 24 weeks. Other Name: Forxiga™ |
| Experimental: Dapagliflozin 10mg + Saxagliptin 2.5mg Tablets administered orally once daily for 24 weeks | Drug: Saxagliptin 2.5 mg Tablets administered orally once daily for 24 weeks. Other Name: Onglyza™ |
| Placebo Comparator: Placebo Tablets administered orally once daily for 24 weeks | Drug: Matching Placebo for Dapagliflozin 10 mg and Saxagliptin 2.5mg Tablets administered orally once daily for 24 weeks. |
