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

Type 2 Diabetes Mellitus, CKD and Albuminuria Clinical Trial

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

Status Completed

Clinical Trial 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)

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Albuminuria
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus, CKD and Albuminuria

• NCT number: NCT02547935
• Study type: Interventional
• Source: AstraZeneca
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 21, 2015
• Completion date: May 18, 2018