Clinical Trial: 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 Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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).

Detailed Summary:
Sponsor: AstraZeneca

Current Primary Outcome:

  • Change in HbA1c (dapagliflozin 10 mg + saxagliptin 2.5 mg) [ Time Frame: From baseline up to 24 weeks of treatment ]
    To compare the mean change from baseline to week 24 in HbA1c between dapagliflozin 10 mg plus saxagliptin 2.5 mg and placebo
  • Percent change in Urine albumin to creatinine ratio (UACR) (dapagliflozin 10 mg + saxagliptin 2.5 mg) [ Time Frame: From baseline up to 24 weeks of treatment ]
    To compare the mean persent change from baseline to week 24 in Urine albumin to creatinine ratio (UACR) between dapagliflozin 10 mg plus saxagliptin 2.5 mg and placebo.
  • Percent change in Urine albumin to creatinine ratio (UACR) (dapagliflozin 10 mg) [ Time Frame: From baseline up to 24 weeks of treatment ]
    To compare the mean percent change from baseline to week 24 in Urine albumin to creatinine ratio (UACR)between dapagliflozin 10 mg and placebo


Original Primary Outcome:

  • Change from baseline in HbA1c at Week 24 (dapagliflozin 10 mg + saxagliptin 2.5 mg) [ Time Frame: 24 weeks of treatment ]
    To compare the mean change from baseline to week 24 in HbA1c between dapagliflozin 10 mg plus saxagliptin 2.5 mg and placebo
  • Percent change from baseline in Urine albumin to creatinine ratio (UACR) at Week 24 (dapagliflozin 10 mg + saxagliptin 2.5 mg) [ Time Frame: 24 weeks of treatment ]
    To compare the mean persent change from baseline to week 24 in Urine albumin to creatinine ratio (UACR) between dapagliflozin 10 mg plus saxagliptin 2.5 mg and placebo.
  • Percent change from baseline in Urine albumin to creatinine ratio (UACR) at Week 24 (dapagliflozin 10 mg) [ Time Frame: 24 weeks of treatment ]
    To compare the mean percent change from baseline to week 24 in Urine albumin to creatinine ratio (UACR)between dapagliflozin 10 mg and placebo


Current Secondary Outcome:

  • Percent change in total body weight [ Time Frame: From baseline up to 24 weeks of treatment ]
    To compare the mean percent change from baseline in total body weight between dapagliflozin 10 mg with and, separately, without saxagliptin 2.5 mg and placebo.
  • Change in FPG [ Time Frame: From baseline up to 24 weeks of treatment ]
    To compare the mean change from baseline in fasting plasma glucose (FPG) between dapagliflozin 10 mg with and, separately, without saxagliptin 2.5 mg and placebo.
  • Proportion of patients that achieve 30% reduction in UACR [ Time Frame: From baseline up to 24 weeks of treatment ]
    To compare the proportion of patients achieving a 30% reduction in UACR between dapagliflozin 10 mg with and, separately, without saxagliptin 2.5 mg and placebo
  • Proportion of patients which achieve HbA1c<7% [ Time Frame: From baseline up to 24 weeks of treatment ]
    To compare the proportion of patients achieving a reduction in HbA1c <7.0% between dapagliflozin 10 mg with and, separately, without saxagliptin 2.5 mg and placebo
  • Change in seated SBP [ Time Frame: From baseline up to 24 weeks of treatment ]
    To compare the mean change from baseline in seated systolic blood pressure (SBP) between dapagliflozin 10 mg with and, separately, without saxagliptin 2.5 mg and placebo
  • Change in HbA1c [ Time Frame: From baseline up to 24 weeks of treatment ]
    To compare the mean change from baseline in HbA1c between dapagliflozin 10 mg and placebo


Original Secondary Outcome:

  • Percent change from baseline in total body weight at Week 24 [ Time Frame: 24 weeks of treatment ]
    To compare the mean percent change from baseline in total body weight between dapagliflozin 10 mg with and, separately, without saxagliptin 2.5 mg and placebo.
  • Change from baseline in FPG at Week 24 [ Time Frame: 24 weeks of treatment ]
    To compare the mean change from baseline in fasting plasma glucose (FPG) between dapagliflozin 10 mg with and, separately, without saxagliptin 2.5 mg and placebo.
  • Proportion of patients that achieve 30% reduction in UACR [ Time Frame: 24 weeks of treatment ]
    To compare the proportion of patients achieving a 30% reduction in UACR between dapagliflozin 10 mg with and, separately, without saxagliptin 2.5 mg and placebo
  • Proportion of patients which achieve HbA1c<7% [ Time Frame: 24 weeks of treatment ]
    To compare the proportion of patients achieving a reduction in HbA1c <7.0% between dapagliflozin 10 mg with and, separately, without saxagliptin 2.5 mg and placebo
  • Change from baseline in seated SBP at Week 24 [ Time Frame: 24 weeks of treatment ]
    To compare the mean change from baseline in seated systolic blood pressure (SBP) between dapagliflozin 10 mg with and, separately, without saxagliptin 2.5 mg and placebo
  • Change from baseline in HbA1c at Week 24 [ Time Frame: 24 weeks of treatment ]
    To compare the mean change from baseline in HbA1c between dapagliflozin 10 mg and placebo


Information By: AstraZeneca

Dates:
Date Received: August 31, 2015
Date Started: September 21, 2015
Date Completion: May 18, 2018
Last Updated: May 8, 2017
Last Verified: May 2017