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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02547935
• Date of registration: 31/08/2015
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: 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
• Scientific 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
• Date of first enrolment: September 21, 2015
• Target sample size: 459
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02547935
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2/Phase 3

Countries of recruitment

Australia, Canada, Japan, Korea, Republic of, Mexico, South Africa, Spain, Taiwan, United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Provision of informed consent prior to any study specific procedures

- Female or male aged =18 years

- History of type 2 diabetes mellitus for more than 12 months

- HbA1c=7.0% and =11.0%

- Stable antidiabetic treatment during the last 12 weeks up to randomization

- eGFR 25-75 mL/minute/1.73m2, inclusive

- Micro or macroalbuminuria (UACR 30 - 3500 mg/g)

- Treatment with ACE inhibitor or an ARB for at least 3 months prior to screening

- Body mass index between 20 and 45 kg/m2

Exclusion Criteria:

- Any of the following CV/Vascular Diseases within 3 month prior to signing the consent
at Visit 1:

- Myocardial infarction

- cardiac surgery or revascularization (CABG/PTCA)

- unstable angina

- unstable HF

- New York Heart Association (NYHA) Class III-IV

- transient ischemic attack (TIA) or significant cerebrovascular disease

- unstable or previously undiagnosed arrhythmia

- Significant hepatic disease, including, but not limited to, chronic active hepatitis
and/or severe hepatic insufficiency

- Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) > 3X ULN

- Total Bilirubin (TB) >2 mg/dL (34.2 µmol/L)

- History of acute kidney injury requiring renal replacement therapy (dialysis or
ultrafiltration) or any biopsy or imaging verifying intercurrent kidney disease other
than diabetic nephropathy or diabetic nephropathy with nephrosclerosis

- Ongoing treatment with a SGLT2 inhibitor, GLP-1 agonist or DPP4 inhibitors

- Any condition which, in the judgment of the Investigator, may render the patient
unable to complete the study or which may pose a significant risk to the patient or
patient suspected or with confirmed poor protocol or medication compliance



Age minimum: 18 Years
Age maximum: 130 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus, CKD and Albuminuria

Intervention(s)

Drug: Saxagliptin 2.5 mg

Drug: Dapagliflozin 10 mg

Drug: Matching Placebo for Dapagliflozin 10 mg and Saxagliptin 2.5mg

Primary Outcome(s)

Adjusted Mean Change From Baseline in Glycosylated Haemoglobin (HbA1c): Comparison of Dapagliflozin 10 mg Plus Saxagliptin 2.5 mg and Placebo at Week 24 [Time Frame: Baseline and Week 24]

Adjusted Mean Percent Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Week 24 [Time Frame: Baseline and Week 24]

Secondary Outcome(s)

Adjusted Mean Change From Baseline in HbA1c: Comparison of Dapagliflozin 10 mg and Placebo at Week 24 [Time Frame: Baseline and Week 24]

Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24 [Time Frame: Baseline and Week 24]

Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24 [Time Frame: Baseline and Week 24]

Percentage of Patients Achieving a Reduction in HbA1c of Less Than 7.0% at Week 24 [Time Frame: From baseline to Week 24]

Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [Time Frame: Baseline and Week 24]

Percentage of Patients Achieving at Least 30% Reduction in UACR at Week 24 [Time Frame: From baseline up to Week 24]

Secondary ID(s)

D1690C00023

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/06/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02547935