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



Status:Completed
Conditions:Endocrine, Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 127
Updated:6/20/2018
Start Date:July 14, 2015
End Date:May 18, 2018

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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

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)


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
We found this trial at
39
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Greensboro, North Carolina 27401
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El Centro, CA
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Greenville, South Carolina 29605
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Morehead City, North Carolina 28557
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New Port Richey, FL
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North Hollywood, California 91606
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Springfield Gardens, New York 11413
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Sugar Land, TX
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