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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus, CKD and Albuminuria

In brief

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)

Key facts

Study ID

NCT02547935

Run by

AstraZeneca

People needed

459

Starts

2015-09-21

Expected to finish

2018-05-18

Last updated by the study team

2019-08-21

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Chula Vista, California, United States
• Research Site — Concord, California, United States
• Research Site — El Centro, California, United States
• Research Site — La Mesa, California, United States
• Research Site — Long Beach, California, United States
• Research Site — Los Gatos, California, United States
• Research Site — North Hollywood, California, United States
• Research Site — Riverside, California, United States
• Research Site — San Diego, California, United States
• Research Site — San Dimas, California, United States
• Research Site — Hollywood, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — New Port Richey, Florida, United States
• Research Site — Palm Harbor, Florida, United States
• Research Site — Pompano Beach, Florida, United States
• Research Site — Augusta, Georgia, United States
• Research Site — Meridian, Idaho, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Bangor, Maine, United States
• Research Site — Kansas City, Missouri, United States
• Research Site — Las Vegas, Nevada, United States
• Research Site — Springfield Gardens, New York, United States
• Research Site — The Bronx, New York, United States
• Research Site — Greensboro, North Carolina, United States
• Research Site — Peoria, Arizona, United States

Full record on ClinicalTrials.gov

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