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

Use our guide to learn which trials are right for you!

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
sites
?
mi
from
Pompano Beach, FL
Click here to add this to my saved trials
?
mi
from
Augusta, GA
Click here to add this to my saved trials
?
mi
from
Bangor, ME
Click here to add this to my saved trials
?
mi
from
Box Hill,
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
?
mi
from
Brownsville, TX
Click here to add this to my saved trials
?
mi
from
Burke, VA
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
?
mi
from
Concord, CA
Click here to add this to my saved trials
?
mi
from
Cypress, TX
Click here to add this to my saved trials
?
mi
from
El Centro, CA
Click here to add this to my saved trials
Greensboro, North Carolina 27401
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Greenville, South Carolina 29605
?
mi
from
Greenville, SC
Click here to add this to my saved trials
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
?
mi
from
La Mesa, CA
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
?
mi
from
Los Gatos, CA
Click here to add this to my saved trials
?
mi
from
Meridian, ID
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Morehead City, North Carolina 28557
?
mi
from
Morehead City, NC
Click here to add this to my saved trials
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
North Hollywood, California 91606
?
mi
from
North Hollywood, CA
Click here to add this to my saved trials
?
mi
from
Palm Harbor, FL
Click here to add this to my saved trials
?
mi
from
Peoria, AZ
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Richmond, VA
Click here to add this to my saved trials
?
mi
from
Riverside, CA
Click here to add this to my saved trials
?
mi
from
Rocky Mount, NC
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
San Dimas, CA
Click here to add this to my saved trials
Springfield Gardens, New York 11413
?
mi
from
Springfield Gardens, NY
Click here to add this to my saved trials
?
mi
from
Sugar Land, TX
Click here to add this to my saved trials