A Study to Evaluate the Effect of Dapagliflozin on Blood Glucose Level and Renal Safety in Patients With Type 2 Diabetes

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

The purpose of this clinical research study is to determine whether dapagliflozin can improve (decrease) blood glucose values in patients with Type 2 diabetes and moderate renal impairment.This study will be conducted at approximately 100 centres from countries across North America and European regions. It is planned to randomize a total of 302 patients.

Key facts

Study ID

NCT02413398

Run by

AstraZeneca

People needed

321

Starts

2015-06-15

Expected to finish

2017-11-07

Last updated by the study team

2018-10-31

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Female or male aged ≥18 years and <75 years.
• History of T2DM for more than 12 months.
• Inadequate glycemic control, defined as HbA1c ≥7.0% and ≤11%
• Stable anti-diabetic treatment regimen
• Renal impairment: CKD 3A

You may not qualify if…

• Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period.
• History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
• Severe uncontrolled hypertension defined as SBP ≥180 mmHg and/or Diastolic Blood Pressure (DBP) ≥110 mmHg
• Any of the following Cardiovascular (CV)/Vascular Diseases within 3 months of prior to signing the consent at visit 1:
• Myocardial infarction, Cardiac surgery or revascularization(CABG/PTCA), Unstable angina, Unstable heart failure (HF), HF New York Heart Association (NYHA) Class IV,Transient ischemic attack (TIA) or significant cerebrovascular disease, Unstable or previously undiagnosed arrhythmia.
• History of any biopsy or imaging verifying intercurrent kidney disease (such as glomerular nephritis or sign of renal artery stenosis) other than diabetic nephropathy or diabetic nephropathy with nephrosclerosis.
• Significant hepatic disease, including, but not limited to, chronic active hepatitis and/or severe hepatic insufficiency.
• Ongoing treatment with any SGLT2-inhibitor, GLP-1 analogue, or rapid/short acting insulins at screening.
• Participation in another clinical study with an Investigational Product (IP) during the last 30 days prior to signing the consent at visit 1.

Where it is running

• Research Site — Burbank, California, United States
• Research Site — Chula Vista, California, United States
• Research Site — Concord, California, United States
• Research Site — Fullerton, California, United States
• Research Site — Huntington Beach, California, United States
• Research Site — Los Gatos, California, United States
• Research Site — Newport Beach, California, United States
• Research Site — Salinas, California, United States
• Research Site — Miami, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Miami Springs, Florida, United States
• Research Site — Pembroke Pines, Florida, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Brownsburg, Indiana, United States
• Research Site — Louisville, Kentucky, United States
• Research Site — Monroe, Louisiana, United States
• Research Site — Flint, Michigan, United States
• Research Site — Jackson, Michigan, United States
• Research Site — Chesterfield, Missouri, United States
• Research Site — Kansas City, Missouri, United States
• Research Site — Chapel Hill, North Carolina, United States
• Research Site — Chattanooga, Tennessee, United States
• Research Site — Houston, Texas, United States
• Research Site — San Antonio, Texas, United States
• Research Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.