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

• Status: Completed
• Trial end date: 2017-11-07
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Dapagliflozin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.