A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase III Study to Evaluate the Glycemic Efficacy and Renal Safety of Dapagliflozin in Patients With Type 2 Diabetes Mellitus and Moderate Renal Impairment (CKD 3A) Who Have Inadequate Glycemic Control.
Overview
- Phase
- Phase 3
- Intervention
- Dapagliflozin 10 mg
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- AstraZeneca
- Enrollment
- 321
- Locations
- 1
- Primary Endpoint
- Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Eligibility 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.
Arms & Interventions
Dapagliflozin
10 mg Tablets, Oral, Once daily, 24 weeks
Intervention: Dapagliflozin 10 mg
Placebo
Matching placebo to Dapagliflozin 10 mg tablet. Oral, Once daily, 24 weeks
Intervention: Matching Placebo for Dapagliflozin
Outcomes
Primary Outcomes
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
Time Frame: Baseline, Week 24
To compare the mean change from baseline in HbA1c between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m\^2). The "number analyzed" (142 dapaglifozin, 134 placebo) represents the number with change from baseline available at Week 24.
Secondary Outcomes
- Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24.(Baseline, Week 24)
- Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24.(Baseline, Week 24)
- Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24.(Baseline, Week 24)