A study to evaluate the effect of dapagliflozin on blood glucose level and renal safety in patients with Type 2 Diabetes
- Conditions
- Type 2 Diabetes Mellitus with Moderate Renal Impairment (CKD 3A)Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2015-000804-24-SE
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 302
1. Female or male aged =18 years and <75 years.
2. History of T2DM for more than 12 months.
3. Inadequate glycemic control, defined as HbA1c =7.0% and =11%.
4. Stable anti-diabetic treatment regimen.
5. Renal impairment: CKD 3A.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 151
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 151
1. Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period.
2. History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
3. Severe uncontrolled hypertension defined as SBP =180 mmHg and/or Diastolic Blood Pressure (DBP) =110 mmHg.
4. 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.
5. 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.
6. Significant hepatic disease, including, but not limited to, chronic active hepatitis and/or severe hepatic insufficiency.
7. Ongoing treatment with any SGLT2-inhibitor or GLP-1 analogue at screening.
8. Participation in another clinical study with an Investigational Product (IP) during the last 30 days prior to signing the consent at visit 1.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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 and CKD stage 3A.;Secondary Objective: 1, To compare the percent change from baseline in total body weight between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment.<br>2, To compare the change from baseline in fasting plasma glucose (FPG) between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment.<br>3, To compare the change from baseline in seated systolic blood pressure (SBP) between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment.<br> ;Primary end point(s): Change from baseline in HbA1c at Week 24;Timepoint(s) of evaluation of this end point: Baseline to end of treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1, Percent change from baseline in total body weight at Week 24 <br>2, Change from baseline in FPG at Week 24<br>3, Change from baseline in seated SBP at Week 24;Timepoint(s) of evaluation of this end point: Baseline to the end of treatment