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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Matching Placebo for Dapagliflozin; Drug: Dapagliflozin 10 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02413398

D1690C00024

Details and patient eligibility

About

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.

Enrollment: 321 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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321 participants in 2 patient groups, including a placebo group

Dapagliflozin

Experimental group

Description:

10 mg Tablets, Oral, Once daily, 24 weeks

Treatment:

Drug: Dapagliflozin 10 mg

Placebo

Placebo Comparator group

Description:

Matching placebo to Dapagliflozin 10 mg tablet. Oral, Once daily, 24 weeks

Treatment:

Drug: Matching Placebo for Dapagliflozin