Phase 3
Completed N=321
A Study to Evaluate the Effect of Dapagliflozin on Blood Glucose Level and Renal Safety in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT02413398 ↗Enrolled (actual)
321
Serious AEs
7.2%
Results posted
Oct 2018
Primary outcomePrimary: Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 — -0.37; -0.03 percent — p=<0.001
◆ Published Evidence
Highly cited
190citations · ~24 / year
Efficacy and safety of dapagliflozin in patients with type 2 diabetes and moderate renal impairment (chronic kidney disease stage 3A): The DERIVE Study.
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.
Linked Publications (2)
-
Efficacy and safety of dapagliflozin in patients with type 2 diabetes and moderate renal impairment (chronic kidney disease stage 3A): The DERIVE Study.
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Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 |
-0.37; -0.03 | <0.001 sig |
| SECONDARY Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24. |
-3.42; -2.02 | <0.001 sig |
| SECONDARY Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24. |
-21.46; -4.87 | 0.001 sig |
| SECONDARY Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24. |
-4.8; -1.7 | <0.050 sig |
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.
Data sourced from ClinicalTrials.gov (NCT02413398) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.