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



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 74
Updated:11/2/2018
Start Date:June 15, 2015
End Date:November 7, 2017

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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.

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.


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.
We found this trial at
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