A Study of BMS-512148 (Dapagliflozin) in Patients with Type 2 Diabetes and Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor or Angiotensin Receptor Blocker

Study identifier:MB102-073 ST

ClinicalTrials.gov identifier:NCT01137474

EudraCT identifier:2010-019797-32

CTIS identifier:N/A

Study Complete

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Subjects with Type 2 Diabetes with Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB)

Medical condition

Type 2 Diabetes

Phase

Phase 3

Healthy volunteers

Study drug

Dapagliflozin, Placebo-matching dapagliflozin

Sex

All

Actual Enrollment

2996

Study type

Interventional

Age

18 Years - 89 Years

Date

Study Start Date: 01 Jul 2010

Primary Completion Date: 01 Feb 2013

Study Completion Date: 01 Feb 2013

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2016 by AstraZeneca

Collaborators

Bristol-Myers Squibb

Inclusion and exclusion criteria

Inclusion Criteria

- Participants willing and able to give signed and written informed consent
- Males and females, aged 18 to 89 years, who have type 2 diabetes with inadequate glycemic control (hemoglobin A1c between 7% and 10.5%) and uncontrolled hypertension (seated systolic blood pressure of 140 to 165 mm Hg and seated diastolic blood pressure 85 to 105 mm Hg)
- Mean 24-hour BP>=130/80 mmHg determined by ABPM
- Stable dose of oral antidiabetic agent (OAD) for at least 6 weeks (12 weeks for thiazolidinedione) or a stable daily dose of insulin as monotherapy or in combination with another OAD, for 8 weeks, and a stable dose of an angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker for at least 4 weeks
- C-peptide level ≥0.8 ng/mL
- Body mass index ≤ 45.0 kg/m^2
Key

Exclusion Criteria

- Aspartate aminotransferase or alanine aminotransferase level >3*upper limit of normal (ULN)
- Serum total bilirubin level >1.5*ULN
- Serum creatinine ≥2.0 mg/dL unless subject was on metformin, where exclusionary limits were serum creatinine ≥1.50 mg/dL for men and ≥1.40 mg/dL for women
-Estimated creatinine clearance of <60 mL/min
-Hemoglobin ≤10.0 g/dL for men and ≤9.0 g/dL for women
-Creatine kinase >3*ULN
-Positive for hepatitis B surface antigen
-Positive for antihepatitis C virus antibody
-Abnormal free T4 value
-History of diabetes insipidus
-Symptoms of poorly controlled diabetes that would preclude participation in this trial, including but not limited to, marked polyuria and polydipsia with greater than 10% weight loss during the 3 months prior to enrollment.
-History of diabetic ketoacidosis or hyperosmolar nonketotic coma
-History of malignant and accelerated hypertension
-Known or suspected secondary hypertension
-Any of the following within 6 months of enrollment visit:
--Myocardial infarction
--Cardiac surgery or revascularization (coronary artery bypass surgery /percutaneous transluminal coronary angioplasty)
-- Unstable angina
--Unstable congestive heart disease or New York Heart Association Class III or IV
--Transient ischemic attack or significant cerebrovascular disease
--Unstable or previously undiagnosed arrhythmia

No locations available

Arms	Assigned Interventions
Experimental: Dapagliflozin, 10 mg Oral tablets administered as 10 mg once daily for up to 12 weeks	Drug: Dapagliflozin Oral tablets administered as 2.5, 5, or 10 mg, once daily for up to 12 weeks Other Name: BMS-512148
Placebo Comparator: Placebo-matching dapagliflozin Oral tablets administered once daily in the morning	Drug: Placebo-matching dapagliflozin Oral tablets administered as 0 mg once daily for up to 12 weeks
Experimental: Dapagliflozin, 2. 5 mg Oral tablets administered as 2.5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8)	Drug: Dapagliflozin Oral tablets administered as 2.5, 5, or 10 mg, once daily for up to 12 weeks Other Name: BMS-512148
Experimental: Dapagliflozin, 5 mg Oral tablets administered as 5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8)	Drug: Dapagliflozin Oral tablets administered as 2.5, 5, or 10 mg, once daily for up to 12 weeks Other Name: BMS-512148

Documents available

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
Download
Redacted_Protocol
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center AstraZeneca

1-877-240 9479

[email protected]

Investigators

Principal Investigator