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A Study of BMS-512148 (Dapagl...

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

Last Updated: 2017-01-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2996 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2013-02-28

Brief Summary

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The purpose of this study is to learn whether dapagliflozin, after 12 weeks, can improve (decrease) blood pressure in patients with type 2 diabetes with uncontrolled hypertension who are on an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker. The safety of this treatment will also be studied.

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Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Dapagliflozin, 10 mg

Oral tablets administered as 10 mg once daily for up to 12 weeks

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

Oral tablets administered as 2.5, 5, or 10 mg, once daily for up to 12 weeks

Placebo-matching dapagliflozin

Oral tablets administered once daily in the morning

Group Type PLACEBO_COMPARATOR

Placebo-matching dapagliflozin

Intervention Type DRUG

Oral tablets administered as 0 mg once daily for up to 12 weeks

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)

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

Oral tablets administered as 2.5, 5, or 10 mg, once daily for up to 12 weeks

Dapagliflozin, 5 mg

Oral tablets administered as 5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8)

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

Oral tablets administered as 2.5, 5, or 10 mg, once daily for up to 12 weeks

Interventions

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Dapagliflozin

Oral tablets administered as 2.5, 5, or 10 mg, once daily for up to 12 weeks

Intervention Type DRUG

Placebo-matching dapagliflozin

Oral tablets administered as 0 mg once daily for up to 12 weeks

Intervention Type DRUG

Other Intervention Names

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BMS-512148

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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University Of Alabama At Birmingham

Birmingham, Alabama, United States

Site Status

Horizon Research Group, Inc.

Mobile, Alabama, United States

Site Status

Iicr, Inc. (International Institute Of Clinical Research)

Ozark, Alabama, United States

Site Status

Hope Research Institute

Phoenix, Arizona, United States

Site Status

43rd Medical Associates

Phoenix, Arizona, United States

Site Status

Central Phoenix Medical Clinic, Llc

Tempe, Arizona, United States

Site Status

Clinical Research Advantage/Desert Clinical Research

Tempe, Arizona, United States

Site Status

Visions Clinical Research - Tucson

Tucson, Arizona, United States

Site Status

Eclipse Clinical Research

Tucson, Arizona, United States

Site Status

Aureus Research, Inc.

Little Rock, Arkansas, United States

Site Status

Preferred Research Partners, Inc.

Little Rock, Arkansas, United States

Site Status

Orange County Research Institute

Anaheim, California, United States

Site Status

Cmp Research

Anaheim, California, United States

Site Status

Med Center

Carmichael, California, United States

Site Status

Catalina Research Institute, Llc

Chino, California, United States

Site Status

Southland Clinical Research Center, Inc.

Fountain Valley, California, United States

Site Status

Marin Endocrine Care & Research, Inc.

Greenbrae, California, United States

Site Status

Del Rosario Medical Clinic, Inc.

Huntington Park, California, United States

Site Status

Time Clinical Research Inc.

Huntington Park, California, United States

Site Status