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NCT01195662

A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes With Inadequately Controlled Hypertension on an ACEI or ARB and an Additional Antihypertensive Medication

NCT ID: NCT01195662

Last Updated: 2016-12-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-02-28

Brief Summary

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The purpose of this study is to learn if BMS-512148 (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 (ACEI) or an Angiotensin Receptor Blocker (ARB).The safety of this treatment will also be studied

Detailed Description

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Conditions

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Type 2 Diabetes

Keywords

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Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Angiotensin Receptor Inhibitors Angiotensin-Converting Enzyme Inhibitors Antihypertensive Agents Cardiovascular Agents Pharmacological Actions

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

Dapagliflozin 10 mg tablets

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

Tablets, Oral, 10 mg, once daily, Up to 12 weeks

Placebo matching Dapagliflozin

Placebo tablets matching dapagliflozin tablets

Group Type PLACEBO_COMPARATOR

Placebo matching Dapagliflozin

Intervention Type DRUG

Tablets, Oral, 0 mg, once daily, Up to 12 weeks

Interventions

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Dapagliflozin

Tablets, Oral, 10 mg, once daily, Up to 12 weeks

Intervention Type DRUG

Placebo matching Dapagliflozin

Tablets, Oral, 0 mg, once daily, Up to 12 weeks

Intervention Type DRUG

Other Intervention Names

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BMS-512148 Farxiga™

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* Males and females, 18 to 89 years old, with type 2 diabetes with inadequate glycemic control HbA1c between 7-10.5% and uncontrolled hypertension Systolic Blood Pressure (SBP) 140-165 and Diastolic Blood Pressure (DBP) 85-105
* Subjects must have a mean 24 hr blood pressure ≥ 130/80 determined by Ambulatory Blood Pressure Monitoring (ABPM) within 1 week prior to Day 1 visit
* Stable dose of oral antidiabetic agent (OAD) for at least 6 weeks \[12 wks for Thiazolidinedione (TZD)\] or a stable daily dose of insulin, as a monotherapy or in combination with another OAD, for 8 weeks, and a stable dose of ACEI or ARB and 1 additional antihypertensive medication for at least 4 weeks
* C-peptide ≥ 0.8 ng/mL
* Body Mass Index ≤ 45.0 kg/m2
* Serum creatinine \< 1.50 mg/dL for men or \< 1.40 mg/dL for women

Exclusion Criteria

* Aspartate aminotransferase (AST) and /or Alanine aminotransferase (ALT) \> 3.0\*upper limit of normal (ULN)
* Serum total bilirubin ≥ 1.5\*ULN
* Creatinine kinase \> 3\*ULN
* Symptoms of severely uncontrolled diabetes
* History of malignant or accelerated hypertension
* Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases

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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Local Institution

Mangalore, Karnataka, India

Site Status

Local Institution

Belagavi, Karnatka, India

Site Status

University Of Alabama At Birmingham

Birmingham, Alabama, United States

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Medical Affiliated Research Center, Inc.

Huntsville, Alabama, United States

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Wilmax Clinical Research, Inc.

Mobile, Alabama, United States

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43rd Medical Associates

Phoenix, Arizona, United States

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Central Phoenix Medical Center

Tempe, Arizona, United States

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Clinical Research Advantage, Inc./Mesa Family Med Ctr, Pc

Tempe, Arizona, United States

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Clinical Research Advantage/Desert Clinical Research

Tempe, Arizona, United States

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Visions Clinical Research - Tucson

Tucson, Arizona, United States

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Eclipse Clinical Research

Tucson, Arizona, United States

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Aureus Research, Inc.

Little Rock, Arkansas, United States

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Preferred Research Partners, Inc.

Little Rock, Arkansas, United States

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Cmp Research

Anaheim, California, United States

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Catalina Research Institute, Llc

Chino, California, United States

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Southland Clinical Research Center, Inc.

Fountain Valley, California, United States

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Marin Endocrine Care & Research, Inc.

Greenbrae, California, United States

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Del Rosario Medical Clinic, Inc.

Huntington Park, California, United States

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