The purpose of this study is to learn if BMS-512148 (dapagliflozin),after 12 wks,can improve (decrease) blood pressure in patients with Type 2 diabetes mellitus with uncontrolled hypertension who are on an Angiotensin-converting enzyme inhibitor (ACEI) or an Angiotensin Receptor Blocker (ARB).

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 (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) and an Additional Antihypertensive Medication

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/09/001983

Enrollment

765

Registered

2011-09-02

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Type 2 Diabetes

Interventions

Intervention1: Dapagliflozin: Tablets, Oral, 5 mg QD, once daily, Up to 12 weeks Intervention2: Dapagliflozin: Tablets, Oral, 10 mg QD, once daily, Up to 12 weeks Control Intervention1: Placebo: Table

Eligibility

Inclusion criteria

Inclusion criteria: Males and females, 18 to 65 years old, with type 2 diabetes with inadequate glycemic control HbA1c between 7-10% and uncontrolled hypertension SBP 140-165 and DBP 85-105. Upper Limit of age of 65 years is in accordance with conditions set by Drug Controller General (India) for subjects participating from Indian sites. Subjects must have a mean 24 hr blood pressure more than or equal to 130/80 determined by ABPM within 1 week prior to Day 1 visit. Stable dose of oral antidiabetic agent (OAD) for 6 weeks (12 wks for TZD) and a stable dose of ACEI or ARB and 1 additional antihypertensive medication for 4 weeks C-peptide more than or equal to .08 ng/mL Body Mass Index less than or equal to 45.0 kg/m2 Serum creatinine < 1.50 mg/dL for men or < 1.40 mg/dL for women

Exclusion criteria

Exclusion criteria: AST and /or ALT 3.0 times the upper limit of normal (ULN) Serum total bilirubin more than 1.5 X ULN Creatinine kinase more than 3 X 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

Design outcomes

Primary

Measure	Time frame
Change from baseline in seated systolic blood pressureTimepoint: After 12 weeks	—

Secondary

Measure	Time frame
Change from baseline in HbA1cTimepoint: After 12 weeks	—

Countries

Australia, Colombia, Denmark, Finland, Germany, Hungary, Mexico, Poland, United Kingdom, United States of America

Contacts

Public ContactSubashri Shivkumar

Bristol-Myers Squibb India Pvt. Ltd

deepak.bachani@bms.com022-66534264

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026