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

Conditions

• Type 2 Diabetes

Eligibility Criteria

Sex

ALL

Age

18 Years - 89 Years

Healthy Volunteers

Not accepted

Interventions

• Dapagliflozin — DRUG
  Oral tablets administered as 2.5, 5, or 10 mg, once daily for up to 12 weeks
• Placebo-matching dapagliflozin — DRUG
  Oral tablets administered as 0 mg once daily for up to 12 weeks

Study Details

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.

Key Dates

Start date

Jul 31, 2010

Status verified

Nov 2016

Primary completion

Feb 28, 2013

Completion

Feb 28, 2013

Study Design

Enrollment

2,996 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dapagliflozin, 10 mg
  Oral tablets administered as 10 mg once daily for up to 12 weeks
• Placebo Comparator: Placebo-matching dapagliflozin
  Oral tablets administered once daily in the morning
• 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)
• Experimental: Dapagliflozin, 5 mg
  Oral tablets administered as 5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8)

Primary Outcome Measure

Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (BP) at Week 12 [ Time Frame: From Baseline to Week 12 ]

Locations (164)

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