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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Dapagliflozin; Drug: Placebo matching Dapagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01195662

2010-019798-13 (EudraCT Number)

MB102-077 ST

Details and patient eligibility

About

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

Enrollment: 2,245 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2,245 participants in 2 patient groups, including a placebo group

Dapagliflozin 10 mg

Experimental group

Description:

Dapagliflozin 10 mg tablets

Treatment:

Drug: Dapagliflozin

Placebo matching Dapagliflozin

Placebo Comparator group

Description:

Placebo tablets matching dapagliflozin tablets

Treatment:

Drug: Placebo matching Dapagliflozin