A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes With Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB)

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01137474
First received: June 3, 2010
Last updated: April 15, 2013
Last verified: April 2013

June 3, 2010
April 15, 2013
July 2010
February 2013   (final data collection date for primary outcome measure)
  • Change from baseline in seated systolic blood pressure [ Time Frame: Baseline and after 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline and after 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01137474 on ClinicalTrials.gov Archive Site
  • Change from baseline in 24-hr ambulatory systolic blood pressure [ Time Frame: Baseline and after 12 weeks ] [ Designated as safety issue: No ]
  • Change in 24-hr ambulatory diastolic blood pressure [ Time Frame: Baseline and after 12 weeks ] [ Designated as safety issue: No ]
  • Change in serum uric acid [ Time Frame: Baseline and after 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in HbA1c [ Time Frame: Baseline and after 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in 24-hr ambulatory systolic blood pressure [ Time Frame: After 12 weeks ] [ Designated as safety issue: No ]
  • Change in 24-hr ambulatory diastolic blood pressure [ Time Frame: Baseline and after 12 weeks ] [ Designated as safety issue: No ]
  • Change in serum uric acid [ Time Frame: Baseline and after 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes With Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor (ACEI) or 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 Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB)

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 (ACE) inhibitor or an Angiotensin Receptor Blocker (ARB). The safety of this treatment will also be studied.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: Dapagliflozin
    Tablets, Oral, 10 mg, once daily, up to 12 weeks
    Other Name: BMS-512148
  • Drug: Placebo matching Dapagliflozin
    Tablets, Oral, 0 mg, once daily, up to 12 weeks
  • Experimental: Dapagliflozin (10 mg)
    Intervention: Drug: Dapagliflozin
  • Placebo Comparator: Placebo matching Dapagliflozin
    Intervention: Drug: Placebo matching Dapagliflozin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
949
February 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
  • 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 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 times the upper limit of normal (ULN)
  • Serum total bilirubin > 1.5 X ULN
  • Creatinine kinase > 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
Both
18 Years to 89 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Colombia,   Czech Republic,   Denmark,   Finland,   Germany,   Hungary,   India,   Mexico,   Peru,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Spain
 
NCT01137474
MB102-073, 2010-019797-32
No
Bristol-Myers Squibb
Bristol-Myers Squibb
AstraZeneca
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP