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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01195662
• Date of registration: 03/09/2010
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: 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
• Scientific title: 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
• Date of first enrolment: October 2010
• Target sample size: 2245
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01195662
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Australia, Canada, Colombia, Czech Republic, Denmark, Finland, Germany, Hungary, India, Ireland, Mexico, Poland, Puerto Rico, Romania, United Kingdom, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 89 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes

Intervention(s)

Drug: Placebo matching Dapagliflozin

Drug: Dapagliflozin

Primary Outcome(s)

Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) for 12 Week Double-Blind Treatment Period - Randomized Participants [Time Frame: Baseline to Week 12]

Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure for 12 Week Double-Blind Treatment Period - Randomized Participants [Time Frame: Baseline to Week 12]

Secondary Outcome(s)

Adjusted Mean Change From Baseline in Serum Uric Acid at Week 12 in Double-Blind Treatment Period - Randomized Participants [Time Frame: Baseline, Week 12]

Number of Participants With Elevated Liver Laboratory Tests in Participants Treated With Double Blind 10 mg Dapagliflozin or Placebo , Including Data After Rescue [Time Frame: Baseline (Day 1) to last dose double blind medication (Week 12) Plus 30 days]

Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 12 (LOCF), Including Data After Rescue [Time Frame: Baseline, Week 12]

Adjusted Mean Change From Baseline in 24-hour Ambulatory Systolic Blood Pressure at Week 12 Last Observation Carried Forward (LOCF) [Time Frame: Baseline, Week 12]

Adjusted Mean Change From Baseline in 24-hr Ambulatory Diastolic Blood Pressure at Week 12 (LOCF) [Time Frame: Baseline, Week 12]

Number of Participants With Marked Chemistry Laboratory Abnormalities in 12 Week Double Blind Treatment Period, Including Data After Rescue [Time Frame: Baseline (Day 1) to last dose double blind medication (Week 12) plus 4 days]

Proportion of Participants With Orthostatic Hypotension at Baseline and Week 12, Including Data After Rescue [Time Frame: Baseline (Day 1), Week 12]

Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure (DBP) for 12 Week Double-Blind Treatment Period - Randomized Participants [Time Frame: Baseline to Week 12]

Number of Participants With Deaths,Serious Adverse Events (SAEs), Adverse Events (AEs), Hypoglycemia Events, Discontinuation Due to AEs, SAEs and Hypoglycemia, During the 12 Week Double Blind Period, Including Data After Rescue [Time Frame: Baseline to last dose of 12 weeks of double blind medication plus 30 days if SAE or plus 4 days if AE/hypoglycemic event]

Secondary ID(s)

MB102-077 ST

2010-019798-13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bristol-Myers Squibb

Results

• Results available: Yes
• Date Posted: 23/05/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01195662