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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01195662




Registration number
NCT01195662
Ethics application status
Date submitted
3/09/2010
Date registered
6/09/2010
Date last updated
29/12/2016

Titles & IDs
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
Secondary ID [1] 0 0
2010-019798-13
Secondary ID [2] 0 0
MB102-077 ST
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dapagliflozin
Treatment: Drugs - Placebo matching Dapagliflozin

Experimental: Dapagliflozin 10 mg - Dapagliflozin 10 mg tablets

Placebo comparator: Placebo matching Dapagliflozin - Placebo tablets matching dapagliflozin tablets


Treatment: Drugs: Dapagliflozin
Tablets, Oral, 10 mg, once daily, Up to 12 weeks

Treatment: Drugs: Placebo matching Dapagliflozin
Tablets, Oral, 0 mg, once daily, Up to 12 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure for 12 Week Double-Blind Treatment Period - Randomized Participants
Timepoint [1] 0 0
Baseline to Week 12
Primary outcome [2] 0 0
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) for 12 Week Double-Blind Treatment Period - Randomized Participants
Timepoint [2] 0 0
Baseline to Week 12
Secondary outcome [1] 0 0
Adjusted Mean Change From Baseline in 24-hour Ambulatory Systolic Blood Pressure at Week 12 Last Observation Carried Forward (LOCF)
Timepoint [1] 0 0
Baseline, Week 12
Secondary outcome [2] 0 0
Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure (DBP) for 12 Week Double-Blind Treatment Period - Randomized Participants
Timepoint [2] 0 0
Baseline to Week 12
Secondary outcome [3] 0 0
Adjusted Mean Change From Baseline in 24-hr Ambulatory Diastolic Blood Pressure at Week 12 (LOCF)
Timepoint [3] 0 0
Baseline, Week 12
Secondary outcome [4] 0 0
Adjusted Mean Change From Baseline in Serum Uric Acid at Week 12 in Double-Blind Treatment Period - Randomized Participants
Timepoint [4] 0 0
Baseline, Week 12
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
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 outcome [6] 0 0
Number of Participants With Marked Chemistry Laboratory Abnormalities in 12 Week Double Blind Treatment Period, Including Data After Rescue
Timepoint [6] 0 0
Baseline (Day 1) to last dose double blind medication (Week 12) plus 4 days
Secondary outcome [7] 0 0
Number of Participants With Elevated Liver Laboratory Tests in Participants Treated With Double Blind 10 mg Dapagliflozin or Placebo , Including Data After Rescue
Timepoint [7] 0 0
Baseline (Day 1) to last dose double blind medication (Week 12) Plus 30 days
Secondary outcome [8] 0 0
Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 12 (LOCF), Including Data After Rescue
Timepoint [8] 0 0
Baseline, Week 12
Secondary outcome [9] 0 0
Proportion of Participants With Orthostatic Hypotension at Baseline and Week 12, Including Data After Rescue
Timepoint [9] 0 0
Baseline (Day 1), Week 12

Eligibility
Key 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
Minimum age
18 Years
Maximum age
89 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2013
Sample size
Target
Accrual to date
Final
2245
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Camperdown
Recruitment hospital [2] 0 0
Local Institution - Heidelberg
Recruitment hospital [3] 0 0
Local Institution - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3081 - Heidelberg
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
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Ponce
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San Juan
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Romania
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Bihor
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Jud. Bihor
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Mures
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Timis
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Cluj-Napoca
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Satu Mare
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Sibiu
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United Kingdom
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Ayrshire
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United Kingdom
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Cambridgeshire
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West Midlands
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United Kingdom
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Wiltshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bristol-Myers Squibb
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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
Trial website
https://clinicaltrials.gov/study/NCT01195662
Trial related presentations / publications
Weber MA, Mansfield TA, Cain VA, Iqbal N, Parikh S, Ptaszynska A. Blood pressure and glycaemic effects of dapagliflozin versus placebo in patients with type 2 diabetes on combination antihypertensive therapy: a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Diabetes Endocrinol. 2016 Mar;4(3):211-220. doi: 10.1016/S2213-8587(15)00417-9. Epub 2015 Nov 27. Erratum In: Lancet Diabetes Endocrinol. 2016 Mar;4(3):e3. Lancet Diabetes Endocrinol. 2016 Mar;4(3):e3. doi: 10.1016/S2213-8587(15)00467-2.
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01195662