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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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01137474
First received: June 3, 2010
Last updated: December 2, 2016
Last verified: November 2016
Results First Received: February 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Interventions: Drug: Dapagliflozin
Drug: Placebo-matching dapagliflozin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

This study was originally designed with 2 additional double-blind treatment arms, dapagliflozin 2.5 and

5 mg, but randomization of new patients into these arms stopped with implementation of Protocol Amendment 8

on 1-11-11. Patients randomized to dapagliflozin 2.5 or 5 mg remained on their blinded medication until study completion.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 2996 participants enrolled, 944 were randomized and received double-blind treatment.

Reporting Groups
  Description
Placebo Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8) Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 2.5 mg, daily with a morning meal.
Dapagliflozin, 5 mg (Randomized Before Protocol Amendment 8) Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 5 mg, daily with a morning meal.
Dapagliflozin 10 mg Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.

Participant Flow:   Overall Study
    Placebo   Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8)   Dapagliflozin, 5 mg (Randomized Before Protocol Amendment 8)   Dapagliflozin 10 mg
STARTED   311   166   165   302 
Received Treatment   311   166   165   302 
COMPLETED   287   154   158   281 
NOT COMPLETED   24   12   7   21 
Adverse Event                3                5                1                3 
Withdrawal by Subject                7                2                6                9 
No longer met study criteria                6                1                0                5 
Lost to Follow-up                5                1                0                2 
Lack of Efficacy                0                0                0                2 
Not specified                3                1                0                0 
Pregnancy                0                1                0                0 
Administrative reason by sponsor                0                1                0                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants who received a least 1 dose of double-blind study medication

Reporting Groups
  Description
Placebo Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8) Participants with type 2 diabetes and inadequate glycemic control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 2.5 mg, daily with a morning meal.
Dapagliflozin, 5 mg (Randomized Before Protocol Amendment 8) Participants with type 2 diabetes and inadequate glycemic control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 5 mg, daily with a morning meal.
Dapagliflozin 10 mg Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
Total Total of all reporting groups

Baseline Measures
   Placebo   Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8)   Dapagliflozin, 5 mg (Randomized Before Protocol Amendment 8)   Dapagliflozin 10 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 311   166   165   302   944 
Age, Customized 
[Units: Participants]
         
Younger than 65 years   259   141   142   260   802 
65 years and older to younger than 75 years   46   25   21   42   134 
75 years and older   6   0   2   0   8 
Gender 
[Units: Participants]
Count of Participants
         
Female      140  45.0%      76  45.8%      76  46.1%      123  40.7%      415  44.0% 
Male      171  55.0%      90  54.2%      89  53.9%      179  59.3%      529  56.0% 
Race/Ethnicity, Customized 
[Units: Participants]
         
White   241   105   108   239   693 
Black or African American   14   11   8   12   45 
Asian   54   49   49   49   201 
Other   2   1   0   2   5 
Body Mass Index 
[Units: Participants]
         
Less than 25 kg/m^2   28   20   18   34   100 
25 kg/m^2 to 30 kg/m^2   131   67   63   95   356 
30 kg/m^2 and greater   152   79   84   173   488 


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

2.  Primary:   Adjusted Mean Change From Baseline in Hemoglobin (HbA1c) at Week 12   [ Time Frame: From Baseline to Week 12 ]

3.  Secondary:   Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure at Week 12 (Last Observation Carried Forward)   [ Time Frame: From Baseline to Week 12 ]

4.  Secondary:   Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure at Week 12   [ Time Frame: From Baseline to Week 12 ]

5.  Secondary:   Adjusted Mean Change in 24-Hour Ambulatory Diastolic Blood Pressure at Week 12 (Last Observation Carried Forward [LOCF])   [ Time Frame: From Baseline to Week 12 ]

6.  Secondary:   Adjusted Mean Change From Baseline in Serum Uric Acid Levels at Week 12   [ Time Frame: From Baseline to Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study originally had 2 additional arms, dapagliflozin 2.5 and 5 mg, but enrolment stopped after Protocol Amendment 8 (1-11-11) implemented. Because endpoints focused on comparison of dapagliflozin 10 mg with placebo, only these arms were summarized.


  More Information