Back to resultsEfficacy and Safety in Patients With Type 2 Diabetes Mellitus, Cardiovascular Disease and Hypertension
Primary Purpose
Type 2 Diabetes Mellitus, Cardiovascular Disease, Hypertension
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dapagliflozin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring dapagliflozin, diabetes, cardiovascular disease, hypertension
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetes mellitus.
- Cardiovascular disease
- Hypertension
Exclusion Criteria:
- Patients with type 1 diabetes or diabetes insipidus
- Patients with 3 or more oral anti-hyperglycaemic drugs with or without insulin and/or poorly controlled diabetes
- Any clinically significant illness, which would compromise the patient's safety and their participation in the study
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Dapagliflozin 10 mg tablet
Matching placebo tablet
Outcomes
Primary Outcome Measures
Adjusted Mean Change in HbA1c Levels
To compare the glycemic efficacy of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease and hypertension, measured as the mean change in HbA1c from baseline to week 24.
Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit
To compare the clinical benefit of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease and hypertension at week 24, measured as the proportion of responders for a 3-item endpoint of clinical benefit, defined as an absolute drop of 0.5% or more from baseline HbA1c, and a relative drop of 3% or more from baseline for total body weight, and an absolute drop of 3 mmHg or more from baseline in seated systolic blood pressure.
Secondary Outcome Measures
Adjusted Mean Change in Seated Systolic Blood Pressure (SBP)
To compare the mean change in seated systolic blood pressure from baseline to week 8 between dapagliflozin 10 mg versus placebo.
Adjusted Mean Percent Change in Body Weight
To compare the mean percent change in body weight from baseline to week 24 between dapagliflozin 10 mg versus placebo.
Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 24 (LOCF)
To compare the mean change in seated systolic blood pressure from baseline to week 24 between dapagliflozin 10 mg versus placebo.
Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m²
To compare the proportion of participants with BMI baseline ≥27 kg/m2 with a reduction from baseline of 5% or more in body weight with dapagliflozin 10 mg versus placebo from baseline to week 24. Least Squares Mean represents the percent of participants adjusted for baseline body weight and age stratum.
Full Information
NCT ID
NCT01031680
First Posted
December 10, 2009
Last Updated
September 24, 2013
Sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT01031680
Brief Title
Efficacy and Safety in Patients With Type 2 Diabetes Mellitus, Cardiovascular Disease and Hypertension
Official Title
A 24-week, Multicentre, Randomised, Double-blind, Age-stratified, Placebo Controlled, Phase III Study With a 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin 10 mg Once Daily in Pts With T2DM, CV Disease and Hypertension Who Exhibit Inadequate Glycaemic Control on Usual Care
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb
4. Oversight
5. Study Description
Brief Summary
This study is carried out to assess whether dapagliflozin lowers blood glucose, body weight and blood pressure, when added to patients existing medications and how it compares with their usual treatment without added dapagliflozin. Safety data will be collected and analysed to confirm that treatment with dapagliflozin is safe and well tolerated in patients who have diabetes, cardiovascular disease and hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Cardiovascular Disease, Hypertension, Inadequate Glycaemic Control
Keywords
dapagliflozin, diabetes, cardiovascular disease, hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
922 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Dapagliflozin 10 mg tablet
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Matching placebo tablet
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Intervention Description
10 mg tablet, oral, once daily, 24- week treatment and 80-week extension period
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period
Primary Outcome Measure Information:
Title
Adjusted Mean Change in HbA1c Levels
Description
To compare the glycemic efficacy of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease and hypertension, measured as the mean change in HbA1c from baseline to week 24.
Time Frame
Baseline to Week 24
Title
Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit
Description
To compare the clinical benefit of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease and hypertension at week 24, measured as the proportion of responders for a 3-item endpoint of clinical benefit, defined as an absolute drop of 0.5% or more from baseline HbA1c, and a relative drop of 3% or more from baseline for total body weight, and an absolute drop of 3 mmHg or more from baseline in seated systolic blood pressure.
Time Frame
Baseline to week 24
Secondary Outcome Measure Information:
Title
Adjusted Mean Change in Seated Systolic Blood Pressure (SBP)
Description
To compare the mean change in seated systolic blood pressure from baseline to week 8 between dapagliflozin 10 mg versus placebo.
Time Frame
Baseline to Week 8
Title
Adjusted Mean Percent Change in Body Weight
Description
To compare the mean percent change in body weight from baseline to week 24 between dapagliflozin 10 mg versus placebo.
Time Frame
Baseline to Week 24
Title
Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 24 (LOCF)
Description
To compare the mean change in seated systolic blood pressure from baseline to week 24 between dapagliflozin 10 mg versus placebo.
Time Frame
Baseline to Week 24
Title
Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m²
Description
To compare the proportion of participants with BMI baseline ≥27 kg/m2 with a reduction from baseline of 5% or more in body weight with dapagliflozin 10 mg versus placebo from baseline to week 24. Least Squares Mean represents the percent of participants adjusted for baseline body weight and age stratum.
Time Frame
Baseline to Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes mellitus.
Cardiovascular disease
Hypertension
Exclusion Criteria:
Patients with type 1 diabetes or diabetes insipidus
Patients with 3 or more oral anti-hyperglycaemic drugs with or without insulin and/or poorly controlled diabetes
Any clinically significant illness, which would compromise the patient's safety and their participation in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. William Cefalu
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
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Gulf Shores
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Hamilton
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Mississauga
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Toronto
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Lachine
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Laval
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Montreal
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Saint-marc-des-carrieres
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Sherbrooke
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Quebec
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Potsdam
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BR
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Germany
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Bad Nauheim
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Germany
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Berlin
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Germany
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Erdmannhausen
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Germany
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Frankfurt
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Germany
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Hamburg
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Germany
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Heilbronn
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Germany
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Hildesheim
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Germany
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Mainz
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Germany
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Munster
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Germany
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Potsdam
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Germany
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Speyer
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Germany
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Wahlstedt
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Germany
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Braila
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Romania
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Brasov
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Romania
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Bucharest
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Romania
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Constanta
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Iasi
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Sibiu
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Suceava
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Slovakia
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Bratislava
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Slovakia
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Dolny Kubin
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Slovakia
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Komarno
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Slovakia
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Kosice
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Slovakia
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Kysucke Nove Mesto
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Slovakia
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Liptovsky Hradok
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Slovakia
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Lucenec
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Slovakia
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Nitra
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Slovakia
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Povazska Bystrica
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Slovakia
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Prievidza
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Slovakia
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Rimavska Sobota
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Slovakia
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Ruzomberok
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Slovakia
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Zilina
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Slovakia
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Cordoba
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Andalucia
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Spain
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Granada
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Andalucia
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Spain
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Sevilla
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Andalucia
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Spain
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Oviedo
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Asturias
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Spain
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Barcelona
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Cataluna
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Spain
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Lerida
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Cataluna
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Spain
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Olot (girona)
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Cataluna
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Spain
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Majadahonda
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Comunidad de Madrid
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Spain
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San Juan (alicante)
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Comunidad Valenciana
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Spain
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Valencia
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Comunidad Valenciana
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Spain
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A Coruna
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Galicia
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Spain
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Santiago de Compostela
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Galicia
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Spain
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Palma de Mallorca
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Islas Baleares
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Spain
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Changhua
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan County
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Taiwan
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Taipei
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Taiwan
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Tao-yuan
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Taiwan
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Hanoi
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Vietnam
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Ho Chi Minh
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Vietnam
12. IPD Sharing Statement
Citations:
PubMed Identifier
25852208
Citation
Cefalu WT, Leiter LA, de Bruin TW, Gause-Nilsson I, Sugg J, Parikh SJ. Dapagliflozin's Effects on Glycemia and Cardiovascular Risk Factors in High-Risk Patients With Type 2 Diabetes: A 24-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With a 28-Week Extension. Diabetes Care. 2015 Jul;38(7):1218-27. doi: 10.2337/dc14-0315. Epub 2015 Apr 7.
Results Reference
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Efficacy and Safety in Patients With Type 2 Diabetes Mellitus, Cardiovascular Disease and Hypertension
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