Efficacy and Safety in Patients With Type 2 Diabetes Mellitus and Cardiovascular Disease

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A 24-week, Multicentre, Randomised, Double-blind,Age-stratified, Placebo Controlled Phase III Study With an 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin 10 mg Once Daily in Patients With T2DM and Cardiovascular Disease, Who Exhibit Inadequate Glycaemic Control on Usual Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01042977
• Other study ID #: D1690C00019
• Status: Completed
• Phase: Phase 3
• First received: January 5, 2010
• Last updated: December 18, 2013
• Start date: March 2010
• Est. completion date: December 2012

Study information

• Verified date: December 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is carried out to assess whether dapagliflozin improves glycemic control, decreases fasting plasma glucose levels, body weight and blood pressure when added to patient's 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 and cardiovascular disease

Recruitment information / eligibility

• Status: Completed
• Enrollment: 964
• Est. completion date: December 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Type 2 diabetes mellitus.

• Cardiovascular disease

• Uninterrupted anti-diabetic treatment for at least 8 weeks before enrolment

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Inadequate Glycaemic Control
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Dapagliflozin
10 mg tablet, oral, once daily, 24- week treatment and 80-week extension period
• Placebo
matching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires	Caba
Argentina	Research Site	Cordoba
Argentina	Research Site	Rosario	Santa Fe
Argentina	Research Site	Salta
Argentina	Research Site	Santa Fe
Australia	Research Site	Adelaide	South Australia
Australia	Research Site	Bedford Park	South Australia
Australia	Research Site	Blacktown	New South Wales
Australia	Research Site	Box Hill	Victoria
Australia	Research Site	Broadmeadow	New South Wales
Australia	Research Site	Carina Heights	Queensland
Australia	Research Site	Heidelberg	Victoria
Australia	Research Site	Herston
Australia	Research Site	Hornsby	New South Wales
Australia	Research Site	Keswick	South Australia
Australia	Research Site	Kippa-ring	Queensland
Australia	Research Site	Wollongong	New South Wales
Austria	Research Site	Wien
Bulgaria	Research Site	Blagoevgrad
Bulgaria	Research Site	Pernik
Bulgaria	Research Site	Pleven
Bulgaria	Research Site	Russe
Bulgaria	Research Site	Sevlievo
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Stara Zagora
Bulgaria	Research Site	Varna
Canada	Research Site	Bay Roberts	Newfoundland and Labrador
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Etobicoke	Ontario
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Mirabel	Quebec
Canada	Research Site	Moncton	New Brunswick
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Quebec
Canada	Research Site	Scarborough	Ontario
Canada	Research Site	Thornhill	Ontario
Canada	Research Site	Toronto	Ontario
Chile	Research Site	Santiago	Region Metropolitana
Germany	Research Site	Damme
Germany	Research Site	Dortmund
Germany	Research Site	Homburg
Germany	Research Site	Munster
Germany	Research Site	Wangen
Hungary	Research Site	Ajka
Hungary	Research Site	Balatonfured
Hungary	Research Site	Budapest
Hungary	Research Site	Esztergom
Hungary	Research Site	Gyor
Hungary	Research Site	Komarom
Hungary	Research Site	Mosonmagyarovar
Hungary	Research Site	TAT
Hungary	Research Site	Veszprem
Poland	Research Site	Bialystok
Poland	Research Site	Chrzanow
Poland	Research Site	Gdansk
Poland	Research Site	Grodzisk Mazowiecki
Poland	Research Site	Ilawa
Poland	Research Site	Kielce
Poland	Research Site	Krakow
Poland	Research Site	Leczna
Poland	Research Site	Leczyca
Poland	Research Site	Lodz
Poland	Research Site	Lublin
Poland	Research Site	Mragowo
Poland	Research Site	Nowy Sacz
Poland	Research Site	Plock
Poland	Research Site	Poznan
Poland	Research Site	Ruda Slaska
Poland	Research Site	Skierniewice
Poland	Research Site	Sopot
Poland	Research Site	Tarnow
Poland	Research Site	Torun
Poland	Research Site	Warszawa
Poland	Research Site	Wroclaw
Poland	Research Site	Zabrze
Poland	Research Site	Zgierz
Poland	Research Site	Zielona Gora
United States	Research Site	Alexandria	Virginia
United States	Research Site	Alexandria	Louisiana
United States	Research Site	Altoona	Pennsylvania
United States	Research Site	Anaheim	California
United States	Research Site	Asheboro	North Carolina
United States	Research Site	Austin	Texas
United States	Research Site	Aventura	Florida
United States	Research Site	Avon	Indiana
United States	Research Site	Bell Gardens	California
United States	Research Site	Berlin	New Jersey
United States	Research Site	Billings	Montana
United States	Research Site	Birmingham	Alabama
United States	Research Site	Boca Raton	Florida
United States	Research Site	Bradenton	Florida
United States	Research Site	Brick	New Jersey
United States	Research Site	Brooksville	Florida
United States	Research Site	Chino	California
United States	Research Site	Chula Vista	California
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Clearwater	Florida
United States	Research Site	Corpus Christi	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Dania	Florida
United States	Research Site	Delray Beach	Florida
United States	Research Site	Erie	Pennsylvania
United States	Research Site	Fargo	North Dakota
United States	Research Site	Franklin	Indiana
United States	Research Site	Greenfield	Indiana
United States	Research Site	Holland	Pennsylvania
United States	Research Site	Huntington Beach	California
United States	Research Site	Irving	Texas
United States	Research Site	Kalamazoo	Michigan
United States	Research Site	Lancaster	Pennsylvania
United States	Research Site	Livonia	Michigan
United States	Research Site	Los Angeles	California
United States	Research Site	Manassas	Virginia
United States	Research Site	Media	Pennsylvania
United States	Research Site	Mission Hills	California
United States	Research Site	Muncie	Indiana
United States	Research Site	New Smyrna Beach	Florida
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Orlando	Florida
United States	Research Site	Paducah	Kentucky
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Redondo Beach	California
United States	Research Site	Richardson	Texas
United States	Research Site	Riverside	California
United States	Research Site	Rockville	Maryland
United States	Research Site	Sacramento	California
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	Scottsdale	Arizona
United States	Research Site	Springfield	Illinois
United States	Research Site	Sugarland	Texas
United States	Research Site	Topeka	Kansas
United States	Research Site	Torrance	California
United States	Research Site	Waterloo	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Bulgaria,  Canada,  Chile,  Germany,  Hungary,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, measured as the mean change in HbA1c from baseline to week 24.	Baseline to Week 24	No
Primary	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 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.	Baseline to Week 24	No
Secondary	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.	Baseline to Week 24	No
Secondary	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.	Baseline to Week 24	No
Secondary	Adjusted Mean Change in Systolic Blood Pressure at Week 8 (LOCF)	To compare the mean change in seated systolic blood pressure from baseline to week 8 between dapagliflozin 10 mg versus placebo.	Baseline to Week 8	No
Secondary	Adjusted Mean Change in Seated Systolic Blood Pressure 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.	Baseline to Week 24	No
Secondary	Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF) in Participants With Baseline SBP>=130 mmHg	To compare the mean change in seated systolic blood pressure (SBP) in participants with baseline seated SBP =130 mmHg achieved with dapagliflozin versus placebo from baseline to week 8.	Baseline to Week 8	No