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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01031680
• Other study ID #: D1690C00018
• Status: Completed
• Phase: Phase 3
• First received: December 10, 2009
• Last updated: September 24, 2013
• Start date: February 2010
• Est. completion date: December 2012

Study information

• Verified date: September 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 922
• 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

• 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

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
• Hypertension
• 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	Buenos Aires
Argentina	Research Site	Caba
Argentina	Research Site	Ciudad de Buenos Aires
Argentina	Research Site	Cordoba
Argentina	Research Site	La Plata	Buenos Aires
Argentina	Research Site	Mendoza
Argentina	Research Site	Santa Fe
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Carbonear	Newfoundland and Labrador
Canada	Research Site	Courtice	Ontario
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Lachine	Quebec
Canada	Research Site	Laval	Quebec
Canada	Research Site	Mississauga	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Mount Pearl	Newfoundland and Labrador
Canada	Research Site	New Westminster	British Columbia
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Saint-marc-des-carrieres	Quebec
Canada	Research Site	Sherbrooke	Quebec
Canada	Research Site	Smiths Falls	Ontario
Canada	Research Site	St. John's	Newfoundland and Labrador
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Winnipeg	Manitoba
Germany	Research Site	Bad Nauheim
Germany	Research Site	Berlin
Germany	Research Site	Erdmannhausen
Germany	Research Site	Frankfurt
Germany	Research Site	Hamburg
Germany	Research Site	Heilbronn
Germany	Research Site	Hildesheim
Germany	Research Site	Mainz
Germany	Research Site	Munster
Germany	Research Site	Potsdam
Germany	Research Site	Potsdam	BR
Germany	Research Site	Speyer
Germany	Research Site	Wahlstedt
Romania	Research Site	Braila
Romania	Research Site	Brasov
Romania	Research Site	Bucharest
Romania	Research Site	Bucuresti
Romania	Research Site	Constanta
Romania	Research Site	Iasi
Romania	Research Site	Sibiu
Romania	Research Site	Suceava
Slovakia	Research Site	Banska Bystrica
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Dolny Kubin
Slovakia	Research Site	Komarno
Slovakia	Research Site	Kosice
Slovakia	Research Site	Kysucke Nove Mesto
Slovakia	Research Site	Liptovsky Hradok
Slovakia	Research Site	Lucenec
Slovakia	Research Site	Nitra
Slovakia	Research Site	Povazska Bystrica
Slovakia	Research Site	Prievidza
Slovakia	Research Site	Rimavska Sobota
Slovakia	Research Site	Ruzomberok
Slovakia	Research Site	Zilina
Spain	Research Site	A Coruna	Galicia
Spain	Research Site	Barcelona	Cataluna
Spain	Research Site	Cordoba	Andalucia
Spain	Research Site	Granada	Andalucia
Spain	Research Site	Lerida	Cataluna
Spain	Research Site	Majadahonda	Comunidad de Madrid
Spain	Research Site	Olot (girona)	Cataluna
Spain	Research Site	Oviedo	Asturias
Spain	Research Site	Palma de Mallorca	Islas Baleares
Spain	Research Site	San Juan (alicante)	Comunidad Valenciana
Spain	Research Site	Santiago de Compostela	Galicia
Spain	Research Site	Sevilla	Andalucia
Spain	Research Site	Valencia	Comunidad Valenciana
Taiwan	Research Site	Changhua
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Tainan County
Taiwan	Research Site	Taipei
Taiwan	Research Site	Tao-yuan
United States	Research Site	Baltimore	Maryland
United States	Research Site	Baton Rouge	Louisiana
United States	Research Site	Brick	New Jersey
United States	Research Site	Bronx	New York
United States	Research Site	Burbank	California
United States	Research Site	Carrollton	Texas
United States	Research Site	Charleston	South Carolina
United States	Research Site	Chicago	Illinois
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Clearwater	Florida
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Columbus	Georgia
United States	Research Site	Dallas	Texas
United States	Research Site	Danville	Virginia
United States	Research Site	Dayton	Ohio
United States	Research Site	Decatur	Georgia
United States	Research Site	Deerfield Beach	Florida
United States	Research Site	Fort Worth	Texas
United States	Research Site	Garden Grove	California
United States	Research Site	Gulf Shores	Alabama
United States	Research Site	Hialeah	Florida
United States	Research Site	Hollywood	Florida
United States	Research Site	Honolulu	Hawaii
United States	Research Site	Houston	Texas
United States	Research Site	Huntington Park	California
United States	Research Site	Jacksonville	Florida
United States	Research Site	Kansas City	Missouri
United States	Research Site	Kingsport	Tennessee
United States	Research Site	Lake Charles	Louisiana
United States	Research Site	Lancaster	California
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Miami	Florida
United States	Research Site	New Hyde Park	New York
United States	Research Site	North Richland Hills	Texas
United States	Research Site	Ogden	Utah
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Oradell	New Jersey
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Phoenix	Arizona
United States	Research Site	Phoenixville	Pennsylvania
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Plano	Texas
United States	Research Site	Port Charlotte	Florida
United States	Research Site	Port Orange	Florida
United States	Research Site	Reading	Pennsylvania
United States	Research Site	Salinas	California
United States	Research Site	San Antonio	Texas
United States	Research Site	San Marino	California
United States	Research Site	San Ramon	California
United States	Research Site	Spokane	Washington
United States	Research Site	St Louis	Missouri
United States	Research Site	Stone Mountain	Georgia
United States	Research Site	Tacoma	Washington
United States	Research Site	Tampa	Florida
United States	Research Site	Tomball	Texas
United States	Research Site	Tustin	California
United States	Research Site	Waterbury	Connecticut
United States	Research Site	West Monroe	Louisiana
United States	Research Site	Wichita	Kansas
United States	Research Site	Winter Park	Florida
Vietnam	Research Site	Hanoi
Vietnam	Research Site	Ho Chi Minh

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Canada,  Germany,  Romania,  Slovakia,  Spain,  Taiwan, 

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 and hypertension, 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 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.	Baseline to week 24	No
Secondary	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.	Baseline to Week 8	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	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.	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