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
| Verified date | December 2013 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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
| 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca | Bristol-Myers Squibb |
United States, Argentina, Australia, Austria, Bulgaria, Canada, Chile, Germany, Hungary, Poland,
| 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02771093 -
An Exploratory Study of the Effects of Trelagliptin and Alogliptin on Glucose Variability in Patients With Type 2 Diabetes Mellitus
|
Phase 4 | |
| Completed |
NCT02545842 -
Assessment Study of Three Different Fasting Plasma Glucose Targets in Chinese Patients With Type 2 Diabetes Mellitus (BEYOND III/FPG GOAL)
|
Phase 4 | |
| Recruiting |
NCT03436212 -
Real-Life Home Glucose Monitoring Over 14 Days in T2D Patients With Intensified Therapy Using Insulin Pump.
|
N/A | |
| Completed |
NCT03244800 -
A Study to Investigate Different Doses of 0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.
|
Phase 2 | |
| Completed |
NCT03960424 -
Diabetes Management Program for Hispanic/Latino
|
N/A | |
| Withdrawn |
NCT02769091 -
A Study in Adult Patients With Nonalcoholic Steatohepatitis Who Also Have Type 2 Diabetes
|
Phase 2 | |
| Recruiting |
NCT06065540 -
A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor
|
Phase 3 | |
| Recruiting |
NCT05008276 -
Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)
|
||
| Completed |
NCT04091373 -
A Study Investigating the Pharmacokinetics of a Single Dose Administration of Cotadutide
|
Phase 1 | |
| Completed |
NCT03296800 -
Study to Evaluate Effects of Probenecid, Rifampin and Verapamil on Bexagliflozin in Healthy Subjects
|
Phase 1 | |
| Recruiting |
NCT06212778 -
Relationship Between Nutritional Status, Hand Grip Strength, and Fatigue in Hospitalized Older Adults With Type 2 Diabetes Mellitus.
|
||
| Completed |
NCT05979519 -
Fresh Carts for Mom's to Improve Food Security and Glucose Management
|
N/A | |
| Recruiting |
NCT05579314 -
XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)
|
Phase 1 | |
| Completed |
NCT03859934 -
Metabolic Effects of Melatonin Treatment
|
Phase 1 | |
| Terminated |
NCT03684642 -
Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
|
Phase 3 | |
| Completed |
NCT03248401 -
Effect of Cilostazol on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes
|
Phase 4 | |
| Completed |
NCT03644134 -
A Personalized Intervention to Manage Physiological Stress and Improve Sleep Patterns
|
N/A | |
| Completed |
NCT05295160 -
Fasting-Associated Immune-metabolic Remission of Diabetes
|
N/A | |
| Completed |
NCT02836873 -
Safety and Efficacy of Bexagliflozin in Type 2 Diabetes Mellitus Patients With Moderate Renal Impairment
|
Phase 3 | |
| Completed |
NCT02252224 -
Forxiga (Dapagliflozin) Regulatory Postmarketing Surveillance
|