Diabetes Mellitus, Non-Insulin-Dependent Clinical Trial
— DECLARE-TIMI58Official title:
Dapagliflozin Effect on Cardiovascular Events A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dapagliflozin 10 mg Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients With Type 2 Diabetes
| Verified date | November 2019 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study is being carried out to determine the effect of dapagliflozin on cardiovacular outcomes when added to current background therapy in patients with type 2 diabetes with either established cardiovacular disease or cardiovascular risk factors.
| Status | Completed |
| Enrollment | 17190 |
| Est. completion date | September 11, 2018 |
| Est. primary completion date | September 11, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years to 130 Years |
| Eligibility |
Inclusion Criteria: - Provision of informed consent prior to any study specific procedures - Female or male aged =40 years - Diagnosed with Type 2 Diabetes - High Risk for Cardiovascular events Exclusion Criteria: - Diagnosis of Type 1 diabetes mellitus History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time - Chronic cystitis and/or recurrent urinary tract infections - Pregnant or breast-feeding patients |
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| Vietnam | Research Site | Hanoi | |
| Vietnam | Research Site | Ho Chi Minh City | |
| Vietnam | Research Site | Ho Chi Minh City | |
| Vietnam | Research Site | Ho Chi Minh City |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca | Bristol-Myers Squibb, Hadassah Medical Organization, The TIMI Study Group |
United States, Vietnam, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Philippines, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke | Safety and co-primary efficacy | up to 5.2 years | |
| Primary | Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure. | Co-primary efficacy | up to 5.2 years | |
| Secondary | Subjects Included in the Renal Composite Endpoint: Confirmed Sustained =40% Decrease in eGFR to eGFR <60 ml/Min/1.73m2 and/or ESRD and/or Renal or CV Death. | Secondary | up to 5.2 years | |
| Secondary | Subjects Included in the Endpoint of All-cause Mortality. | Secondary | up to 5.2 years |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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Clinical Trial With Broccoli Sprout Extract to Patients With Type 2 Diabetes
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Phase 2 | |
| Withdrawn |
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Effect of Lycopene and Isoflavones on Glucose Metabolism
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N/A | |
| Completed |
NCT00754130 -
MK-0941 Multiple Dose Study in Japanese Patients With Type 2 Diabetes (MK-0941-011).
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Phase 1 | |
| Completed |
NCT00006305 -
Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes
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Phase 3 | |
| Completed |
NCT00004983 -
Education and Group Support for Diabetic Hispanics
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N/A | |
| Completed |
NCT00010751 -
Effects of Reiki on Painful Neuropathy and Cardiovascular Risk Factors
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Phase 2 | |
| Completed |
NCT02299388 -
To Evaluate the Effect of Liraglutide on Ambulatory Blood Pressure-A Pilot Study
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Phase 4 | |
| Completed |
NCT00550329 -
Bioequivalence Study Of Glucotrol XL 2.5 Mg Tablets
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Phase 1 | |
| Completed |
NCT00172536 -
Effects of Exercise Training on Left Ventricular Function in Type 2 Diabetic Patients Post Coronary Artery Bypass Graft
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N/A | |
| Completed |
NCT00071422 -
Safety and Efficacy of INGAP-Peptide in Patients With Type 2 Diabetes
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Phase 2 | |
| Completed |
NCT00029848 -
Obese Patients With Type 2 Diabetes
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Phase 3 | |
| Completed |
NCT01608724 -
The Efficacy and Safety Study in Patients With Type 2 Diabetes Mellitus
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Phase 4 | |
| Completed |
NCT01694758 -
OPtimal Type 2 dIabetes Management Including Benchmarking and Standard Treatment in CEEMEA
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N/A | |
| Completed |
NCT00979368 -
Safety Study of BMS-816336 in Healthy Male Subjects
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Phase 1 | |
| Completed |
NCT00791661 -
MK-1006 Single Dose Study in Japanese Type 2 Diabetes Patients (MK-1006-005)
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Phase 1 | |
| Active, not recruiting |
NCT02088658 -
Technology Intensified Diabetes Education Study in African Americans
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N/A | |
| Completed |
NCT01105429 -
Single Ascending Dose Study of BMS-820132 in Patients With Type 2 Diabetes
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Phase 1 | |
| Completed |
NCT00701090 -
A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin (0431-803)(COMPLETED)
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Phase 3 | |
| Completed |
NCT00952991 -
The Effects of LAF237 on Gastric Function in Type 2 Diabetes
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Phase 3 | |
| Completed |
NCT00035984 -
Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus
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Phase 3 |