- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04215523
Replication of the DECLARE Diabetes Trial in Healthcare Claims
Replication of the Dapagliflozin Effect on Cardiovascular Events (DECLARE)-TIMI 58 Diabetes Trial in Healthcare Claims
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02120
- Brigham & Women's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Please see: https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.
Eligible cohort entry dates:
Market availability of dapagliflozin in the U.S. started on January 8, 2014.
- For Marketscan and Medicare: Jan 8, 2014-Dec 31, 2017 (end of data availability).
- For Optum: Jan 8, 2014-Mar 31, 2019 (end of data availability).
Inclusion Criteria:
- Provision of informed consent prior to any study specific procedures (including run-in)
- Female or male aged ≥ 40 years
- Diagnosed with T2DM
High Risk for CV event defined as having either established CV disease and/or multiple risk factors:
- Established CV Disease (See Appendix E for details) OR No known cardiovascular disease AND at least two cardiovascular risk factors in addition to
T2DM, defined as:
- Age > 55 years in men and > 60 in women AND presence of at least 1 of the following additional risk factors (see Appendix E for details)
- Dyslipidemia
- Hypertension
- Tobacco use
WOCBP must take precautions to avoid pregnancy throughout the study and for 4 weeks after intake of the last dose.
- WOCBP must have a negative urine pregnancy test. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal.
- WOCBP must be willing to use a medically accepted method of contraception that is considered reliable in the judgment of the Investigator. For inclusion in the optional genetic research, patients must fulfill the criterion specified in
Exclusion Criteria:
Patients should not meet any exclusion criteria at the time of randomization. If at the time of enrollment, it is known that the patient will not meet criteria after a successful run-in period he/she should not be entered into run in.
Use of the following excluded medications:
- Current or recent (within 24 months) treatment with pioglitazone and/or use of pioglitazone for 2 years or more at any time
- Current or recent (within 12 months) treatment with rosiglitazone
- Previous treatment with any SGLT2 inhibitor
- Any patient currently receiving chronic (>30 consecutive days) treatment with an oral steroid at a dose equivalent to oral prednisolone ≥10 mg (e.g., betamethasone ≥1.2 mg, dexamethasone ≥1.5 mg, hydrocortisone ≥40 mg) per day
- Acute cardiovascular event [e.g., acute coronary syndrome (ACS), transient ischemic attack (TIA), stroke, any revascularization, decompensated HF, sustained tachycardia <8 weeks prior to randomization. Patients with acute cardiovascular events can be enrolled in the run-in period as long as randomization does not occur within 8 weeks of the event.
- Systolic BP >180 or diastolic BP >100 mmHg at randomization
- Diagnosis of Type 1 diabetes mellitus, MODY, or secondary diabetes mellitus
- History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
- History of any other malignancy within 5 years (with the exception of successfully treated non-melanoma skin cancers)
- Chronic cystitis and/or recurrent urinary tract infections (3 or more in the last year)
- Any conditions that, in the opinion of the Investigator, may render the patient unable to complete the study including but not limited to cardiovascular (NYHA class IV CHF, recurrent ventricular arrhythmias) or non-cardiovascular disease (e.g., active malignancy with the exception of basal cell carcinoma, cirrhosis, chronic lung disease, severe autoimmune disease) and/or a likely fatal outcome within 5 years
- Pregnant or breast-feeding patients
- Involvement in the planning and/or conduct of the study or other dapagliflozin studies (applies to AZ, BMS, Hadassah and Thrombolysis in Myocardial Infarction [TIMI] or representative staff and/or staff at the study site)
- Previous randomization in the present study
- Active participation in another clinical study with IP and/or investigational device
- Individuals at risk for poor protocol or medication compliance during run-in period (reasonable compliance defined as 80 - 120%, unless a reason for non-compliance is judged acceptable by the Investigator). If for any reason, the Investigator believes that the patient will not tolerate or be compliant with IP or study procedures, the patient should not be randomized and considered a run-in failure. Patients will be excluded during run-in and should not be randomized if the following are observed from laboratory or observation during enrollment and run-in assessments:
- HbA1c ≥12% or HbA1c<6.5%
- AST or ALT >3x ULN or Total bilirubin >2.5 x ULN
- CrCl < 60 ml/min (based on the Cockroft-Gault equation)
- Hematuria (confirmed by microscopy at Visit 1) with no explanation as judged by the Investigator up to randomization. If bladder cancer is identified, patients are not eligible to participate.
- Any reason the Investigator believes the patient is not likely to be compliant with the study medication and protocol.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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DPP-4 inhibitor
Reference group
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DPP4 inhibitor dispensing claim for any dose is reference
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Dapagliflozin
Exposure group
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Dapagliflozin dispensing claim for any dose is exposure
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite outcome of Stroke, MI, and Mortality
Time Frame: Through study completion (a median of 120-140 days)
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Composite outcome of MI, stroke, and mortality - Please refer to uploaded protocol for full definition due to size limitations.
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Through study completion (a median of 120-140 days)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shirley Wang, PhD, ScM, Brigham and Womens
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protease Inhibitors
- Sodium-Glucose Transporter 2 Inhibitors
- Dapagliflozin
- Dipeptidyl-Peptidase IV Inhibitors
Other Study ID Numbers
- 2018P002966-DUP-DECLARE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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