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Replication of the TECOS Diabetes Trial in Healthcare Claims

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ClinicalTrials.gov Identifier: NCT03936062
Recruitment Status : Active, not recruiting
First Posted : May 3, 2019
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Jessica Franklin, Brigham and Women's Hospital

Brief Summary:
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

Condition or disease Intervention/treatment
Diabetes Drug: Sitagliptin Drug: Sulfonylurea

Detailed Description:
This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.

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Study Type : Observational
Actual Enrollment : 349476 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Replication of the TECOS Diabetes Trial in Healthcare Claims
Actual Study Start Date : September 22, 2017
Estimated Primary Completion Date : September 22, 2020
Estimated Study Completion Date : September 22, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
2nd Generation SUs
Reference group
Drug: Sulfonylurea
2nd generation sulfonylurea dispensing claim is used as the reference

Sitagliptin
Exposure group
Drug: Sitagliptin
Sitagliptin dispensing claim is used as the exposure




Primary Outcome Measures :
  1. Relative hazard of composite outcome of ACS/unstable angina, Stroke, MI, and Mortality [ Time Frame: Through study completion (a median of 118 days) ]
    Relative hazard of composite outcome of ACS/unstable angina, MI, stroke, and mortality - Please refer to uploaded protocol for full definition due to size limitations.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
This study will involve a new user, parallel group, cohort study design comparing sitagliptin to the 2nd generation sulfonylurea antidiabetic class as a proxy for placebo, since this class of antidiabetic drugs is not known to have an impact on the outcome of interest. The patients will be required to have continuous enrollment during the baseline period of 180 days before initiation of sitagliptin or a comparator drug (index date). Follow-up for the outcome (4P-MACE), begins the day after drug initiation. As in the trial, patients are allowed to take other antidiabetic medications during the study. Eligible cohort entry dates: 10/17/2006-12/31/2016 (market availability of sitagliptin in the U.S. started on 10/17/2006). For Optum, 10/17/2006-9/30/201.
Criteria

Please see: https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.

Inclusion Criteria:

  • Patients with a diagnosis of T2DM (ICD-9 Dx code of 250.x0 or 250.x2; ICD-10 Dx code of E11.x) in the 6 months prior to drug initiation
  • Metformin, pioglitazone, or a sulfonylurea (monotherapy or any dual combination) for each day in the prior 3 months
  • Any insulin use for each day in the prior 3 months
  • 2 outpatient visits
  • Patient is ≥50 years of age
  • History of a major clinical manifestation of coronary artery disease (i.e., MI, surgical or percutaneous [balloon and/or stent] coronary revascularization procedure
  • Ischemic cerebrovascular disease, including:

    • History of ischemic stroke. Strokes not known to be hemorrhagic will be allowed as part of this criterion;
    • Occlusion and stenosis of carotid artery without mention of cerebral infarction as History of carotid arterial disease as documented by ≥50% stenosis documented by carotid ultrasound, magnetic resonance imaging (MRI), or angiography, with or without symptoms of neurologic deficit
    • Peripheral arterial stenting or surgical revascularization, Lower extremity amputation, and Ankle brachial pressue index <0.9 as: Atherosclerotic peripheral arterial disease, as documented by objective evidence such as amputation due to vascular disease, current symptoms of intermittent claudication confirmed by an anklebrachial pressure index or toe brachial pressure index less than 0.9, or history of surgical or percutaneous revascularization procedure.
  • Encounter for contraceptive management and oral contraceptives as Female patients agree to use an effective method of contraception or must not otherwise be at risk of becoming pregnant.

Exclusion Criteria:

  • Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis.
  • Patient has a history of ≥2 episodes of severe hypoglycemia during the 12 months prior to enrollment. Severe hypoglycemia (hypoglycemia requiring assistance) refers to instances in which the patient was sufficiently disoriented or incapacitated as to require help from another individual or from medical personnel (whether or not this assistance was actually provided).
  • Patient has taken an approved or investigational DPP-4 inhibitor agent (eg, sitagliptin, alogliptin, saxagliptin, or vildagliptin), GLP-1 analogues (eg, exenatide, exenatide LAR, or liraglutide), or a thiazolidinedione other than pioglitazone within the past 3 months.
  • Patient has cirrhosis of the liver, as assessed by medical history.
  • Pregnancy or planned pregnancy during the trial period.
  • Exclude patients with a combined comorbidity score >95th percentile as Patient has medical history that indicates a life expectancy of b2 years or might limit the individual's ability to take trial treatments for the duration of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03936062


Locations
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United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02120
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Jessica Franklin, PhD Brigham and Womens
  Study Documents (Full-Text)

Documents provided by Jessica Franklin, Brigham and Women's Hospital:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jessica Franklin, Assistant Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03936062    
Other Study ID Numbers: DUPLICATE-TECOS
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action