- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03936062
Replication of the TECOS Diabetes Trial in Healthcare Claims
July 25, 2023 updated by: Shirley Vichy Wang, Brigham and Women's Hospital
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.
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
349476
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02120
- Brigham & Women's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
2nd Generation SUs
Reference group
|
2nd generation sulfonylurea dispensing claim is used as the reference
|
Sitagliptin
Exposure group
|
Sitagliptin dispensing claim is used as the exposure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Through study completion (a median of 118 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shirley Wang, PhD, ScM, Brigham and Womens
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 22, 2017
Primary Completion (Actual)
February 18, 2021
Study Completion (Actual)
February 18, 2021
Study Registration Dates
First Submitted
April 29, 2019
First Submitted That Met QC Criteria
April 30, 2019
First Posted (Actual)
May 3, 2019
Study Record Updates
Last Update Posted (Actual)
July 27, 2023
Last Update Submitted That Met QC Criteria
July 25, 2023
Last Verified
July 1, 2023
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
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Sitagliptin Phosphate
Other Study ID Numbers
- 2018P002966-DUP-TECOS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Diabetes
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
Guang NingRecruitingType 2 Diabetes Mellitus | Type1 Diabetes Mellitus | Monogenetic Diabetes | Pancreatogenic Diabetes | Drug-Induced Diabetes Mellitus | Other Forms of Diabetes MellitusChina
-
University of Trás-os-Montes and Alto DouroCompletedType 2 Diabetes Mellitus | Diabetes-Related ComplicationsPortugal
-
Northern Care Alliance NHS Foundation TrustBrighter ABCompletedDiabetes type1 | Diabetes type2United Kingdom
-
VeraLight, Inc.InLight SolutionsUnknownGestational Diabetes | Insulin Dependent Diabetes | Non Insulin Dependent DiabetesUnited States
-
Garvan Institute of Medical ResearchWeizmann Institute of ScienceActive, not recruitingType 2 Diabetes Mellitus | Pre DiabetesAustralia
-
Oregon State UniversitySanofiCompletedType I or Type II Diabetes (Excludes Gestational Diabetes)
-
Taichung Veterans General HospitalNational Health Research Institutes, TaiwanRecruitingDiabetes Complications | Type 2 Diabetes | Maturity-Onset Diabetes of the Young (MODY)Taiwan
-
University of RoehamptonRecruitingType2 Diabetes Mellitus | Pre DiabetesUnited Kingdom
-
Peking Union Medical College HospitalUnknownType 2 Diabetes Mellitus | Type 1 Diabetes Mellitus | Gestational Diabetes Mellitus | Pancreatogenic Diabetes Mellitus | Pregestational Diabetes Mellitus | Diabetes Patients in Perioperative PeriodChina
Clinical Trials on Sulfonylurea
-
Royal Devon and Exeter NHS Foundation TrustWellcome Trust; Haukeland University Hospital; Hôpital Necker-Enfants MaladesCompletedDiabetes Mellitus
-
Royal Devon and Exeter NHS Foundation TrustUniversity of Chicago; University of Bergen; University of Rome Tor VergataRecruitingEpilepsy | Intellectual Disability | ADHD | Neurodevelopmental Disorders | Autism Spectrum Disorder | Development DelayUnited States, United Kingdom, Italy, Norway
-
CinnagenUnknownDiabetes Mellitus, Type 2
-
Mitsubishi Tanabe Pharma CorporationCompletedType 2 Diabetes MellitusJapan
-
University Hospital, Gentofte, CopenhagenCompleted
-
All India Institute of Medical Sciences, BhubaneswarChemical ResourcesCompletedType-2 Diabetes MellitusIndia
-
TakedaCompletedType II Diabetes MellitusKorea, Republic of
-
All India Institute of Medical Sciences, BhubaneswarCompletedDiabetes Mellitus, Type 2India
-
Haukeland University HospitalUnknownInsulin-dependent Diabetes Mellitus | Maturity-Onset Diabetes of the Young, Type 3 | Maturity Onset Diabetes of the Young, Type 1 | Childhood Diabetes MellitusNorway