DiabetesNCT05162183
Replication of the LEAD-2 Diabetes Trial in Healthcare Claims Data
An observational study of Diabetes, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Glimepiride and Liraglutide
- How many people
- 3,474 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will involve a new user, parallel group, propensity score-matched, retrospective cohort design comparing injectable subcutaneous liraglutide (1.2 or 1.8 mg/day) to oral glimepiride (4 mg once daily). Treatments in both arms are administered in combination with metformin (up to 2,000 mg/day). Patients will be required to have continuous enrollment during a baseline period of 180 days before initiation of liraglutide or glimepiride. The analyses will be restricted to individuals with type 2 diabetes mellitus who have been previously treated with antidiabetic drugs. In the replication, previous anti-diabetic treatment was defined as the presence of at least 2 prescriptions for metformin within 6 months before and including cohort entry.
Who may be able to join
- Diagnosis of Type 2 Diabetes mellitus [0,0] days
- 3 or more recorded HbA1c values [-365, 0] days
- At least two dispensing claims for metformin [-180,0] days
- 1 or more recorded HbA1c values [-90,0] days
- Age between 18-80 [0,0] days
Who cannot join
- Cancer, malignant neoplasm, or MEN2 [-1,825,0] days
- Use of other anti-diabetic medications [-180,0] days
- Cirrhosis or Hepatic decompensation [-180,0] days
- Viral hepatitis B or C [-180,0] days
- Stage 5 CKD, ESRD, dialysis or renal transplant [-180,0] days
- MI or HF [-180,0] days
Show all 14Show fewer
- Treatment with Anti-VEGFi or Photocoagulation [-180,0] days
- Hypertensive crisis or uncontrolled hypertension [-180,0] days
- Two diagnoses of hypoglycemia [-180,0] days
- Alcohol/drug abuse/dependence [-180,0] days
- Dementia and brain damages or non-compliance [-180,0] days
- Pregnancy [-180,0] days
- Type 1 DM, DKA, or other metabolic acidosis [-180,0] days
- Systemic corticosteroids [-90,0] days
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02135
About this study
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.
Read the 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 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 through 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.
- Conditions
- Diabetes
- Being tested
- Glimepiride, Liraglutide
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlimepirideDrug
Glimepiride dispensing claim is used as the reference group.
LiraglutideDrug
Liraglutide dispensing claim is used as the exposure group.
| Study group | Role | What they receive |
|---|---|---|
| Glimepiride | Reference Group Receives: Drug: Glimepiride | |
| Liraglutide | Exposure group Receives: Drug: Liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Hazard of change in HbA1c from baseline to 26 weeks of treatment (end of follow-up)
Claims-based algorithm: relative hazard of change in HbA1c from baseline to 26 weeks of treatment (end of follow-up)
Measured: 26-week follow-up window with a median follow-up time of 99 [84, 148] days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start1 Sep 2019
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,474 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shirley Vichy Wang, Brigham and Women's Hospital
- Investigators
- Shirley Wang, PhD, ScM, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162183
- Sponsor's protocol ID
- 2018P002966-DUP-LEAD2
- Status last verified
- Jul 2023
- First submitted
- 20 Sep 2021
- Last updated
- 27 Jul 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Replication of the LEAD-2 Diabetes Trial in Healthcare Claims Data
- ClinicalTrials.gov ID
- NCT05162183
- Acronym / sponsor ID
- 2018P002966-DUP-LEAD2
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,474 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 through 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glimepiride | – | Drug: GlimepirideReference Group |
| Liraglutide | – | Drug: LiraglutideExposure group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will involve a new user, parallel group, propensity score-matched, retrospective cohort design comparing injectable subcutaneous liraglutide (1.2 or 1.8 mg/day) to oral glimepiride (4 mg once daily). Treatments in both arms are administered in combination with metformin (up to 2,000 mg/day). Patients will be required to have continuous enrollment during a baseline period of 180 days before initiation of liraglutide or glimepiride. The analyses will be restricted to individuals with type 2 diabetes mellitus who have been previously treated with antidiabetic drugs. In the replication, previous anti-diabetic treatment was defined as the presence of at least 2 prescriptions for metformin within 6 months before and including cohort entry.
Key inclusion criteria (5 listed)
- Diagnosis of Type 2 Diabetes mellitus [0,0] days
- 3 or more recorded HbA1c values [-365, 0] days
- At least two dispensing claims for metformin [-180,0] days
- 1 or more recorded HbA1c values [-90,0] days
- Age between 18-80 [0,0] days
Key exclusion criteria (14 listed)
- Cancer, malignant neoplasm, or MEN2 [-1,825,0] days
- Use of other anti-diabetic medications [-180,0] days
- Cirrhosis or Hepatic decompensation [-180,0] days
- Viral hepatitis B or C [-180,0] days
- Stage 5 CKD, ESRD, dialysis or renal transplant [-180,0] days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlimepirideGlimepiride dispensing claim is used as the reference group. | Drug | Glimepiride |
| LiraglutideLiraglutide dispensing claim is used as the exposure group. | Drug | Liraglutide |
Primary outcome
Relative Hazard of change in HbA1c from baseline to 26 weeks of treatment (end of follow-up)
Time frame: 26-week follow-up window with a median follow-up time of 99 [84, 148] days
Claims-based algorithm: relative hazard of change in HbA1c from baseline to 26 weeks of treatment (end of follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shirley Wang, PhD, ScM principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative Hazard of change in HbA1c from baseline to 26 weeks of treatment (end of follow-up) (time frame: 26-week follow-up window with a median follow-up time of 99 [84, 148] days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.