Replication of the LEAD-2 Diabetes Trial in Healthcare Claims Data

Diabetes Clinical Trial

Official title:

Replication of the LEAD-2 Diabetes Trial in Healthcare Claims Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05162183
• Other study ID #: 2018P002966-DUP-LEAD2
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: September 1, 2021

Study information

• Verified date: July 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3474
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Drug:
• Glimepiride
Glimepiride dispensing claim is used as the reference group.
• Liraglutide
Liraglutide dispensing claim is used as the exposure group.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	26-week follow-up window with a median follow-up time of 99 [84, 148] days