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

NCT05162183 | Completed FDA Drug

• 1 other identifier: 2018P002966-DUP-LEAD2
• Study Type: observational
• Target: 3,474
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Glimepiride

Reference Group

Drug: Glimepiride

Liraglutide

Exposure group

Drug: Liraglutide

Interventions

Glimepiride DRUG

Glimepiride dispensing claim is used as the reference group.

Glimepiride

Liraglutide DRUG

Liraglutide dispensing claim is used as the exposure group.

Liraglutide

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Diagnosis of Type 2 Diabetes mellitus \[0,0\] days
• or more recorded HbA1c values \[-365, 0\] days
• At least two dispensing claims for metformin \[-180,0\] days
• or more recorded HbA1c values \[-90,0\] days
• Age between 18-80 \[0,0\] days

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02135, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

glimepiride; Liraglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Shirley Wang, PhD, ScM

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: December 17, 2021
• Study Start: September 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

US (1)