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Descriptive Analysis of Long- and Intermediate-Acting Insulin in Adult Diabetics

NCT02922179 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 103951

Last updated 2021-07-30

No results posted yet for this study

Summary

Over the past 40 years, new types of insulins have been marketed to mirror the effect of endogenous insulin. With the existing long-acting insulin product patents expiring and the FDA approval of new biosimilar and innovator insulins, adults with diabetes and their physicians will have additional therapeutic options. This observational study will describe the patient characteristics of new and existing users of long-acting or intermediate acting insulins with and without oral anti-diabetic agents (OAD) as well as acute hypoglycemic episodes, acute cardiac events, and A1C measures. The Biologic and Biosimilars Collective Intelligence Consortium (BBCIC) will use the findings from this descriptive analysis to design a comparative study evaluating the real-world effectiveness and safety of biosimilar and innovator insulins.

Conditions

Interventions

DRUG

Long- and intermediate- acting insulins

alone or in combination with metformin, short-acting insulin, or second-generation sulfonylurea

Sponsors & Collaborators

  • HealthCore, Inc.

    collaborator INDUSTRY

  • Aetna, Inc.

    collaborator INDUSTRY

  • University of Alabama; Rheumatologist and Healthcare Research

    collaborator UNKNOWN

  • AbbVie

    collaborator INDUSTRY

  • Amgen

    collaborator INDUSTRY

  • Boehringer Ingelheim

    collaborator INDUSTRY

  • Kaiser Permanente

    collaborator OTHER

  • Harvard Pilgrim Health Care

    collaborator OTHER

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Momenta Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • University of Pittsburgh

    collaborator OTHER

  • Biologics & Biosimilars Collective Intelligence Consortium

    lead OTHER

Principal Investigators

  • Dan Kent, PharmD,CDE · Kaiser Permanente

  • Cheryl Walraven, PhD · Aetna, Inc.

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-01
Primary Completion
2015-09-30
Completion
2019-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02922179 on ClinicalTrials.gov