Descriptive Analysis of Long- and Intermediate-Acting Insulin in Adult Diabetics
Status:
Completed
Trial end date:
2019-01-01
Target enrollment:
Participant gender:
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.
AbbVie Aetna, Inc. Amgen Boehringer Ingelheim Group Health Cooperative Harvard Pilgrim Health Care HealthCore, Inc. Kaiser Permanente Merck Sharp & Dohme Corp. Momenta Pharmaceuticals, Inc. Pfizer University of Alabama; Rheumatologist and Healthcare Research University of Pittsburgh UPMC