NCT02922179

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 103,951 (actual)
• Sponsor: Biologics & Biosimilars Collective Intelligence Consortium · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Additional information: This protocol was designed as a descriptive analysis, not to support a hypothesis. This information is being provided to the public in the interest of transparency and for demonstrating the BBCIC's Distributed Research Network's (DRN) ability to define exposures, outcomes, covariates and confounders. When published, the report will caution that the protocol does not support any ability to compare safety or effectiveness but instead is to be used only to explore the feasibility of future, more detailed comparative analyses and to better understand the capabilities of the BBCIC project. Further, the report will caution that information from this protocol should not affect use of the medical products described in any way and the fact that the BBCIC is performing this descriptive analysis in no way suggests there is a safety or effectiveness issue with any of the products described.

Conditions

• Diabetes

Interventions

Type	Name	Description
DRUG	Long- and intermediate- acting insulins	alone or in combination with metformin, short-acting insulin, or second-generation sulfonylurea

Timeline

• Start date: 2011-01-01
• Primary completion: 2015-09-30
• Completion: 2019-01-01
• First posted: 2016-10-04
• Last updated: 2021-07-30