Overview

This trial is active, not recruiting.

Condition diabetes
Treatment long- and intermediate- acting insulins
Sponsor Biologics & Biosimilars Collective Intelligence Consortium
Collaborator HealthCore, Inc.
Start date January 2011
End date September 2015
Trial size 100000 participants
Trial identifier NCT02922179, BBCIC Insulins

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
Individuals diagnosed with type 1 diabetes exposed to Long- and intermediate- acting insulins
long- and intermediate- acting insulins NPH, Lantus, Levemir, Toujeo
alone or in combination with metformin, short-acting insulin, or second-generation sulfonylurea
Individuals diagnosed with type 2 diabetes exposed to Long- and intermediate- acting insulins
long- and intermediate- acting insulins NPH, Lantus, Levemir, Toujeo
alone or in combination with metformin, short-acting insulin, or second-generation sulfonylurea

Primary Outcomes

Measure
serious hypoglycemic events
time frame: Anticipated completion January 2017

Secondary Outcomes

Measure
Serious cardiac events
time frame: Anticipated completion January 2017

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Individuals with baseline period of 183 days with continuous medical and pharmacy coverage preceding the first prescription fill - new and current users of the following exposures - Long-acting insulin (insulin detemir, glargine) alone or with metformin (LAI) - Long-acting insulin (insulin detemir, glargine) plus rapid/short acting insulin (with or without metformin) (LAI+R) - Long-acting insulin (insulin detemir, glargine) plus second-generation sulfonylurea agent (Glimepiride, Glipizide, Glipizide/Metformin, Glyburide, Glyburide/Metformin) (with or without metformin) (LAI+sulfa) - NPH insulin (Humulin, Novolin) alone or with metformin (NPH) - NPH insulin (Humulin, Novolin) plus rapid/short acting insulin (with or without metformin) (NHP+R) - NPH insulin (Humulin, Novolin) plus second-generation sulfonylurea agent (Glimepiride, Glipizide, Glipizide/Metformin, Glyburide, Glyburide/Metformin (with or without metformin) (NPH + sulfa) Exclusion Criteria: - Adult patients with diabetes with health insurance evidence of insulin pumps and/ or insulin pump supplies, gestational diabetes, liver disorders, dialysis, end-stage renal disease (ESRD), amputations, hemoglobinopathy, hemolytic anemia, or sickle cell anemia or transfusion - Emergency Department (ED) visit for hypoglycemia; hospitalization or ED visit for cardiovascular event (stroke, acute myocardial infarction, unstable angina or diagnosis consistent with unstable angina -- i.e., occlusion without infarction or coronary insufficiency). - Adult patients with diabetes on any other insulins except cohort insulins (i.e., rapid/short unless in combinations above).* - Adult patients with diabetes on first-generation sulfonylureas, Dipeptidyl peptidase-4 (DPP4), Glucagon-like Peptide (GLP), Sodium-glucose cotransporter-2 (SGLT-2) or Thiazolidinediones (TZD) agents, alone or in combination with cohort defining drugs*: - First generation sulfonylurea agents (chlorpropamide, tolazamide ) - TZDs (pioglitazone, pioglitazone/metformin, rosiglitazone, rosiglitazone/metformin - DPP4s (sitagliptin, saxagliptin, linagliptin, alogliptin) - GLP1 (exenatide, liraglutide, dulaglutide) - SGLT-2 (empagliflozin, canagliflozin, dapagliflozin)

Additional Information

Official title Descriptive Analysis of Long- and Intermediate-Acting Insulin in Adult Diabetics
Principal investigator Dan Kent, PharmD,CDE
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Biologics & Biosimilars Collective Intelligence Consortium.