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