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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02922179
• Other study ID #: BBCIC Insulins
• Status: Completed
• Start date: January 1, 2011
• Est. completion date: January 2019

Study information

• Verified date: July 2021
• Source: Biologics & Biosimilars Collective Intelligence Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103951
• Est. completion date: January 2019
• Est. primary completion date: September 30, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• Long- and intermediate- acting insulins
alone or in combination with metformin, short-acting insulin, or second-generation sulfonylurea

Locations

Country	Name	City	State
n/a

Sponsors (13)

Lead Sponsor	Collaborator
Biologics & Biosimilars Collective Intelligence Consortium	AbbVie, Aetna, Inc., Amgen, Boehringer Ingelheim, 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

References & Publications (2)

Kent DJ, McMahill-Walraven CN, Panozzo CA, Pawloski PA, Haynes K, Marshall J, Brown J, Eichelberger B, Lockhart CM. Descriptive Analysis of Long- and Intermediate-Acting Insulin and Key Safety Outcomes in Adults with Type 2 Diabetes Mellitus. J Manag Care — View Citation

McMahill-Walraven CN, Kent DJ, Panozzo CA, Pawloski PA, Haynes K, Marshall J, Brown J, Eichelberger B, Lockhart CM. Harnessing the Biologics and Biosimilars Collective Intelligence Consortium to Evaluate Patterns of Care. J Manag Care Spec Pharm. 2019 Nov — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	A1C control	A1C control in adult patient with diabetes population who use long- or intermediate-acting insulin	Anticipated completion January 2017
Primary	serious hypoglycemic events	Incidence of serious hypoglycemic events in adult patient with diabetes population who use long- or intermediate-acting insulin	Anticipated completion January 2017
Secondary	Serious cardiac events	Incidence of serious cardiac events in adult patient with diabetes population who use long- or intermediate-acting insulin	Anticipated completion January 2017

External Links

•   The Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) was established in 2015 to address anticipated needs for post-marketed evidence generation for novel biologics, their corresponding biosimilars and other related products.