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

NCT02922179 | Completed DMC

• 1 other identifier: BBCIC Insulins
• Study Type: observational
• Target: 103,951
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Diabetes

Keywords

Insulin; Diabetes; Biologic and Biosimilars Collective Intelligence Consortium; BBCIC; Descriptive analysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Serious cardiac events

  Anticipated completion January 2017

Other Outcomes (1)

• A1C control

  Anticipated completion January 2017

Study Arms (2)

Diabetes Type 1

Individuals diagnosed with type 1 diabetes exposed to Long- and intermediate- acting insulins

Drug: Long- and intermediate- acting insulins

Diabetes Type 2

Individuals diagnosed with type 2 diabetes exposed to Long- and intermediate- acting insulins

Drug: Long- and intermediate- acting insulins

Interventions

Long- and intermediate- acting insulins DRUG

alone or in combination with metformin, short-acting insulin, or second-generation sulfonylurea

Also known as: NPH, Lantus, Levemir, Toujeo

Diabetes Type 1; Diabetes Type 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study subjects are selected according to inclusion criteria from a source population within the Sentinel Common Data Mode v5.0.1 (SCDM). The SCDM includes over 100 million individuals with 358 million person-years of observation time who are covered by Aetna, Anthem, Group Health Cooperative, Harvard Pilgrim Health Care, and HealthPartners. The time period assessed will be 1/1/2011 - 9/30/2015.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Biologics & Biosimilars Collective Intelligence Consortium: lead
• HealthCore, Inc.: collaborator
• Aetna, Inc.: collaborator
• University of Alabama; Rheumatologist and Healthcare Research: collaborator
• AbbVie: collaborator
• Amgen: collaborator
• Boehringer Ingelheim: collaborator
• Kaiser Permanente: collaborator
• Harvard Pilgrim Health Care: collaborator
• Merck Sharp & Dohme LLC: collaborator
• Momenta Pharmaceuticals, Inc.: collaborator
• Pfizer: collaborator
• University of Pittsburgh: collaborator

Related 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 Spec Pharm. 2019 Nov;25(11):1162-1171. doi: 10.18553/jmcp.2019.19042. Epub 2019 Aug 12.

  PMID: 31405345 RESULT

• 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;25(11):1156-1161. doi: 10.18553/jmcp.2019.19041. Epub 2019 Aug 9.

  PMID: 31397619 RESULT

Related 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.

MeSH Terms

Conditions

Diabetes Mellitus; Insulin Resistance

Interventions

Insulin Glargine; Insulin Detemir

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Dan Kent, PharmD,CDE

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

• Cheryl Walraven, PhD

  Aetna, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: October 4, 2016
• Study Start: January 1, 2011
• Primary Completion: September 30, 2015
• Study Completion: January 1, 2019
• Last Updated: July 30, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP