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| Name | Class |
|---|---|
| HealthCore, Inc. | INDUSTRY |
| Aetna, Inc. | INDUSTRY |
| University of Alabama; Rheumatologist and Healthcare Research | UNKNOWN |
| AbbVie |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes Type 1 | Individuals diagnosed with type 1 diabetes exposed to Long- and intermediate- acting insulins |
| |
| Diabetes Type 2 | Individuals diagnosed with type 2 diabetes exposed to Long- and intermediate- acting insulins |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Long- and intermediate- acting insulins | Drug | alone or in combination with metformin, short-acting insulin, or second-generation sulfonylurea |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| A1C control | A1C control in adult patient with diabetes population who use long- or intermediate-acting insulin | Anticipated completion January 2017 |
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
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*:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Dan Kent, PharmD,CDE | Kaiser Permanente | Principal Investigator |
| Cheryl Walraven, PhD | Aetna, Inc. | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31405345 | Result | 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. | |
| 31397619 |
| Label | URL |
|---|---|
| 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. | View source |
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BBCIC Charter requires transparency and publication
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| D000069057 | Insulin Detemir |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| INDUSTRY |
| Amgen | INDUSTRY |
| Boehringer Ingelheim | INDUSTRY |
| Kaiser Permanente | OTHER |
| Harvard Pilgrim Health Care | OTHER |
| Merck Sharp & Dohme LLC | INDUSTRY |
| Momenta Pharmaceuticals, Inc. | INDUSTRY |
| Pfizer | INDUSTRY |
| University of Pittsburgh | OTHER |
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|
| 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. |
| D006946 | Hyperinsulinism |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |