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

NCT02922179

Last updated date
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetes
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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)

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

DiabetesEffects of Statins on Lower Extremity Arterial Function Assessed by Magnetic Resonance Imaging
NCT00770679
  1. Baltimore, Maryland
ALL GENDERS
40 Years+
years
MULTIPLE SITES
DiabetesImproving Care for Patients With Diabetes and Poor Numeracy Skills
NCT00311922
  1. Nashville, Tennessee
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Descriptive Analysis of Long- and Intermediate-Acting Insulin in Adult Diabetics
Official Title Descriptive Analysis of Long- and Intermediate-Acting Insulin in Adult Diabetics
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.
Detailed 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Diabetes
Intervention Drug: Long- and intermediate- acting insulins
alone or in combination with metformin, short-acting insulin, or second-generation sulfonylurea
Other Name: NPH, Lantus, Levemir, Toujeo
Study Groups/Cohorts
  • Diabetes Type 1
    Individuals diagnosed with type 1 diabetes exposed to Long- and intermediate- acting insulins
    Intervention: Drug: Long- and intermediate- acting insulins
  • Diabetes Type 2
    Individuals diagnosed with type 2 diabetes exposed to Long- and intermediate- acting insulins
    Intervention: Drug: Long- and intermediate- acting insulins
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October 3, 2016)
100000
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2017
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study:Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02922179
Other Study ID Numbers BBCIC Insulins
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD:Yes
Plan Description:BBCIC Charter requires transparency and publication
Responsible Party Biologics & Biosimilars Collective Intelligence Consortium
Study Sponsor Biologics & Biosimilars Collective Intelligence Consortium
Collaborators
  • HealthCore, Inc.
  • Aetna, Inc.
  • University of Alabama; Rheumatologist and Healthcare Research
  • AbbVie
  • Amgen
  • Boehringer Ingelheim
  • Kaiser Permanente
  • Harvard Pilgrim Health Care
  • Merck Sharp & Dohme Corp.
  • Momenta Pharmaceuticals, Inc.
  • Pfizer
  • University of Pittsburgh
Investigators
Principal Investigator:Dan Kent, PharmD,CDEKaiser Permanente
Principal Investigator:Cheryl Walraven, PhDAetna, Inc.
PRS Account Biologics & Biosimilars Collective Intelligence Consortium
Verification Date September 2016