DiabetesNCT02922179
Descriptive Analysis of Long- and Intermediate-Acting Insulin in Adult Diabetics
An observational study of Diabetes, run by Biologics & Biosimilars Collective Intelligence Consortium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Diabetes
- What is being tested?
- Long- and intermediate- acting insulins
- How many people
- 103,951 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- DPP4s (sitagliptin, saxagliptin, linagliptin, alogliptin)
- GLP1 (exenatide, liraglutide, dulaglutide)
- SGLT-2 (empagliflozin, canagliflozin, dapagliflozin)
About this study
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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- Long- and intermediate- acting insulins
- Keywords
- Insulin, Diabetes, Biologic and Biosimilars Collective Intelligence Consortium, BBCIC, Descriptive analysis
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long- and intermediate- acting insulinsDrug
Also called NPH, Lantus, Levemir, Toujeo
alone or in combination with metformin, short-acting insulin, or second-generation sulfonylurea
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Type 1 | Individuals diagnosed with type 1 diabetes exposed to Long- and intermediate- acting insulins Receives: Drug: Long- and intermediate- acting insulins | |
| Diabetes Type 2 | Individuals diagnosed with type 2 diabetes exposed to Long- and intermediate- acting insulins Receives: Drug: Long- and intermediate- acting insulins |
What is being measured
The primary outcome is the main question the study is designed to answer.
serious hypoglycemic events
Incidence of serious hypoglycemic events in adult patient with diabetes population who use long- or intermediate-acting insulin
Measured: Anticipated completion January 2017
Secondary outcomes (1)
Serious cardiac events
Incidence of serious cardiac events in adult patient with diabetes population who use long- or intermediate-acting insulin
Measured: Anticipated completion January 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study start1 Jan 2011
- Primary completion30 Sep 2015
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 103,951 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biologics & Biosimilars Collective Intelligence Consortium
- Sponsor type
- University, hospital or other
- 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 LLC, Momenta Pharmaceuticals, Inc., Pfizer, University of Pittsburgh
- Responsible party
- Sponsor
- Investigators
- Dan Kent, PharmD,CDE, Principal investigator, Kaiser PermanenteCheryl Walraven, PhD, Principal investigator, Aetna, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922179
- Sponsor's protocol ID
- BBCIC Insulins
- Status last verified
- Jul 2021
- First submitted
- 28 Sep 2016
- Last updated
- 30 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: BBCIC Charter requires transparency and publication
Publications
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.
PubMed 31405345McMahill-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.
PubMed 31397619
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Analysis of Long- and Intermediate-Acting Insulin in Adult Diabetics
- ClinicalTrials.gov ID
- NCT02922179
- Acronym / sponsor ID
- BBCIC Insulins
- Conditions
- Diabetes
- Keywords
- Insulin, Diabetes, Biologic and Biosimilars Collective Intelligence Consortium, BBCIC, Descriptive analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103,951 participants (actual)
- Lead sponsor
- Biologics & Biosimilars Collective Intelligence ConsortiumUniversity, hospital or other
- 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 LLC, Momenta Pharmaceuticals, Inc., Pfizer, University of Pittsburgh
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 30 Sep 2015 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes Type 1 | – | Drug: Long- and intermediate- acting insulinsIndividuals diagnosed with type 1 diabetes exposed to Long- and intermediate- acting insulins |
| Diabetes Type 2 | – | Drug: Long- and intermediate- acting insulinsIndividuals diagnosed with type 2 diabetes exposed to Long- and intermediate- acting insulins |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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*:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long- and intermediate- acting insulinsAlso: NPH, Lantus, Levemir, Toujeoalone or in combination with metformin, short-acting insulin, or second-generation sulfonylurea | Drug | Diabetes Type 1, Diabetes Type 2 |
Primary outcome
serious hypoglycemic events
Time frame: Anticipated completion January 2017
Incidence of serious hypoglycemic events in adult patient with diabetes population who use long- or intermediate-acting insulin
1 secondary outcome
Serious cardiac events
Time frame: Anticipated completion January 2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Results publication: PubMed 31405345Kent 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.
- Results publication: PubMed 31397619McMahill-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.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. BBCIC Charter requires transparency and publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Kent, PharmD,CDE principal investigator
Kaiser Permanente
Cheryl Walraven, PhD principal investigator
Aetna, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Biologics & Biosimilars Collective Intelligence Consortium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serious hypoglycemic events (time frame: Anticipated completion January 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02922179, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2021.