NCT04034524

Brief Summary

This study will compare hemoglobin a1c (HbA1c) and cardiovascular (CV) outcomes among patients with type 2 diabetes newly initiating a GLP1-receptor agonist or basal insulin.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

1.7 years

First QC Date

July 24, 2019

Last Update Submit

July 7, 2020

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Time until first composite CV event (myocardial infarction, stroke)

    Through Study Completion, an estimated average of 1 year

Secondary Outcomes (5)

  • Time until first myocardial infarction

    Through Study Completion, an estimated average of 1 year

  • Time until first stroke

    Through Study Completion, an estimated average of 1 year

  • Time until first serious hypoglycemic event

    Through Study Completion, an estimated average of 1 year

  • Time until first episode of acute pancreatitis

    Through Study Completion, an estimated average of 1 year

  • Time until first episode of acute cholecystitis

    Through Study Completion, an estimated average of 1 year

Other Outcomes (3)

  • Proportion of patients with HbA1c post-index < 7% (EAGLE)

    24 weeks

  • Proportion of patients with HbA1c post-index < 8% (EAGLE)

    24 weeks

  • Change from baseline HbA1c

    24 weeks

Study Arms (2)

New users of GLP1 receptor agonists (exposure)

Drug: GLP-1 receptor agonist

New users of basal insulin (reference)

Drug: Insulin

Interventions

GLP-1 receptor agonistDRUG

any GLP-1 receptor agonist (other than Saxenda or liraglutide 3.0mg)

New users of GLP1 receptor agonists (exposure)
InsulinDRUG

glargine, detemir, neutral protamine Hagedorn (NPH), degludec

Also known as: Basal Insulin
New users of basal insulin (reference)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with type 2 diabetes with prior and concomitant use of metformin and other oral anti diabetic agents

You may qualify if:

  • Age\>=18 years
  • at least 180 days of continuous enrollment prior to index date
  • at least 1 Type 2 diabetes diagnosis code prior to index date
  • (for cohort #1) at least 2 metformin dispensings prior to index date AND days supply overlap on cohort entry date (with 14 days of grace period before)

You may not qualify if:

  • any type 1 diabetes diagnosis code prior to index date
  • medullary thyroid carcinoma, multiple endocrine neoplasia type 2 (both black box warnings) prior to index date
  • h/o pancreatitis
  • h/o recurrent hypoglycemia (i.e. more than 1 hospitalization / emergency department encounter in primary diagnosis position for hypoglycemia)
  • index injectable is a combination of GLP1-RA plus insulin
  • index GLP1-RA is Saxenda (indicated for weight loss) or liraglutide at 3.0mg dose
  • index insulin regimen includes both basal and prandial insulin, or premixed insulin
  • Any prior GLP1-RA use (Applied washout for 180 days)
  • Any prior insulin use; Sometimes insulin is transiently used at diagnosis (Applied washout for 180 days)
  • Secondary diabetes
  • Gestational diabetes
  • Nursing home admission (because we don't have pharmacy claims)
  • Age \<18 years
  • Chronic kidney disease stage 4-6
  • Advanced cancer
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Jessica M Franklin, PHD

    Brigham and Women's Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor of Medicine

Study Record Dates

First Submitted

July 24, 2019

First Posted

July 26, 2019

Study Start

May 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

July 9, 2020

Record last verified: 2020-07

Locations

US(1)