Status:
UNKNOWN
Cardiovascular Outcomes and HbA1c Among Patients With Type 2 Diabetes Newly Initiating GLP1RAs vs Basal Insulin
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
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.
Detailed Description
The 2019 ADA-EASD clinical treatment guidelines recommend a GLP-1RA over basal insulin for patients with type 2 diabetes with suboptimal glycemic control despite metformin and a second-line glucose lo...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
- End stage renal disease
- For A1c cohort only:
- HbA1c \>12%
Key Trial Info
Start Date :
May 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
20000 Patients enrolled
Trial Details
Trial ID
NCT04034524
Start Date
May 1 2019
End Date
December 31 2020
Last Update
July 9 2020
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02138