Cardiovascular Outcomes and HbA1c Among Patients With Type 2 Diabetes Newly Initiating GLP1RAs vs Basal Insulin
Status unconfirmed
Conditions studied: Diabetes Mellitus, Type 2
In brief
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.
Key facts
- Study ID
- NCT04034524
- Run by
- Brigham and Women's Hospital
- People needed
- 20000
- Starts
- 2019-05-01
- Expected to finish
- 2020-12-31
- Last updated by the study team
- 2020-07-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
- End stage renal disease
- For A1c cohort only:
- HbA1c >12%
Where it is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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