Cardiovascular Outcomes and HbA1c Among Patients With Type 2 Diabetes Newly Initiating GLP1RAs vs Basal Insulin
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: GLP-1 receptor agonist
- Registration Number
- NCT04034524
- Lead Sponsor
- Brigham and Women's Hospital
- 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 lowering agent. The basis of this recommendation is due to the side effect profiles of these two medications (i.e. reduced risk of hypoglycemia, some weight loss with GLP-1RA), convenience (once weekly injection) and the fact that the price of insulin has skyrocketed in recent years. Prior head-to-head randomized trials (EAGLE, LEAD 5) comparing select GLP-1RA and basal insulin have found mixed results. In EAGLE, adding either insulin glargine or liraglutide to patients with poorly controlled type 2 diabetes found no differences in the primary outcome (percentage of people reaching HbA1c \< 7%). In LEAD 5, liraglutide was associated with a slightly greater HbA1c reduction than glargine, however the dose of insulin was approximately 50% less than the dose used in EAGLE. The objective of this observational study is to describe the comparative effectiveness and safety of newly initiating a GLP1RA versus basal insulin in patients with type 2 diabetes using metformin and another oral glucose lowering medicine.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20000
- 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)
- 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%
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description New users of GLP1 receptor agonists (exposure) GLP-1 receptor agonist - New users of basal insulin (reference) Insulin -
- Primary Outcome Measures
Name Time Method Time until first composite CV event (myocardial infarction, stroke) Through Study Completion, an estimated average of 1 year
- Secondary Outcome Measures
Name Time Method Time until first myocardial infarction 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 stroke 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
Trial Locations
- Locations (1)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States