Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DRUGGLP-1 receptor agonist
any GLP-1 receptor agonist (other than Saxenda or liraglutide 3.0mg)
DRUGInsulin
glargine, detemir, neutral protamine Hagedorn (NPH), degludec
Sponsors
Brigham and Women's Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* 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 criteria
* 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%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time until first composite CV event (myocardial infarction, stroke) | Through Study Completion, an estimated average of 1 year |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Time until first myocardial infarction | Through Study Completion, an estimated average of 1 year |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline HbA1c | 24 weeks | Weighted mean |
| Proportion of patients with HbA1c post-index < 8% (EAGLE) | 24 weeks | — |
| Proportion of patients with HbA1c post-index < 7% (EAGLE) | 24 weeks | — |
Countries
United States
Outcome results
None listed