Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New users of GLP1 receptor agonists (exposure) |
| ||
| New users of basal insulin (reference) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLP-1 receptor agonist | Drug | any GLP-1 receptor agonist (other than Saxenda or liraglutide 3.0mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time until first composite CV event (myocardial infarction, stroke) | Through Study Completion, an estimated average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
For A1c cohort only:
-HbA1c >12%
Not provided
Not provided
Not provided
Not provided
Patients with type 2 diabetes with prior and concomitant use of metformin and other oral anti diabetic agents
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jessica M Franklin, PHD | Brigham and Women's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02138 | United States |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
| Insulin | Drug | glargine, detemir, neutral protamine Hagedorn (NPH), degludec |
|
|
| 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 |
Weighted mean |
| 24 weeks |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |