Observational Study: Glycemic Control & CV Outcomes Among Patients With T2DM Newly Initiating GLP1-RAs vs Basal Insulin

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

An Observational Study of Glycemic Control and Cardiovascular Outcomes Among Patients With Type 2 Diabetes Newly Initiating GLP1 Receptor Agonists Versus Basal Insulin in Routine Care Settings.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04006379
• Other study ID #: GLP1vsBasalInsulin
• Status: Active, not recruiting
• Start date: May 1, 2019
• Est. completion date: October 1, 2019

Study information

• Verified date: July 2019
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will compare HbA1c and CV outcomes among patients with type 2 diabetes newly initiating a GLP1-receptor agonist or basal insulin.

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 LAED 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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 20000
• Est. completion date: October 1, 2019
• Est. primary completion date: August 1, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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 CED (with 14 days of grace period before)

Exclusion Criteria:

• any type 1 diabetes diagnosis code prior to index date

• medullary thyroid carcinoma, MEN type 2 (both black box warnings) prior to index date

• h/o pancreatitis

• h/o recurrent hypoglycemia (i.e. more than 1 hospitalization / ED 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

• CKD 4-6

• Advanced cancer

• ESRD

For A1c cohort only:

-HbA1c >12%

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• GLP-1 receptor agonist
GLP-1 receptor agonist
• Basal insulin
Basal insulin

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of patients with A1c post-index <7% (EAGLES)		24 weeks
Other	Proportion of patients with A1c post-index <8% (EAGLES)		24 weeks
Other	Change from baseline A1c	Weighted mean	24 weeks
Primary	Composite: MI, stroke (2-point MACE)	Composite Myocardial Infarction, stroke (2-point MACE)	24 weeks
Secondary	MI	Myocardial Infarction	24 weeks
Secondary	Stroke	Stroke	24 weeks
Secondary	Serious hypoglycemic events	Serious hypoglycemic events	24 weeks
Secondary	Pancreatitis	Pancreatitis	24 weeks
Secondary	Cholecystitis	Cholecystitis	24 weeks