GLP-1/Basal Insulin Combination Therapy

NCT ID: NCT02895672

Last Updated: 2017-02-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2016-12-31

Brief Summary

This is a real-world, pre-post observational study from an ambulatory endocrinology practice which will determine the effectiveness and safety of the addition of glucagon-like peptide-1(GLP-1) agonist therapy (weekly exenatide {Bydureon} or daily liraglutide {Victoza}), added to the regimens of T2DM patients who have already received a minimum of one year of basal insulin therapy. Specifically, the investigators hypothesize that GLP-1 agonist therapy added to basal insulin therapy will result in statistically significant improved glycemic control and weight loss, with no higher risk of hypoglycemia compared to baseline.

Detailed Description

This is a pre-post observational study which will assess the efficacy and safety of 12 months of GLP-1 therapy added to the therapeutic regimen of a group of T2DM patients. This study was reviewed and approved by the Albany College of Pharmacy and Health Sciences Institutional Review Board. Potential subjects will be identified via a computerized text search of the medication and problem fields of patient electronic medical records (EMR). Search terms include exenatide, Bydureon, liraglutide, Victoza, GLP-1 agonist, NPH, Lantus, Levemir, and T2DM. Individual records of identified patients will be reviewed to ascertain if all applicable study criteria are met. Inclusion criteria are: T2DM, age 18-85 years, documentation of basal insulin therapy for minimum of one year prior to GLP-1 initiation, and addition of weekly exenatide or daily liraglutide added to basal insulin therapy for a minimum of 12 months. Exclusion criteria include: Type 1 diabetes, patients receiving prescription medications for weight loss, and initiation of additional diabetes, hypertension or cholesterol drugs during the follow-up period.

A data collection form will be utilized to collect the following patient information: baseline demographic information (gender, age, height, weight), duration of diabetes, medications, laboratory information (HbA1C, cholesterol profile [total cholesterol, triglycerides, LDL-C, HDL-C]), and blood pressure. The primary study outcome is change in HbA1C from baseline to 12 months after GLP-1 therapy is added to basal insulin therapy. A separate analysis including patients who do not complete 12 months of GLP-1 therapy will also be performed. Secondary outcomes are change in weight, percentage of patients achieving an A1C of <7%, changes in systolic and diastolic blood pressures, changes in lipid parameters (TC, LDL-C, HDL-C, and TG's), and reductions in number/doses of diabetes, blood pressure, and lipid lowering medications. Safety will be assessed by collection of reported adverse effects. Medication compliance will be assessed by review of an insurance data base record of refills.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Weekly GLP-1 therapy: exenatide

Patients receiving weekly exenatide

GLP-1 therapy

Intervention Type: DRUG

The investigators will assess the efficacy and safety of 12 months of GLP-1 therapy added to the therapeutic regimen of a group of T2DM patients who have received basal insulin therapy for a minimum of one year.

Daily GLP-1 therapy liraglutide

Patients receiving daily liraglutide

GLP-1 therapy

Intervention Type: DRUG

The investigators will assess the efficacy and safety of 12 months of GLP-1 therapy added to the therapeutic regimen of a group of T2DM patients who have received basal insulin therapy for a minimum of one year.

Interventions

GLP-1 therapy

The investigators will assess the efficacy and safety of 12 months of GLP-1 therapy added to the therapeutic regimen of a group of T2DM patients who have received basal insulin therapy for a minimum of one year.

Intervention Type: DRUG

Other Intervention Names

Bydureon, Victoza

Eligibility Criteria

Inclusion Criteria

• T2DM, age 18-85 years, documentation of basal insulin therapy for minimum of one year prior to GLP-1 initiation, and addition of weekly exenatide or daily liraglutide added to basal insulin therapy

Exclusion Criteria

• Type 1 diabetes, patients receiving prescription medications for weight loss, and initiation of additional diabetes, hypertension or cholesterol drugs during the follow-up period

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Albany College of Pharmacy and Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

15-026

Identifier Type: -

Identifier Source: org_study_id