GLP-1/Basal Insulin Combination Therapy

NCT02895672 | Completed

• 1 other identifier: 15-026
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• A1C

  from baseline to 12 months after GLP-1 therapy is added to basal insulin therapy

  12 months

Study Arms (2)

Weekly GLP-1 therapy: exenatide

Patients receiving weekly exenatide

Drug: GLP-1 therapy

Daily GLP-1 therapy liraglutide

Patients receiving daily liraglutide

Drug: GLP-1 therapy

Interventions

GLP-1 therapy 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.

Also known as: Bydureon, Victoza

Daily GLP-1 therapy liraglutide; Weekly GLP-1 therapy: exenatide

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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 from a community endocrinology practice who have received basal insulin therapy for a minimum of one year.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Albany College of Pharmacy and Health Sciences: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exenatide; Liraglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 12, 2016
• Study Start: August 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 2, 2017

Record last verified: 2017-01