Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

GLP-1/Basal Insulin Combination Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02895672
Recruitment Status : Completed
First Posted : September 12, 2016
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
Albany College of Pharmacy and Health Sciences

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.

Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus Drug: GLP-1 therapy

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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Real-world, Observational Study of GLP-1 Therapy Added to Basal Insulin in Patients With Type 2 Diabetes Mellitus
Study Start Date : August 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Group/Cohort Intervention/treatment
Weekly GLP-1 therapy: exenatide
Patients receiving weekly exenatide
Drug: 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.
Other Name: Bydureon, Victoza

Daily GLP-1 therapy liraglutide
Patients receiving daily liraglutide
Drug: 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.
Other Name: Bydureon, Victoza




Primary Outcome Measures :
  1. A1C [ Time Frame: 12 months ]
    from baseline to 12 months after GLP-1 therapy is added to basal insulin therapy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Layout table for additonal information
Responsible Party: Albany College of Pharmacy and Health Sciences
ClinicalTrials.gov Identifier: NCT02895672     History of Changes
Other Study ID Numbers: 15-026
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Glucagon
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents