Clinical trial NCT02895672: GLP-1/Basal Insulin Combination Therapy
Official title: A Real-world, Observational Study of GLP-1 Therapy Added to Basal Insulin in Patients With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Albany College of Pharmacy and Health Sciences
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: A1C
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
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