GLP-1/Basal Insulin Combination Therapy
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

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.
    

Intervention name(s): GLP-1 therapy
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): Bydureon, Victoza
Intervention MeSH terms: Exenatide
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.