Liraglutide as Additional Treatment in Patients With Type 1 Diabetes Mellitus

Liraglutide as Additional Treatment in Patients With Type 1 Diabetes Mellitus, a Retrospective Chart Review

Evaluating the use of Liraglutide in patients with Type 1 Diabetes.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Drug: Liraglutide

Detailed Description

This investigation will be a retrospective chart review of in type 1 diabetics who have been treated with liraglutide. The study will be conducted at Diabetes-Endocrinology Center of WNY at Millard Fillmore Hospital, affiliated to the State University of New York at Buffalo.

Study Population: 40 patients with type 1 diabetes on treatment with either continuous subcutaneous insulin infusion (CSII; also known as insulin pump) or multiple (four or more) injections of insulin per day on continuous glucose monitoring system (CGMS) will be included in the study. These patients with type 1 diabetes have been treated with liraglutide in addition to insulin. The investigators would retrospectively review their charts to evaluate decreases in fasting, postprandial and the overall mean glucose concentrations.

The investigators will compare the mean fasting, the mean weekly glucose and the standard deviation of weekly blood glucose concentrations as recorded by continuous glucose monitoring prior to and following one week and 12 weeks of treatment with liraglutide daily. In addition, the investigators will compare the time spent at glucose concentrations >150 and 200mg/dl and <70 and <40 mg/dl. HbA1c levels before and after 12 weeks of treatment with liraglutide daily will be compared.

• Study Type: Observational
• Enrollment (Actual): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Type 1 Diabetes Mellitus

Description

Inclusion Criteria:

• Type 1 Diabetes Mellitus

Exclusion Criteria:

• Type 2 Diabetes Mellitus

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improved Blood Glucose comtrol in Type 1 Diabetes Patients with Liraglutide	20 weeks

Collaborators and Investigators

• Sponsor: University at Buffalo
• Investigators: Principal Investigator: Paresh Dandona, University at Buffalo

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: February 1, 2011
• First Submitted That Met QC Criteria: February 17, 2011
• First Posted (Estimate): February 18, 2011

Study Record Updates

• Last Update Posted (Estimate): February 9, 2017
• Last Update Submitted That Met QC Criteria: February 8, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide
• Other Study ID Numbers: 1954