Liraglutide as Additional Treatment in Patients With Type 1 Diabetes Mellitus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Kaleida Health.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University at Buffalo
Information provided by (Responsible Party):
Paresh Dandona, MD, Kaleida Health
ClinicalTrials.gov Identifier:
NCT01299012
First received: February 1, 2011
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Type 1 Diabetes Mellitus
Drug: Liraglutide
Phase 4

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Liraglutide as Additional Treatment in Patients With Type 1 Diabetes Mellitus, a Retrospective Chart Review

Resource links provided by NLM:


Further study details as provided by Kaleida Health:

Primary Outcome Measures:
  • Improved Blood Glucose comtrol in Type 1 Diabetes Patients with Liraglutide [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: October 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Liraglutide
    Liraglutide s/c 0.6mg once daily.
    Other Name: Victoza
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Type 1 Diabetes Mellitus

Criteria

Inclusion Criteria:

  • Type 1 Diabetes Mellitus

Exclusion Criteria:

  • Type 2 Diabetes Mellitus
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01299012

Sponsors and Collaborators
Kaleida Health
University at Buffalo
Investigators
Principal Investigator: Paresh Dandona University at Buffalo
  More Information

No publications provided

Responsible Party: Paresh Dandona, MD, MD, Kaleida Health
ClinicalTrials.gov Identifier: NCT01299012     History of Changes
Other Study ID Numbers: 1954
Study First Received: February 1, 2011
Last Updated: June 5, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Liraglutide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014