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Liraglutide as Additional Treatment in Patients With Type 1 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paresh Dandona, Kaleida Health
ClinicalTrials.gov Identifier:
NCT01299012
First received: February 1, 2011
Last updated: February 8, 2017
Last verified: February 2017

February 1, 2011
February 8, 2017
October 2010
February 2013   (Final data collection date for primary outcome measure)
Improved Blood Glucose comtrol in Type 1 Diabetes Patients with Liraglutide [ Time Frame: 20 weeks ]
Same as current
Complete list of historical versions of study NCT01299012 on ClinicalTrials.gov Archive Site
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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.

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.

Observational
Observational Model: Other
Time Perspective: Retrospective
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Probability Sample
Type 1 Diabetes Mellitus
Type 1 Diabetes Mellitus
Drug: Liraglutide
Liraglutide s/c 0.6mg once daily.
Other Name: Victoza
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2013
February 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 1 Diabetes Mellitus

Exclusion Criteria:

  • Type 2 Diabetes Mellitus
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
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NCT01299012
1954
No
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Paresh Dandona, Kaleida Health
University at Buffalo
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Principal Investigator: Paresh Dandona University at Buffalo
University at Buffalo
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP