Liraglutide as Additional Treatment in Patients With Type 1 Diabetes Mellitus
| Tracking Information | |||||
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| First Received Date ICMJE | February 1, 2011 | ||||
| Last Updated Date | June 5, 2012 | ||||
| Start Date ICMJE | October 2010 | ||||
| Estimated Primary Completion Date | February 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Improved Blood Glucose comtrol in Type 1 Diabetes Patients with Liraglutide [ Time Frame: 20 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01299012 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Liraglutide as Additional Treatment in Patients With Type 1 Diabetes Mellitus | ||||
| Official Title ICMJE | Liraglutide as Additional Treatment in Patients With Type 1 Diabetes Mellitus, a Retrospective Chart Review | ||||
| Brief Summary | Evaluating the use of Liraglutide in patients with Type 1 Diabetes. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Retrospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Type 1 Diabetes Mellitus |
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| Condition ICMJE | Type 1 Diabetes Mellitus | ||||
| Intervention ICMJE | Drug: Liraglutide
Liraglutide s/c 0.6mg once daily.
Other Name: Victoza |
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| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 10 | ||||
| Estimated Completion Date | June 2013 | ||||
| Estimated Primary Completion Date | February 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01299012 | ||||
| Other Study ID Numbers ICMJE | 1954 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Paresh Dandona, MD, Kaleida Health | ||||
| Study Sponsor ICMJE | Kaleida Health | ||||
| Collaborators ICMJE | University at Buffalo | ||||
| Investigators ICMJE |
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| Information Provided By | Kaleida Health | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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