Exeantide in Type 2 Diabetes on Insulin
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ClinicalTrials.gov Identifier: NCT01154933 |
Recruitment Status :
Completed
First Posted : July 1, 2010
Last Update Posted : December 17, 2012
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Sponsor:
Kaleida Health
Collaborator:
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
Paresh Dandona, MD, Kaleida Health
Tracking Information | ||||
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First Submitted Date ICMJE | June 30, 2010 | |||
First Posted Date ICMJE | July 1, 2010 | |||
Last Update Posted Date | December 17, 2012 | |||
Study Start Date ICMJE | April 2008 | |||
Actual Primary Completion Date | November 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
insulin dose [ Time Frame: 12 weeks ] To compare the total insulin dose at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients.
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Exeantide in Type 2 Diabetes on Insulin | |||
Official Title ICMJE | The Effect of Exenatide on Insulin Requirement, Weight and Inflammation in Obese Type 2 Diabetic Subjects on Insulin | |||
Brief Summary | Exenatide has been shown to result in better glycemic control in type II diabetes patients. Obesity and diabetes are states of increased inflammation; exenatide is expected to lead to decreased inflammation by virtue of better glycemic control and weight loss. The purpose of this study is to determine if the addition of Exenatide to diabetic patients will reduce the requirements of insulin particularly the short acting insulin. Exenatide may also lead to decreased inflammation by virtue of better glycemic control and weight loss, or an independent effect. |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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Condition ICMJE | Type 2 Diabetes | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Dandona P, Ghanim H, Abuaysheh S, Green K, Dhindsa S, Makdissi A, Batra M, Kuhadiya ND, Chaudhuri A. Exenatide Increases IL-1RA Concentration and Induces Nrf-2-Keap-1-Regulated Antioxidant Enzymes: Relevance to β-Cell Function. J Clin Endocrinol Metab. 2018 Mar 1;103(3):1180-1187. doi: 10.1210/jc.2017-02343. | |||
* 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 | Completed | |||
Actual Enrollment ICMJE |
63 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | November 2011 | |||
Actual Primary Completion Date | November 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01154933 | |||
Other Study ID Numbers ICMJE | 1930 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Paresh Dandona, MD, Kaleida Health | |||
Study Sponsor ICMJE | Kaleida Health | |||
Collaborators ICMJE | Amylin Pharmaceuticals, LLC. | |||
Investigators ICMJE |
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PRS Account | Kaleida Health | |||
Verification Date | December 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |