Sitagliptin in Type I Diabetic Patients
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|ClinicalTrials.gov Identifier: NCT01741103|
Recruitment Status : Unknown
Verified June 2012 by Paresh Dandona, MD, Kaleida Health.
Recruitment status was: Recruiting
First Posted : December 4, 2012
Last Update Posted : December 4, 2012
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Type I||Drug: sitagliptin Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of Sitagliptin on Glycemic Control, Post-prandial Glucagon, and Inflammation in Type 1 Diabetics|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||September 2013|
sitagliptin 100mg by mouth once a day for 12 weeks
Other Name: Januvia/Sitagliptin 100mg
|Placebo Comparator: Placebo||
Take one by mouth daily for 12 weeks
- change from baseline in mean glucose concentrations [ Time Frame: baseline and 3 months ]The primary endpoint of the study is to detect the change from baseline in mean glucose concentrations as measured by both HbA1c, and mean glucose over the three days of continuous glucose monitoring.
- Glycemic changes [ Time Frame: baseline and 3 months ]Glycemic changes including standard deviations of the glycemic levels, fructosamine, and the duration of time spent in hyperglycemia and hypoglycemia.
- Post meal hyperglycemia [ Time Frame: baseline and 3 months ]Post meal hyperglycemia will be measured as area under the curve (AUC).
- Changes in post prandial glucose, glucagon, insulin, c-peptide, DPP-IV, GIP and, GLP-1 concentrations following meal challenge. [ Time Frame: baseline and 3 months ]
- Changes in NF kappa B in the fasting state. [ Time Frame: baseline and 3 months ]
- Change in NFkappaB following meal challenge. [ Time Frame: baseline and 3 Months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741103
|Contact: Paresh Dandona, MDemail@example.com|
|United States, New York|
|115 Flint Road||Recruiting|
|Williamsville, New York, United States, 14221|
|Contact: Paresh Dandona, MD 716-626-7998 firstname.lastname@example.org|
|Principal Investigator:||Paresh Dandona, MD||Kaleida Health and University at Buffalo|