Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00425490
Status:
COMPLETED
Last Update Posted:
2009-09-23
First Post:
2007-01-22
Brief Title:
Effect of Januvia on Beta Cell Function in Patients With Diabetes Mellitus
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
Phase III Study on the Effect of Sitagliptin on Maximal Beta Cell Stimulation
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is designed to investigate the effect of 18 weeks treatment with Sitagliptin 100 mgday on the insulin secretion capacity of beta cells
Patients who meet the study enrollment criteria will undergo 2 experiments see description below a graded hyperglycemic technique and a meal test prior to randomization and after a 12-wk double-blind study period The treatment effect will shed light on the magnitude of the beta cell capacity to increase its mass and function
Patients who meet the study enrollment criteria will undergo 2 experiments see description below a graded hyperglycemic technique and a meal test prior to randomization and after a 12-wk double-blind study period The treatment effect will shed light on the magnitude of the beta cell capacity to increase its mass and function
Detailed Description:
Study design and duration This will be an Israeli three center study Study drug Sitagliptin 100 mg The study will be a double blind randomized two arms parallel group study The duration of the study will be up to 18 weeks with 8 visits for each patient This will include a screening period of up to 4 weeks Visit 1 to visit 2 a 2 week single blind placebo run-in period visit 2 to visit 4 and a 12 week placebo controlled double blind treatment period visit 4 to visit 8
Patients with T2DM who have not been treated with an AHA or who are on AHA monotherapy or low dose oral combination therapy low dose defined as 50 of the maximum labeled dose of each agent may participate if they meet all enrollment criteria Patients eligible to be randomized will have a HbA1c ³65 and 10
Patients who meet the study enrollment criteria will undergo 2 experiments see description below a graded hyperglycemic technique and a meal test prior to randomization Visit 3 and 4 These experiments will be will be completed after a 12-hour overnight fast The 2 experiments will be repeated at the conclusion of the 12-wk double-blind study period Visits 7 and 8
Efficacy measurements 1 Glycemic control FPG HbA1c β-cell Function ParametersΦs Φd Φb Φ Φob T Insulin Secretion Rate determined from C-peptide deconvolution 1st and 2nd phase insulin secretion Insulin response after arginine injection Insulin sensitivity index glucose insulin C-peptide total and incremental area under the curve
Patients with T2DM who have not been treated with an AHA or who are on AHA monotherapy or low dose oral combination therapy low dose defined as 50 of the maximum labeled dose of each agent may participate if they meet all enrollment criteria Patients eligible to be randomized will have a HbA1c ³65 and 10
Patients who meet the study enrollment criteria will undergo 2 experiments see description below a graded hyperglycemic technique and a meal test prior to randomization Visit 3 and 4 These experiments will be will be completed after a 12-hour overnight fast The 2 experiments will be repeated at the conclusion of the 12-wk double-blind study period Visits 7 and 8
Efficacy measurements 1 Glycemic control FPG HbA1c β-cell Function ParametersΦs Φd Φb Φ Φob T Insulin Secretion Rate determined from C-peptide deconvolution 1st and 2nd phase insulin secretion Insulin response after arginine injection Insulin sensitivity index glucose insulin C-peptide total and incremental area under the curve
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None