Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00411411
Status:
COMPLETED
Last Update Posted:
2014-08-13
First Post:
2006-12-13
Brief Title:
Long Term Effects of DPP-IV Inhibitor Treatment in Patients With Type 2 Diabetes
Sponsor:
University Hospital Gentofte Copenhagen
Organization:
University Hospital Gentofte Copenhagen
Study Overview
Official Title:
Phase 3 Double Blinded Placebo Controlled Study of the Effects of 12 Weeks DPP-IV Inhibitor Treatment on Secretion and Action of the Incretin Hormones in Patients With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2014-07
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:
We wish to evaluate the effect of long term treatment with a DPP-IV inhibitor on the function of the incretin hormones
Hypothesis We hypothesize that that a gradual improvement in metabolic control induced by DPP-IV inhibitor Januvia treatment significantly ameliorates the impaired secretion and potency of GLP-1 and leads to a restoration of the lost action of GIP
Hypothesis We hypothesize that that a gradual improvement in metabolic control induced by DPP-IV inhibitor Januvia treatment significantly ameliorates the impaired secretion and potency of GLP-1 and leads to a restoration of the lost action of GIP
Detailed Description:
Background The incretin effect primarily mediated by the peptide hormones GIP and GLP-1 is known to be impaired in patients with type 2 diabetes and characterised by reduced GLP-1 secretion and potency and a lack of responsiveness to the insulinotropic effect of GIP The cause of this defect remains unknown but exogenous administration of GLP-1 has shown promising results in attempts to restore the incretin effect Due to rapid degradation of both incretin hormones by the enzyme dipeptidyl-peptidase IV DPP-IV treatment strategies now focus on GLP-1 analogues and prevention of hormone degradation through DPP-IV inhibition
Hypothesis We hypothesize that that a gradual improvement in metabolic control induced by DPP-IV inhibitor Januvia treatment significantly ameliorates the impaired secretion and potency of GLP-1 and leads to a restoration of the lost action of GIP
Objective To assess the effect of three months treatment with Januvia administered as tablets once daily on metabolic control in metformin treated patients with type 2 diabetes measured as increases in incretin hormones and insulin secretion
Efficacy end points Primary efficacy end point in trial part one is the relative increase in meal-induced total GLP-1 secretion after one and twelve weeks of Januvia treatment
Primary efficacy end point in part two is restoration of the insulinotropic effect of GIP measured as the relative increase in GIP induced amplification of the late phase insulin secretion AUC response to glucose after 12 weeks of Januvia treatment
Secondary objectives are examination of GLP-2 somatostatin glucagon peptide-YY and two glycaemic control parameters HbA1c and fasting plasma glucose
Design This is a single centre randomized double blinded placebo controlled trial The trial consists of two parts each consisting of three months of inhibitor treatment In each part 24 patients recruited from the Diabetes Outpatient Clinic of Gentofte University Hospital will be randomized to a treatment supplement of either Januvia or placebo
Procedures During the trial patients will be tested with well established procedures In part one patients will undergo a standardized meal test and two β-cell secretory capacity tests In part two patients will undergo standardized hyperglycaemic GIP GLP-1 and saline clamps
Safety The trial has a short time span of only three months With more than ten visits during this time and regular blood sampling the patients are well monitored
Hypothesis We hypothesize that that a gradual improvement in metabolic control induced by DPP-IV inhibitor Januvia treatment significantly ameliorates the impaired secretion and potency of GLP-1 and leads to a restoration of the lost action of GIP
Objective To assess the effect of three months treatment with Januvia administered as tablets once daily on metabolic control in metformin treated patients with type 2 diabetes measured as increases in incretin hormones and insulin secretion
Efficacy end points Primary efficacy end point in trial part one is the relative increase in meal-induced total GLP-1 secretion after one and twelve weeks of Januvia treatment
Primary efficacy end point in part two is restoration of the insulinotropic effect of GIP measured as the relative increase in GIP induced amplification of the late phase insulin secretion AUC response to glucose after 12 weeks of Januvia treatment
Secondary objectives are examination of GLP-2 somatostatin glucagon peptide-YY and two glycaemic control parameters HbA1c and fasting plasma glucose
Design This is a single centre randomized double blinded placebo controlled trial The trial consists of two parts each consisting of three months of inhibitor treatment In each part 24 patients recruited from the Diabetes Outpatient Clinic of Gentofte University Hospital will be randomized to a treatment supplement of either Januvia or placebo
Procedures During the trial patients will be tested with well established procedures In part one patients will undergo a standardized meal test and two β-cell secretory capacity tests In part two patients will undergo standardized hyperglycaemic GIP GLP-1 and saline clamps
Safety The trial has a short time span of only three months With more than ten visits during this time and regular blood sampling the patients are well monitored
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