Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00393445
Status:
COMPLETED
Last Update Posted:
2011-10-04
First Post:
2006-10-26
Brief Title:
Exendin9-39Amide as a Glucagon-like Peptide-1 GLP-1 Receptor Antagonist in Humans
Sponsor:
Ludwig-Maximilians - University of Munich
Organization:
Ludwig-Maximilians - University of Munich
Study Overview
Official Title:
Effect of GLP-1 on Glucose Metabolism in Healthy Subjects and Patients With T2DM Part 1 A Pilot Study to Assess the Efficacy of Exendin9-39Amide as a GLP-1 Receptor Antagonist in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2011-10
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 purpose of this study is to determine the dose of the GLP-1 receptor antagonist exendin9-39 which blocks the insulinotropic action of synthetic GLP-1 by at least 95
Detailed Description:
Following a meal gut-produced incretin hormones such as glucagon-like peptide-1 GLP-1 and glucose-dependent insulinotropic polypeptide GIP are released into the circulation GLP-1 and GIP the two dominant incretin hormones are part of a natural endogenous system involved in maintaining glucose homeostasis In the presence of normal or elevated but not low glucose concentration both GLP-1 and GIP increase insulin secretion from pancreatic islet beta-cells β-cells GLP-1 also lowers glucagon secretion from pancreatic alpha-cells and delays nutrient delivery from the stomach by inhibiting gastric emptying This rise in insulin concentration enhances glucose clearance in peripheral tissues such as muscle and the lower glucagon concentration combined with the rise in insulin reduces hepatic glucose production By enhancing glucose clearance and lowering hepatic glucose production the post-meal glucose excursion is reduced
However the role that each incretin has in glucoregulation is not fully understood Use of a GLP-1 antagonist exendin 9-39NH2 will allow for the assessment of non-GLP-1 incretins role in glucoregulation Therefore it is of great interest to examine the role that specific incretins have in glucoregulation in patients with T2DM
Exendin9-39 has been shown a specific and reversible antagonist at the human GLP-1 receptor in vivo In initial validation studies intravenous exendin9-39 dose-dependently reduced the insulinotropic action of intravenous GLP-1 The maximal dose of 300 pmolkgmin used in these studies was sufficient to reduce GLP-1 stimulated insulin plasma levels by about 83 However to quantify the contribution of incretin hormones to the incretin effect as stated above a nearly complete inhibition of the GLP-1 action is necessary
Therefore the purpose of this pilot study is to characterize the dose-response characteristics of exendin9-39 more completely and to find a dosage which inhibits the insulinotropic action of GLP-1 by at least 95
However the role that each incretin has in glucoregulation is not fully understood Use of a GLP-1 antagonist exendin 9-39NH2 will allow for the assessment of non-GLP-1 incretins role in glucoregulation Therefore it is of great interest to examine the role that specific incretins have in glucoregulation in patients with T2DM
Exendin9-39 has been shown a specific and reversible antagonist at the human GLP-1 receptor in vivo In initial validation studies intravenous exendin9-39 dose-dependently reduced the insulinotropic action of intravenous GLP-1 The maximal dose of 300 pmolkgmin used in these studies was sufficient to reduce GLP-1 stimulated insulin plasma levels by about 83 However to quantify the contribution of incretin hormones to the incretin effect as stated above a nearly complete inhibition of the GLP-1 action is necessary
Therefore the purpose of this pilot study is to characterize the dose-response characteristics of exendin9-39 more completely and to find a dosage which inhibits the insulinotropic action of GLP-1 by at least 95
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DFG Schi 5271-2 | None | None | None |