Dose-response Study of Exendin-9,39 on Glucose Metabolism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Adrian Vella, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01218633
First received: October 8, 2010
Last updated: January 18, 2013
Last verified: January 2013

October 8, 2010
January 18, 2013
May 2011
July 2012   (final data collection date for primary outcome measure)
Insulin Secretion [ Time Frame: over 360 minutes of study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01218633 on ClinicalTrials.gov Archive Site
glucagon secretion [ Time Frame: over 360 minutes of study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Dose-response Study of Exendin-9,39 on Glucose Metabolism
A Dose-response Study of the Effects of Exendin-9,39 on Glucose Metabolism, Glucagon and Insulin Secretion and on Insulin Action.

Multiple studies have examined the effect of endogenous GLP-1 secretions by using a competitive antagonist of GLP-1 - Exendin-9,39 - infused at rates of 300pmol/kg/min. However, the presence of an effect does not necessarily imply that this effect is due to the blockade of the endogenous GLP-1 actions at the receptor. It is possible that the supraphysiologic concentrations of Exendin may have effects of its own. To examine the effect of Exendin on glucose metabolism the investigators propose a dose-response study to determine whether the compound has effects in a dose-dependent fashion.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Pancreatic Effects of 9,39-Exendin and 9,36-GLP-1
  • Drug: saline infusion
    saline infused at 30ml/hour
  • Drug: GLP-1-9,36 infusion
    infused @ 1.2pmol/kg/min
  • Drug: Exendin-9,39 at low dose
    infused at 30pmol/kg/min
  • Drug: Exendin-9,39 at high dose
    infused @ 300pmol/kg/min
  • Placebo Comparator: Saline
    Intervention: Drug: saline infusion
  • Active Comparator: GLP-1-(9,36)-amide
    Intervention: Drug: GLP-1-9,36 infusion
  • Active Comparator: Exendin-9,39 @30pmol/kg/min
    Intervention: Drug: Exendin-9,39 at low dose
  • Active Comparator: Exendin-9,39 @300pmol/kg/min
    Intervention: Drug: Exendin-9,39 at high dose
Sathananthan M, Farrugia LP, Miles JM, Piccinini F, Dalla Man C, Zinsmeister AR, Cobelli C, Rizza RA, Vella A. Direct effects of exendin-(9,39) and GLP-1-(9,36)amide on insulin action, β-cell function, and glucose metabolism in nondiabetic subjects. Diabetes. 2013 Aug;62(8):2752-6. doi: 10.2337/db13-0140. Epub 2013 Apr 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
December 2012
July 2012   (final data collection date for primary outcome measure)

Healthy Not on any medication other than thyroid hormone replacement or OCP No history of diabetes No prior upper GI surgery

Both
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01218633
10-003435
No
Adrian Vella, Mayo Clinic
Adrian Vella
Not Provided
Principal Investigator: Adrian Vella, MD Mayo Clinic
Mayo Clinic
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP