A Study to Compare Methodologies for Assessing Glucose-Dependent Insulin Secretion (0000-104)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00782418
First received: October 29, 2008
Last updated: April 29, 2014
Last verified: April 2014
Results First Received: March 19, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Diagnostic
Condition: The Methodology Assessment of Glucose Dependent Insulin Secretion.
Interventions: Drug: Comparator: exenatide
Drug: Comparator: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

First Patient Entered: 19-Sep-2008

Last Patient, Last Visit: 05-Mar-2009

1 site


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Inclusion criteria: Subjects with a Body Mass Index (BMI) of ≤26 kg/m2

Exclusion criteria: History of diabetes or family history of diabetes.

Subjects on a carbohydrate restricted diet.

An amendment added 8 subjects to go before study completion and instituted down dosing for subjects assigned to exenatide 5 μg in the HGC period to placebo


Reporting Groups
  Description
HGC - Exenatide 5 μg Hyperglycemic Clamp (HGC): Treatment Group Exenatide 5 μg
HGC - Exenatide 1.5 μg Hyperglycemic Clamp: Treatment Group Exenatide 1.5 μg
HGC - Placebo Hyperglycemic Clamp: Treatment Group Placebo
Exenatide 5 ug Down Dosed to Placebo (HGC) Hyperglycemic Clamp: Treatment Group Exenatide 5 ug down dosed to placebo
GGI - Exenatide 5 μg Graded Glucose Infusion (GGI): Treatment Group Exenatide 5 μg
GGI - Exenatide 1.5 μg Graded Glucose Infusion: Treatment Group Exenatide 1.5 μg
Placebo (HGC or GGI) Hyperglycemic Clamp or Graded Glucose Infusion: Treatment Group Placebo

Participant Flow for 2 periods

Period 1:   Period 1 Procedure/Treatment Groups
    HGC - Exenatide 5 μg     HGC - Exenatide 1.5 μg     HGC - Placebo     Exenatide 5 ug Down Dosed to Placebo (HGC)     GGI - Exenatide 5 μg     GGI - Exenatide 1.5 μg     Placebo (HGC or GGI)  
STARTED     3     4     4     2     5     5     4  
COMPLETED     1     4     4     2     4     4     4  
NOT COMPLETED     2     0     0     0     1     1     0  
Adverse Event                 1                 0                 0                 0                 0                 0                 0  
Study placed on temporary hold                 1                 0                 0                 0                 1                 1                 0  

Period 2:   Period 2 Procedure/Treatment Groups
    HGC - Exenatide 5 μg     HGC - Exenatide 1.5 μg     HGC - Placebo     Exenatide 5 ug Down Dosed to Placebo (HGC)     GGI - Exenatide 5 μg     GGI - Exenatide 1.5 μg     Placebo (HGC or GGI)  
STARTED     3     4     4     1     3     4     4  
COMPLETED     3     4     4     1     3     4     4  
NOT COMPLETED     0     0     0     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Patients All patients from all arms

Baseline Measures
    All Patients  
Number of Participants  
[units: participants]
  27  
Age  
[units: years]
Mean ± Standard Deviation
  29.3  ± 9.1  
Gender  
[units: participants]
 
Female     0  
Male     27  
Body Mass Index  
[units: kg/m^2]
Mean ± Standard Deviation
  23.3  ± 2.1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Insulin Secretion Rate (ISR) Normalized to Ambient Plasma Glucose   [ Time Frame: Steady-state of HGC: 90 – 120 minutes post dose; highest glucose infusion rate of GGI: 120 – 160 minutes post dose ]

2.  Primary:   Change From Baseline in C-peptide Concentration   [ Time Frame: Pre and Post glucose infusion ]

3.  Primary:   Change From Baseline in Insulin Concentration   [ Time Frame: Pre and Post glucose infusion ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00782418     History of Changes
Other Study ID Numbers: 0000-104, 2008_568
Study First Received: October 29, 2008
Results First Received: March 19, 2010
Last Updated: April 29, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products