Evaluation of the Glucoregulatory Effects of Glucagon-like Peptide-1 Receptor (GLP-1 Receptor) Activation in Participants With Type 2 Diabetes Mellitus (MK-0000-222)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01373450
First received: June 13, 2011
Last updated: February 10, 2014
Last verified: February 2014
Results First Received: May 20, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Oxyntomodulin
Drug: Liraglutide 0.6 mg
Drug: Liraglutide 1.2 mg
Drug: Placebo for Oxyntomodulin
Drug: Placebo for Liraglutide

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
OXM --> Lg-0.6--> Pbo--> Lg-1.2 Participants received Oxyntomodulin (OXM) 3.0 pmol/kg/min in the first, Liraglutide (Lg) 0.6 mg in the second, Placebo (Pbo) in the third, and Liraglutide 1.2 mg in the fourth period
Lg-0.6 mg--> Pbo--> OXM--> Pbo Participants received Liraglutide 0.6 mg in the first, Placebo in the second, Oxyntomodulin 3.0 pmol/kg/min in the third, and Placebo in the fourth period
Pbo--> OXM--> Lg-0.6-->Pbo Participants received Placebo in the first, Oxyntomodulin 3.0 pmol/kg/min in the second, Liraglutide 0.6 mg in the third, and Placebo in the fourth period
Lg-0.6--> OXM--> Pbo--> Lg-1.2 Participants received Liraglutide 0.6 mg in the first, Oxyntomodulin 3.0 pmol/kg/min in the second, Placebo in the third and Liraglutide 1.2 mg in the fourth period
OXM--> Pbo--> Lg-0.6--> Pbo Participants received Oxyntomodulin 3.0 pmol/kg/min in the first; Placebo in the second, Liraglutide 0.6 mg in the third, and Placebo in the fourth period
Pbo--> Lg-0.6--> OXM--> Lg-1.2 Participants received Placebo in the first, Liraglutide 0.6 mg in the second, Oxyntomodulin 3.0 pmol/kg/min in the third, and Liraglutide 1.2 mg in the fourth period

Participant Flow for 7 periods

Period 1:   Crossover Period 1
    OXM --> Lg-0.6--> Pbo--> Lg-1.2     Lg-0.6 mg--> Pbo--> OXM--> Pbo     Pbo--> OXM--> Lg-0.6-->Pbo     Lg-0.6--> OXM--> Pbo--> Lg-1.2     OXM--> Pbo--> Lg-0.6--> Pbo     Pbo--> Lg-0.6--> OXM--> Lg-1.2  
STARTED     2     2     2     2     2     2  
COMPLETED     2     2     2     2     2     2  
NOT COMPLETED     0     0     0     0     0     0  

Period 2:   7 Day Wash-out
    OXM --> Lg-0.6--> Pbo--> Lg-1.2     Lg-0.6 mg--> Pbo--> OXM--> Pbo     Pbo--> OXM--> Lg-0.6-->Pbo     Lg-0.6--> OXM--> Pbo--> Lg-1.2     OXM--> Pbo--> Lg-0.6--> Pbo     Pbo--> Lg-0.6--> OXM--> Lg-1.2  
STARTED     2     2     2     2     2     2  
COMPLETED     2     2     2     2     2     2  
NOT COMPLETED     0     0     0     0     0     0  

Period 3:   Crossover Period 2
    OXM --> Lg-0.6--> Pbo--> Lg-1.2     Lg-0.6 mg--> Pbo--> OXM--> Pbo     Pbo--> OXM--> Lg-0.6-->Pbo     Lg-0.6--> OXM--> Pbo--> Lg-1.2     OXM--> Pbo--> Lg-0.6--> Pbo     Pbo--> Lg-0.6--> OXM--> Lg-1.2  
STARTED     2     2     2     2     2     2  
COMPLETED     2     2     2     2     2     2  
NOT COMPLETED     0     0     0     0     0     0  

Period 4:   7 Day Wash-out
    OXM --> Lg-0.6--> Pbo--> Lg-1.2     Lg-0.6 mg--> Pbo--> OXM--> Pbo     Pbo--> OXM--> Lg-0.6-->Pbo     Lg-0.6--> OXM--> Pbo--> Lg-1.2     OXM--> Pbo--> Lg-0.6--> Pbo     Pbo--> Lg-0.6--> OXM--> Lg-1.2  
STARTED     2     2     2     2     2     2  
COMPLETED     2     2     2     2     2     2  
NOT COMPLETED     0     0     0     0     0     0  

Period 5:   Crossover Period 3
    OXM --> Lg-0.6--> Pbo--> Lg-1.2     Lg-0.6 mg--> Pbo--> OXM--> Pbo     Pbo--> OXM--> Lg-0.6-->Pbo     Lg-0.6--> OXM--> Pbo--> Lg-1.2     OXM--> Pbo--> Lg-0.6--> Pbo     Pbo--> Lg-0.6--> OXM--> Lg-1.2  
STARTED     2     2     2     2     2     2  
COMPLETED     2     2     2     2     2     2  
NOT COMPLETED     0     0     0     0     0     0  

Period 6:   7 Day Wash-out
    OXM --> Lg-0.6--> Pbo--> Lg-1.2     Lg-0.6 mg--> Pbo--> OXM--> Pbo     Pbo--> OXM--> Lg-0.6-->Pbo     Lg-0.6--> OXM--> Pbo--> Lg-1.2     OXM--> Pbo--> Lg-0.6--> Pbo     Pbo--> Lg-0.6--> OXM--> Lg-1.2  
STARTED     2     2     2     2     2     2  
COMPLETED     2     2     2     2     2     2  
NOT COMPLETED     0     0     0     0     0     0  

Period 7:   Crossover Period 4
    OXM --> Lg-0.6--> Pbo--> Lg-1.2     Lg-0.6 mg--> Pbo--> OXM--> Pbo     Pbo--> OXM--> Lg-0.6-->Pbo     Lg-0.6--> OXM--> Pbo--> Lg-1.2     OXM--> Pbo--> Lg-0.6--> Pbo     Pbo--> Lg-0.6--> OXM--> Lg-1.2  
STARTED     2     2     2     2     2     2  
COMPLETED     2     2     2     2     2     2  
NOT COMPLETED     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 Treated Participants No text entered.

Baseline Measures
    All Treated Participants  
Number of Participants  
[units: participants]
  12  
Age  
[units: years]
Mean ± Standard Deviation
  58.8  ± 3.8  
Gender  
[units: participants]
 
Female     0  
Male     12  



  Outcome Measures
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1.  Primary:   Change From Baseline in Time-weighted Average of Glucose Measured by Area Under the Curve (AUC) After a Single Dose of Oxyntomodulin (OXM)   [ Time Frame: Baseline and during GGI at time points 0, 20, 40, 60, 80, 100, 120, 140, 160 and 165 minutes ]

2.  Primary:   Change From Baseline in Maximum Ambient Glucose Concentration (Gmax) After a Single Dose of OXM   [ Time Frame: Baseline and up to 160 minutes after start of GGI ]

3.  Primary:   Change From Baseline in Beta Cell Sensitivity to Glucose (Φ) After a Single Dose of OXM   [ Time Frame: Baseline and up to160 minutes after start of GGI ]

4.  Secondary:   Change From Baseline in Insulinotrophic Effect (ISR/G) at the Highest Glucose Infusion Rate After Two Periods of Placebo Treatment   [ Time Frame: Baseline and 160 minutes after start of GGI at each placebo treatment period ]

5.  Secondary:   Change From Baseline in Gmax After Single Doses of 0.6 mg Lg, or 1.2 mg Lg, Compared With Single Doses of Placebo or OXM   [ Time Frame: Baseline and up to 160 minutes after start of GGI ]

6.  Secondary:   Change From Baseline in Insulinotrophic Effect (ISR/G) After Single Doses of 0.6 mg Lg, or 1.2 mg Lg, Compared With Single Doses of Placebo or OXM   [ Time Frame: Baseline and up to 160 minutes after start of GGI ]


  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
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  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: NCT01373450     History of Changes
Other Study ID Numbers: 0000-222
Study First Received: June 13, 2011
Results First Received: May 20, 2013
Last Updated: February 10, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)