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A Study to Test the Effectiveness and Safety of MK0893 in Combination With Other Drugs Used to Treat Type 2 Diabetes (0893-015)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00631488
First received: February 21, 2008
Last updated: January 14, 2012
Last verified: January 2012
Results First Received: October 7, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: MK-0893
Drug: Sitagliptin
Drug: Metformin
Drug: Placebo for MK-0893
Drug: Placebo for Sitagliptin
Drug: Placebo for Metformin

  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
Participants received matching placebos to MK-0893, Sitagliptin, and Metformin during a 2-week run-in period.

Reporting Groups
  Description
MK-0893 + Sitagliptin Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
MK-0893 + Metformin Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
Sitagliptin + Metformin Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.

Participant Flow:   Overall Study
    MK-0893 + Sitagliptin     MK-0893 + Metformin     Sitagliptin + Metformin  
STARTED     48     49     49  
Completed Post-Treatment Period     44     47     47  
COMPLETED     44     47     47  
NOT COMPLETED     4     2     2  
Adverse Event                 1                 0                 0  
Lost to Follow-up                 2                 2                 0  
Physician Decision                 1                 0                 1  
Protocol Violation                 0                 0                 1  



  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
MK-0893 + Sitagliptin Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
MK-0893 + Metformin Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
Sitagliptin + Metformin Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
Total Total of all reporting groups

Baseline Measures
    MK-0893 + Sitagliptin     MK-0893 + Metformin     Sitagliptin + Metformin     Total  
Number of Participants  
[units: participants]
  48     49     49     146  
Age  
[units: years]
Mean ± Standard Deviation
  53.6  ± 8.0     52.0  ± 9.7     53.8  ± 8.7     53.2  ± 8.8  
Gender  
[units: participants]
       
Female     16     26     15     57  
Male     32     23     34     89  



  Outcome Measures
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1.  Primary:   Change From Baseline (BL) to Week 4 in 24-hour Weighted Mean Glucose (WMG) Levels   [ Time Frame: BL, 4 weeks (end of double-blind treatment period) ]

2.  Secondary:   Change From BL to Week 4 in Fasting Plasma Glucose (FPG)   [ Time Frame: BL, 4 weeks (end of double-blind treatment period) ]

3.  Secondary:   Change From BL to Week 4 in 2-hr Glucose Area Under The Curve (AUC)   [ Time Frame: BL, 4 weeks (end of double-blind treatment period) ]

4.  Secondary:   Change From BL to Week 4 in the 2-Hour Total GLP-1 Total AUC   [ Time Frame: BL, 4 weeks (end of double-blind treatment period) ]

5.  Secondary:   Change From BL to Week 4 in the 2-Hour Active GLP-1 Total AUC   [ Time Frame: BL, 4 weeks (end of double-blind treatment period) ]


  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: NCT00631488     History of Changes
Other Study ID Numbers: MK-0893-015, 2007_646
Study First Received: February 21, 2008
Results First Received: October 7, 2011
Last Updated: January 14, 2012
Health Authority: United States: Food and Drug Administration