Text Size

A Study to Test MK-0941 in Adults With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin (MK-0941-018)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00824616
First received: January 16, 2009
Last updated: July 17, 2012
Last verified: July 2012
History of Changes
Results First Received: July 17, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: MK-0941
Drug: Placebo
Drug: Insulin

  Participant Flow
  Hide Participant Flow

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
Placebo Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
MK-0941 Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily

Participant Flow:   Overall Study
    Placebo     MK-0941  
STARTED     34     34  
COMPLETED     28     27  
NOT COMPLETED     6     7  
Adverse Event                 2                 1  
Creatinine/Creatinine Clearance                 0                 2  
Hyperglycemia                 1                 1  
Lack of Efficacy                 2                 1  
Lost to Follow-up                 0                 1  
Withdrawal by Subject                 1                 1  



  Baseline Characteristics
  Show Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Hemoglobin A1c (HbA1c) Level   [ Time Frame: Baseline (Day 1) and End of Treatment (Week 20) ]
  Show Outcome Measure 1

2.  Primary:   Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)   [ Time Frame: From first dose of study drug (Week 0) to last dose of study drug (Week 20) ]
  Show Outcome Measure 2


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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.


Limitations and Caveats
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.  


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
ClinicalTrials.gov Identifier: NCT00824616     History of Changes
Other Study ID Numbers: 0941-018, 2009_516, MK-0941-018
Study First Received: January 16, 2009
Results First Received: July 17, 2012
Last Updated: July 17, 2012
Health Authority: United States: Food and Drug Administration