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An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (MK0431-023)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00094757
First received: October 22, 2004
Last updated: September 10, 2010
Last verified: September 2010
History of Changes
Results First Received: June 22, 2010  
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: Comparator: sitagliptin 100 mg
Drug: Comparator: sitagliptin 200 mg
Drug: Comparator: placebo
Drug: Comparator: pioglitazone

  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 In: 15-Oct-2004. Last Patient Last Visit: 28-Apr-2006. 60 medical clinics in the United States (US), 37 in 4 countries in Europe, and 17 in 5 countries in the rest of the world.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients 18-75 years of age with type 2 diabetes mellitus (T2DM) with inadequate glycemic control (Hemoglobin A1C ≥7% and ≤10.0%) on diet and exercise alone were eligible to enter the study.

Reporting Groups
  Description
Sitagliptin 100 mg The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
Sitagliptin 200 mg The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
Placebo/Pioglitazone The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.

Participant Flow:   Overall Study
    Sitagliptin 100 mg     Sitagliptin 200 mg     Placebo/Pioglitazone  
STARTED     205     206     110  
COMPLETED     152     144     80  
NOT COMPLETED     53     62     30  
Adverse Event                 11                 9                 6  
Lack of Efficacy                 11                 15                 8  
Lost to Follow-up                 3                 5                 6  
Patient Moved                 2                 1                 1  
Protocol Violation                 8                 5                 3  
Withdrawal by Subject                 14                 21                 5  
Unspecified                 3                 3                 1  
Protocol specified discontinuation                 1                 3                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Sitagliptin 100 mg The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
Sitagliptin 200 mg The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
Placebo/Pioglitazone The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
Total Total of all reporting groups

Baseline Measures
    Sitagliptin 100 mg     Sitagliptin 200 mg     Placebo/Pioglitazone     Total  
Number of Participants  
[units: participants]
 		  205     206     110     521  
Age  
[units: years]
Mean ± Standard Deviation 		  54.5  ± 10.0     55.4  ± 9.2     55.5  ± 10.1     55.1  ± 9.7  
Gender  
[units: participants]
 		       
Female     95     102     41     238  
Male     110     104     69     283  
Race/Ethnicity, Customized  
[units: participants]
 		       
White     142     146     68     356  
Black     16     11     12     39  
Hispanic     37     39     22     98  
Asian     8     7     5     20  
Other     2     3     3     8  
Hemoglobin A1C (A1C)  
[units: Percent]
Mean ± Standard Deviation 		  8.0  ± 0.8     8.1  ± 0.9     8.0  ± 0.9     8.1  ± 0.9  



  Outcome Measures
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1.  Primary:   Change From Baseline in A1C at Week 18   [ Time Frame: Weeks 0-18 ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline in FPG at Week 18   [ Time Frame: Weeks 0-18 ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in A1C at Week 54   [ Time Frame: Weeks 0-54 ]
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Measure Type Secondary
Measure Title Change From Baseline in A1C at Week 54
Measure Description A1C is measured as percent. Thus this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent.
Time Frame Weeks 0-54  
Safety Issue No  

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.
All Patients Treated included patients who received at least 1 dose of study therapy post-Week 18, a baseline value and ≥1 post-Week 18 value for this outcome. The last post- Week 18 observed measurement was carried forward to Week 54 for patients with no data at Week 54. Data after initiation of glycemic rescue were considered missing.

Reporting Groups
  Description
Sitagliptin 100 mg The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
Sitagliptin 200 mg The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
Placebo/Pioglitazone The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.

Measured Values
    Sitagliptin 100 mg     Sitagliptin 200 mg     Placebo/Pioglitazone  
Number of Participants Analyzed  
[units: participants]
 		  156     158     68  
Change From Baseline in A1C at Week 54  
[units: percent]
Least Squares Mean ( 95% Confidence Interval ) 		  -0.28  
  ( -0.42 to -0.14 )   		  -0.19  
  ( -0.33 to -0.05 )   		  -0.87  
  ( -1.08 to -0.66 )  

No statistical analysis provided for Change From Baseline in A1C at Week 54



4.  Secondary:   Change From Baseline in FPG at Week 54   [ Time Frame: Weeks 0-54 ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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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.


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 of Late Stage Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@spcorp.com


Publications:


Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00094757     History of Changes
Other Study ID Numbers: 2004_045, MK0431-023
Study First Received: October 22, 2004
Results First Received: June 22, 2010
Last Updated: September 10, 2010
Health Authority: United States: Food and Drug Administration