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MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00722371
First received: July 22, 2008
Last updated: September 9, 2011
Last verified: September 2011
History of Changes
Results First Received: September 9, 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: Type 2 Diabetes Mellitus
Interventions: Drug: Sitagliptin phosphate
Drug: Pioglitazone hydrochloride
Drug: Matching placebo to sitagliptin
Drug: Matching placebo to pioglitazone
Drug: 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
No text entered.

Reporting Groups
  Description
Sitagliptin 100 mg Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
Pioglitazone 15 mg Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
Pioglitazone 30 mg Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
Pioglitazone 45 mg Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
Sitagliptin 100 mg/ Pioglitazone 15 mg Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
Sitagliptin 100 mg/ Pioglitazone 30 mg Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
Sitagliptin 100 mg/ Pioglitazone 45 mg Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.

Participant Flow:   Overall Study
    Sitagliptin 100 mg     Pioglitazone 15 mg     Pioglitazone 30 mg     Pioglitazone 45 mg     Sitagliptin 100 mg/ Pioglitazone 15 mg     Sitagliptin 100 mg/ Pioglitazone 30 mg     Sitagliptin 100 mg/ Pioglitazone 45 mg  
STARTED     231     230     233     230     230     231     230  
COMPLETED     175     158     168     167     182     178     179  
NOT COMPLETED     56     72     65     63     48     53     51  
Adverse Event                 6                 13                 9                 10                 6                 8                 4  
Contraindication                 0                 0                 1                 0                 0                 0                 0  
Creatinine / Creatinine clearance                 2                 1                 2                 3                 2                 1                 1  
Excluded medication                 0                 1                 1                 0                 0                 0                 1  
Hyperglycemia                 2                 6                 4                 2                 5                 1                 1  
Hypoglycemia                 1                 0                 0                 0                 0                 0                 0  
Lack of Efficacy                 4                 6                 6                 6                 2                 3                 0  
Lost to Follow-up                 11                 14                 21                 13                 8                 16                 13  
Physician Decision                 5                 2                 2                 5                 2                 3                 4  
Pregnancy                 1                 1                 0                 0                 0                 1                 0  
Protocol Violation                 6                 1                 0                 1                 4                 2                 1  
Withdrawal by Subject                 18                 27                 19                 23                 19                 18                 26  



  Baseline Characteristics
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Reporting Groups
  Description
Sitagliptin 100 mg Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
Pioglitazone 15 mg Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
Pioglitazone 30 mg Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
Pioglitazone 45 mg Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
Sitagliptin 100 mg/ Pioglitazone 15 mg Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
Sitagliptin 100 mg/ Pioglitazone 30 mg Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
Sitagliptin 100 mg/ Pioglitazone 45 mg Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
Total Total of all reporting groups

Baseline Measures
    Sitagliptin 100 mg     Pioglitazone 15 mg     Pioglitazone 30 mg     Pioglitazone 45 mg     Sitagliptin 100 mg/ Pioglitazone 15 mg     Sitagliptin 100 mg/ Pioglitazone 30 mg     Sitagliptin 100 mg/ Pioglitazone 45 mg     Total  
Number of Participants  
[units: participants]
 		  231     230     233     230     230     231     230     1615  
Age, Customized  
[units: Participants]
 		               
<=20 years     0     0     0     0     0     0     0     0  
21 to 30 years     5     6     2     5     5     8     4     35  
31 to 40 years     37     39     33     20     17     34     15     195  
41 to 50 years     64     73     60     70     73     60     68     468  
51 to 60 years     83     67     88     76     80     75     87     556  
61 to 70 years     31     34     45     53     44     49     51     307  
>70 years     11     11     5     6     11     5     5     54  
Gender  
[units: participants]
 		               
Female     95     82     106     117     112     96     95     703  
Male     136     148     127     113     118     135     135     912  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Hemoglobin A1C (A1C) at Week 24   [ Time Frame: Baseline and Week 24 ]
  Show Outcome Measure 1

2.  Primary:   Change From Baseline in A1C at Week 54   [ Time Frame: Baseline and Week 54 ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24   [ Time Frame: Baseline and Week 24 ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline in 2-Hour Post-meal Glucose (PMG) at Week 24   [ Time Frame: Baseline and Week 24 ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline in FPG at Week 54   [ Time Frame: Baseline and Week 54 ]
  Hide Outcome Measure 5

Measure Type Secondary
Measure Title Change From Baseline in FPG at Week 54
Measure Description No text entered.
Time Frame Baseline and Week 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.
Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.

Reporting Groups
  Description
Sitagliptin 100 mg Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
Pioglitazone 15 mg Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
Pioglitazone 30 mg Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
Pioglitazone 45 mg Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
Sitagliptin 100 mg/ Pioglitazone 15 mg Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
Sitagliptin 100 mg/ Pioglitazone 30 mg Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
Sitagliptin 100 mg/ Pioglitazone 45 mg Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.

Measured Values
    Sitagliptin 100 mg     Pioglitazone 15 mg     Pioglitazone 30 mg     Pioglitazone 45 mg     Sitagliptin 100 mg/ Pioglitazone 15 mg     Sitagliptin 100 mg/ Pioglitazone 30 mg     Sitagliptin 100 mg/ Pioglitazone 45 mg  
Number of Participants Analyzed  
[units: participants]
 		  179     176     185     181     189     181     193  
Change From Baseline in FPG at Week 54  
[units: mg/dL]
Least Squares Mean ( 95% Confidence Interval ) 		  -13.1  
  ( -21.6 to -4.5 )   		  -10.5  
  ( -19.0 to -2.0 )   		  -24.0  
  ( -32.4 to -15.5 )   		  -33.3  
  ( -41.8 to -24.8 )   		  -33.9  
  ( -42.2 to -25.7 )   		  -37.1  
  ( -45.5 to -28.6 )   		  -47.8  
  ( -56.1 to -39.5 )  

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



6.  Secondary:   Change From Baseline in 2-Hour PMG at Week 54   [ Time Frame: Baseline and Week 54 ]
  Show Outcome Measure 6


  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, 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: NCT00722371     History of Changes
Other Study ID Numbers: MK-0431-102, 2008_522
Study First Received: July 22, 2008
Results First Received: September 9, 2011
Last Updated: September 9, 2011
Health Authority: United States: Food and Drug Administration