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Sitagliptin Metformin/PPARg Agonist Combination Therapy Add-on

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00350779
First received: July 7, 2006
Last updated: April 20, 2010
Last verified: April 2010
History of Changes
Results First Received: May 13, 2009  
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
Drug: Comparator: Placebo
Drug: rosiglitazone
Drug: metformin
Drug: glipizide

  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
Phase III First Patient In: 29-Aug-06. Last Patient Enrolled: 23-Mar-07. Last Patient Last Visit: 27-May-08; 41 study centers worldwide

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients 18-78 years of age with T2DM and inadequate glycemic control (HbA1c ≥7.5 and ≤11.0%) who were on stable doses of rosiglitazone (≥4 mg/day) and metformin (≥1500 mg/day) after an up to 20-week dose-titration and stabilization period were eligible to enter the 54-week study.

Reporting Groups
  Description
Sitagliptin 100 mg The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
Placebo The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).

Participant Flow:   Overall Study
    Sitagliptin 100 mg     Placebo  
STARTED     170     92  
COMPLETED     148     71  
NOT COMPLETED     22     21  
Adverse Event                 4                 2  
Lack of Efficacy                 0                 4  
Lost to Follow-up                 2                 0  
Physician Decision                 2                 4  
Protocol Violation                 3                 1  
Withdrawal by Subject                 9                 8  
Patient Moved                 2                 1  
Non-compliance with study procedures                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Sitagliptin 100 mg The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
Placebo The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
Total Total of all reporting groups

Baseline Measures
    Sitagliptin 100 mg     Placebo     Total  
Number of Participants  
[units: participants]
 		  170     92     262  
Age  
[units: years]
Mean ± Standard Deviation 		  54.4  ± 8.8     54.8  ± 9.5     54.5  ± 9.0  
Gender  
[units: participants]
 		     
Female     74     37     111  
Male     96     55     151  
Race/Ethnicity  
[units: participants]
 		     
White     82     51     133  
Black     7     3     10  
Hispanic     13     10     23  
Asian     58     24     82  
Other     10     4     14  
HbA1c (Hemoglobin A1c)  
[units: Percent]
Mean ± Standard Deviation 		  8.8  ± 1.0     8.7  ± 1.0     8.8  ± 1.0  



  Outcome Measures
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1.  Primary:   Change From Baseline in HbA1c (Hemoglobin A1C) at Week 18   [ Time Frame: Baseline and 18 Weeks ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline in FPG (Fasting Plasma Glucose) at Week 18   [ Time Frame: Baseline and 18 Weeks ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in 2-hour PMG (Post-meal Glucose) at Week 18   [ Time Frame: Baseline and Week 18 ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54   [ Time Frame: Baseline and Week 54 ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54   [ Time Frame: Baseline and Week 54 ]
  Show Outcome Measure 5

6.  Secondary:   Change From Baseline in 2-hour PMG (Post-meal Glucose) 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
Non-serious adverse event results represent those events included in the primary safety analysis for this study (events occurred prior to initiation of glycemic rescue therapy). Site 0520039 was non-compliant with GDP, data was removed from analyses.  


Results Point of Contact:  
Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


No publications provided by Merck

Publications automatically indexed to this study:


Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00350779     History of Changes
Other Study ID Numbers: 2006_507, MK0431-052
Study First Received: July 7, 2006
Results First Received: May 13, 2009
Last Updated: April 20, 2010
Health Authority: United States: Food and Drug Administration