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Sulfonylurea Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-035)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00106704
First received: March 29, 2005
Last updated: June 4, 2015
Last verified: June 2015
Results First Received: November 19, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Comparator: Sitagliptin
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: 27-Apr-2005. Last Patient Last Visit: 09-Jan-2007. 27 medical clinics in the United States (US), 25 in 11 countries in Europe, and 22 in 11 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 [A1C] ≥7.5% and ≤10.5%) at screening or after treatment with glimepiride (≥4 mg) alone or in combination with metformin (≥1500 mg) for a dose stable period of up to 10 weeks were eligible to participate.

Reporting Groups
  Description
Sitagliptin The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
Placebo/ Pioglitazone The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).

Participant Flow:   Overall Study
    Sitagliptin   Placebo/ Pioglitazone
STARTED   222   219 
COMPLETED   91   68 
NOT COMPLETED   131   151 
Adverse Event                10                7 
Death                2                1 
Lack of Efficacy                67                69 
Lost to Follow-up                7                3 
Pregnancy                1                0 
Protocol Violation                4                7 
Withdrawal by Subject                14                21 
Patient moved                1                0 
Site terminated                0                1 
Planned major surgery                1                0 
Patient Received Glycemic Medication                22                41 
Unable to re-enter US                1                0 
Laboratory test                1                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
Sitagliptin The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
Placebo/ Pioglitazone The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
Total Total of all reporting groups

Baseline Measures
   Sitagliptin   Placebo/ Pioglitazone   Total 
Overall Participants Analyzed 
[Units: Participants]
 222   219   441 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.6  (9.6)   56.5  (9.6)   56.0  (9.6) 
Gender 
[Units: Participants]
     
Female   105   102   207 
Male   117   117   234 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   136   140   276 
Black   10   12   22 
Hispanic   39   32   71 
Asian   22   25   47 
Other   15   10   25 
Fasting Plasma Glucose (FPG) 
[Units: mg/dL]
Mean (Standard Deviation)
 180.9  (37.7)   181.6  (42.5)   181.2  (40.1) 
Hemoglobin A1C (A1C) 
[Units: Percent]
Mean (Standard Deviation)
 8.34  (0.76)   8.34  (0.74)   8.34  (0.75) 


  Outcome Measures
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1.  Primary:   Change From Baseline in A1C at Week 24   [ Time Frame: Baseline and 24 Weeks ]

2.  Secondary:   Change From Baseline in FPG at Week 24   [ Time Frame: Baseline and 24 Weeks ]


  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
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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.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00106704     History of Changes
Other Study ID Numbers: 0431-035
2005_009
Study First Received: March 29, 2005
Results First Received: November 19, 2010
Last Updated: June 4, 2015
Health Authority: United States: Food and Drug Administration