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: September 9, 2014
Last verified: September 2014
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  
Number of Participants  
[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: September 9, 2014
Health Authority: United States: Food and Drug Administration