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A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin (0431-803)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00701090
First received: June 17, 2008
Last updated: March 23, 2015
Last verified: March 2015
Results First Received: September 13, 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
Conditions: Type 2 Diabetes Mellitus, Non Insulin Dependent.
Diabetes Mellitus, Non-Insulin-Dependent
Interventions: Drug: sitagliptin
Drug: Comparator: glimepiride
Drug: open-label 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

Phase III

First Patient In: 14-May-2008; Last Patient Last Visit: 27-Oct-2009; 109 study centers worldwide


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients at least 18 years of age with type 2 diabetes mellitus with inadequate glycemic control (A1C ≥6.5 and ≤9.0%) on a stable dose of metformin (at a dose of at least 1500 mg per day for at least 12 weeks) were eligible to enter the 30 week study. Up to a 2 week screening period, followed by a 2-week placebo run-in.

Reporting Groups
  Description
Sitagliptin The Sitagliptin 100 mg q.d. (q.d. = once daily) 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 metformin oral tablets (≥1500 mg/day).
Glimepiride The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).

Participant Flow:   Overall Study
    Sitagliptin   Glimepiride
STARTED   516   519 
COMPLETED   468   468 
NOT COMPLETED   48   51 
Adverse Event                11                2 
Death                0                1 
Lack of Efficacy                5                4 
Lost to Follow-up                9                9 
Physician Decision                3                4 
Protocol Violation                2                3 
Withdrawal by Subject                11                16 
Other                7                12 



  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 100 mg q.d. (q.d. = once daily) 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 metformin oral tablets (≥1500 mg/day).
Glimepiride The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
Total Total of all reporting groups

Baseline Measures
   Sitagliptin   Glimepiride   Total 
Overall Participants Analyzed 
[Units: Participants]
 516   519   1035 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.3  (9.7)   56.2  (10.1)   56.3  (9.9) 
Gender 
[Units: Participants]
     
Female   232   240   472 
Male   284   279   563 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   297   298   595 
Black   6   6   12 
Asian   109   111   220 
American Indian/Alaska Native   25   26   51 
Other   79   78   157 
A1C (Hemoglobin A1c) 
[Units: Percent]
Mean (Standard Deviation)
 7.50  (0.70)   7.51  (0.76)   7.50  (0.73) 


  Outcome Measures
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1.  Primary:   Change From Baseline in HbA1c at Week 30   [ Time Frame: Week 0 to Week 30 ]

2.  Secondary:   Change From Baseline in FPG (Fasting Plasma Glucose) at Week 30   [ Time Frame: Week 0 to Week 30 ]

3.  Secondary:   Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30   [ Time Frame: Week 0 to Week 30 ]

4.  Secondary:   Change From Baseline in Body Weight at Week 30   [ Time Frame: Week 0 to Week 30 ]

5.  Secondary:   Percent of Patients With A1C <7.0% at Week 30   [ Time Frame: Week 30 ]

6.  Secondary:   Percent of Patients With A1C <6.5% at Week 30   [ Time Frame: Week 30 ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description Particpants analyzed are those who received at least 1 dose of study medication. One participant in the Glimepiride group did not receive any study medication and is not included in the analysis.

Frequency Threshold
Threshold above which other adverse events are reported   5  

Reporting Groups
  Description
Sitagliptin The Sitagliptin 100 mg q.d. (q.d. = once daily) 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 metformin oral tablets (≥1500 mg/day).
Glimepiride The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).

Other Adverse Events
    Sitagliptin   Glimepiride
Total, other (not including serious) adverse events     
# participants affected / at risk   58/519 (11.18%)   134/518 (25.87%) 
Infections and infestations     
Nasopharyngitis * 1     
# participants affected / at risk   25/519 (4.82%)   36/518 (6.95%) 
Metabolism and nutrition disorders     
Hypoglycaemia * 1     
# participants affected / at risk   36/519 (6.94%)   114/518 (22.01%) 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (12.1)



  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