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Safety and Efficacy of Co-Administration of Sitagliptin and Metformin in China (MK-0431-121)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01076088
First received: February 24, 2010
Last updated: April 27, 2017
Last verified: April 2017
History of Changes
Results First Received: December 17, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Sitagliptin 50 mg
Drug: Metformin 500 mg
Drug: Sitagliptin 100 mg
Drug: Placebo
Drug: Metformin 850 mg

  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
In total, 744 participants were randomized to treatment. Of these 744 participants, 1 participant, assigned to the placebo group, did not receive study medication. This participant was not included in the safety analyses.

Reporting Groups
  Description
Sitagliptin 50 mg + Metformin 500 mg Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
Sitagliptin 50 mg + Metformin 850 mg Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
Metformin 500 mg Metformin 500 mg twice daily
Metformin 850 Metformin 850 mg twice daily
Sitagliptin 100 mg Sitagliptin 100 mg once daily
Placebo Matching placebo to sitagliptin and/or metformin. Population includes 1 participant who did not receive any study medication.

Participant Flow:   Overall Study
    Sitagliptin 50 mg + Metformin 500 mg   Sitagliptin 50 mg + Metformin 850 mg   Metformin 500 mg   Metformin 850   Sitagliptin 100 mg   Placebo
STARTED   122   125   126   124   120   127 
COMPLETED   111   107   109   109   104   104 
NOT COMPLETED   11   18   17   15   16   23 
Adverse Event                1                6                3                2                3                3 
Lost to Follow-up                1                1                0                1                1                2 
Non-compliance with study drug                0                0                0                1                0                0 
Physician Decision                1                3                0                1                1                0 
Withdrawal by Subject                8                8                14                10                11                17 
Other protocol specified criteria                0                0                0                0                0                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 50 mg + Metformin 500 mg Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
Sitagliptin 50 mg + Metformin 850 mg Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
Metformin 500 mg Metformin 500 mg twice daily
Metformin 850 Metformin 850 mg twice daily
Sitagliptin 100 mg Sitagliptin 100 mg once daily
Placebo Matching placebo to sitagliptin and/or metformin. Population includes 1 participant who did not receive any study medication.
Total Total of all reporting groups

Baseline Measures
   Sitagliptin 50 mg + Metformin 500 mg   Sitagliptin 50 mg + Metformin 850 mg   Metformin 500 mg   Metformin 850   Sitagliptin 100 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 122   125   126   124   120   127   744 
Age 
[Units: Years]
Mean (Standard Deviation) 		 52.6  (11.3)   52.4  (9.3)   52.6  (9.5)   53.0  (10.3)   51.7  (10.2)   53.6  (9.7)   52.7  (10.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		             
Female      37  30.3%      58  46.4%      57  45.2%      49  39.5%      46  38.3%      40  31.5%      287  38.6% 
Male      85  69.7%      67  53.6%      69  54.8%      75  60.5%      74  61.7%      87  68.5%      457  61.4% 
Hemoglobin A1c (A1C) 
[Units: Percent of glycosylated hemoglobin]
Mean (Standard Deviation) 		 8.46  (0.97)   8.66  (0.95)   8.69  (0.99)   8.67  (1.08)   8.74  (1.14)   8.97  (1.05)   8.70  (1.04) 
Fasting plasma glucose (FPG) 
[Units: mg/dL]
Mean (Standard Deviation) 		 175.6  (40.6)   181.9  (43.0)   184.6  (46.8)   183.5  (47.7)   182.5  (44.0)   185.8  (47.3)   182.3  (45.0) 
2-hour post meal glucose (2-h PMG) [1] 
[Units: mg/dL]
Mean (Standard Deviation) 		 292.7  (81.2)   292.9  (68.4)   303.2  (74.1)   298.8  (74.6)   297.7  (74.7)   308.3  (83.6)   299.0  (76.2) 
[1] Participants with data: sita50/met500, n=121; sita50/met850, n=125; met500, n=125; met850, n=123; sita100, n=119; placebo; n=126; total, n=739


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

2.  Secondary:   Change From Baseline in 2-hour Post Meal Glucose (2-h PMG) at Week 24   [ Time Frame: Baseline and Week 24 ]
  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


  Serious Adverse Events
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Time Frame No text entered.
Additional Description All participants as treated population. Serious and non-serious adverse events (AEs) include and exclude data after rescue therapy, respectively. One event of hypoglycaemia that, per protocol, should have been reported as an AE was not reported as an AE. This event occurred in a participant who had another event of hypoglycaemia that was reported.

Reporting Groups
  Description
Sitagliptin 50 mg + Metformin 500 mg Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
Sitagliptin 50 mg + Metformin 850 mg Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
Metformin 500 mg Metformin 500 mg twice daily
Metformin 850 Metformin 850 mg twice daily
Sitagliptin 100 mg Sitagliptin 100 mg once daily
Placebo Matching placebo to sitagliptin and/or metformin. Population excludes 1 participant who did not receive any study medication.

Serious Adverse Events
    Sitagliptin 50 mg + Metformin 500 mg   Sitagliptin 50 mg + Metformin 850 mg   Metformin 500 mg   Metformin 850   Sitagliptin 100 mg   Placebo
Total, Serious Adverse Events             
# participants affected / at risk   0/122 (0.00%)   0/125 (0.00%)   1/126 (0.79%)   1/124 (0.81%)   3/120 (2.50%)   1/126 (0.79%) 
Blood and lymphatic system disorders             
Coagulopathy † 1             
# participants affected / at risk   0/122 (0.00%)   0/125 (0.00%)   0/126 (0.00%)   0/124 (0.00%)   0/120 (0.00%)   1/126 (0.79%) 
# events   0   0   0   0   0   1 
Infections and infestations             
Lung infection † 1             
# participants affected / at risk   0/122 (0.00%)   0/125 (0.00%)   0/126 (0.00%)   0/124 (0.00%)   0/120 (0.00%)   1/126 (0.79%) 
# events   0   0   0   0   0   1 
Injury, poisoning and procedural complications             
Femur fracture † 1             
# participants affected / at risk   0/122 (0.00%)   0/125 (0.00%)   1/126 (0.79%)   0/124 (0.00%)   0/120 (0.00%)   0/126 (0.00%) 
# events   0   0   1   0   0   0 
Lumbar vertebral fracture † 1             
# participants affected / at risk   0/122 (0.00%)   0/125 (0.00%)   0/126 (0.00%)   1/124 (0.81%)   0/120 (0.00%)   0/126 (0.00%) 
# events   0   0   0   1   0   0 
Thoracic vertebral fracture † 1             
# participants affected / at risk   0/122 (0.00%)   0/125 (0.00%)   0/126 (0.00%)   1/124 (0.81%)   0/120 (0.00%)   0/126 (0.00%) 
# events   0   0   0   1   0   0 
Investigations             
Coagulation time shortened † 1             
# participants affected / at risk   0/122 (0.00%)   0/125 (0.00%)   0/126 (0.00%)   0/124 (0.00%)   1/120 (0.83%)   0/126 (0.00%) 
# events   0   0   0   0   1   0 
Transaminases increased † 1             
# participants affected / at risk   0/122 (0.00%)   0/125 (0.00%)   0/126 (0.00%)   0/124 (0.00%)   1/120 (0.83%)   0/126 (0.00%) 
# events   0   0   0   0   1   0 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Renal cancer † 1             
# participants affected / at risk   0/122 (0.00%)   0/125 (0.00%)   0/126 (0.00%)   0/124 (0.00%)   0/120 (0.00%)   1/126 (0.79%) 
# events   0   0   0   0   0   1 
Nervous system disorders             
Cerebral infarction † 1             
# participants affected / at risk   0/122 (0.00%)   0/125 (0.00%)   0/126 (0.00%)   0/124 (0.00%)   1/120 (0.83%)   0/126 (0.00%) 
# events   0   0   0   0   1   0 
Subarachnoid haemorrhage † 1             
# participants affected / at risk   0/122 (0.00%)   0/125 (0.00%)   0/126 (0.00%)   1/124 (0.81%)   0/120 (0.00%)   0/126 (0.00%) 
# events   0   0   0   1   0   0 
† Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 15.1




  Other Adverse Events
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  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
No text entered.


  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 of Results:


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01076088     History of Changes
Other Study ID Numbers: 0431-121
2010_514 ( Other Identifier: Merck Registration Number )
Study First Received: February 24, 2010
Results First Received: December 17, 2013
Last Updated: April 27, 2017