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
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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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Outcome Measures

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1. Primary:

Change From Baseline in Hemoglobin A1C (A1C) at Week 24 [ Time Frame: Baseline and Week 24 ]

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2. Secondary:

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

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3. Secondary:

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline and Week 24 ]

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Serious Adverse Events

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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
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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.

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:

Ji L, Han P, Wang X, Liu J, Zheng S, Jou YM, O'Neill EA, Golm GT, Engel SS, Kaufman KD, Shankar RR. Randomized clinical trial of the safety and efficacy of sitagliptin and metformin co-administered to Chinese patients with type 2 diabetes mellitus. J Diabetes Investig. 2016 Sep;7(5):727-36. doi: 10.1111/jdi.12511. Epub 2016 May 19.

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

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