A Study to Assess the Safety and Tolerability of Sitagliptin/Simvastatin Fixed-dose Combination (FDC) in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy (MK-0431D-312)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT01702298

First received: October 4, 2012

Last updated: April 2, 2015

Last verified: April 2015

History of Changes

Results First Received: May 1, 2014

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Type 2 Diabetes Mellitus
Interventions:	Drug: Sitagliptin 100 mg/simvastatin 40 mg FDC Drug: 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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Sitagliptin 100 mg/Simvastatin 40 mg FDC	Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).

Participant Flow: Overall Study

	Sitagliptin 100 mg/Simvastatin 40 mg FDC
STARTED	42
COMPLETED	41
NOT COMPLETED	1
Withdrawal by Subject	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.
All participants enrolled

Reporting Groups

	Description
Sitagliptin 100 mg/Simvastatin 40 mg FDC	Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).

Baseline Measures

	Sitagliptin 100 mg/Simvastatin 40 mg FDC
Number of Participants [units: participants]	42
Age [units: Years] Mean (Standard Deviation)	48.3 (7.1)
Gender [units: Participants]
Female	19
Male	23
Fasting Plasma Glucose (FPG) [units: mg/dL] Mean (Standard Deviation)	159.3 (40.9)
Low-density lipoprotein cholesterol (LDL-C) [units: mg/dL] Mean (Standard Deviation)	109.6 (27.2)
Total Cholesterol (TC) [units: md/dL] Mean (Standard Deviation)	195.2 (36.4)
(Non-High-Density Lipoprotein Cholesterol (non-HDL-C) [units: mg/dL] Mean (Standard Deviation)	152.0 (37.9)
Triglycerides (TG) [units: mg/dL] Mean (Standard Deviation)	225.3 (152.5)
High-Density Lipoprotein Cholesterol (HDL-C) [units: mg/dL] Mean (Standard Deviation)	43.1 (11.9)

Outcome Measures

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1. Primary:

Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline and Week 6 ]

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2. Primary:

Percentage of Participants Who Experienced at Least One Adverse Event [ Time Frame: Up to 8 weeks (including 14 days after final dose of study drug) ]

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3. Primary:

Number of Participants Who Discontinued Study Drug Due to an Adverse Event [ Time Frame: Up to 6 weeks ]

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4. Secondary:

Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) [ Time Frame: Baseline and Week 6 ]

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5. Secondary:

Change From Baseline in Total Cholesterol (TC) [ Time Frame: Baseline and Week 6 ]

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6. Secondary:

Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) [ Time Frame: Baseline and Week 6 ]

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Measure Type	Secondary
Measure Title	Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C)
Measure Description	Change from baseline in non-HDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.
Time Frame	Baseline and Week 6
Safety Issue	No

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.
FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements. One participant, who had no on-treatment data, was excluded from the FAS for the LDA analysis of non-HDL-C.

Reporting Groups

	Description
Sitagliptin 100 mg/Simvastatin 40 mg FDC	Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).

Measured Values

	Sitagliptin 100 mg/Simvastatin 40 mg FDC
Number of Participants Analyzed [units: participants]	41
Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) [units: Percent change] Least Squares Mean (95% Confidence Interval)	-43.1 (-47.4 to -38.9)

No statistical analysis provided for Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C)

7. Secondary:

Change From Baseline in Triglycerides (TG) [ Time Frame: Baseline and Week 6 ]

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8. Secondary:

Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline and Week 6 ]

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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

Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT01702298 History of Changes
Other Study ID Numbers:	0431D-312
Study First Received:	October 4, 2012
Results First Received:	May 1, 2014
Last Updated:	April 2, 2015
Health Authority:	Vietnam: Ministry of Health

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