Sitagliptin/Metformin Fed Bioequivalence Study

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00929201

First received: June 25, 2009

Last updated: April 21, 2010

Last verified: April 2010

History of Changes

Results First Received: January 5, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Bio-equivalence Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Type 2 Diabetes Mellitus
Interventions:	Drug: sitagliptin phosphate (+) metformin hydrochloride Drug: Comparator: sitagliptin Drug: Comparator: 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
Group A/B	Sitagliptin 50 mg and metformin 500 mg individual tablets/ Sitagliptin/Metformin 50 mg/500 mg final marketed image (FMI) fixed-dose combination (FDC) tablet
Group B/A	Sitagliptin/Metformin 50 mg/500 mg final marketed image (FMI) fixed-dose combination (FDC) tablet/ Sitagliptin 50 mg and metformin 500 mg individual tablets

Participant Flow for 2 periods

Period 1: Period 1

	Group A/B	Group B/A
STARTED	30	31
COMPLETED	30	30
NOT COMPLETED	0	1
Withdrawal by Subject	0	1

Period 2: Period 2

	Group A/B	Group B/A
STARTED	30	30
COMPLETED	30	30
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
All Participants	All Participants from Groups A/B and B/A for both trial periods.

Baseline Measures

	All Participants
Number of Participants [units: participants]	61
Age [units: Years] Mean ( Full Range )	32.4 ( 18 to 45 )
Gender [units: participants]
Female	31
Male	30
Height [units: Centimeters] Mean ( Full Range )	164.9 ( 150.0 to 184.0 )
Weight [units: Kilograms] Mean ( Full Range )	73.0 ( 45.9 to 102.3 )

Outcome Measures

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1. Primary:

Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin [ Time Frame: 72 Hours Post Dose ]

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Measure Type	Primary
Measure Title	Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin
Measure Description	No text entered.
Time Frame	72 Hours Post Dose
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.
Healthy Adult Subjects

Reporting Groups

	Description
Group A	Sitagliptin 50 mg and metformin 500 mg individual tablets
Group B	Sitagliptin/Metformin 50 mg/500 mg final marketed image (FMI) fixed-dose combination (FDC) tablet

Measured Values

	Group A	Group B
Number of Participants Analyzed [units: participants]	60	60
Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin [units: μg * hr/mL] Least Squares Mean ± Standard Deviation	7.65 ± 1.39	7.45 ± 1.48

Statistical Analysis 1 for Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Least-Squares Mean Ratio ^[3]	0.97
90% Confidence Interval	( 0.95 to 1.00 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Least-Squares Mean Ratio (B/A) A = Sitagliptin 50 mg and metformin 500 mg individual tablets B = Sitagliptin/Metformin 50 mg/500 mg combination tablet
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	The FMI sitagliptin/metformin 50/500 mg FDC tablet and coadministration of corresponding doses of sitagliptin and metformin as individual tablets after consumption of a standard high-fat breakfast will be bioequivalent for metformin based on assessment of the AUC0-∞ for metformin [i.e., the true metformin AUC0-∞GMR (sitagliptin/metformin 50/500 mg FDC tablet/co-administration of sitagliptin and metformin as individual tablets will be contained within (0.80, 1.25)].
[3]	Other relevant estimation information:
	No text entered.

2. Secondary:

Peak Plasma Concentration (Cmax) of Metformin [ Time Frame: 72 Hours Post Dose ]

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Serious Adverse Events

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Other Adverse Events

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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: Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

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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Results Point of Contact:

Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00929201 History of Changes
Other Study ID Numbers:	2009_607, MK0431A-080
Study First Received:	June 25, 2009
Results First Received:	January 5, 2010
Last Updated:	April 21, 2010
Health Authority:	United States: Food and Drug Administration

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