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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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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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

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

Other Adverse Events

	Group A	Group B
Total, other (not including serious) adverse events
# participants affected / at risk	2/60	6/61
Nervous system disorders
Headache ^{* 1}
# participants affected / at risk	2/60 (3.33%)	6/61 (9.84%)

*	Events were collected by non-systematic assessment
1	Term from vocabulary, MedDRA

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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