A Study to Test the Effectiveness and Safety of MK0893 in Combination With Other Drugs Used to Treat Type 2 Diabetes (0893-015)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT00631488

First received: February 21, 2008

Last updated: January 14, 2012

Last verified: January 2012

History of Changes

Results First Received: October 7, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Diabetes Mellitus, Type 2
Interventions:	Drug: MK-0893 Drug: Sitagliptin Drug: Metformin Drug: Placebo for MK-0893 Drug: Placebo for Sitagliptin Drug: Placebo for 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
Participants received matching placebos to MK-0893, Sitagliptin, and Metformin during a 2-week run-in period.

Reporting Groups

	Description
MK-0893 + Sitagliptin	Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
MK-0893 + Metformin	Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
Sitagliptin + Metformin	Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.

Participant Flow: Overall Study

	MK-0893 + Sitagliptin	MK-0893 + Metformin	Sitagliptin + Metformin
STARTED	48	49	49
Completed Post-Treatment Period	44	47	47
COMPLETED	44	47	47
NOT COMPLETED	4	2	2
Adverse Event	1	0	0
Lost to Follow-up	2	2	0
Physician Decision	1	0	1
Protocol Violation	0	0	1

Baseline Characteristics

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Reporting Groups

	Description
MK-0893 + Sitagliptin	Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
MK-0893 + Metformin	Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
Sitagliptin + Metformin	Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
Total	Total of all reporting groups

Baseline Measures

	MK-0893 + Sitagliptin	MK-0893 + Metformin	Sitagliptin + Metformin	Total
Number of Participants [units: participants]	48	49	49	146
Age [units: years] Mean ± Standard Deviation	53.6 ± 8.0	52.0 ± 9.7	53.8 ± 8.7	53.2 ± 8.8
Gender [units: participants]
Female	16	26	15	57
Male	32	23	34	89

Outcome Measures

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1. Primary:

Change From Baseline (BL) to Week 4 in 24-hour Weighted Mean Glucose (WMG) Levels [ Time Frame: BL, 4 weeks (end of double-blind treatment period) ]

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2. Secondary:

Change From BL to Week 4 in Fasting Plasma Glucose (FPG) [ Time Frame: BL, 4 weeks (end of double-blind treatment period) ]

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3. Secondary:

Change From BL to Week 4 in 2-hr Glucose Area Under The Curve (AUC) [ Time Frame: BL, 4 weeks (end of double-blind treatment period) ]

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4. Secondary:

Change From BL to Week 4 in the 2-Hour Total GLP-1 Total AUC [ Time Frame: BL, 4 weeks (end of double-blind treatment period) ]

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5. Secondary:

Change From BL to Week 4 in the 2-Hour Active GLP-1 Total AUC [ Time Frame: BL, 4 weeks (end of double-blind treatment period) ]

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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: 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. SPONSOR review can be expedited to meet publication guidelines.

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: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00631488 History of Changes
Other Study ID Numbers:	MK-0893-015, 2007_646
Study First Received:	February 21, 2008
Results First Received:	October 7, 2011
Last Updated:	January 14, 2012
Health Authority:	United States: Food and Drug Administration

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