A Study to Test MK-0941 in Adults With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin (MK-0941-018)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT00824616

First received: January 16, 2009

Last updated: July 17, 2012

Last verified: July 2012

History of Changes

Results First Received: July 17, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Type 2 Diabetes Mellitus
Interventions:	Drug: MK-0941 Drug: Placebo Drug: Insulin

Participant Flow

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Baseline Characteristics

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Reporting Groups

	Description
Placebo	Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
MK-0941	Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
Total	Total of all reporting groups

Baseline Measures

	Placebo	MK-0941	Total
Number of Participants [units: participants]	34	34	68
Age [units: years] Mean ± Standard Deviation	55.5 ± 8.8	54.1 ± 10.2	54.8 ± 9.5
Gender [units: participants]
Female	15	16	31
Male	19	18	37

Outcome Measures

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1. Primary:

Change From Baseline in Hemoglobin A1c (HbA1c) Level [ Time Frame: Baseline (Day 1) and End of Treatment (Week 20) ]

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2. Primary:

Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic) [ Time Frame: From first dose of study drug (Week 0) to last dose of study drug (Week 20) ]

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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: After multicenter publication or 24 months after study completion, whichever comes first, an investigator may publish the results for their study site only. Sponsor can review publications 60 days prior to submission.

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
No text entered.

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:	NCT00824616 History of Changes
Other Study ID Numbers:	0941-018, 2009_516, MK-0941-018
Study First Received:	January 16, 2009
Results First Received:	July 17, 2012
Last Updated:	July 17, 2012
Health Authority:	United States: Food and Drug Administration

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