A Single-Dose Crossover Study of MK0893 in Patients With Type 2 Diabetes (0893-019 AM4)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT00902161

First received: May 13, 2009

Last updated: April 10, 2012

Last verified: April 2012

History of Changes

Results First Received: April 10, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Type 2 Diabetes Mellitus
Interventions:	Drug: MK0893 Drug: MK0893-matched Placebo Drug: Propranolol Hydrochloride (HCL)

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
Propanolol + MK0893 / Propanolol + Placebo	After a 4 week wash-out period with a 4-week propanolol run-on, single dose MK0893 was added on Day -1 of Period 1 (Study Visit 6) and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol alone. Following the washout, participants were treated with a single dose of MK0893-matched placebo on Day 21 (Visit 8) while continuing on propanolol.
Propanolol + Placebo / Propanolol + MK0893	After a 4 week wash-out period with a 4-week propanolol run-on, MK0893-matched placebo was added on Day -1 of Period 1 (Study Visit 6) and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol alone. Following the washout, participants were treated with a single dose of MK0893 on Day 21 (Visit 8) while continuing on propanolol.
Propanolol Alone	Participants received treatment with propanolol alone during a 4 week run-on before the 1st clamp procedure at Visit 6, and during a 3 week washout between clamp procedures at Visits 6 (Period 1) and 8 (Period 2). Overall, participants were treated with propranolol for approximately 7 weeks (from propranol titration through Visit 8 clamp procedures).

Participant Flow for 4 periods

Period 1: Pre-study Washout/Propanolol Run-in

	Propanolol + MK0893 / Propanolol + Placebo	Propanolol + Placebo / Propanolol + MK0893	Propanolol Alone
STARTED	0	0	22
COMPLETED	0	0	22
NOT COMPLETED	0	0	0

Period 2: Period 1

	Propanolol + MK0893 / Propanolol + Placebo	Propanolol + Placebo / Propanolol + MK0893
STARTED	12	10
COMPLETED	12	10
NOT COMPLETED	0	0

Period 3: Post-clamp Washout

	Propanolol + MK0893 / Propanolol + Placebo	Propanolol + Placebo / Propanolol + MK0893	Propanolol Alone
STARTED	0	0	22
COMPLETED	0	0	22 ^[1]
NOT COMPLETED	0	0	0

[1]	2 participants discontinued washout and were replaced; 1 due to an AE and 1 due to lack of efficacy

Period 4: Period 2

	Propanolol + MK0893 / Propanolol + Placebo	Propanolol + Placebo / Propanolol + MK0893
STARTED	8	9
COMPLETED	8 ^[1]	9
NOT COMPLETED	0	0

[1]	2 participants discontinued and were replaced; 1 due to protocol deviation and 1 withdrew consent

Baseline Characteristics

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Reporting Groups

	Description
MK0893 + Propanolol	Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
Placebo + Propanolol	Participants received a single dose of MK0893-matched placebo added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
Total	Total of all reporting groups

Baseline Measures

	MK0893 + Propanolol	Placebo + Propanolol	Total
Number of Participants [units: participants]	12	10	22
Age [units: years] Mean ± Standard Deviation	51.3 ± 5.66	48.5 ± 6.88	50.0 ± 6.26
Gender [units: participants]
Female	2	4	6
Male	10	6	16

Outcome Measures

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1. Primary:

Recovery Time (Rt[65] From Insulin-induced Hypoglycemia [ Time Frame: From the time of hypoglycemic clamp (t=0 minutes) through 270 minutes ]

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2. Secondary:

Maximum Plasma Concentration (Cmax) and Concentration Average Over 8-12 Hours (C[Ave] 8-12 hr) Post Single Dose MK0893 [ Time Frame: From time of MK0893 administration through 24 hours post-dose ]

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3. Secondary:

Plasma Concentration at 32 Hours (C[32hr]) Post Single Dose MK0893 [ Time Frame: From time of MK0893 administration through estimated 32 hours post-dose ]

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4. Secondary:

Number of Participants With An Adverse Event (AE) [ Time Frame: From time of administration of study treatment through end of Post-Study (up to 21 days after administration of last dose of study treatment). ]

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5. Secondary:

Number of Participants Who Discontinued Study Treatment Due To AEs [ Time Frame: From time of first administration of study treatment to time of last administration of study treatment (up to Day 21) ]

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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:	NCT00902161 History of Changes
Other Study ID Numbers:	MK-0893-019, 2009_592
Study First Received:	May 13, 2009
Results First Received:	April 10, 2012
Last Updated:	April 10, 2012
Health Authority:	United States: Food and Drug Administration

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