A Single Dose Study to Investigate the Pharmacokinetics of MK-0941 in Participants With Renal Insufficiency (MK-0941-015-02) - Study Results

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Pharmacokinetics Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Type 2 Diabetes
Interventions:	Drug: MK-0941 20 mg Drug: MK-0941 5 mg

Participant Flow

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
MK-0941 20 mg Mild Renal Insufficiency	MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with mild renal insufficiency.
Control + MK-0941 20 mg	Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus but without mild renal insufficiency (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
MK-0941 20 mg Moderate Renal Insufficiency	MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with moderate renal insufficiency.
Control + 20 mg MK-0941	Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without moderate renal insufficiency who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
MK-0941 5 mg Severe Renal Insufficiency	MK-0941 administered as a single oral dose of 5 mg to participants with severe renal insufficiency.
Control + MK-0941 5 mg	Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without severe renal insufficiency who received MK-941 at a dose of 5 mg administered as a single oral dose.

Participant Flow: Overall Study

	MK-0941 20 mg Mild Renal Insufficiency	Control + MK-0941 20 mg	MK-0941 20 mg Moderate Renal Insufficiency	Control + 20 mg MK-0941
STARTED	8	8	8	8
COMPLETED	8	8	8	8
NOT COMPLETED	0	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
MK-0941 20 mg Mild Renal Insufficiency	MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with mild renal insufficiency.
Control + MK-0941 20 mg	Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus but without mild renal insufficiency (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
MK-0941 20 mg Moderate Renal Insufficiency	MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with moderate renal insufficiency.
Control + 20 mg MK-0941	Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without moderate renal insufficiency who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
MK-0941 5 mg Severe Renal Insufficiency	MK-0941 administered as a single oral dose of 5 mg to participants with severe renal insufficiency.
Control + MK-0941 5 mg	Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without severe renal insufficiency who received MK-941 at a dose of 5 mg administered as a single oral dose.
Total	Total of all reporting groups

Baseline Measures

	MK-0941 20 mg Mild Renal Insufficiency	Control + MK-0941 20 mg	MK-0941 20 mg Moderate Renal Insufficiency	Control + 20 mg MK-0941	MK-0941 5 mg Severe Renal Insufficiency	Control + MK-0941 5 mg	Total
Number of Participants [units: participants]	8	8	8	8	0	0	32
Age [units: participants]
<=18 years	0	0	0	0			0
Between 18 and 65 years	6	6	7	7			26
>=65 years	2	2	1	1			6
Gender [units: participants]
Female	6	6	5	5			22
Male	2	2	3	3			10

Outcome Measures

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1. Primary:

Plasma Area Under the Curve (AUC [0-infinity]) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls [ Time Frame: 72 Hours Post-Dose ]

Show Outcome Measure 1

2. Primary:

Plasma AUC (0-infinity) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among With Moderate Renal Insufficiency vs Matched Controls [ Time Frame: 72-Hours Post-Dose ]

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3. Primary:

Plasma AUC (0-infinity) After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls [ Time Frame: 72-Hours Post-Dose ]

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4. Secondary:

Maximum Plasma Concentration (Cmax) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls [ Time Frame: 72-Hours Post-Dose ]

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5. Secondary:

Cmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls [ Time Frame: 72-Hours Post-Dose ]

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6. Secondary:

Cmax After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls [ Time Frame: 72-Hours Post-Dose ]

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7. Secondary:

Time to Maximum Plasma Concentration (Tmax) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls [ Time Frame: 72-Hours Post-Dose ]

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8. Secondary:

Tmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls [ Time Frame: 72-Hours Post-Dose ]

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9. Secondary:

Tmax After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls [ Time Frame: 72-Hours Post-Dose ]

Show Outcome Measure 9

10. Secondary:

Time to Apparent Half Life (T 1/2) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls [ Time Frame: 72-Hours Post-Dose ]

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11. Secondary:

T 1/2 After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls [ Time Frame: 72-Hours Post-Dose ]

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12. Secondary:

T 1/2 After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls [ Time Frame: 72-Hours Post-Dose ]

Show Outcome Measure 12

13. Secondary:

Amount of MK-0941 Excreted Unchanged in the Urine (Fe) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency Versus Matched Controls [ Time Frame: 36-Hours Post-Dose ]

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14. Secondary:

Fe After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency Versus Matched Controls [ Time Frame: 36-Hours Post-Dose ]

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15. Secondary:

Fe After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency Versus Matched Controls [ Time Frame: 36-Hours Post-Dose ]

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16. Secondary:

CLCR After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Mild Renal Insufficiency Versus Matched Controls [ Time Frame: 36-Hours Post-Dose ]

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17. Secondary:

CLCR After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Moderate Renal Insufficiency Versus Matched Controls [ Time Frame: 36-Hours Post-Dose ]

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18. Secondary:

CLCR After Administration of a Single Oral Dose of 5 mg of MK-0941 to Participants With Severe Renal Insufficiency Versus Matched Controls [ Time Frame: 36-Hours Post-Dose ]

Show Outcome Measure 18

19. Secondary:

Plasma Glucose Concentration After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Mild Renal Insufficiency Versus Matched Controls [ Time Frame: Up to 12 Hours Post-Dose ]

Show Outcome Measure 19

20. Secondary:

Plasma Glucose Concentration After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Moderate Renal Insufficiency Versus Matched Controls [ Time Frame: Up to 12 Hours Post-Dose ]

Show Outcome Measure 20

21. Secondary:

Plasma Glucose Concentration After Administration of a Single Oral Dose of 5 mg of MK-0941 to Participants With Severe Renal Insufficiency Versus Matched Controls [ Time Frame: Up to 12 Hours Post-Dose ]

Show Outcome Measure 21

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.

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: (800) 672-6372
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00830791 History of Changes
Other Study ID Numbers:	MK-0941-015, 2009_522
Study First Received:	January 26, 2009
Results First Received:	May 1, 2012
Last Updated:	February 28, 2013
Health Authority:	Russia: Pharmacological Committee, Ministry of Health