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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00830791
First received: January 26, 2009
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

This study will assess the pharmacokinetics of MK-0941 in participants with varying degrees of renal insufficiency.


Condition Intervention Phase
Type 2 Diabetes
Drug: MK-0941 20 mg
Drug: MK-0941 5 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Dose Study to Investigate the Pharmacokinetics of MK-0941 in Subjects With Renal Insufficiency

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency taking a single oral dose of 20 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour creatinine clearance (CLCR) of > 50 to 80 mL/min/1.73m^2.

  • 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 ] [ Designated as safety issue: No ]
    Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency taking a single oral dose of 20 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.

  • 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 ] [ Designated as safety issue: No ]
    Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency taking a single oral dose of 5 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of > 30 mL/min/1.73m^2.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.

  • 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 ] [ Designated as safety issue: No ]
    Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.

  • 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 ] [ Designated as safety issue: No ]
    Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of > 30 mL/min/1.73m^2.

  • 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 ] [ Designated as safety issue: No ]
    Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.

  • 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 ] [ Designated as safety issue: No ]
    Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.

  • 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 ] [ Designated as safety issue: No ]
    Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of > 30 mL/min/1.73m^2.

  • 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 ] [ Designated as safety issue: No ]
    T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.

  • 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 ] [ Designated as safety issue: No ]
    T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 20 mg of MK-0941 versus controls with normal renal function that received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.

  • 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 ] [ Designated as safety issue: No ]
    T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of > 30 mL/min/1.73m^2.

  • 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 ] [ Designated as safety issue: No ]
    Fe was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.

  • 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 ] [ Designated as safety issue: No ]
    Fe was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 20 mg of MK-0941 versus controls with normal renal function that received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.

  • 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 ] [ Designated as safety issue: No ]
    Fe was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 5 mg of MK-0941 versus controls with normal renal function that received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of < 30 mL/min/1.73m^2.

  • 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 ] [ Designated as safety issue: No ]
    CICR was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.

  • 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 ] [ Designated as safety issue: No ]
    CICR was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 20 mg of MK-0941 versus controls with normal renal function that received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.

  • 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 ] [ Designated as safety issue: No ]
    CICR was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency that received 5 mg of MK-0941 versus controls with normal renal function that received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of < 30 mL/min/1.73m^2.

  • 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 ] [ Designated as safety issue: No ]
    The glucose concentration-time profile was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.

  • 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 ] [ Designated as safety issue: No ]
    The glucose concentration-time profile was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to < 50 mL/min/1.73m^2.

  • 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 ] [ Designated as safety issue: No ]
    The glucose concentration-time profile was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of < 30 mL/min/1.73m^2.


Enrollment: 32
Study Start Date: January 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-0941 20 mg Mild Renal Insufficiency
MK-0941 20 mg administered to participants with mild renal insufficiency and type 2 diabetes.
Drug: MK-0941 20 mg
Two 10-mg tablets of MK-0941 administered as a single oral dose.
Experimental: MK-0941 20 mg Moderate Renal Insufficiency
MK-0941 20 mg administered to participants with moderate renal insufficiency and type 2 diabetes.
Drug: MK-0941 20 mg
Two 10-mg tablets of MK-0941 administered as a single oral dose.
Experimental: MK-0941 5 mg Severe Renal Insufficiency
MK-0941 5 mg administered to participants with severe renal insufficiency and type 2 diabetes.
Drug: MK-0941 5 mg
MK-0941 administered as one single 5-mg tablet.
Experimental: MK-0941 20 mg Matched Controls
MK-0941 20 mg administered to age-, gender-, race-, body mass index (BMI)-, and hemoglobin A1C (HbAIc)-matched control subjects with normal renal function and type 2 diabetes.
Drug: MK-0941 20 mg
Two 10-mg tablets of MK-0941 administered as a single oral dose.
Experimental: MK-0941 5 mg Matched Controls
MK-0941 5 mg administered to age-, gender-, race-, body mass index (BMI)-, and HbAIc-matched control subjects with normal renal function and type 2 diabetes.
Drug: MK-0941 5 mg
MK-0941 administered as one single 5-mg tablet.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or nonpregnant female age 18 to 75 years
  • Female of childbearing potential on appropriate method of contraception
  • Body mass index (BMI) less than or equal to 40 kg/m2
  • Participant is in good health
  • Participant diagnosed with Type 2 Diabetes
  • Participant agrees to follow smoking restrictions
  • Willing to follow the study diet restrictions

Exclusion Criteria:

  • Mental or legal incapacitation
  • Participant has had kidney removed
  • History of Type 1 diabetes
  • History of stroke, chronic seizures or major neurological disorder
  • History of neoplastic disease
  • Nursing mother
  • Consumes greater than 4 glasses of alcoholic beverages per day
  • Consumes greater than 6 servings of caffeinated beverages per day
  • Participant has had surgery or donated 1 unit of blood within 1 month of screening
  • Participant has history of recent eye infection within 2 weeks of study drug administration
  • Clinically diagnosed with glaucoma or blindness
  • Has trauma to one or both eyes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830791

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00830791     History of Changes
Other Study ID Numbers: 0941-015, 2009_522
Study First Received: January 26, 2009
Results First Received: May 1, 2012
Last Updated: January 24, 2014
Health Authority: Russia: Pharmacological Committee, Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Renal Insufficiency
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014