MK-0941 Multiple Dose Study in Japanese Patients With Type 2 Diabetes (MK-0941-011)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00754130
First received: September 16, 2008
Last updated: August 31, 2012
Last verified: August 2012
  Purpose

The multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-0941 in Japanese patients with Type 2 Diabetes.


Condition Intervention Phase
Diabetes Mellitus, Non-Insulin-Dependent
Drug: Placebo
Drug: MK-0941
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-0941 in Japanese Patients With Type 2 Diabetes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Participants Who Experienced at Least One Adverse Event (AE) [ Time Frame: Up to 14 days after last dose of study drug ] [ Designated as safety issue: Yes ]

    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.

    Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.


  • Number of Participants Who Discontinued Study Drug Due to an AE [ Time Frame: Up to 14 days after last dose of study drug ] [ Designated as safety issue: Yes ]

    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.

    Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.



Secondary Outcome Measures:
  • Plasma Pharmacokinetic Parameter: Area Under the Concentration-time Curve (AUC)(0-24hr) of MK-0941 [ Time Frame: Up to 72 hours after study drug administration ] [ Designated as safety issue: No ]
    Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.

  • Plasma Pharmacokinetic Parameter: Maximum Concentration (Cmax) of MK-0941 [ Time Frame: Up to 72 hours after study drug administration ] [ Designated as safety issue: No ]
    Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.

  • Plasma Pharmacokinetic Parameter: Time to Reach Cmax (Tmax) of MK-0941 [ Time Frame: Up to 72 hours after study drug administration ] [ Designated as safety issue: No ]
    Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.

  • Plasma Pharmacokinetic Parameter: Concentration of MK-0941 at 24 Hours (C24hr) [ Time Frame: Up to 72 hours after study drug administration ] [ Designated as safety issue: No ]
    Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.

  • Plasma Pharmacokinetic Parameter: Apparent Terminal Elimination Half-life (t1/2) of MK-0941 [ Time Frame: Up to 72 hours after study drug administration ] [ Designated as safety issue: No ]
    Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.

  • Plasma Pharmacokinetic Parameter: Day 5 to Day 1 Accumulation Ratio for AUC (0-24hr), Cmax, and C24hr [ Time Frame: Day 5 and Day 1 ] [ Designated as safety issue: No ]
    Geometric Mean of the Day 5 to Day 1 Accumulation Ratio


Enrollment: 16
Study Start Date: September 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo/MK-0941 20mg
Participants received Placebo during Period 1 and MK-0941 20 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods.
Drug: Placebo
Placebo tablets before every meal (q.a.c) Treatment period is 5 days.
Drug: MK-0941
MK-0941 5 mg tablets q.a.c.; 10 mg tablets q.a.c.; 20 mg tablets q.a.c.; or 40 mg tablets q.a.c. Treatment period is 5 days.
Experimental: MK-0941 5mg/Placebo
Participants received MK-0941 5 mg during Period 1 and Placebo during Period 2. There was a washout period of at least 8 days between the two treatment periods.
Drug: Placebo
Placebo tablets before every meal (q.a.c) Treatment period is 5 days.
Drug: MK-0941
MK-0941 5 mg tablets q.a.c.; 10 mg tablets q.a.c.; 20 mg tablets q.a.c.; or 40 mg tablets q.a.c. Treatment period is 5 days.
Experimental: MK-0941 5mg/MK-0941 20mg
Participants received MK-0941 5 mg during Period 1 and MK-0941 20 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods.
Drug: MK-0941
MK-0941 5 mg tablets q.a.c.; 10 mg tablets q.a.c.; 20 mg tablets q.a.c.; or 40 mg tablets q.a.c. Treatment period is 5 days.
Experimental: Placebo/MK-0941 40mg
Participants received Placebo during Period 1 and MK-0941 40 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods.
Drug: Placebo
Placebo tablets before every meal (q.a.c) Treatment period is 5 days.
Drug: MK-0941
MK-0941 5 mg tablets q.a.c.; 10 mg tablets q.a.c.; 20 mg tablets q.a.c.; or 40 mg tablets q.a.c. Treatment period is 5 days.
Experimental: MK-0941 10mg/Placebo
Participants received MK-0941 10 mg during Period 1 and Placebo during Period 2. There was a washout period of at least 8 days between the two treatment periods.
Drug: Placebo
Placebo tablets before every meal (q.a.c) Treatment period is 5 days.
Drug: MK-0941
MK-0941 5 mg tablets q.a.c.; 10 mg tablets q.a.c.; 20 mg tablets q.a.c.; or 40 mg tablets q.a.c. Treatment period is 5 days.
Experimental: MK-0941 10mg/MK-0941 40mg
Participants received MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods.
Drug: MK-0941
MK-0941 5 mg tablets q.a.c.; 10 mg tablets q.a.c.; 20 mg tablets q.a.c.; or 40 mg tablets q.a.c. Treatment period is 5 days.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Japanese Male or Female between 20 to 65 years of age
  • Diagnosis of Type 2 Diabetes
  • Patient being treated by diet and exercise alone

Exclusion Criteria:

  • Patient has a history of Type 1 Diabetes
  • Patient is being treated with glaucoma medications
  • Patient has donated blood or participated in another clinical study in the past 12 weeks
  • Patient is a regular user of any illicit drugs or has a history of drug, including alcohol, abuse
  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: NCT00754130

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: NCT00754130     History of Changes
Other Study ID Numbers: 0941-011, 2008_023, MK-0941-011
Study First Received: September 16, 2008
Results First Received: August 31, 2012
Last Updated: August 31, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on October 19, 2014