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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00754130
Recruitment Status : Completed
First Posted : September 17, 2008
Results First Posted : October 3, 2012
Last Update Posted : March 12, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Number of Participants Who Experienced at Least One Adverse Event (AE) [ Time Frame: Up to 14 days after last dose of study drug ]

    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.


  2. Number of Participants Who Discontinued Study Drug Due to an AE [ Time Frame: Up to 14 days after last dose of study drug ]

    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 :
  1. 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 ]
    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.

  2. Plasma Pharmacokinetic Parameter: Maximum Concentration (Cmax) of MK-0941 [ Time Frame: Up to 72 hours after study drug administration ]
    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.

  3. Plasma Pharmacokinetic Parameter: Time to Reach Cmax (Tmax) of MK-0941 [ Time Frame: Up to 72 hours after study drug administration ]
    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.

  4. Plasma Pharmacokinetic Parameter: Concentration of MK-0941 at 24 Hours (C24hr) [ Time Frame: Up to 72 hours after study drug administration ]
    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.

  5. Plasma Pharmacokinetic Parameter: Apparent Terminal Elimination Half-life (t1/2) of MK-0941 [ Time Frame: Up to 72 hours after study drug administration ]
    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.

  6. Plasma Pharmacokinetic Parameter: Day 5 to Day 1 Accumulation Ratio for AUC (0-24hr), Cmax, and C24hr [ Time Frame: Day 5 and Day 1 ]
    Geometric Mean of the Day 5 to Day 1 Accumulation Ratio



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00754130


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00754130    
Other Study ID Numbers: 0941-011
2008_023 ( Other Identifier: Merck Registration ID )
MK-0941-011 ( Other Identifier: Merck Protocol ID )
First Posted: September 17, 2008    Key Record Dates
Results First Posted: October 3, 2012
Last Update Posted: March 12, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases