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Completed

NCT Number: NCT00754130

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

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

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Key information

Conditions

Diabetes Mellitus, Non-Insulin-Dependent Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Placebo tablets before every meal (q.a.c) Treatment period is 5 days.

MK-0941

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-0941 in Japanese Patients With Type 2 Diabetes

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Sep 17, 2008
Registry last updated
Mar 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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