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NCT Number: NCT00511667

A Multiple Dose Investigational Drug Study in Patients With Type 2 Diabetes (MK-0941-005)

A multiple dose study to assess the safety and pharmacokinetics of an investigational drug in patients with type 2 diabetes. The primary hypotheses of the study are that multiple daily MK-0941 in subjects with T2DM with or without adequate control on metformin will be sufficiently safe and well tolerated to permit continued clinical investigation.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 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

  • Nonsmoking Male or Female (of non-child bearing potential)
  • Diagnosis of Type 2 Diabetes and is being treated with diet and exercise alone or with less than 3 oral anti-hyperglycemic agents
  • Panel E only (MK0941 60 mg before 2 meals each day): diagnosis of Type 2 Diabetes and is on a dose of metformin of greater than or equal to 1500 mg for 8 weeks or more

Exclusion criteria

  • Subject is on insulin or a peroxisome proliferator-activated receptor (PPAR) agonist
  • Subject is on 3 or more oral anti-diabetes medications
  • Subject has a history of type 1 diabetes
  • Subject has a diagnosis of glaucoma or is blind
  • Subject has had trauma to one or both eyes

Treatment and study plan

MK0941

Drug

MK0941 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day

Comparator: placebo

Drug

Placebo 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day

Primary outcomes

  1. Participants With Any Clinical Adverse Experience

    Time frame: Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)

  2. Participants Discontinued Because of Any Clinical Adverse Experience

    Time frame: Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)

Secondary outcomes

  1. Area Under the Concentration-time Curve (AUC0-24) of MK-0941 After Multiple Doses of MK0941

    Time frame: Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)

  2. Maximum Concentration (Cmax) of MK-0941 After Multiple Doses of MK-0941

    Time frame: Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)

  3. Time to Maximum Concentration (Tmax) of MK-0941 After Multiple Doses of MK-0941

    Time frame: Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)

  4. Apparent Terminal Elimination Half-life (T1/2) of MK-0941 After Multiple Doses of MK0941

    Time frame: Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)

  5. Concentration of MK-0941 at 24 Hours (C24hr) After Multiple Doses of MK-0941

    Time frame: Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Sequential Panel Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK0941 After Multiple Daily Administration of MK0941 Before Each Meal (q.a.c.) in Subjects With Type 2 Diabetes

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 6, 2007
Registry last updated
Aug 24, 2016

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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