A Multiple-Dose Study of MK-1006 (MK-1006-004)(TERMINATED)

NCT00758680 | Terminated Phase 1 Results

• 2 other identifiers: 1006-0042008_550
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will asses the safety, tolerability, multiple-dose pharmacokinetics and pharmacodynamics of MK1006 in participants with type 2 diabetes.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Number of Participants Experiencing Adverse Events (AEs) On Study

  An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the study treatment, was also an adverse event.

  From Day 1 through the end of poststudy period (up to Day 25)

• Number of Participants Who Discontinued Treatment Due to an AE

  An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the study treatment, was also an adverse event.

  From Day 1 through the end of poststudy period (up to Day 25)

Secondary Outcomes (1)

• Least Squares Mean Change From Baseline in 24-Hour Weighted Mean Glucose (WMG)

  Day -1 (pre-dose baseline), Day 1 (First Dosing Day), Day 10 (Last Dosing Day)

Study Arms (10)

MK-1006 20 mg Once Daily (Panel A)

EXPERIMENTAL

After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).

Drug: MK-1006

MK-1006 40 mg Once Daily (Panel B)

EXPERIMENTAL

After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.

Drug: MK-1006

MK-1006 80 mg Once Daily (Panel C)

EXPERIMENTAL

After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.

Drug: MK-1006

MK-1006 120 mg Once Daily (Panel D)

EXPERIMENTAL

After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.

Drug: MK-1006

MK-1006 20 mg Twice Daily (Panel E)

EXPERIMENTAL

After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.

Drug: MK-1006

MK-1006 30 mg Twice Daily (Panel F)

EXPERIMENTAL

After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.

Drug: MK-1006

MK-1006 50 mg Twice Daily (Panel G)

EXPERIMENTAL

After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.

Drug: MK-1006

MK-1006 120 mg Once Daily Outpatient (Panel H)

EXPERIMENTAL

After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.

Drug: MK-1006

MK-1006 50 mg Twice Daily Outpatient (Panel I)

EXPERIMENTAL

After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.

Drug: MK-1006

Placebo

PLACEBO COMPARATOR

After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.

Drug: Comparator: Placebo comparator

Interventions

MK-1006 DRUG

MK-1006 capsules (10 mg and 20 mg) administered orally from 20 mg to 120 mg per dose over a multiple dosing period.

MK-1006 120 mg Once Daily (Panel D); MK-1006 120 mg Once Daily Outpatient (Panel H); MK-1006 20 mg Once Daily (Panel A); MK-1006 20 mg Twice Daily (Panel E); MK-1006 30 mg Twice Daily (Panel F); MK-1006 40 mg Once Daily (Panel B); MK-1006 50 mg Twice Daily (Panel G); MK-1006 50 mg Twice Daily Outpatient (Panel I); MK-1006 80 mg Once Daily (Panel C)

Comparator: Placebo comparator DRUG

Dose-matched MK-1006 placebo capsules (1 mg, 10 mg and 20 mg) administered orally over a multiple dosing period.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has a BMI less than or equal to 42 kg/m\^2 at the screening visit
• Participant has been diagnosed with Type 2 Diabetes that is being treated either by diet and exercise alone or by single or combination oral anti-hyperglycemic medications
• Participant is willing to follow a diet containing approximately 50% carbohydrates, 20% protein, and 30% fat during the study
• Participant is a nonsmoker and has not used nicotine containing products for \~ 6 months before start of study

You may not qualify if:

• Participant must not be treated with three or more oral anti-hyperglycemic medications, insulin, or PPAR-gamma agonists
• Participant has a history of stroke, chronic seizures, or a major neurological disorder
• Participant has had an eye infection or other inflammatory eye condition within 2 weeks of first dose of study drug
• Participant has glaucoma or is blind
• Participant has a condition known to be related to cataract development
• Participant has had or will have incisional eye surgery within 6 months before screening or has had laser surgery (other than Lasik) within 3 months of screening
• Participant has a history of type 1 diabetes or ketoacidosis
• Participant cannot stop taking certain current medications during the study
• Participant consumes greater than 3 alcoholic beverages per day
• Participant consumes more than 6 servings of caffeinated beverages per day (1 serving is \~ 120 mg caffeine)
• Participant has a history of significant multiple or severe allergies or has had a reaction to or is intolerant of prescription/non-prescription drugs or food
• Participant uses recreational drugs or has had a history of drug abuse within 6 months of start of study

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2008
• First Posted: September 25, 2008
• Study Start: August 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: February 5, 2016
• Results First Posted: August 28, 2012

Record last verified: 2016-02