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

Type 2 Diabetes Clinical Trial

Official title:

A Multiple Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-1006.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00758680
• Other study ID #: 1006-004
• Secondary ID: 2008_550
• Status: Terminated
• Phase: Phase 1
• First received: September 23, 2008
• Last updated: February 4, 2016
• Start date: August 2008
• Est. completion date: March 2010

Study information

• Verified date: February 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 112
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• MK-1006
MK-1006 capsules (10 mg and 20 mg) administered orally from 20 mg to 120 mg per dose over a multiple dosing period.
• Comparator: Placebo comparator
Dose-matched MK-1006 placebo capsules (1 mg, 10 mg and 20 mg) administered orally over a multiple dosing period.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Primary	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)	Yes
Secondary	Least Squares Mean Change From Baseline in 24-Hour Weighted Mean Glucose (WMG)	Plasma glucose concentration was determined using a glucometer and measured before drug was given to establish a baseline fasting plasma glucose concentration. Plasma glucose concentrations were then measured every ~30 minutes over a 24 hour period after the Day 1 dose (First Dosing Day) and after the Day 10 dose (Last Dosing Day) to obtain a weighted mean average value for Day 1 and for Day 10. Results were expressed as the change from baseline to the Day 1 weighted average (First Dosing Day), and as the change from baseline to the Day 10 weighted average (Last Dosing Day).	Day -1 (pre-dose baseline), Day 1 (First Dosing Day), Day 10 (Last Dosing Day)	No