A Multiple-Dose Study of MK1006 - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00758680

Purpose

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

Condition	Intervention	Phase
Type 2 Diabetes	Drug: MK1006 Drug: Comparator: Placebo comparator	Phase I

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Multiple Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK1006

Further study details as provided by Merck:

Primary Outcome Measures:

Safety and tolerability of MK1006 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Plasma PK of MK1006 and reduction in plasma glucose concentrations [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	128
Study Start Date:	August 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Panel A: study drug (20 mg) + matching placebo	Drug: MK1006 Part 1: Subjects in Panels A, B, C, and D will be given oral doses of study drug capsules (20mg to 120mg) every day for 10 consecutive days. Part 2: Subjects in Panels E, F, and G will be given oral doses of study drug capsules (20mg to 80mg) twice a day for 10 consecutive days Part 3: Subjects in Panels H, I, and J will be given oral doses of study drug capsules either 120mg each day or 80mg twice a day for 28 days. Drug: Comparator: Placebo comparator Part 1: Subjects in Panels A, B, C, and D will be given oral doses of placebo to study drug capsules (20mg to 120mg) every day for 10 consecutive days. Part 2: Subjects in Panels E, F, and G will be given oral doses of placebo to study drug capsules (20mg to 80mg) twice a day for 10 consecutive days Part 3: Subjects in Panels H, I, and J will be given oral doses of placebo to study drug capsules either 120mg each day or 80mg twice a day for 28 days.
B: Experimental Panel B: study drug (40mg) or matching placebo	Drug: MK1006 Part 1: Subjects in Panels A, B, C, and D will be given oral doses of study drug capsules (20mg to 120mg) every day for 10 consecutive days. Part 2: Subjects in Panels E, F, and G will be given oral doses of study drug capsules (20mg to 80mg) twice a day for 10 consecutive days Part 3: Subjects in Panels H, I, and J will be given oral doses of study drug capsules either 120mg each day or 80mg twice a day for 28 days. Drug: Comparator: Placebo comparator Part 1: Subjects in Panels A, B, C, and D will be given oral doses of placebo to study drug capsules (20mg to 120mg) every day for 10 consecutive days. Part 2: Subjects in Panels E, F, and G will be given oral doses of placebo to study drug capsules (20mg to 80mg) twice a day for 10 consecutive days Part 3: Subjects in Panels H, I, and J will be given oral doses of placebo to study drug capsules either 120mg each day or 80mg twice a day for 28 days.
C: Experimental Panel C: study drug (80mg qd) or matching placebo	Drug: MK1006 Part 1: Subjects in Panels A, B, C, and D will be given oral doses of study drug capsules (20mg to 120mg) every day for 10 consecutive days. Part 2: Subjects in Panels E, F, and G will be given oral doses of study drug capsules (20mg to 80mg) twice a day for 10 consecutive days Part 3: Subjects in Panels H, I, and J will be given oral doses of study drug capsules either 120mg each day or 80mg twice a day for 28 days. Drug: Comparator: Placebo comparator Part 1: Subjects in Panels A, B, C, and D will be given oral doses of placebo to study drug capsules (20mg to 120mg) every day for 10 consecutive days. Part 2: Subjects in Panels E, F, and G will be given oral doses of placebo to study drug capsules (20mg to 80mg) twice a day for 10 consecutive days Part 3: Subjects in Panels H, I, and J will be given oral doses of placebo to study drug capsules either 120mg each day or 80mg twice a day for 28 days.
D: Experimental Panel D: study drug (120mg qd) or matching placebo	Drug: MK1006 Part 1: Subjects in Panels A, B, C, and D will be given oral doses of study drug capsules (20mg to 120mg) every day for 10 consecutive days. Part 2: Subjects in Panels E, F, and G will be given oral doses of study drug capsules (20mg to 80mg) twice a day for 10 consecutive days Part 3: Subjects in Panels H, I, and J will be given oral doses of study drug capsules either 120mg each day or 80mg twice a day for 28 days. Drug: Comparator: Placebo comparator Part 1: Subjects in Panels A, B, C, and D will be given oral doses of placebo to study drug capsules (20mg to 120mg) every day for 10 consecutive days. Part 2: Subjects in Panels E, F, and G will be given oral doses of placebo to study drug capsules (20mg to 80mg) twice a day for 10 consecutive days Part 3: Subjects in Panels H, I, and J will be given oral doses of placebo to study drug capsules either 120mg each day or 80mg twice a day for 28 days.
E: Experimental Panel E: study drug (20 mg bid) or matching placebo	Drug: MK1006 Part 1: Subjects in Panels A, B, C, and D will be given oral doses of study drug capsules (20mg to 120mg) every day for 10 consecutive days. Part 2: Subjects in Panels E, F, and G will be given oral doses of study drug capsules (20mg to 80mg) twice a day for 10 consecutive days Part 3: Subjects in Panels H, I, and J will be given oral doses of study drug capsules either 120mg each day or 80mg twice a day for 28 days. Drug: Comparator: Placebo comparator Part 1: Subjects in Panels A, B, C, and D will be given oral doses of placebo to study drug capsules (20mg to 120mg) every day for 10 consecutive days. Part 2: Subjects in Panels E, F, and G will be given oral doses of placebo to study drug capsules (20mg to 80mg) twice a day for 10 consecutive days Part 3: Subjects in Panels H, I, and J will be given oral doses of placebo to study drug capsules either 120mg each day or 80mg twice a day for 28 days.
F: Experimental Panel F: study drug (40mg bid) or matching placebo	Drug: MK1006 Part 1: Subjects in Panels A, B, C, and D will be given oral doses of study drug capsules (20mg to 120mg) every day for 10 consecutive days. Part 2: Subjects in Panels E, F, and G will be given oral doses of study drug capsules (20mg to 80mg) twice a day for 10 consecutive days Part 3: Subjects in Panels H, I, and J will be given oral doses of study drug capsules either 120mg each day or 80mg twice a day for 28 days. Drug: Comparator: Placebo comparator Part 1: Subjects in Panels A, B, C, and D will be given oral doses of placebo to study drug capsules (20mg to 120mg) every day for 10 consecutive days. Part 2: Subjects in Panels E, F, and G will be given oral doses of placebo to study drug capsules (20mg to 80mg) twice a day for 10 consecutive days Part 3: Subjects in Panels H, I, and J will be given oral doses of placebo to study drug capsules either 120mg each day or 80mg twice a day for 28 days.
G: Experimental Panel G: study drug (80mg bid) or matching placebo)	Drug: MK1006 Part 1: Subjects in Panels A, B, C, and D will be given oral doses of study drug capsules (20mg to 120mg) every day for 10 consecutive days. Part 2: Subjects in Panels E, F, and G will be given oral doses of study drug capsules (20mg to 80mg) twice a day for 10 consecutive days Part 3: Subjects in Panels H, I, and J will be given oral doses of study drug capsules either 120mg each day or 80mg twice a day for 28 days. Drug: Comparator: Placebo comparator Part 1: Subjects in Panels A, B, C, and D will be given oral doses of placebo to study drug capsules (20mg to 120mg) every day for 10 consecutive days. Part 2: Subjects in Panels E, F, and G will be given oral doses of placebo to study drug capsules (20mg to 80mg) twice a day for 10 consecutive days Part 3: Subjects in Panels H, I, and J will be given oral doses of placebo to study drug capsules either 120mg each day or 80mg twice a day for 28 days.
H: Experimental Panel H: study drug (120mg qd) or matching placebo	Drug: MK1006 Part 1: Subjects in Panels A, B, C, and D will be given oral doses of study drug capsules (20mg to 120mg) every day for 10 consecutive days. Part 2: Subjects in Panels E, F, and G will be given oral doses of study drug capsules (20mg to 80mg) twice a day for 10 consecutive days Part 3: Subjects in Panels H, I, and J will be given oral doses of study drug capsules either 120mg each day or 80mg twice a day for 28 days. Drug: Comparator: Placebo comparator Part 1: Subjects in Panels A, B, C, and D will be given oral doses of placebo to study drug capsules (20mg to 120mg) every day for 10 consecutive days. Part 2: Subjects in Panels E, F, and G will be given oral doses of placebo to study drug capsules (20mg to 80mg) twice a day for 10 consecutive days Part 3: Subjects in Panels H, I, and J will be given oral doses of placebo to study drug capsules either 120mg each day or 80mg twice a day for 28 days.
I: Experimental Panel I: study drug (80mg bid) or matching placebo	Drug: MK1006 Part 1: Subjects in Panels A, B, C, and D will be given oral doses of study drug capsules (20mg to 120mg) every day for 10 consecutive days. Part 2: Subjects in Panels E, F, and G will be given oral doses of study drug capsules (20mg to 80mg) twice a day for 10 consecutive days Part 3: Subjects in Panels H, I, and J will be given oral doses of study drug capsules either 120mg each day or 80mg twice a day for 28 days. Drug: Comparator: Placebo comparator Part 1: Subjects in Panels A, B, C, and D will be given oral doses of placebo to study drug capsules (20mg to 120mg) every day for 10 consecutive days. Part 2: Subjects in Panels E, F, and G will be given oral doses of placebo to study drug capsules (20mg to 80mg) twice a day for 10 consecutive days Part 3: Subjects in Panels H, I, and J will be given oral doses of placebo to study drug capsules either 120mg each day or 80mg twice a day for 28 days.
J: Experimental Panel J: study drug (either 120 mg qd or 80 mg bid) or matching placebo	Drug: MK1006 Part 1: Subjects in Panels A, B, C, and D will be given oral doses of study drug capsules (20mg to 120mg) every day for 10 consecutive days. Part 2: Subjects in Panels E, F, and G will be given oral doses of study drug capsules (20mg to 80mg) twice a day for 10 consecutive days Part 3: Subjects in Panels H, I, and J will be given oral doses of study drug capsules either 120mg each day or 80mg twice a day for 28 days. Drug: Comparator: Placebo comparator Part 1: Subjects in Panels A, B, C, and D will be given oral doses of placebo to study drug capsules (20mg to 120mg) every day for 10 consecutive days. Part 2: Subjects in Panels E, F, and G will be given oral doses of placebo to study drug capsules (20mg to 80mg) twice a day for 10 consecutive days Part 3: Subjects in Panels H, I, and J will be given oral doses of placebo to study drug capsules either 120mg each day or 80mg twice a day for 28 days.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject has a BMI less than or equal to 42 kg/m2 at the screening visit
Subject 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
Subject is willing to follow a diet containing Approximately 50% carbohydrates, 20% protein, and 30% fat during the study
Subject is a nonsmoker and has not used nicotine containing products for ~ 6 months before start of study

Exclusion Criteria:

Subjects must not be treated with three or more oral anti-hyperglycemic medications, insulin, or PPARgamma agonists
Subject has a history of stroke, chronic seizures, or a major neurological disorder
Subject has had an eye infection or other inflammatory eye condition within 2 weeks of first dose of study drug
Subject has glaucoma or is blind
Subject has a condition known to be related to cataract development
Subject 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
Subject has a history of type 1 diabetes or ketoacidosis
Subject cannot stop taking certain current medications during the study
Subject consumes greater than 3 alcoholic beverages per day
Subject consumes more than 6 servings of caffeinated beverages per day (1 serving is ~ 120 mg caffeine)
Subject 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
Subject uses recreational drugs or has had a history of drug abuse within 6 months of start of study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00758680

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

United States, Florida
Call for Information	Recruiting
Miramar, Florida, United States, 33025
United States, Texas
Call for Information	Recruiting
San Antonio, Texas, United States, 78209

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_550, MK1006-004
Study First Received:	September 23, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00758680
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009