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

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

U.S. FDA Resources

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:	October 2010
Estimated Primary Completion Date:	April 2010 (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 (20 mg to 80 mg) 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 50mg 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 (20 mg to 80 mg) 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 120 mg each day or 50 mg twice a day for 28 days.
B: Experimental Panel B: study drug (40 mg) 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 (20 mg to 80 mg) 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 50mg 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 (20 mg to 80 mg) 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 120 mg each day or 50 mg twice a day for 28 days.
C: Experimental Panel C: study drug (80 mg 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 (20 mg to 80 mg) 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 50mg 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 (20 mg to 80 mg) 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 120 mg each day or 50 mg twice a day for 28 days.
D: Experimental Panel D: study drug (120 mg 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 (20 mg to 80 mg) 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 50mg 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 (20 mg to 80 mg) 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 120 mg each day or 50 mg 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 (20 mg to 80 mg) 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 50mg 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 (20 mg to 80 mg) 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 120 mg each day or 50 mg twice a day for 28 days.
F: Experimental Panel F: study drug (40 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 (20 mg to 80 mg) 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 50mg 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 (20 mg to 80 mg) 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 120 mg each day or 50 mg twice a day for 28 days.
G: Experimental Panel G: study drug (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 (20 mg to 80 mg) 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 50mg 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 (20 mg to 80 mg) 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 120 mg each day or 50 mg twice a day for 28 days.
H: Experimental Panel H: study drug (120 mg 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 (20 mg to 80 mg) 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 50mg 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 (20 mg to 80 mg) 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 120 mg each day or 50 mg twice a day for 28 days.
I: Experimental Panel I: study drug (50 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 (20 mg to 80 mg) 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 50mg 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 (20 mg to 80 mg) 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 120 mg each day or 50 mg twice a day for 28 days.
J: Experimental Panel J: study drug (dose to be determined) 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 (20 mg to 80 mg) 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 50mg 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 (20 mg to 80 mg) 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 120 mg each day or 50 mg 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 approx. 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

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

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:	August 18, 2009
ClinicalTrials.gov Identifier:	NCT00758680 History of Changes
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
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on September 11, 2009