A Dose-Range Finding Study in Patient With Type 2 Diabetes (MK-3102-006 EXT1[AM3]) | RxWiki

A Dose-Range Finding Study in Patient With Type 2 Diabetes (MK-3102-006 EXT1[AM3])

Overview[ - collapse ][ - ]

Purpose	The purpose of this study is to assess the hypothesis that treatment with study medication (MK-3102) provides greater reduction in A1C Hemoglobin (a marker of diabetic severity) compared with placebo, after 12 weeks of treatment. The study will evaluate 5 different doses of MK-3102 to identify which dose is the most effective in the treatment of type 2 diabetes.
Condition	Type 2 Diabetes Mellitus
Intervention	Drug: MK-3102 Drug: Placebo Drug: pioglitazone Drug: metformin
Phase	Phase 2
Sponsor	Merck Sharp & Dohme Corp.
Responsible Party	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier	NCT01217073
First Received	October 6, 2010
Last Updated	March 26, 2014
Last verified	March 2014

Tracking Information[ + expand ][ + ]

First Received Date	October 6, 2010
Last Updated Date	March 26, 2014
Start Date	October 2010
Estimated Primary Completion Date	April 2013
Current Primary Outcome Measures	Change from baseline in plasma A1C levels [Time Frame: Baseline and Week 12] [Designated as safety issue: No] Percentage of participants who experienced at least one adverse event [Time Frame: Up to Week 16] [Designated as safety issue: Yes] Percentage of participants who discontinued from the study due to an adverse event [Time Frame: Up to Week 12] [Designated as safety issue: Yes] Percentage of participants who experienced at least one adverse event [Time Frame: Up to Week 82] [Designated as safety issue: Yes] Percentage of participants who discontinued from the study due to an adverse event [Time Frame: Up to Week 78] [Designated as safety issue: Yes]
Current Secondary Outcome Measures	Change from baseline in 2 hour-post-meal glucose (2h-PMG) levels [Time Frame: Baseline and Week 12] [Designated as safety issue: No] Change from baseline in fasting plasma glucose (FPG) levels [Time Frame: Baseline and Week 12] [Designated as safety issue: No] Change from baseline in plasma A1C levels [Time Frame: Baseline and Week 78] [Designated as safety issue: No] Change from baseline in 2h-PMG levels [Time Frame: Baseline and Week 78] [Designated as safety issue: No] Change from baseline in FPG levels [Time Frame: Baseline and Week 78] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	A Dose-Range Finding Study in Patient With Type 2 Diabetes (MK-3102-006 EXT1[AM3])
Official Title	A Phase IIb, Randomized, Placebo-Controlled, Dose-Range Finding Clinical Trial to Study the Safety and Efficacy of MK-3102 in Patients With Type 2 Diabetes Mellitus (T2DM) and Inadequate Glycemic Control
Brief Summary	The purpose of this study is to assess the hypothesis that treatment with study medication (MK-3102) provides greater reduction in A1C Hemoglobin (a marker of diabetic severity) compared with placebo, after 12 weeks of treatment. The study will evaluate 5 different doses of MK-3102 to identify which dose is the most effective in the treatment of type 2 diabetes.
Detailed Description	MK-3102-006-Ext 1 added a 66-week extension to the base study (MK-3102 P006) to assess the long-term safety and tolerability of MK-3102. To be eligible for the extension, participants must complete the double-blind base study, must have had at least a 75% compliance with study drug during the base study and can not meet any of the criteria for discontinuation. Participants randomized to placebo in the base study will be switched in a blinded manner to pioglitazone 30 mg once daily, in the extension study prior to implementation of amendment P006-13. Once amendment P006-13 has been IRB/IEC approved and blinded metformin drug supply is available at the site, participants will be switched from pioglitazone to metformin, starting at 500 mg once daily and titrated up to 1000 mg twice daily. Participants with a contraindication to metformin will be discontinued from the study. Participants randomized to 0.25 mg, 1 mg, 3 mg, and 10 mg of MK-3102 in the base study will be switched to MK-3102 25 mg; those randomized to 25 mg of MK-3102 in the base study will continue on the same dose in the extension study. After the clinical dose of MK-3102 selected for further development has been identified based upon the results of the base study, all participants randomized to MK-3102 will be switched to the identified clinical dose.
Study Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Type 2 Diabetes Mellitus
Intervention	Drug: MK-3102 2 capsules, MK-3102 will be administered, orally, (p.o.), for 12 weeks Drug: Placebo 2 capsules, of matching placebo for MK-3102 will be administered, (p.o.), for 12 weeks Drug: pioglitazone Participants randomized to placebo in the base study will be switched in a blinded manner to pioglitazone 30 mg once daily Drug: metformin Participants will be switched from pioglitazone to metformin, starting at 500 mg once daily and titrated up to 1000 mg twice a day
Study Arm (s)	Experimental: MK-3102 0.25 mg Administration of 0.25 mg MK-3102 Experimental: MK-3102 1 mg Administration of 1 mg MK-3102 Experimental: MK-3102 3 mg Administration of 3 mg MK-3102 Experimental: MK-3102 10 mg Administration of 10 mg MK-3102 Experimental: MK-3102 25 mg Administration of 25 mg MK-3102 Placebo Comparator: Placebo Administration of placebo to match MK-3102

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	685
Estimated Completion Date	April 2013
Estimated Primary Completion Date	January 2012
Eligibility Criteria	Inclusion Criteria : The prospective participant must meet, at least, all of the criteria below (among others determined by the study staff) to be eligible for study participation. The participant: - Has type 2 diabetes mellitus and is between 18 and 70 years of age; for Japan, 20 to 70 years of age; - Has a body mass index (BMI) > 20 kg/m^2 and < 43 kg/m^2; - Is currently not on an antihyperglycemic agent (AHA) medication (off for ≥ 14 weeks) or is on oral AHA therapy but has inadequate glycemic control; - Is a male, or a female who is highly unlikely to conceive. Exclusion Criteria: If the prospective participant meets any of the criteria below (among others determined by the study staff) they will NOT be eligible for study participation. The participant: - Has a history of type 1 diabetes mellitus or a history of ketoacidosis; - Is on a weight loss program or has started a weight loss medication within the prior 8 weeks; - Has required insulin therapy within 14 weeks prior to signing informed consent; - Has a medical history of active liver disease (other than nonalcoholic hepatic steatosis), including chronic active hepatitis B or C, cirrhosis, or symptomatic gallbladder disease; - Has congestive heart failure or has new or worsening signs or symptoms of coronary heart disease; - Had any of the following disorders within the past 3 months: acute coronary syndrome, coronary artery intervention, stroke or transient ischemic neurological disorder; - Has bladder cancer or a history of bladder cancer.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Not Provided

Administrative Information[ + expand ][ + ]

NCT Number	NCT01217073
Other Study ID Numbers	3102-006
Has Data Monitoring Committee	No
Information Provided By	Merck Sharp & Dohme Corp.
Study Sponsor	Merck Sharp & Dohme Corp.
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	March 2014