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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01217073
First received: October 6, 2010
Last updated: March 26, 2014
Last verified: March 2014
  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 Intervention Phase
Type 2 Diabetes Mellitus
Drug: MK-3102
Drug: Placebo
Drug: pioglitazone
Drug: metformin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 ]

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 ]

Enrollment: 685
Study Start Date: October 2010
Study Completion Date: April 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-3102 0.25 mg
Administration of 0.25 mg MK-3102
Drug: MK-3102
2 capsules, MK-3102 will be administered, orally, (p.o.), for 12 weeks
Experimental: MK-3102 1 mg
Administration of 1 mg MK-3102
Drug: MK-3102
2 capsules, MK-3102 will be administered, orally, (p.o.), for 12 weeks
Experimental: MK-3102 3 mg
Administration of 3 mg MK-3102
Drug: MK-3102
2 capsules, MK-3102 will be administered, orally, (p.o.), for 12 weeks
Experimental: MK-3102 10 mg
Administration of 10 mg MK-3102
Drug: MK-3102
2 capsules, MK-3102 will be administered, orally, (p.o.), for 12 weeks
Experimental: MK-3102 25 mg
Administration of 25 mg MK-3102
Drug: MK-3102
2 capsules, MK-3102 will be administered, orally, (p.o.), for 12 weeks
Placebo Comparator: Placebo
Administration of placebo to match MK-3102
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01217073     History of Changes
Other Study ID Numbers: 3102-006
Study First Received: October 6, 2010
Last Updated: March 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014