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

October 6, 2010
March 26, 2014
October 2010
January 2012   (final data collection date for primary outcome measure)
  • 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 ]
Change from baseline in plasma A1C levels at Week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01217073 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change from baseline in 2 hour post-meal glucose (2h-PMG) levels at Week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose (FPG) levels at Week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Dose-Range Finding Study in Patient With Type 2 Diabetes (MK-3102-006 EXT1[AM3])
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • 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
  • Experimental: MK-3102 0.25 mg
    Administration of 0.25 mg MK-3102
    Intervention: Drug: MK-3102
  • Experimental: MK-3102 1 mg
    Administration of 1 mg MK-3102
    Intervention: Drug: MK-3102
  • Experimental: MK-3102 3 mg
    Administration of 3 mg MK-3102
    Intervention: Drug: MK-3102
  • Experimental: MK-3102 10 mg
    Administration of 10 mg MK-3102
    Intervention: Drug: MK-3102
  • Experimental: MK-3102 25 mg
    Administration of 25 mg MK-3102
    Intervention: Drug: MK-3102
  • Placebo Comparator: Placebo
    Administration of placebo to match MK-3102
    Interventions:
    • Drug: Placebo
    • Drug: pioglitazone
    • Drug: metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
685
April 2013
January 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01217073
3102-006
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP