A Dose-Range Finding Study in Participants With Type 2 Diabetes (MK-3102-006)

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the hypothesis that treatment with study medication (omarigliptin; 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 omarigliptin to identify which dose is the most effective in the treatment of type 2 diabetes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Metformin; Pioglitazone

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; for Japan: BMI >18 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 a history of malignancy or clinically important hematological disorder