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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 CONTRO

Not Applicable
Conditions
-E11 Non-insulin-dependent diabetes mellitus
Non-insulin-dependent diabetes mellitus
E11
Registration Number
PER-087-10
Lead Sponsor
MERCK SHARP & DOHME PERU S.R.L.,
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Not specified
Target Recruitment
22
Inclusion Criteria

• 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

• 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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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