Status:
COMPLETED
A Dose-Range Finding Study in Participants With Type 2 Diabetes (MK-3102-006)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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...
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 omarigliptin. To be eligible for the extension, participants must comple...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 8 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
685 Patients enrolled
Trial Details
Trial ID
NCT01217073
Start Date
October 8 2010
End Date
April 1 2013
Last Update
September 10 2018
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