Status:
COMPLETED
Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.
Eligibility Criteria
Inclusion
- Patients with type 2 diabetes mellitus
- Patient is not pregnant or breastfeeding
- Male or female patient unlikely to conceive
- Patient not on an antihyperglycemic drug
Exclusion
- Patient has history of type 1 diabetes mellitus
- Patient has history of ketoacidosis
- Patient requires insulin within 8 weeks prior to start of study
- Patient on weight loss program and is not in maintenance phase
- Patient taking weight loss medication within 8 weeks prior to start of study
- Patient on or likely to require = 14 days or repeated courses of corticosteroids
- Patient taking immunosuppressive/immunomodulating medication
- Patient taking digoxin or other cardiac medication
- Patient has undergone surgical general anesthesia within 30 days prior to start of study
- Patient taking investigational drug within 8 weeks prior to start of study
- Patient is diagnosed with liver disease
- Patient has chronic myopathy, progressive neurological/neuromuscular disorder
- Patient has with severe cardiac conditions within the last 6 months
- Patient is Human immunodeficiency virus (HIV) positive
- Patient has hematological disorder
- Patient has history of malignancy
- Patient has history of alcohol or drug abuse within the past 3 years
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
741 Patients enrolled
Trial Details
Trial ID
NCT00087516
Start Date
June 1 2004
End Date
February 1 2007
Last Update
July 3 2015
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