Status:
COMPLETED
Pioglitazone Add-on Study in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.
Eligibility Criteria
Inclusion
- Patient has type 2 diabetes mellitus (T2DM)
- Patient is 18 years of age (or older)
- Patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and poststudy follow-up period
Exclusion
- Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
- Patient required insulin within the prior 8 weeks
- Patient is on a weight loss program and is not in the maintenance phase
- Patient started on a weight loss medication (e.g., orlistat or sibutramine) within the prior 8 weeks
- Patient is on or likely to require treatment with treatment with immunosuppressive agents (e.g., cyclosporin, methotrexate)
- Patient has cirrhosis, active liver disease (other than fatty liver) or symptomatic gallbladder disease
- Patient has chronic myopathy, or a progressive neurological or neuromuscular disorder (e.g., multiple sclerosis or polymyositis)
- Patient has any of the following disorders within the past 6 months:
- Acute coronary syndrome (e.g., MI or unstable angina), Coronary artery intervention, Stroke or transient ischemic neurological disorder.
- Patient has new or worsening signs or symptoms of coronary heart disease within the past 3 months
- Patient has severe peripheral vascular disease
- Patient has congestive heart failure
- Patient is HIV positive
- Patient has a clinically important hematological disorder (e.g., aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
- Patient has a history of neoplastic disease
- Patient has a history of alcohol or drug abuse within the past 3 years
- Patient has viral hepatitis (hepatitis B or C)
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
353 Patients enrolled
Trial Details
Trial ID
NCT00086502
Start Date
June 1 2004
End Date
November 1 2005
Last Update
February 5 2016
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