Pioglitazone Add-on Study in Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)