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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Comparator: Placebo; Drug: Comparator: Pioglitazone; Drug: Comparator: Sitagliptin; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00086502

Formally-A0604T2DPT

0431-019

2006_410

Details and patient eligibility

About

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

Enrollment: 353 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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353 participants in 2 patient groups, including a placebo group

Sitagliptin 100 mg

Active Comparator group

Description:

Sitagliptin 100 mg

Treatment:

Drug: Metformin

Drug: Comparator: Sitagliptin

Drug: Comparator: Pioglitazone

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Metformin

Drug: Comparator: Pioglitazone

Drug: Comparator: Placebo