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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Metformin

• Registration Number: NCT00086502
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2004-07-02
• Study First Submitted QC: 2004-07-02
• Study First Posted: 2004-07-05
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Results First Submitted: 2010-03-30
• Results First Submitted QC: 2010-03-30
• Results First Posted: 2010-04-19
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-04
• Last Update Posted: 2016-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 353

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Metformin	Placebo
Sitagliptin 100 mg	Metformin	Sitagliptin 100 mg

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24	Baseline and week 24	HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24	Baseline and week 24	Change from baseline at Week 24 is defined as Week 24 minus Week 0.