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

NCT ID: NCT00086502

Last Updated: 2016-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 353 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2005-11-30

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sitagliptin 100 mg

Sitagliptin 100 mg

Group Type: ACTIVE_COMPARATOR

Comparator: Sitagliptin

Intervention Type: DRUG

Sitagliptin 100 mg once daily, from Visit 4 through Visit 8. Day 1 through week 24

Comparator: Pioglitazone

Intervention Type: DRUG

Pioglitazone 30 mg or 45 mg once daily, Visit 2 through Visit 8

Metformin

Intervention Type: DRUG

Metformin rescue for patients meeting

pre-specified glycemic criteria. Metformin 500 mg,once daily, Visit 4 through Visit 8

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type: DRUG

Placebo (to match Sitagliptin 100 mg) once daily, from Visit 4 through Visit 8. Day 1 through Week 24

Comparator: Pioglitazone

Intervention Type: DRUG

Pioglitazone 30 mg or 45 mg once daily, Visit 2 through Visit 8

Metformin

Intervention Type: DRUG

Metformin rescue for patients meeting

pre-specified glycemic criteria. Metformin 500 mg,once daily, Visit 4 through Visit 8

Interventions

Comparator: Sitagliptin

Sitagliptin 100 mg once daily, from Visit 4 through Visit 8. Day 1 through week 24

Intervention Type: DRUG

Comparator: Placebo

Placebo (to match Sitagliptin 100 mg) once daily, from Visit 4 through Visit 8. Day 1 through Week 24

Intervention Type: DRUG

Comparator: Pioglitazone

Pioglitazone 30 mg or 45 mg once daily, Visit 2 through Visit 8

Intervention Type: DRUG

Metformin

Metformin rescue for patients meeting

pre-specified glycemic criteria. Metformin 500 mg,once daily, Visit 4 through Visit 8

Intervention Type: DRUG

Other Intervention Names

Januvia; ACTOS

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Rosenstock J, Brazg R, Andryuk PJ, Lu K, Stein P; Sitagliptin Study 019 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing pioglitazone therapy in patients with type 2 diabetes: a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2006 Oct;28(10):1556-68. doi: 10.1016/j.clinthera.2006.10.007.

Reference Type: BACKGROUND

PMID: 17157112 (View on PubMed)

Other Identifiers

Formally-A0604T2DPT

Identifier Type: -

Identifier Source: secondary_id

2006_410

Identifier Type: -

Identifier Source: secondary_id

0431-019

Identifier Type: -

Identifier Source: org_study_id