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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Addition of MK0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Pioglitazone Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00086502
• Other study ID #: 0431-019
• Secondary ID: Formally-A0604T2
• Status: Completed
• Phase: Phase 3
• First received: July 2, 2004
• Last updated: February 4, 2016
• Start date: June 2004
• Est. completion date: November 2005

Study information

• Verified date: February 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Comparator: Sitagliptin
Sitagliptin 100 mg once daily, from Visit 4 through Visit 8. Day 1 through week 24
• Comparator: Placebo
Placebo (to match Sitagliptin 100 mg) once daily, from Visit 4 through Visit 8. Day 1 through Week 24
• Comparator: Pioglitazone
Pioglitazone 30 mg or 45 mg once daily, Visit 2 through Visit 8
• Metformin
Metformin rescue for patients meeting pre-specified glycemic criteria. Metformin 500 mg,once daily, Visit 4 through Visit 8

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in HbA1c (Hemoglobin A1C) at 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.	Baseline and week 24	No
Secondary	Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24	Change from baseline at Week 24 is defined as Week 24 minus Week 0.	Baseline and week 24	No

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site