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

• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2	Drug: Comparator: Sitagliptin; Drug: Comparator: Placebo; Drug: Comparator: Pioglitazone; Drug: Metformin	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	353 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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
Study Start Date :	June 2004
Actual Primary Completion Date :	November 2005
Actual Study Completion Date :	November 2005

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Sitagliptin 100 mg; Sitagliptin 100 mg	Drug: Comparator: Sitagliptin; Sitagliptin 100 mg once daily, from Visit 4 through Visit 8. Day 1 through week 24; Other Name: Januvia; Drug: Comparator: Pioglitazone; Pioglitazone 30 mg or 45 mg once daily, Visit 2 through Visit 8; Other Name: ACTOS; Drug: Metformin; Metformin rescue for patients meeting pre-specified glycemic criteria. Metformin 500 mg,once daily, Visit 4 through Visit 8
Placebo Comparator: Placebo; Placebo	Drug: Comparator: Placebo; Placebo (to match Sitagliptin 100 mg) once daily, from Visit 4 through Visit 8. Day 1 through Week 24; Drug: Comparator: Pioglitazone; Pioglitazone 30 mg or 45 mg once daily, Visit 2 through Visit 8; Other Name: ACTOS; Drug: Metformin; Metformin rescue for patients meeting pre-specified glycemic criteria. Metformin 500 mg,once daily, Visit 4 through Visit 8

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 [ Time Frame: 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 :

1. Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24 [ Time Frame: Baseline and week 24 ]
   Change from baseline at Week 24 is defined as Week 24 minus Week 0.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

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Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

Additional Information:

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

Publications:

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.

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Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00086502 History of Changes
Other Study ID Numbers:	0431-019; Formally-A0604T2DPT; 2006_410
First Posted:	July 5, 2004
Results First Posted:	April 19, 2010
Last Update Posted:	February 5, 2016
Last Verified:	February 2016

Additional relevant MeSH terms:

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Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Metformin; Sitagliptin Phosphate; Pioglitazone; Hypoglycemic Agents	Physiological Effects of Drugs; Incretins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dipeptidyl-Peptidase IV Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action