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

NCT00086502 | Completed Phase 3 Results

• 3 other identifiers: 0431-019Formally-A0604T2DPT2006_410
• Study Type: interventional
• Target: 353
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24

  Baseline and week 24

Study Arms (2)

Sitagliptin 100 mg

ACTIVE COMPARATOR

Sitagliptin 100 mg

Drug: Comparator: Sitagliptin; Drug: Comparator: Pioglitazone; Drug: Metformin

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Comparator: Placebo; Drug: Comparator: Pioglitazone; Drug: Metformin

Interventions

Comparator: Sitagliptin DRUG

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

Also known as: Januvia

Sitagliptin 100 mg

Comparator: Placebo DRUG

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

Placebo

Comparator: Pioglitazone DRUG

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

Also known as: ACTOS

Placebo; Sitagliptin 100 mg

Metformin DRUG

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

Placebo; Sitagliptin 100 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related 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. doi: 10.1016/j.clinthera.2006.10.007.

  PMID: 17157112 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; Pioglitazone; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Biguanides; Guanidines; Amidines

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2004
• First Posted: July 5, 2004
• Study Start: June 1, 2004
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: February 5, 2016
• Results First Posted: April 19, 2010

Record last verified: 2016-02