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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00086502
First received: July 2, 2004
Last updated: May 27, 2010
Last verified: May 2010
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Comparator: Sitagliptin
Drug: Comparator: Placebo
Drug: Comparator: Pioglitazone
Drug: Metformin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 [ Time Frame: Baseline and week 24 ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24 [ Time Frame: Baseline and week 24 ] [ Designated as safety issue: No ]
    Change from baseline at Week 24 is defined as Week 24 minus Week 0.


Enrollment: 353
Study Start Date: June 2004
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Metformin
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
Other Name: Metformin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00086502

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Publications:
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00086502     History of Changes
Other Study ID Numbers: 2006_410, MK0431-019, Formally-A0604T2DPT
Study First Received: July 2, 2004
Results First Received: March 30, 2010
Last Updated: May 27, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Sitagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014