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

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ClinicalTrials.gov Identifier: NCT00086502
Recruitment Status : Completed
First Posted : July 5, 2004
Results First Posted : April 19, 2010
Last Update Posted : February 5, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00086502


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

Publications:

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    Key Record Dates
Results First Posted: April 19, 2010
Last Update Posted: February 5, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Metformin
Sitagliptin Phosphate
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