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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 21, 2014