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Effect of SCH 497079 on Metabolic Parameters and Influence of Race/Ethnic Origin on Therapeutic Response (Study P05338AM1)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00673465
First received: May 5, 2008
Last updated: September 30, 2009
Last verified: September 2009
History of Changes
  Purpose

The purpose of this study is to evaluate the effect of SCH 497079 on metabolic parameters and to determine the influence of race/ethnic origin on therapeutic response.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: SCH 497079
Drug: Placebo
Drug: Metformin extended release
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled, Three-Way Crossover Study to Evaluate the Effect of SCH 497079 on Metabolic Parameters and to Determine the Influence of Race/Ethnic Origin on Therapeutic Response

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • 24-hour glycemic profile [ Time Frame: after 4 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adverse events, vital signs, clinical labs, ecgs [ Time Frame: after 4 weeks of treatment ] [ Designated as safety issue: Yes ]
  • pharmcodynamic effects [ Time Frame: after 4 weeks of treatment ] [ Designated as safety issue: No ]
  • steady state pharmacokinetics [ Time Frame: after 4 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: May 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SCH 497079 Drug: SCH 497079
100 mg, administered orally, once-daily x 28 days
Placebo Comparator: Placebo Drug: Placebo
Placebo capsules matching SCH 497079 administered once daily x 28 days
Metformin hydrochloride Drug: Metformin extended release
1500 mg, administered orally, once-daily x 28 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >=18 years of age to 65 years of age, of either sex, and having a body mass index (BMI) between 27 and 35, inclusive (USA subjects)
  • Clinical laboratory tests (CBC blood chemistry, and urinalysis) within normal limits (excluding glucose and other changes usually associated with diabetes eg, dyslipidemia)
  • Type 2 diabetes mellitus

Exclusion Criteria:

  • Female subjects who are premenopausal or are not surgically sterilized. Subjects who are pregnant, intend to become pregnant (within 3 months of ending the study), or are breast-feeding.
  • Subjects who have received insulin therapy within 6 months, prior to Day/Period 1 or who require thiazide diuretics, beta-blockers and cyclic hormone therapy.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00673465     History of Changes
Other Study ID Numbers: P05338
Study First Received: May 5, 2008
Last Updated: September 30, 2009
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
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013