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 (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00673465
First received: May 5, 2008
Last updated: October 25, 2013
Last verified: October 2013
  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:


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

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 ]
  • pharmacodynamic 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 ]

Enrollment: 17
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
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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00673465     History of Changes
Other Study ID Numbers: P05338
Study First Received: May 5, 2008
Last Updated: October 25, 2013
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 October 01, 2014