A Dose-Finding Study of RO4998452 in Patients With Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00800176
First received: December 1, 2008
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This 6 arm study will evaluate the efficacy, safety and pharmacokinetics of 5 do ses of RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Patients will be randomized to one of 6 groups to receive RO4998452 at doses of 2.5mg, 5mg, 10mg, 20mg or 40mg po daily, or placebo daily. Patients pre-treated with stable metformin will continue to take their usual dose of metformin throug hout the study.The anticipated time on study treatment is <=3 months


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Placebo
Drug: RO4998452
Phase 2

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 Multi-center, Double-blind, Randomized, Parallel Group, Placebo-controlled 12-week Study to Investigate Glycemic Parameters of Efficacy, Safety/ Tolerability and Pharmacokinetics of Five Dose Levels of RO4998452 in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Absolute change in HbA1c [ Time Frame: From baseline to end of treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute change in parameters of glycemic control [ Time Frame: From baseline to end of treatment period ] [ Designated as safety issue: No ]
  • Absolute change in body weight, waist-to-hip ratio, waist circumference [ Time Frame: From baseline to end of treatment period ] [ Designated as safety issue: No ]
  • Adverse events, laboratory parameters, vital signs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 405
Study Start Date: January 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RO4998452
2.5mg po daily for 12 weeks
Experimental: 2 Drug: RO4998452
5mg po daily for 12 weeks
Experimental: 3 Drug: RO4998452
10mg po daily for 12 weeks
Experimental: 4 Drug: RO4998452
20mg po daily for 12 weeks
Experimental: 5 Drug: RO4998452
40mg po daily for 12 weeks
Placebo Comparator: 6 Drug: Placebo
po daily for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, 18-75 years of age;
  • type 2 diabetes, diagnosed for >=3 months;
  • either treated with diet, exercise and stable metformin, or with diet and exercise alone.

Exclusion Criteria:

  • type 1 diabetes mellitus;
  • currently or within 2 months prior to screening treated with an oral or injectable anti-diabetic agent except stable doses of metformin;
  • currently or within 6 months prior to screening treated with any PPARgamma agonist;
  • uncontrolled hypertension;
  • significant pre-diagnosed diabetic complications requiring treatment.
  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: NCT00800176

  Show 67 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00800176     History of Changes
Other Study ID Numbers: BC21587, 2008-001249-24
Study First Received: December 1, 2008
Last Updated: October 6, 2014
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

ClinicalTrials.gov processed this record on October 23, 2014