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: April 7, 2014
Last verified: April 2014
  Purpose

This 6 arm study will evaluate the efficacy, safety and pharmacokinetics of 5 doses 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 throughout the study.The anticipated time on study treatment is <=3 months


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: RO4998452
Drug: Placebo
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
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: April 7, 2014
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

ClinicalTrials.gov processed this record on April 17, 2014