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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: December 1, 2008
Last updated: July 26, 2016
Last verified: July 2016
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: Placebo
Drug: RO4998452
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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

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 ]

Secondary Outcome Measures:
  • Absolute change in parameters of glycemic control [ Time Frame: From baseline to end of treatment period ]
  • Absolute change in body weight, waist-to-hip ratio, waist circumference [ Time Frame: From baseline to end of treatment period ]
  • Adverse events, laboratory parameters, vital signs [ Time Frame: Throughout study ]

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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00800176

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

Responsible Party: Hoffmann-La Roche Identifier: NCT00800176     History of Changes
Other Study ID Numbers: BC21587
Study First Received: December 1, 2008
Last Updated: July 26, 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on May 22, 2017