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

  Hide Study Locations
Locations
United States, Arizona
Phoenix, Arizona, United States, 85015
United States, California
Los Angeles, California, United States, 90057
Palm Springs, California, United States, 92262
United States, Florida
Bradenton, Florida, United States, 34208
Jacksonville, Florida, United States, 32216
United States, Georgia
Atlanta, Georgia, United States, 30342
United States, Idaho
Hayden Lake, Idaho, United States, 83835
United States, New York
Rochester, New York, United States, 14609
United States, North Carolina
Greensboro, North Carolina, United States, 27408
United States, Texas
Midland, Texas, United States, 79707
United States, Virginia
Richmond, Virginia, United States, 23294
Australia
Adelaide, Australia, 5000
St. Leonards, Australia, 2065
Brazil
Fortaleza, Brazil, 60120-021
Goiania, Brazil, 74043011
Sao Paulo, Brazil, 01244-030
Sao Paulo, Brazil, 04022-001
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1L8
Canada, Ontario
London, Ontario, Canada, NGA 4V2
Toronto, Ontario, Canada, M9W 4L6
Toronto, Ontario, Canada, M4G 3E8
Canada, Quebec
Montreal, Quebec, Canada, H2W 1T8
Germany
Berlin, Germany, 10115
Falkensee, Germany, 14612
Luebeck, Germany, 23562
Mainz, Germany, 55116
Neuss, Germany, 41460
Hong Kong
Hong Kong, Hong Kong
Hong Kong, Hong Kong, 852
Japan
Fukuoka, Japan, 812-0025
Ibaraki, Japan, 311-0113
Kanagawa, Japan, 232-0064
Osaka, Japan, 530-0001
Saitama, Japan, 343-0827
Saitama, Japan, 362-0021
Tokyo, Japan, 192-0071
Tokyo, Japan, 160-0017
Latvia
Jelgava, Latvia, LV-3001
Riga, Latvia, 1002
Talsi, Latvia, 3200
Valmiera, Latvia, 4201
Mexico
Chihuahua, Mexico, 31238
Guadalajara, Mexico, 44600
Guadalajara, Mexico, 44650
Mexico City, Mexico, 11650
Romania
Alba-iulia, Romania, 51077
Brasov, Romania, 500365
Bucharest, Romania, 020045
Bucharest, Romania
Bucharest, Romania, 020475
Bucharest, Romania, 020725
Targu-mures, Romania, 540004
Russian Federation
Moscow, Russian Federation, 117049
Moscow, Russian Federation, 129110
Moscow, Russian Federation, 119121
Nizhny Novgorod, Russian Federation, 603126
Novosibirsk, Russian Federation, 630047
S.petersburg, Russian Federation, 194017
Saratov, Russian Federation, 410038
St Petersburg, Russian Federation, 197198
St Petersburg, Russian Federation, 197089
St Petersburg, Russian Federation, 195257
St. Petersburg, Russian Federation, 191124
Yaroslavl, Russian Federation, 150062
Spain
Alzira, Spain, 46600
Lerida, Spain, 25198
Sevilla, Spain, 41013
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