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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00800176
Recruitment Status : Completed
First Posted : December 2, 2008
Last Update Posted : July 28, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: Placebo Drug: RO4998452 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 405 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : January 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Absolute change in HbA1c [ Time Frame: From baseline to end of treatment period ]

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

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00800176

  Hide Study 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
Adelaide, Australia, 5000
St. Leonards, Australia, 2065
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, M4G 3E8
Toronto, Ontario, Canada, M9W 4L6
Canada, Quebec
Montreal, Quebec, Canada, H2W 1T8
Berlin, Germany, 10115
Falkensee, Germany, 14612
Luebeck, Germany, 23562
Mainz, Germany, 55116
Neuss, Germany, 41460
Hong Kong
Hong Kong, Hong Kong, 852
Hong Kong, Hong Kong
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, 160-0017
Tokyo, Japan, 192-0071
Jelgava, Latvia, LV-3001
Riga, Latvia, 1002
Talsi, Latvia, 3200
Valmiera, Latvia, 4201
Chihuahua, Mexico, 31238
Guadalajara, Mexico, 44600
Guadalajara, Mexico, 44650
Mexico City, Mexico, 11650
Alba-iulia, Romania, 51077
Brasov, Romania, 500365
Bucharest, Romania, 020045
Bucharest, Romania, 020475
Bucharest, Romania, 020725
Bucharest, Romania
Targu-mures, Romania, 540004
Russian Federation
Moscow, Russian Federation, 117049
Moscow, Russian Federation, 119121
Moscow, Russian Federation, 129110
Nizhny Novgorod, Russian Federation, 603126
Novosibirsk, Russian Federation, 630047
S.petersburg, Russian Federation, 194017
Saratov, Russian Federation, 410038
St Petersburg, Russian Federation, 195257
St Petersburg, Russian Federation, 197089
St Petersburg, Russian Federation, 197198
St. Petersburg, Russian Federation, 191124
Yaroslavl, Russian Federation, 150062
Alzira, Spain, 46600
Lerida, Spain, 25198
Sevilla, Spain, 41013
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT00800176     History of Changes
Other Study ID Numbers: BC21587
First Posted: December 2, 2008    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases