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Clinical Trial Details

Trial ID: L1994
Source ID: NCT00800176
Associated Drug: Placebo
Title: A Dose-Finding Study of RO4998452 in Patients With Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00800176/results
Conditions: Diabetes Mellitus Type 2
Interventions: DRUG: Placebo|DRUG: RO4998452|DRUG: RO4998452|DRUG: RO4998452|DRUG: RO4998452|DRUG: RO4998452
Outcome Measures: Primary: Absolute Change in HbA1c, Baseline, Week 4, Week 8 and Week 12 | Secondary: Change From Baseline in Fasting Plasma Glucose (mmol/L), Baseline and Week 12|Change From Baseline in Mean Daily Glucose Concentration (mmol/L), Baseline and Week 12|Change From Baseline in Fructosamine Concentration (μmol/L), Baseline and 12 weeks|Change From Baseline in Meal Tolerance Test: 0-3h Mean Glucose Concentration (mmol/L), Baseline and Week 12|Change From Baseline in Meal Tolerance Test: 0-3h Mean Insulin Concentration (mmol/L), Baseline and Week 12|Change From Baseline in Meal Tolerance Test: 0-3h Urinary Glucose Excretion (mmol/L), Baseline and Week 12|Change From Baseline in Body Weight (kg), Baseline and Week 12|Percentage of Participants Treated to Target HbA1c < 7%, Baseline up to 12 weeks|Percentage of Participants Treated to Target HbA1c < 6.5%, Baseline up to 12 weeks|Percentage of Participants With at Least One Adverse Event, Baseline up to 12 weeks
Sponsor/Collaborators: Sponsor: Hoffmann-La Roche
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 394
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2009-01-22
Completion Date: 2009-10-28
Results First Posted: 2020-11-18
Last Update Posted: 2020-11-18
Locations: Phoenix, Arizona, 85015, United States|Los Angeles, California, 90057, United States|Palm Springs, California, 92262, United States|Bradenton, Florida, 34208, United States|Jacksonville, Florida, 32216, United States|Atlanta, Georgia, 30342, United States|Hayden Lake, Idaho, 83835, United States|Rochester, New York, 14609, United States|Greensboro, North Carolina, 27408, United States|Midland, Texas, 79707, United States|Richmond, Virginia, 23294, United States|Adelaide, 5000, Australia|St. Leonards, 2065, Australia|Fortaleza, 60120-021, Brazil|Goiania, 74043011, Brazil|Sao Paulo, 01244-030, Brazil|Sao Paulo, 04022-001, Brazil|Vancouver, British Columbia, V5Z 1L8, Canada|London, Ontario, NGA 4V2, Canada|Toronto, Ontario, M4G 3E8, Canada|Toronto, Ontario, M9W 4L6, Canada|Montreal, Quebec, H2W 1T8, Canada|Berlin, 10115, Germany|Falkensee, 14612, Germany|Luebeck, 23562, Germany|Mainz, 55116, Germany|Neuss, 41460, Germany|Hong Kong, 852, Hong Kong|Hong Kong, Hong Kong|Fukuoka, 812-0025, Japan|Ibaraki, 311-0113, Japan|Kanagawa, 232-0064, Japan|Osaka, 530-0001, Japan|Saitama, 343-0827, Japan|Saitama, 362-0021, Japan|Tokyo, 160-0017, Japan|Tokyo, 192-0071, Japan|Jelgava, LV-3001, Latvia|Riga, 1002, Latvia|Talsi, 3200, Latvia|Valmiera, 4201, Latvia|Chihuahua, 31238, Mexico|Guadalajara, 44600, Mexico|Guadalajara, 44650, Mexico|Mexico City, 11650, Mexico|Alba-iulia, 51077, Romania|Brasov, 500365, Romania|Bucharest, 020045, Romania|Bucharest, 020475, Romania|Bucharest, 020725, Romania|Bucharest, Romania|Targu-mures, 540004, Romania|Moscow, 117049, Russian Federation|Moscow, 119121, Russian Federation|Moscow, 129110, Russian Federation|Nizhny Novgorod, 603126, Russian Federation|Novosibirsk, 630047, Russian Federation|S.petersburg, 194017, Russian Federation|Saratov, 410038, Russian Federation|St Petersburg, 195257, Russian Federation|St Petersburg, 197089, Russian Federation|St Petersburg, 197198, Russian Federation|St. Petersburg, 191124, Russian Federation|Yaroslavl, 150062, Russian Federation|Alzira, 46600, Spain|Lerida, 25198, Spain|Sevilla, 41013, Spain
URL: https://clinicaltrials.gov/show/NCT00800176

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress