Study to Determine the Efficacy, Safety, Tolerability & Pharmacokinetics of RO 205-2349 in Patients With Type 2 Diabetes Mellitus
NCT ID: NCT00057304
Last Updated: 2023-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
190 participants
INTERVENTIONAL
2003-06-30
2004-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
treatment
TREATMENT
DOUBLE
Study Groups
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RO 205-2349 2 mg QD
RO 205-2349 2 mg was taken once daily (QD) for 16 weeks during the double-blind treatment period.
RO 205-2349
RO 205-2349 5 mg QD
RO 205-2349 5 mg was taken once daily (QD) for 16 weeks during the double-blind treatment period.
RO 205-2349
Interventions
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RO 205-2349
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes for longer than 3 months
* HbA1c (glycosylated hemoglobin A1c) greater than 7.0% at screening
* FPG (fasting plasma glucose) greater than 126 mg/dL at screening
* BMI (body mass index) less than 40 kg/square meter
Exclusion Criteria
* Type 2 diabetes patients currently treated with insulin
* Type 2 diabetes patients currently or previously treated with Actos, Avandia or Rezulin
* FPG (fasting plasma glucose) greater than 270 mg/dL at baseline
* Impaired liver or kidney function
* Triglycerides greater than 600 mg/dL
* Uncontrolled hypertension
* Pregnant or lactating women
* Women not using adequate contraception
35 Years
75 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Locations
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Hollywood, Florida, United States
Durham, North Carolina, United States
Morrisville, North Carolina, United States
Portland, Oregon, United States
Portland, Oregon, United States
Camp Hill, Pennsylvania, United States
Greer, South Carolina, United States
Memphis, Tennessee, United States
Memphis, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
Midland, Texas, United States
Lebanon, Virginia, United States
Virginia Beach, Virginia, United States
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Tallinn, , Estonia
Tartu, , Estonia
Tartu, , Estonia
Võru, , Estonia
Chihuahua, Chih., , Mexico
Guadalajara, , Mexico
Guadalajara, JAL., , Mexico
Mexico City, , Mexico
Mérida, , Mexico
Monterrey, , Mexico
Monterrey, , Mexico
Monterrey, , Mexico
Pachuca, Hidalgo, , Mexico
Panama City, , Panama
Ponce, , Puerto Rico
Arad, , Romania
Brasov, , Romania
Bucharest, , Romania
Bucharest, , Romania
Craiova, , Romania
Galati, , Romania
Ploieşti, , Romania
Târgovişte, , Romania
Târgu Mureş, , Romania
Meyrin, , Switzerland
Bracknell, , United Kingdom
Nottingham, , United Kingdom
Countries
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Other Identifiers
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BM17151
Identifier Type: -
Identifier Source: org_study_id
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