Study of Ro 205-2349 in Patients With Type 2 Diabetes Mellitus

NCT00057317 | Completed Phase 2

• 1 other identifier: WM16177
• Study Type: interventional
• Target: N/A
• Locations: 11 countries
• Sites: 117

Brief Summary

The objective of the study is to determine the dose(s) of Ro 205-2349 which, when compared to placebo, are efficacious, safe and tolerable in improving glycemic control in patients with type 2 diabetes. Doses of 5 to 20 mg/day will be studied.

Conditions

Diabetes

Interventions

Ro 205-2349 DRUG

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 35 to 75
• 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

You may not qualify if:

• Type I diabetes
• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (117)

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Huntsville, Alabama, 35801, United States

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Mesa, Arizona, 85206, United States

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Scottsdale, Arizona, 85251, United States

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Tucson, Arizona, 85710, United States

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Tucson, Arizona, 85723, United States

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Encino, California, 91436, United States

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Fountain Valley, California, 92708, United States

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Fremont, California, 94538, United States

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Fresno, California, 93720, United States

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Irvine, California, 92618, United States

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Modesto, California, 95355, United States

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Pasadena, California, 91106, United States

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San Bruno, California, 94066, United States

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Santa Rosa, California, 95405, United States

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Sunnyvale, California, 94086, United States

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Hamden, Connecticut, 06518, United States

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Norwalk, Connecticut, 06850, United States

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Newark, Delaware, 19713, United States

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Hollywood, Florida, 33021, United States

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Jacksonville, Florida, 32204, United States

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Ocala, Florida, 34471, United States

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West Palm Beach, Florida, 33401, United States

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Atlanta, Georgia, 30322, United States

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Lawrenceville, Georgia, 30045, United States

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Honolulu, Hawaii, 96813, United States

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Indianapolis, Indiana, 46214-2985, United States

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Overland Park, Kansas, 66211, United States

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New Orleans, Louisiana, 70121, United States

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Boston, Massachusetts, 02215, United States

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Kansas City, Missouri, 64111, United States

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St Louis, Missouri, 63104, United States

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St Louis, Missouri, 63110, United States

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Billings, Montana, 59101, United States

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Omaha, Nebraska, 68198-3032, United States

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Las Vegas, Nevada, 89102, United States

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Trenton, New Jersey, 08611, United States

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Albuquerque, New Mexico, 87106, United States

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Buffalo, New York, 14209, United States

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New Hyde Park, New York, 11040, United States

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Rochester, New York, 14609, United States

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Charlotte, North Carolina, 28209, United States

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Durham, North Carolina, 27710, United States

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Greenville, North Carolina, 27858-4354, United States

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Morrisville, North Carolina, 27560, United States

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Portland, Oregon, 97201, United States

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Tualatin, Oregon, 97062, United States

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Camp Hill, Pennsylvania, 17011, United States

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Connellsville, Pennsylvania, 15425, United States

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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19107, United States

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East Providence, Rhode Island, 02914, United States

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Greer, South Carolina, 29651, United States

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Memphis, Tennessee, 38119, United States

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Dallas, Texas, 75230, United States

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El Paso, Texas, 79902, United States

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Houston, Texas, 77030, United States

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Midland, Texas, 79705, United States

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San Antonio, Texas, 78229-4801, United States

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San Antonio, Texas, 78229, United States

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San Antonio, Texas, 78284, United States

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Lebanon, Virginia, 24266, United States

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Richmond, Virginia, 23294, United States

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Virginia Beach, Virginia, 23451, United States

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Edmonds, Washington, 98026, United States

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Wenatchee, Washington, 98801, United States

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Pleven, 5800, Bulgaria

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Plovdiv, 4002, Bulgaria

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Sofia, 1233, Bulgaria

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Sofia, 1431, Bulgaria

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Calgary, Alberta, T3B 0M3, Canada

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Winnipeg, Manitoba, R3E 3P4, Canada

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Halifax, Nova Scotia, B3H 1V7, Canada

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Courtice, Ontario, L1E 3C3, Canada

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Ottawa, Ontario, K1Y 4E9, Canada

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Windsor, Ontario, N8X 1K4, Canada

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Laval, Quebec, H7T 2P5, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Sainte-Foy, Quebec, G1V 4G2, Canada

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Sherbrooke, Quebec, J1G 5K2, Canada

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St. John's, A1B 3V6, Canada

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Tallinn, 10138, Estonia

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Tartu, 50406, Estonia

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Tartu, 50708, Estonia

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Võru, 65609, Estonia

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Ogre, 5001, Latvia

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Talsi, 3201, Latvia

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Tukums, 3100, Latvia

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Valmiera, LV-4201, Latvia

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Kaunas, 3036, Lithuania

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Kaunas, 3040, Lithuania

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Kaunas, 3042, Lithuania

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Vilnius, Lithuania

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Guadalajara, 44280, Mexico

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Guadalajara, 44349, Mexico

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Mexico City, 03100, Mexico

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Mexico City, 06700, Mexico

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Mexico City, 14050, Mexico

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Mérida, 97000, Mexico

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Monterrey, 64320, Mexico

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Monterrey, 64410, Mexico

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Monterrey, 64460, Mexico

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Pachuca, Hidalgo, 42039, Mexico

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Tijuana, 22320, Mexico

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Panama City, Panama

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Ponce, 00732-7994, Puerto Rico

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Arad, 2900, Romania

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Brasov, 500326, Romania

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Bucharest, 020475, Romania

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Bucharest, 7000, Romania

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Galati, 6200, Romania

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Ploieşti, 2000, Romania

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Târgovişte, 0200, Romania

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Târgu Mureş, 4300, Romania

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Bracknell, RG12 1HX, United Kingdom

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Nottingham, NG2 3HF, United Kingdom

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Plymouth, PL6 8BX, United Kingdom

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MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 31, 2003
• First Posted: April 1, 2003
• Study Start: December 1, 2001
• Primary Completion: December 1, 2003
• Study Completion: December 1, 2003
• Last Updated: August 24, 2016

Record last verified: 2016-08

Locations

RO (8); CA (12); PR (1); ES (4); US (65); PA (1); GB (3); BU (4); LA (4); LI (4); ME (11)