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

NCT ID: NCT00057317

Last Updated: 2016-08-24

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2003-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Ro 205-2349

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Locations

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Huntsville, Alabama, United States

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Mesa, Arizona, United States

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Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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Tucson, Arizona, United States

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Encino, California, United States

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Fountain Valley, California, United States

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Fremont, California, United States

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Fresno, California, United States

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Irvine, California, United States

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Modesto, California, United States

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Pasadena, California, United States

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San Bruno, California, United States

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Santa Rosa, California, United States

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Sunnyvale, California, United States

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Hamden, Connecticut, United States

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Norwalk, Connecticut, United States

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Newark, Delaware, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Ocala, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Lawrenceville, Georgia, United States

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Honolulu, Hawaii, United States

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Indianapolis, Indiana, United States

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Overland Park, Kansas, United States

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New Orleans, Louisiana, United States

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Boston, Massachusetts, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Billings, Montana, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Trenton, New Jersey, United States

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Albuquerque, New Mexico, United States

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Buffalo, New York, United States

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New Hyde Park, New York, United States

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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Greenville, North Carolina, United States

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Morrisville, North Carolina, United States

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Portland, Oregon, United States

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Tualatin, Oregon, United States

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Camp Hill, Pennsylvania, United States

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Connellsville, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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East Providence, Rhode Island, United States

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Greer, South Carolina, United States

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Memphis, Tennessee, United States

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Dallas, Texas, United States

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El Paso, Texas, United States

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Houston, Texas, United States

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Midland, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Lebanon, Virginia, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Edmonds, Washington, United States

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Wenatchee, Washington, United States

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Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Calgary, Alberta, Canada

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Winnipeg, Manitoba, Canada

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Halifax, Nova Scotia, Canada

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Courtice, Ontario, Canada

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Ottawa, Ontario, Canada

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Windsor, Ontario, Canada

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Laval, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Sainte-Foy, Quebec, Canada

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Sherbrooke, Quebec, Canada

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St. John's, , Canada

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Tallinn, , Estonia

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Tartu, , Estonia

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Tartu, , Estonia

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Võru, , Estonia

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Ogre, , Latvia

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Talsi, , Latvia

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Tukums, , Latvia

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Valmiera, , Latvia

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Kaunas, , Lithuania

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Kaunas, , Lithuania

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Kaunas, , Lithuania

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Vilnius, , Lithuania

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Guadalajara, , Mexico

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Guadalajara, , Mexico

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Mexico City, , Mexico

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Mexico City, , Mexico

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Mexico City, , Mexico

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Mérida, , Mexico

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Monterrey, , Mexico

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Monterrey, , Mexico

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Monterrey, , Mexico

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Pachuca, Hidalgo, , Mexico

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Tijuana, , Mexico

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Panama City, , Panama

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Ponce, , Puerto Rico

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Arad, , Romania

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Brasov, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Galati, , Romania

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Ploieşti, , Romania

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Târgovişte, , Romania

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Târgu Mureş, , Romania

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Bracknell, , United Kingdom

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Nottingham, , United Kingdom

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Plymouth, , United Kingdom

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Countries

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United States Bulgaria Canada Estonia Latvia Lithuania Mexico Panama Puerto Rico Romania United Kingdom

Other Identifiers

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WM16177

Identifier Type: -

Identifier Source: org_study_id

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