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Study of Ro 205-2349 in Patients With Type 2 Diabetes Mellitus
This study has been completed.
First Received: March 31, 2003   Last Updated: June 23, 2005   History of Changes
Sponsor: Hoffmann-La Roche
Information provided by: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00057317
  Purpose

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.


Condition Intervention Phase
Diabetes
 Drug: Ro 205-2349
 Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Official Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Determine the Efficacy, Safety, Tolerability and Pharmacokinetics of Ro 205-2349 in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
Drug Information available for: Ro 205-2349
U.S. FDA Resources
  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00057317

  Hide Study Locations
Locations
United States, Alabama
Huntsville, Alabama, United States, 35801
United States, Arizona
Scottsdale, Arizona, United States, 85251
Tucson, Arizona, United States, 85723
Tucson, Arizona, United States, 85710
Mesa, Arizona, United States, 85206
United States, California
Irvine, California, United States, 92618
Fountain Valley, California, United States, 92708
Encino, California, United States, 91436
Modesto, California, United States, 95355
Fresno, California, United States, 93720
San Bruno, California, United States, 94066
Sunnyvale, California, United States, 94086
Fremont, California, United States, 94538
Santa Rosa, California, United States, 95405
Pasadena, California, United States, 91106
United States, Connecticut
Hamden, Connecticut, United States, 06518
Norwalk, Connecticut, United States, 06850
United States, Delaware
Newark, Delaware, United States, 19713
United States, Florida
West Palm Beach, Florida, United States, 33401
Hollywood, Florida, United States, 33021
Jacksonville, Florida, United States, 32204
Ocala, Florida, United States, 34471
United States, Georgia
Lawrenceville, Georgia, United States, 30045
Atlanta, Georgia, United States, 30322
United States, Hawaii
Honolulu, Hawaii, United States, 96813
United States, Indiana
Indianapolis, Indiana, United States, 46214-2985
United States, Kansas
Overland Park, Kansas, United States, 66211
United States, Louisiana
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Boston, Massachusetts, United States, 02215
United States, Missouri
St. Louis, Missouri, United States, 63110
St. Louis, Missouri, United States, 63104
Kansas City, Missouri, United States, 64111
United States, Montana
Billings, Montana, United States, 59101
United States, Nebraska
Omaha, Nebraska, United States, 68198-3032
United States, Nevada
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Trenton, New Jersey, United States, 08611
United States, New Mexico
Albuquerque, New Mexico, United States, 87106
United States, New York
Rochester, New York, United States, 14609
Buffalo, New York, United States, 14209
New Hyde Park, New York, United States, 11040
United States, North Carolina
Durham, North Carolina, United States, 27710
Greenville, North Carolina, United States, 27858-4354
Charlotte, North Carolina, United States, 28209
Morrisville, North Carolina, United States, 27560
United States, Oregon
Portland, Oregon, United States, 97201
Portland, Oregon, United States, 97201
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Philadelphia, Pennsylvania, United States, 19107
Camp Hill, Pennsylvania, United States, 17011
Connellsville, Pennsylvania, United States, 15425
United States, Rhode Island
East Providence, Rhode Island, United States, 02914
United States, South Carolina
Greer, South Carolina, United States, 29651
United States, Tennessee
Memphis, Tennessee, United States, 38119
United States, Texas
Dallas, Texas, United States, 75230
San Antonio, Texas, United States, 78229
El Paso, Texas, United States, 79902
San Antonio, Texas, United States, 78284
San Antonio, Texas, United States, 78229-4801
Houston, Texas, United States, 77030
Midland, Texas, United States, 79705
United States, Virginia
Richmond, Virginia, United States, 23294
Virginia Beach, Virginia, United States, 23451
Lebanon, Virginia, United States, 24266
United States, Washington
Wenatchee, Washington, United States, 98801
Edmonds, Washington, United States, 98026
Bulgaria
Sofia, Bulgaria, 1431
Sofia, Bulgaria, 1233
Pleven, Bulgaria, 5800
Plovdiv, Bulgaria, 4002
Canada, Alberta
Calgary, Alberta, Canada, T3B 0M3
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Newfoundland and Labrador
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Ottawa, Ontario, Canada, K1Y 4E9
Windsor, Ontario, Canada, N8X 1K4
Courtice, Ontario, Canada, L1E 3C3
Canada, Quebec
Montreal, Quebec, Canada, H1T 2M4
Sherbrooke, Quebec, Canada, J1G 5K2
Sainte-Foy, Quebec, Canada, G1V 4G2
Laval, Quebec, Canada, H7T 2P5
Montreal, Quebec, Canada, H3T 1E2
Estonia
Tartu, Estonia, 50406
Tartu, Estonia, 50708
VORU, Estonia, 65609
Tallinn, Estonia, 10138
Latvia
OGRE, Latvia, 5001
TALSI, Latvia, 3201
TUKUMS, Latvia, 3100
VALMIERA, Latvia, LV-4201
Lithuania
Kaunas, Lithuania, 3036
Kaunas, Lithuania, 3042
Kaunas, Lithuania, 3040
Vilnius, Lithuania
Mexico
Monterrey, Mexico, 64320
Monterrey, Mexico, 64410
Monterrey, Mexico, 64460
PACHUCA, HIDALGO, Mexico, 42039
Mexico City, Mexico, 06700
Mexico City, Mexico, 03100
Merida, Mexico, 97000
Guadalajara, Mexico, 44349
Guadalajara, Mexico, 44280
Mexico City, Mexico, 14050
Tijuana, Mexico, 22320
Panama
Panama, Panama
Puerto Rico
Ponce, Puerto Rico, 00732-7994
Romania
Bucuresti, Romania, 020475
TIRGU-MURES, Romania, 4300
Ploiesti, Romania, 2000
Bucuresti, Romania, 7000
TARGOVISTE, Romania, 0200
GALATI, Romania, 6200
Brasov, Romania, 500326
Arad, Romania, 2900
United Kingdom
Plymouth, United Kingdom, PL6 8BX
Bracknell, United Kingdom, RG12 1HX
Nottingham, United Kingdom, NG2 3HF
Sponsors and Collaborators
Hoffmann-La Roche
  More Information

No publications provided

Study ID Numbers: WM16177
Study First Received: March 31, 2003
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00057317     History of Changes
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 27, 2009



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