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

August 23, 2016 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Primary Completion (Actual)

December 1, 2003

Study Completion (Actual)

December 1, 2003

Study Registration Dates

First Submitted

March 31, 2003

First Submitted That Met QC Criteria

March 31, 2003

First Posted (Estimate)

April 1, 2003

Study Record Updates

Last Update Posted (Estimate)

August 24, 2016

Last Update Submitted That Met QC Criteria

August 23, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WM16177

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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