Study Evaluating PPM-204 In Subjects With Type 2 Diabetes

December 18, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

A 24-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Of The Safety And Efficacy Of PPM-204 In Subjects With Type 2 Diabetes

The purpose of this study is to learn whether PPM-204 has an effect on lowering blood glucose (blood sugar) levels and is safe in treating people with type 2 diabetes.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The objectives of the study are to identify doses of PPM-204 that are therapeutically effective and well tolerated in improving glycemic control over 24 weeks of treatment in subjects with type 2 diabetes mellitus (T2DM).

Study Type

Interventional

Enrollment

500

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

  • Argentina
      • Buenos Aires, Argentina, C1117ABH
      • Corrientes, Argentina, 3400
      • La Plata, Argentina, 1900
      • Mar del Plata Pcia de Bs. As, Argentina, 7600
      • Ramos Mejia, Pcia de Bs., Argentina, 1704
  • Australia
    • South Australia
      • Daws Park, South Australia, Australia, 5041
      • Keswick, South Australia, Australia, 5035
    • Victoria
      • Box Hill, Victoria, Australia, 3128
  • Brazil
      • Vila Clementino - Sao Paulo, Brazil, 04020-060
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5G 3G6
    • Ontario
      • Toronto, Ontario, Canada, M9W 4L6
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada, C1E 1J7
    • Quebec
      • Laval, Quebec, Canada, H7P 2P5
      • Saint-Janvier, Quebec, Canada, J7J 2K8
  • China
      • Beijing, China, 100730
      • Beijing, China, 100853
  • Croatia
      • Krapinske Toplice, Croatia, 49000
      • Rijeka, Croatia, 51000
      • Zagreb, Croatia, 10000
  • Former Serbia and Montenegro
      • Belgrade, Former Serbia and Montenegro, 11000
  • Greece
      • Athens, Greece, 115 21
      • Thessaloniki, Greece, 56429
  • Hong Kong
      • Wanchai, Hong Kong
  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560043
    • Kerala
      • Cochin, Kerala, India, 682 026
    • Maharashtra
      • Pune, Maharashtra, India, 411001
    • Tamil Nadu
      • Vellore, Tamil Nadu, India, 632004
    • Tamil nadu
      • Chennai, Tamil nadu, India, 600 013
  • Italy
      • Catanzaro, Italy, 88100
      • Pisa, Italy, 56124
  • Mexico
      • Aguascalientes, Mexico, 20230
      • Mexico D.F., Mexico, 11650
      • Mexico DF, Mexico, 14000
      • Miguel Hidalgo, Mexico, 11550
      • Monterrey N.L, Mexico, 64410
      • Tlapan, Mexico, 14080
  • Romania
      • Bucuresti, Romania, 20475
      • Bucuresti, Romania, 10825
      • Cluj-Napoca, Romania, 400006
  • Russian Federation
      • Moscow, Russian Federation, 117036
      • Moscow, Russian Federation, 117292
      • Moscow, Russian Federation, 125315
      • Moscow, Russian Federation, 123154
      • St. Petersburg, Russian Federation, 194354
      • St. Petersburg, Russian Federation, 194044
  • South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6014
    • Gauteng
      • Benoni, Gauteng, South Africa, 1501
      • Pretoria, Gauteng, South Africa, 0002
      • Pretoria, Gauteng, South Africa, 39
    • North West Province
      • Temba, North West Province, South Africa, 400
  • Ukraine
      • Kharkiv, Ukraine, 61070
      • Kyiv, Ukraine, 02175
      • Poltava, Ukraine, 36024
      • Uzhgorod, Ukraine, 80312
  • United Kingdom
      • Dundee, United Kingdom, DD1 9SY
      • Edinburgh, United Kingdom, EH4 2XU
      • Livingston, United Kingdom, EH54 6PP
  • United States
    • California
      • Artesia, California, United States, 90701
      • Los Angeles, California, United States, 90057
    • Florida
      • Chipley, Florida, United States, 32428
      • Destin, Florida, United States, 32541
      • Marianna, Florida, United States, 32446
      • West Palm Beach, Florida, United States, 33401
    • Nebraska
      • Omaha, Nebraska, United States, 68131
    • New York
      • New York, New York, United States, 10032
    • Texas
      • Austin, Texas, United States, 78705
    • Virginia
      • Richmond, Virginia, United States, 23249
    • Washington
      • Tacoma, Washington, United States, 98405

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women of non-childbearing potential, 18 to 70 years old
  • Subjects currently treated with diet and exercise alone and subjects receiving a single oral antidiabetic medication
  • BMI > 23 and < 43
  • For subjects currently treated with 1 antidiabetic medication: HbA1c is greater than or equal to 6.8% and less than or equal to 8.5%.
  • For subjects not currently treated with antidiabetic medications: HbA1c is greater than or equal to 7.2% and less than or equal to 9.0%

Exclusion Criteria:

  • Subjects requiring insulin therapy
  • Subjects currently receiving 2 or more oral antidiabetic medications
  • Subjects requiring systemic corticosteroids, unless treatment was discontinued at least 4 weeks before the screening visit
  • Subjects receiving warfarin
  • Subjects currently receiving thiazolidinediones, unless treatment was discontinued 8 weeks before the screening visit
  • Significant diabetic complications (retinopathy, nephropathy, symptomatic neuropathy)

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
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Fasting Plasma Glucose

Secondary Outcome Measures

Outcome Measure
Mean changes of HbA1c, Fasting Insulin, HOMA-IR and QUICKI indices, Body weight, waist measurements, total cholesterol, LDL-C, HDL-C, total/HDL, apolipoprotein A-1 & B, triglycerides, free fatty acids, hs C-reactive protein, adiponectin, edema.

Collaborators and Investigators

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

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

  • Principal Investigator: Trial Manager, For Australia, medinfo@wyeth.com
  • Principal Investigator: Trial Manager, For Austria, WPVIMED@wyeth.com
  • Principal Investigator: Trial Manager, For Greece, decresg@wyeth.com
  • Principal Investigator: Trial Manager, For Romania, WVPIMED@wyeth.com
  • Principal Investigator: Trial Manager, For UK/Great Britian, ukmedinfo@wyeth.com
  • Principal Investigator: Trial Manager, For South Africa, ZAFinfo@wyeth.com
  • Principal Investigator: Trial Manager, For Brazil, xavierl@wyeth.com
  • Principal Investigator: Trial Manager, For Mexico, gomezzlj@wyeth.com
  • Principal Investigator: Trial Manager, For Canada, clintrialparticipation@wyeth.com
  • Principal Investigator: Trial Manager, For Croatia, WPBUMED@wyeth.com
  • Principal Investigator: Trial Manager, For Argentina, Scheima@wyeth.com
  • Principal Investigator: Trial Manager, For Chile, scheima@wyeth.com
  • Principal Investigator: Trial Manager, For Russia, WVPIMED@wyeth.com
  • Principal Investigator: Trial Manager, For Ukraine, WVPIMED@wyeth.com
  • Principal Investigator: Trial Manager, For Hong Kong, medinfo@wyeth.com
  • Principal Investigator: Trial Manager, For Serbia, WPVIMED@wyeth.com

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

January 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

January 19, 2007

First Submitted That Met QC Criteria

January 19, 2007

First Posted (Estimate)

January 23, 2007

Study Record Updates

Last Update Posted (Estimate)

December 27, 2007

Last Update Submitted That Met QC Criteria

December 18, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3180A1-200

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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