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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Fasting Plasma Glucose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 27, 2007

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2007

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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