Study Evaluating PPM-204 In Subjects With Type 2 Diabetes

NCT ID: NCT00425919

Last Updated: 2007-12-27

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Type 2 Diabetes Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PPM-204

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Argentina, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Australia, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Brazil, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Austria, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Canada, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Chile, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For China, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Croatia, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Greece, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Hong Kong, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Italy, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Mexico, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Romania, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Russia, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Serbia, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For South Africa, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For UK/Great Britian, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Ukraine, [email protected]

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Artesia, California, United States

Site Status

Los Angeles, California, United States

Site Status

Chipley, Florida, United States

Site Status

Destin, Florida, United States

Site Status

Marianna, Florida, United States

Site Status

West Palm Beach, Florida, United States

Site Status

Omaha, Nebraska, United States

Site Status

New York, New York, United States

Site Status

Austin, Texas, United States

Site Status

Richmond, Virginia, United States

Site Status

Tacoma, Washington, United States

Site Status

Buenos Aires, , Argentina

Site Status

Corrientes, , Argentina

Site Status

La Plata, , Argentina

Site Status

Mar Del Plata Pcia de Bs. As, , Argentina

Site Status

Ramos Mejia, Pcia de Bs., , Argentina

Site Status

Daws Park, South Australia, Australia

Site Status

Keswick, South Australia, Australia

Site Status

Box Hill, Victoria, Australia

Site Status

Vila Clementino - Sao Paulo, , Brazil

Site Status

Edmonton, Alberta, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Charlottetown, Prince Edward Island, Canada

Site Status

Laval, Quebec, Canada

Site Status

Saint-Janvier, Quebec, Canada

Site Status

Beijing, , China

Site Status

Beijing, , China

Site Status

Krapinske Toplice, , Croatia

Site Status

Rijeka, , Croatia

Site Status

Zagreb, , Croatia

Site Status

Athens, , Greece

Site Status

Thessaloniki, , Greece

Site Status

Wan Chai, , Hong Kong

Site Status

Bangalore, Karnataka, India

Site Status

Kochi, Kerala, India

Site Status

Pune, Maharashtra, India

Site Status

Chennai, Tamil Nadu, India

Site Status

Vellore, Tamil Nadu, India

Site Status

Catanzaro, , Italy

Site Status

Pisa, , Italy

Site Status

Aguascalientes, , Mexico

Site Status

Mexico City, , Mexico

Site Status

Mexico City, , Mexico

Site Status

Miguel Hidalgo, , Mexico

Site Status

Monterrey N.L, , Mexico

Site Status

Tlapan, , Mexico

Site Status

Bucharest, , Romania

Site Status

Bucharest, , Romania

Site Status

Cluj-Napoca, , Romania

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Belgrade, , Serbia and Montenegro

Site Status

Port Elizabeth, Eastern Cape, South Africa

Site Status

Benoni, Gauteng, South Africa

Site Status

Pretoria, Gauteng, South Africa

Site Status

Pretoria, Gauteng, South Africa

Site Status

Temba, North West, South Africa

Site Status

Kharkiv, , Ukraine

Site Status

Kyiv, , Ukraine

Site Status

Poltava, , Ukraine

Site Status

Uzhhorod, , Ukraine

Site Status

Dundee, , United Kingdom

Site Status

Edinburgh, , United Kingdom

Site Status

Livingston, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Brazil Canada China Croatia Greece Hong Kong India Italy Mexico Romania Russia Serbia and Montenegro South Africa Ukraine United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

3180A1-200

Identifier Type: -

Identifier Source: org_study_id