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Diabetes MellitusPhase 2NCT00425919

Study Evaluating PPM-204 In Subjects With Type 2 Diabetes

A Phase 2 study testing PPM-204 in people with Diabetes Mellitus, run by Wyeth is now a wholly owned subsidiary of Pfizer at 68 sites in 18 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Diabetes Mellitus
What is being tested?
PPM-204
How many people
500 participants
Where
68 sitesin 18 countries
Study dates
Jan 2007to Oct 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%

Who cannot join

  • 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)

Trial locations and contacts

68 sites in 18 countries.

68 sites in 18 countries

United States11 sites

  • Study site

    Artesia, California, 90701

  • Study site

    Austin, Texas, 78705

  • Study site

    Chipley, Florida, 32428

  • Study site

    Destin, Florida, 32541

  • Study site

    Los Angeles, California, 90057

  • Study site

    Marianna, Florida, 32446

  • Study site

    New York, New York, 10032

  • Study site

    Omaha, Nebraska, 68131

  • Study site

    Richmond, Virginia, 23249

  • Study site

    Tacoma, Washington, 98405

  • Study site

    West Palm Beach, Florida, 33401

Other trials in United States

Mexico6 sites

  • Study site

    Aguascalientes, 20230

  • Study site

    Mexico City, 11650

  • Study site

    Mexico City, 14000

  • Study site

    Miguel Hidalgo, 11550

  • Study site

    Monterrey N.L, 64410

  • Study site

    Tlapan, 14080

Other trials in Mexico

Russia6 sites

  • Study site

    Moscow, 117036

  • Study site

    Moscow, 117292

  • Study site

    Moscow, 123154

  • Study site

    Moscow, 125315

  • Study site

    Saint Petersburg, 194044

  • Study site

    Saint Petersburg, 194354

Other trials in Russia

Argentina5 sites

  • Study site

    Buenos Aires, C1117ABH

  • Study site

    Corrientes, 3400

  • Study site

    La Plata, 1900

  • Study site

    Mar Del Plata Pcia de Bs. As, 7600

  • Study site

    Ramos Mejia, Pcia de Bs., 1704

Other trials in Argentina

Canada5 sites

  • Study site

    Charlottetown, Prince Edward Island, C1E 1J7

  • Study site

    Edmonton, Alberta, T5G 3G6

  • Study site

    Laval, Quebec, H7P 2P5

  • Study site

    Saint-Janvier, Quebec, J7J 2K8

  • Study site

    Toronto, Ontario, M9W 4L6

Other trials in Canada

India5 sites

  • Study site

    Bangalore, Karnataka, 560043

  • Study site

    Chennai, Tamil Nadu, 600 013

  • Study site

    Kochi, Kerala, 682 026

  • Study site

    Pune, Maharashtra, 411001

  • Study site

    Vellore, Tamil Nadu, 632004

Other trials in India

South Africa5 sites

  • Study site

    Benoni, Gauteng, 1501

  • Study site

    Port Elizabeth, Eastern Cape, 6014

  • Study site

    Pretoria, Gauteng, 0002

  • Study site

    Pretoria, Gauteng, 39

  • Study site

    Temba, North West, 400

Other trials in South Africa

Ukraine4 sites

  • Study site

    Kharkiv, 61070

  • Study site

    Kyiv, 02175

  • Study site

    Poltava, 36024

  • Study site

    Uzhhorod, 80312

Other trials in Ukraine

Australia3 sites

  • Study site

    Box Hill, Victoria, 3128

  • Study site

    Daws Park, South Australia, 5041

  • Study site

    Keswick, South Australia, 5035

Other trials in Australia

Croatia3 sites

  • Study site

    Krapinske Toplice, 49000

  • Study site

    Rijeka, 51000

  • Study site

    Zagreb, 10000

Other trials in Croatia

Romania3 sites

  • Study site

    Bucharest, 10825

  • Study site

    Bucharest, 20475

  • Study site

    Cluj-Napoca, 400006

Other trials in Romania

United Kingdom3 sites

  • Study site

    Dundee, DD1 9SY

  • Study site

    Edinburgh, EH4 2XU

  • Study site

    Livingston, EH54 6PP

Other trials in United Kingdom

China2 sites

  • Study site

    Beijing, 100730

  • Study site

    Beijing, 100853

Other trials in China

Greece2 sites

  • Study site

    Athens, 115 21

  • Study site

    Thessaloniki, 56429

Other trials in Greece

Italy2 sites

  • Study site

    Catanzaro, 88100

  • Study site

    Pisa, 56124

Other trials in Italy

Brazil1 site

  • Study site

    Vila Clementino - Sao Paulo, 04020-060

Other trials in Brazil

Hong Kong1 site

  • Study site

    Wan Chai

Other trials in Hong Kong

Serbia and Montenegro1 site

  • Study site

    Belgrade, 11000

Other trials in Serbia and Montenegro

About this study

Official title: 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.

Read the 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).

Being tested
PPM-204
Keywords
Type 2 Diabetes, Diabetes
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PPM-204Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fasting Plasma Glucose

Secondary outcomes (1)

  1. 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2007 (estimated)
  2. Study startJan 2007
  3. Study completionOct 2007

Why it stopped: Study terminated as a result of interim analysis not meeting predetermined criteria.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
500 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00425919
Sponsor's protocol ID
3180A1-200
Status last verified
Dec 2007
First submitted
19 Jan 2007
Last updated
27 Dec 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PPM-204 in people with Diabetes Mellitus, run by Wyeth is now a wholly owned subsidiary of Pfizer at 68 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, Mexico, Russia, Argentina, Canada and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study terminated as a result of interim analysis not meeting predetermined criteria.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fasting Plasma Glucose. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00425919.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2007.

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