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Study Evaluating PPM-204 In Subjects With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00425919
Recruitment Status : Terminated (Study terminated as a result of interim analysis not meeting predetermined criteria.)
First Posted : January 23, 2007
Last Update Posted : December 27, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: PPM-204 Phase 2

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  (Clinical Trial)
Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : January 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Fasting Plasma Glucose

Secondary Outcome Measures :
  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.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00425919


  Hide Study Locations
Locations
United States, California
Artesia, California, United States, 90701
Los Angeles, California, United States, 90057
United States, Florida
Chipley, Florida, United States, 32428
Destin, Florida, United States, 32541
Marianna, Florida, United States, 32446
West Palm Beach, Florida, United States, 33401
United States, Nebraska
Omaha, Nebraska, United States, 68131
United States, New York
New York, New York, United States, 10032
United States, Texas
Austin, Texas, United States, 78705
United States, Virginia
Richmond, Virginia, United States, 23249
United States, Washington
Tacoma, Washington, United States, 98405
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
Australia, Victoria
Box Hill, Victoria, Australia, 3128
Brazil
Vila Clementino - Sao Paulo, Brazil, 04020-060
Canada, Alberta
Edmonton, Alberta, Canada, T5G 3G6
Canada, Ontario
Toronto, Ontario, Canada, M9W 4L6
Canada, Prince Edward Island
Charlottetown, Prince Edward Island, Canada, C1E 1J7
Canada, 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
Bangalore, Karnataka, India, 560043
Cochin, Kerala, India, 682 026
Pune, Maharashtra, India, 411001
Chennai, Tamil nadu, India, 600 013
Vellore, Tamil Nadu, India, 632004
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, 10825
Bucuresti, Romania, 20475
Cluj-Napoca, Romania, 400006
Russian Federation
Moscow, Russian Federation, 117036
Moscow, Russian Federation, 117292
Moscow, Russian Federation, 123154
Moscow, Russian Federation, 125315
St. Petersburg, Russian Federation, 194044
St. Petersburg, Russian Federation, 194354
South Africa
Port Elizabeth, Eastern Cape, South Africa, 6014
Benoni, Gauteng, South Africa, 1501
Pretoria, Gauteng, South Africa, 0002
Pretoria, Gauteng, South Africa, 39
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
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Argentina, Scheima@wyeth.com
Principal Investigator: Trial Manager For Australia, medinfo@wyeth.com
Principal Investigator: Trial Manager For Brazil, xavierl@wyeth.com
Principal Investigator: Trial Manager For Austria, WPVIMED@wyeth.com
Principal Investigator: Trial Manager For Canada, clintrialparticipation@wyeth.com
Principal Investigator: Trial Manager For Chile, scheima@wyeth.com
Principal Investigator: Trial Manager For China, medinfo@wyeth.com
Principal Investigator: Trial Manager For Croatia, WPBUMED@wyeth.com
Principal Investigator: Trial Manager For Greece, decresg@wyeth.com
Principal Investigator: Trial Manager For Hong Kong, medinfo@wyeth.com
Principal Investigator: Trial Manager For Italy, descresg@wyeth.com
Principal Investigator: Trial Manager For Mexico, gomezzlj@wyeth.com
Principal Investigator: Trial Manager For Romania, WVPIMED@wyeth.com
Principal Investigator: Trial Manager For Russia, WVPIMED@wyeth.com
Principal Investigator: Trial Manager For Serbia, WPVIMED@wyeth.com
Principal Investigator: Trial Manager For South Africa, ZAFinfo@wyeth.com
Principal Investigator: Trial Manager For UK/Great Britian, ukmedinfo@wyeth.com
Principal Investigator: Trial Manager For Ukraine, WVPIMED@wyeth.com

ClinicalTrials.gov Identifier: NCT00425919     History of Changes
Other Study ID Numbers: 3180A1-200
First Posted: January 23, 2007    Key Record Dates
Last Update Posted: December 27, 2007
Last Verified: December 2007

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Type 2 Diabetes
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases