Study Evaluating PPM-204 In Subjects With Type 2 Diabetes

NCT00425919 | Terminated Phase 2

• 1 other identifier: 3180A1-200
• Study Type: interventional
• Target: 500
• Locations: 18 countries
• Sites: 68

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.

Conditions

Diabetes Mellitus

Keywords

Type 2 Diabetes; Diabetes

Outcome Measures

Primary Outcomes (1)

• Fasting Plasma Glucose

Secondary Outcomes (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.

Interventions

PPM-204 DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (68)

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Artesia, California, 90701, United States

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Los Angeles, California, 90057, United States

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Chipley, Florida, 32428, United States

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Destin, Florida, 32541, United States

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Marianna, Florida, 32446, United States

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West Palm Beach, Florida, 33401, United States

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Omaha, Nebraska, 68131, United States

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New York, New York, 10032, United States

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Austin, Texas, 78705, United States

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Richmond, Virginia, 23249, United States

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Tacoma, Washington, 98405, United States

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Buenos Aires, C1117ABH, Argentina

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Corrientes, 3400, Argentina

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La Plata, 1900, Argentina

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Mar Del Plata Pcia de Bs. As, 7600, Argentina

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Ramos Mejia, Pcia de Bs., 1704, Argentina

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Daws Park, South Australia, 5041, Australia

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Keswick, South Australia, 5035, Australia

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Box Hill, Victoria, 3128, Australia

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Vila Clementino - Sao Paulo, 04020-060, Brazil

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Edmonton, Alberta, T5G 3G6, Canada

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Toronto, Ontario, M9W 4L6, Canada

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Charlottetown, Prince Edward Island, C1E 1J7, Canada

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Laval, Quebec, H7P 2P5, Canada

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Saint-Janvier, Quebec, J7J 2K8, Canada

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Beijing, 100730, China

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Beijing, 100853, China

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Krapinske Toplice, 49000, Croatia

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Rijeka, 51000, Croatia

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Zagreb, 10000, Croatia

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Athens, 115 21, Greece

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Thessaloniki, 56429, Greece

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Wan Chai, Hong Kong

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Bangalore, Karnataka, 560043, India

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Kochi, Kerala, 682 026, India

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Pune, Maharashtra, 411001, India

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Chennai, Tamil Nadu, 600 013, India

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Vellore, Tamil Nadu, 632004, India

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Catanzaro, 88100, Italy

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Pisa, 56124, Italy

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Aguascalientes, 20230, Mexico

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Mexico City, 11650, Mexico

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Mexico City, 14000, Mexico

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Miguel Hidalgo, 11550, Mexico

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Monterrey N.L, 64410, Mexico

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Tlapan, 14080, Mexico

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Bucharest, 10825, Romania

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Bucharest, 20475, Romania

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Cluj-Napoca, 400006, Romania

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Moscow, 117036, Russia

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Moscow, 117292, Russia

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Moscow, 123154, Russia

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Moscow, 125315, Russia

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Saint Petersburg, 194044, Russia

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Saint Petersburg, 194354, Russia

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Belgrade, 11000, Serbia and Montenegro

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Port Elizabeth, Eastern Cape, 6014, South Africa

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Benoni, Gauteng, 1501, South Africa

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Pretoria, Gauteng, 0002, South Africa

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Pretoria, Gauteng, 39, South Africa

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Temba, North West, 400, South Africa

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Kharkiv, 61070, Ukraine

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Kyiv, 02175, Ukraine

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Poltava, 36024, Ukraine

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Uzhhorod, 80312, Ukraine

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Dundee, DD1 9SY, United Kingdom

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Edinburgh, EH4 2XU, United Kingdom

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Livingston, EH54 6PP, United Kingdom

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MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 19, 2007
• First Posted: January 23, 2007
• Study Start: January 1, 2007
• Study Completion: October 1, 2007
• Last Updated: December 27, 2007

Record last verified: 2007-12

Locations

US (11); GB (3); IT (2); RO (3); CN (2); HK (1); IN (5); GR (2); ME (6); RU (6); AU (3); SE (1); ZA (5); CR (3); CA (5); AR (5); BR (1); UA (4)