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Study Evaluating PPM-204 In Subjects With Type 2 Diabetes

Last updated on November 11, 2019

FOR MORE INFORMATION
Study Location
Artesia, California, 90701 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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)

NCT00425919
Pfizer
Terminated
Study Evaluating PPM-204 In Subjects With Type 2 Diabetes

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Descriptive Information
Brief Title  ICMJE Study Evaluating PPM-204 In Subjects With Type 2 Diabetes
Official Title  ICMJE A 24-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Of The Safety And Efficacy Of PPM-204 In Subjects With Type 2 Diabetes
Brief SummaryThe 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 DescriptionThe 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE Drug: PPM-204
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: January 19, 2007)
500
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2007
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Brazil,   Canada,   China,   Croatia,   Former Serbia and Montenegro,   Greece,   Hong Kong,   India,   Italy,   Mexico,   Romania,   Russian Federation,   South Africa,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00425919
Other Study ID Numbers  ICMJE 3180A1-200
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Argentina, [email protected]
Principal Investigator:Trial ManagerFor Australia, [email protected]
Principal Investigator:Trial ManagerFor Brazil, [email protected]
Principal Investigator:Trial ManagerFor Austria, [email protected]
Principal Investigator:Trial ManagerFor Canada, [email protected]
Principal Investigator:Trial ManagerFor Chile, [email protected]
Principal Investigator:Trial ManagerFor China, [email protected]wyeth.com
Principal Investigator:Trial ManagerFor Croatia, [email protected]
Principal Investigator:Trial ManagerFor Greece, [email protected]
Principal Investigator:Trial ManagerFor Hong Kong, [email protected]
Principal Investigator:Trial ManagerFor Italy, [email protected]
Principal Investigator:Trial ManagerFor Mexico, [email protected]
Principal Investigator:Trial ManagerFor Romania, [email protected]
Principal Investigator:Trial ManagerFor Russia, [email protected]
Principal Investigator:Trial ManagerFor Serbia, [email protected]
Principal Investigator:Trial ManagerFor South Africa, [email protected]
Principal Investigator:Trial ManagerFor UK/Great Britian, [email protected]
Principal Investigator:Trial ManagerFor Ukraine, [email protected]
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateDecember 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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