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Study Evaluating PPM-204 In Subjects With Type 2 Diabetes

Last updated on May 10, 2018

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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Study Evaluating PPM-204 In Subjects With Type 2 Diabetes
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.
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).
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Diabetes Mellitus
Drug: PPM-204
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
500
October 2007
Not Provided

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)
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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
 
 
NCT00425919
3180A1-200
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Argentina, [email protected]
Principal Investigator: Trial Manager For Australia, [email protected]
Principal Investigator: Trial Manager For Brazil, [email protected]
Principal Investigator: Trial Manager For Austria, [email protected]
Principal Investigator: Trial Manager For Canada, [email protected]
Principal Investigator: Trial Manager For Chile, [email protected]
Principal Investigator: Trial Manager For China, [email protected]
Principal Investigator: Trial Manager For Croatia, [email protected]
Principal Investigator: Trial Manager For Greece, [email protected]
Principal Investigator: Trial Manager For Hong Kong, [email protected]
Principal Investigator: Trial Manager For Italy, [email protected]
Principal Investigator: Trial Manager For Mexico, [email protected]
Principal Investigator: Trial Manager For Romania, [email protected]
Principal Investigator: Trial Manager For Russia, [email protected]
Principal Investigator: Trial Manager For Serbia, [email protected]
Principal Investigator: Trial Manager For South Africa, [email protected]
Principal Investigator: Trial Manager For UK/Great Britian, [email protected]
Principal Investigator: Trial Manager For Ukraine, [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
December 2007

ICMJE     Data element required by the

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

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