Subjects with type 2 diabetes mellitus
Conditions
Interventions
Product Name: PPM-204 15 mg Capsules
Product Code: PPM-204
Pharmaceutical Form: Capsule*
CAS Number: 835619-41-5
Current Sponsor code: PPM-204
Other descriptive name: Way-283204, PLX204
Concentration
Sponsors
Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria at Screening (Week -3) 1. Type 2 diabetic men and women of non-childbearing potential, 18 to 70 years old. - Women of non-childbearing potential may be included if they are surgically sterile (hysterectomy and/or oophorectomy) or postmenoausal (at least 12 months of spontaneous amenorrhea). If the menopausal status is uncertain, a FSH level > 38 mIU/mL will allow enrollment. Surgical sterility must be documented in the subject’s source documents prior to randomization. 2. Subjects currently treated with diet and exercise alone, and subjects receiving a single oral antidiabetic medication. 3. BMI > 23 and or= 7.2% and or= 7.2% and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria at Screening (Week -3): 1. Subjects requiring insulin therapy. 2. Subjects currently receiving 2 or more oral antidiabetic medications; subjects receiving an oral antidiabetic medication are required to discontinue the treatment at screening. 3. Subjects currently receiving thiazolidinediones. Subjects previously treated with thiazolidinediones may enroll if they discontinued treatment at least 8 weeks before the screening visit. 4. Subjects requiring systemic corticosteroids (however, topical, inhaled or nasal corticosteroids are acceptable). Subjects previously treated with systemic corticosteroids may enroll if they discontinue treatment at least 4 weeks before the screening visit. 5. Subjects receiving warfarin. 6. Significant diabetic complications (proliferative retinopathy or history of macular edema), nephropathy (defined by e-GFR or= 3.0 times upper limit of normal (ULN). 8. Total bilirubin >or= 1.5 mg/dL (>or= 26 mmol/L), unless the elevation is due to Gilbert’s disease. 9. Estimated GFR 500 mg/dL [5.6 mmol/L]. 11. TSH or =9.0 mIU/mL. 12. Hemoglobin 160 mmHg; diastolic BP >110 mmHg, treated or untreated. 14. History of heart failure: NYHA Class 3 and 4 are excluded. 15. History or clinical manifestation of significant central nervous system, hematological, metabolic, pulmonary, cardiovascular (within 6 months: angioplasty, stroke, myocardial infarction or CABG), gastrointestinal, endocrine (except type 2 diabetes), renal or hepatic disorder. 16. HIV infection as determined in the medical history. 17. Positive serologic findings hepatitis B surface antigen, and/or hepatitis C virus antibodies. 18. Evidence of clinically significant infection. 19. Known or suspected drug or alcohol abuse within the past year. 20. Psychiatric or emotional disorders that might prevent the successful completion of the study. 21. Surgical or medical condition that might interfere with the absorption, distribution, metabolism or excretion of the test article. 22. History of malignancy within 5 years of enrollment into the study (with the exception of adequately treated basal cell carcinoma of the skin). Exclusion Criteria at Week -1: 1 Evidence of clinically significant infection. 2. Acute disease state (e.g., nausea, vomiting, fever, diarrhea) within 7 days before Day 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: To examine the effects of PPM-204 on body weight, on plasma lipids, to examine the sources of variability in the plasma concentrations of PPM-204 using population PK methods.;Primary end point(s): The primary efficacy endpoint is change from baseline to week 12 on fasting plasma glucose (FPG). | — |
Countries
Italy, United Kingdom
Outcome results
None listed