A 24-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE SAFETY AND EFFICACY OF PPM-204 IN SUBJECTS WITH TYPE 2 DIABETES.

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-003897-87-GB
• Date of registration: 17/12/2006
• Prospective Registration: Yes
• Primary sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development
• Public 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.
• Scientific 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.
• Date of first enrolment: 19/06/2007
• Target sample size: 500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003897-87
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Run-in period in single blind If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: yes Other specify the comparator: Pioglitazone 30mg

Countries of recruitment

Italy, United Kingdom

Key inclusion & exclusion 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 < 43.

4. HbA1c at screening (week –3)·

- for subjects currently treated with 1 antidiabetic medication: HbA1c >or= 7.2% and
- for subjects not currently treated with antidiabetic medications: HbA1c >or= 7.2% and
5. Willingness to comply with the prescribed weight maintenance diet and physical exercise regimen.

6. Participation in a drug investigational trial within 30 days before screening visit (Week-3 visit).

Inclusion Criteria at Week -1; All subjects:

1 HbA1c < or = to 9.0 %.

- The value of HbA1c at week -1 will be used to determine the subject’s eligibility for the treatment period.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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
7. Aspartate transaminase (AST), alanine transaminase (ALT) or alkaline phosphatase >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
10. Total fasting triglycerides > 500 mg/dL [5.6 mmol/L].

11. TSH or =9.0 mIU/mL.

12. Hemoglobin < 10.0 g/dL (100.0 g/L).

13. Uncontrolled hypertension, i.e., systolic BP > 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Subjects with type 2 diabetes mellitus

Intervention(s)

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 unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Product Name: PPM-204 30 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 unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Product Name: PPM-204 60 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 unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Product Name: PPM-204 120 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 unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Trade Name: Actos Tablets 30 mg
Product Name: Actos (Pioglitazone) 30 mg Tablet-in-Capsule
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pioglitazone hydrochloride
CAS Number: 112529-15-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

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.

Primary end point(s): The primary efficacy endpoint is change from baseline to week 12 on fasting plasma glucose (FPG).

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.

Secondary ID(s)

3180A1-200-WW