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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-003897-87-IT
• Date of registration: 27/04/2007
• Prospective Registration: No
• Primary sponsor: Wyeth Research Division of Wyeth Pharmaceutical 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 - ND
• 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 - ND
• Date of first enrolment: 26/04/2007
• 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: periodo run-in in singolo cieco If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no

Countries of recruitment

Italy, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
? 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.? Subjects currently treated with diet and exercise alone and subjects receiving a single oral antidiabetic medication ? BMI > 23 and < 43 ? HbA1c at screening (week ?3) o for subjects currently treated with one antidiabetic medication: HbA1c > o = 7.2% and
For subjects not currently treated with antidiabetic medications: HbA1c >o= 7.2% and
HbA1c at baseline (Day 1)o HbA1c ? 9.0 %
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:
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)

Aspartate transaminase (AST), alanine transaminase (ALT) or alkaline phosphatase >o= 3.0 times ULN

Total bilirubin >o= 1.5 mg/dL (>o= 26 μmol/L)

Estimated GFR <40 mL/min/1.73 m2 (estimated by MDRD equation)

Total fasting triglycerides > 500 mg/dL [5.6 mmol/L]

TSH ?0.2 μIU/mL or >o=9.0 μIU/mL

Hemoglobin < 10.0 g/dL (100 g/L)

History of heart failure: NYHA Class 3 and 4 are excluded

Uncontrolled hypertension, i.e., systolic BP> 160 mmHg; diastolic BP>110 mmHg, treated or untreated


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

Health Condition(s) or Problem(s) studied

Diabetes mellitus type 2
MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus

Intervention(s)

Product Name: PPM-204 15 mg capsules
Product Code: PPM-204
Pharmaceutical Form: Capsule, hard
CAS Number: 8835619-41-5
Current Sponsor code: PPM-204
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, hard
CAS Number: 8835619-41-5
Current Sponsor code: PPM-204
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, hard
CAS Number: 8835619-41-5
Current Sponsor code: PPM-204
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, hard
CAS Number: 8835619-41-5
Current Sponsor code: PPM-204
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
Pharmaceutical Form: Capsule, hard
CAS Number: 112519-15-4
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 in subjects with type 2 diabetes mellitus (T2DM).

Primary end point(s): Efficacy Evaluation: Primary Endpoint: Mean changes of FPG from baseline to week 12 among the PPM-204 active treatment groups and placebo. A normal dynamic linear model will be used to estimate the FPG dose-response.

Secondary Objective: -To examine the effects of PPM-204 on body weight.

-To examine the effects of PPM-204 on plasma lipids.

-To examine the sources of variability in the plasma concentrations of PPM-204 using population PK methods

Secondary ID(s)

2006-003897-87-GB

3180A1-200-WW