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

• Conditions: Diabetes mellitus type 2; MedDRA version: 9.1Level: LLTClassification code 10012601Term: Diabetes mellitus

• Registration Number: EUCTR2006-003897-87-IT
• Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceutical Inc., Clinical Research and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

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) ofor 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)oHbA1c ? 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified