A PHASE 2A, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTIPLE-DOSE STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF 12-WEEK ORAL ADMINISTRATION OF PF-00734200 TABLETS TO SUBJECTS WITH TYPE 2 DIABETES MELLITUS ON STABLE TREATMENT WITH METFORMIN - ND
- Conditions
- PF-00734200 is indicated for the treatment of T2DM.MedDRA version: 9.1Level: LLTClassification code 10012601Term: Diabetes mellitus
- Registration Number
- EUCTR2007-001922-28-IT
- Lead Sponsor
- PFIZER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 320
Diagnosis of Type 2 Diabetes Mellitus per ADA Subjects must be diagnosed with type 2 diabetes mellitus in accordance with the ADA guidelines. Diagnosis may have occurred in the recent past (documented patient medical history). Guidelines for diagnosis include at least one of the following criteria: Symptoms of diabetes in addition to casual plasma glucose concentration >/=200 mg/dl. Term ?casual? is defined as plasma glucose concentration at any time of day without regard to time since last meal. The classic symptoms of diabetes include polyuria, polydipsia, and/or unexplained weight loss. OR: FPG (fasting plasma glucose) >/=126 mg/dL. Term ?fasting? is defined as no caloric intake for at least 8 hours. OR: Two-hour post-load glucose >/=200 mg/dL during an OGTT (oral glucose tolerance test). The test should be performed as described by WHO (World Health Organization), using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in ambient water. Inclusion Criteria 1. Male and/or female subjects (non-childbearing potential) between the ages of 18 and 70 years, inclusive. 2. Subjects currently taking a stable dose of metformin for treatment of their diabetes within past 2 months or longer before enrollment. 3. HbA1c >7% - 11% inclusive. 4. Fasting blood glucose levels in a range of >/=140 mg/dl to <270 mg /dL. 5. BMI >/=25 and /=50 kg (110 Lbs). 6. Documented evidence of obtained written and witnessed informed consent - a subject (or their legal representative) signed and dated informed consent document in the presence of a witness. 7. Subjects are willing and able to comply with all study required procedures, including scheduled visits, assigned treatment, clinical laboratory tests. 8. Subjects are willing and able to perform self-test of blood sugars twice daily.
Female Subjects of Non-Childbearing Potential Inclusion Criteria Female subjects of non-childbearing potential must meet at least one of the following criteria: Natural or surgically postmenopausal females, defined as: Natural postmenopausal - females over the age of 60 years, (FSH >40mIU/mL) Natural postmenopausal - females who are 45 to 60 years of age must be amenorrheic for at least 2 years and have a serum FSH (follicle-stimulating hormone) level within the regional standard laboratory reference range for postmenopausal women and/or FSH >40mIU/mL. Surgically postmenopausal - females who have undergone a total hysterectomy and/or total bilateral oophorectomy 6 months or earlier before the enrollment. All other female subjects (including women who have undergone tubal ligations) will be considered as women of childbearing potential and will be excluded from participation in this study.
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
1. Recent (within 12 months of enrollment) evidence or medical history of unstable concurrent disease. For example, documented evidence or history of clinically significant hematological, renal, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding clinically insignificant drug allergies and untreated, asymptomatic, seasonal allergies). 2. Any medical condition possibly affecting study drug absorption (eg, gastrectomy). 3. A positive urine screen test for illegitimate/non-prescribed use of commonly abused drugs. 4. Treatment with any class of investigational drug within 30 days preceding the screening. 5. Fasting serum triglycerides result >/=500 mg/dL. 6. Treatment with any oral hypoglycemic agent within 2 months before enrollment. The exception to these criteria is a stable dose of metformin for treatment of T2DM within the past 2 months or longer of enrollment. 7. History of repeated or frequent documented hypoglycemia over the last 6 months prior to enrollment. 8. Screening fasting blood glucose level <140 or >270 mg/dL. 9. Diagnosis of Type 1 diabetes mellitus. 10. Presence of positive glutamic acid decarboxylase (GAD) antibody titer. 11. Women of childbearing potential, pregnant or nursing. 12. The following therapeutic agents use is specifically not permitted: Anticonvulsants, opioids, antiarrhythmics, coumarin-type anticoagulants, antipsychotics, tricyclic and related antidepressants, and paroxetine. Corticosteroids, sympathomimetic agents, and over the counter omega-3 fatty acids are not permitted. Herbal supplements must be discontinued at least 28 days before the first double-blind dose of study drug. Acetaminophen (paracetamol [EU]) allowed to be used at doses of 450 msec. 21. Persistent severe uncontrolled hypertension, eg, supine systolic blood pressure (BP) >/=180 mm Hg and/or diastolic BP >/=105 mm Hg on at least 2 consecutive measurements following at least 10 minutes of rest between the measurements. 22. Any medical history or clinical evidence of congestive heart failure, NYHA (New York Heart Association) Functional Classification, Classes III-IV.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method