A Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single Doses Of PF-04937319 In Subjects With Type 2 Diabetes Mellitus
NCT01044537
ABOUT THIS STUDY
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- Patients with type 2 diabetes mellitus who are taking stable doses of metformin only. Subjects treated with a sulfonylurea (SU) or a dipeptidyl peptidase-IV inhibitor (DPP-IVi) in combination with metformin may be eligible if washed off the SU or DPP-IVi to metformin only for a minimum of 4 weeks before dosing.
- Male and/or female subjects (females will be women of non childbearing potential) between the ages of 18 and 65 years, inclusive, with a body mass index (BMI) of 18.5 to 45.0 kg/m2 and C-peptide >0.8 ng/mL.
- Screening and Day -2 troponin I concentration =0.05 ng/mL as measured by the Bayer Centaur Ultra assay.
- HbA1c >/=7% and =11%. If the patient requires to be washed off an SU or DPP-IVi, the HbA1c limits will be >/=7% and =9.5%.
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).
- Evidence or history of diabetic complications with significant end organ damage, eg,
proliferative retinopathy and/or macular edema, creatinine clearance =60 mL/min
based on the Cockcroft-Gault equation, diabetic neuropathy complicated by neuropathic
ulcers.
- History of stroke, transient ischemic attack, or myocardial infarction within the past
6 months. Additionally, history of coronary artery bypass graft or stent implantation,
clinically significant peripheral vascular disease, or congestive heart failure (NYHA
Classes II-IV). Furthermore, a current history of angina/unstable angina. Also, 12
lead electrocardiogram (ECG) demonstrating QTc >450 msec at screening, ECG findings
suggestive of asymptomatic myocardial ischemia, or supine blood pressure >/=160 mm Hg
(systolic) or =100 mm Hg (diastolic).
- One or more self reported episodes of hypoglycemia within the last 3 months, or two or
more self reported episodes of hypoglycemia within the last 6 months.
- Screening or Day -2 fasting (>/=8 hours) blood glucose, =70 or >/=270 mg/dL,
confirmed by a single repeat if deemed necessary.
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Descriptive Information | ||||
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Brief Title ICMJE | A Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single Doses Of PF-04937319 In Subjects With Type 2 Diabetes Mellitus | |||
Official Title ICMJE | A Phase 1 Placebo-controlled Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single Escalating Oral Doses Of Pf-04937319 In Adult Subjects With Type 2 Diabetes Mellitus | |||
Brief Summary | The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-04937319 following single escalating oral doses in adult subjects with Type 2 Diabetes Mellitus (T2DM). | |||
Detailed Description | The purpose of this phase 1 study is to characterize the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF04937319 following single escalating oral doses in adult subjects with T2DM. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Other | |||
Condition ICMJE | Type 2 Diabetes Mellitus | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 50 | |||
Original Estimated Enrollment ICMJE | 54 | |||
Actual Study Completion Date ICMJE | May 2010 | |||
Actual Primary Completion Date | May 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01044537 | |||
Other Study ID Numbers ICMJE | B1621001 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | January 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |