Multiple Dose Study Of PF-04937319 In Patients With Type 2 Diabetes
NCT01272804
ABOUT THIS STUDY
FOR MORE INFORMATION
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- Patients with type 2 diabetes mellitus who are taking metformin only.
- Treatment should be stable, where this is defined as no change in the treatment, including dose, over the past 2 months. Regimens may include once daily and twice daily dosing only.
- Male and/or female patients (females will be women of non childbearing potential)
- Body Mass Index (BMI) of 18.5 to 45.0 kg/m2; and a total body weight >50 kg (110 lbs).
- HbA1c between 7.0% and 10.0%.
- 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). Patients who have chronic conditions other than
T2DM (for example, hypercholesterolemia or hypertension) but are controlled by either
diet or stable (for the last 2 months) doses of medications may be included as well
(for example, a subject with hypercholesterolemia on appropriate treatment is
eligible).
- Evidence or history of diabetic complications with significant end organ damage, eg,
proliferative retinopathy and/or macular edema, creatinine clearance less than 60
mL/min
- Any condition possibly affecting drug absorption (eg, gastrectomy)
- History of stroke or transient ischemic attack or myocardial infarction within the
past 6 months
- History of coronary artery bypass graft or stent implantation.
- Clinically significant peripheral vascular disease (eg, manifested by claudication).
- Any history or clinical evidence of congestive heart failure, NYHA Classes II to IV.
- One or more self reported significant/severe/requiring treatment episodes of
hypoglycemia within the last 3 months, or two or more self reported
significant/severe/requiring treatment episodes of hypoglycaemia within the last 6
months.
- Current history of angina/unstable angina.
- Milk or soy allergy
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Descriptive Information | ||||
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Brief Title ICMJE | Multiple Dose Study Of PF-04937319 In Patients With Type 2 Diabetes | |||
Official Title ICMJE | A Phase 1 Placebo-controlled Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Multiple Escalating Oral Doses Of Pf-04937319 In Adult Patients With Type 2 Diabetes Mellitus (t2dm) | |||
Brief Summary | The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-04937319 following multiple (14 days) escalating oral doses in patients with type 2 diabetes. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Sharma R, Litchfield J, Atkinson K, Eng H, Amin NB, Denney WS, Pettersen JC, Goosen TC, Di L, Lee E, Pfefferkorn JA, Dalvie DK, Kalgutkar AS. Metabolites in safety testing assessment in early clinical development: a case study with a glucokinase activator. Drug Metab Dispos. 2014 Nov;42(11):1926-39. doi: 10.1124/dmd.114.060087. Epub 2014 Aug 20. | |||
* 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 | 61 | |||
Original Estimated Enrollment ICMJE | 60 | |||
Actual Study Completion Date ICMJE | July 2011 | |||
Actual Primary Completion Date | July 2011 (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 70 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 | NCT01272804 | |||
Other Study ID Numbers ICMJE | B1621003 | |||
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 | October 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |