Description:

Safety and Tolerability Study of MBX-2044 in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00422487

Link:

https://clinicaltrials.gov/show/NCT00422487

Keywords:
Versions (2) ▾
  1. 7/1/17
  2. 9/20/21
Uploaded on:

September 20, 2021

DOI:
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License:
Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00422487

Eligibility Type 2 Diabetes Mellitus NCT00422487

Inclusion Criteria
type 2 diabetes previously controlled with up to one or two non-tzd hypoglycemic agents including sulfonylureas (e.g., glyburide, glipizide, glimeprimide), meglitinides (e.g., prandin®, starlix®), metformin (e.g., glucophage®), α-glucosidase inhibitors (e.g.,acarbose, miglitol) or byetta®
all female patients must be either surgically sterile or post-menopausal.
male patients with female partners of childbearing potential must agree to use condoms, or their partner must use a medically acceptable form of contraception.
bmi 24-44 kg/m2.
patients must have a fpg ≤ 200 mg/dl at screening.
patients must have hemoglobin a1c ≥ 6.5%, ≤ 10.0% at screening.
electrocardiogram (ecg) and chest x-ray must be normal, or considered not clinically significant, for participation in this study.
patients must have a blood pressure ≤ 160/90 mm/hg including hypertensive patients controlled with medication.
Exclusion Criteria
history of type 1 diabetes or diabetes secondary to pancreatitis or pancreatectomy.
history of tzd use (actos or avandia) within 6 months of screening visit.
history of tzd discontinuation due to lack of efficacy.
history of congestive heart failure within last 5 years.
history of significant pulmonary disease, myocardial infarction, cerebrovascular accident, or nephrotic syndrome within last 1 year.
malignancy within the last 5 years (except resected basal cell carcinoma).
ongoing active infection.
change in treatment with lipid-lowering agent within 7 days of screening visit.
current or expected requirement for anticoagulant therapy [except for low-dose aspirin ≤ 325 mg/d or plavix® ≤ 75 mg/d].
current or expected treatment with phenytoin for the duration of the study.
known hypersensitivity to nsaids.

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