Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
OPKO Health, Inc.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Type 2 Diabetes for at least 6 months
Treated with metformin and/or thiazolidinediones with stable dose for at least 3 months
BMI of 21-45 kg/m2, inclusive
HbA1c level of 7.50 - 10.00%, inclusive
If a female of childbearing potential, willing to utilize contraception from Screening through 4 weeks after the last dose of study drug
You may not be if
Treatment with insulin, sulfonylurea, DPP-4 inhibitors, Symlin® and/or GLP-1 analogues ≤ 3 months prior to the Screening
Severe hypoglycemia ≤ 60 days prior to the Screening visit or currently diagnosed with having hypoglycemia unawareness
History of peptic ulcer(s) and/or gastrointestinal bleeding/perforation
Previous gastric surgery, including gastric bypass, or has gastric bypass/other major surgery planned to occur during the 10 month trial
Myocardial infarction within the last 2 years, current congestive heart failure with NYHA class 2 or greater, or chronic atrial fibrillation
Current clinically significant and/or chronic illness
Takes regular courses of non-steroidal anti-inflammatory drugs (NSAIDS). If these medications are discontinued upon starting Screening procedures and are not planned to be regularly used during the trial, the patient will be allowed to enter the Study
Use of systemic corticosteroids (oral, suppository, injected). Use of inhaled or topical corticosteroids is permitted
Clareo Health | A Trial of TT223 in Patients With Type 2 Diabetes Who Are Taking Metformin and/or Thiazolidinedione
