A Trial of TT223 in Patients With Type 2 Diabetes Who Are Taking Metformin and/or Thiazolidinedione
Completed · Phase 2 · Has a placebo group
Conditions studied: Diabetes Mellitus, Type 2
In brief
This trial is designed to show the effect of treatment with TT223 or placebo on blood glucose control after 12 weeks of treatment with a 6 month follow-up. TT223 is administered by injection once daily to patients currently treated with Metformin and/or Thiazolidinedione.
Key facts
- Study ID
- NCT00743002
- Run by
- OPKO Health, Inc.
- People needed
- 87
- Starts
- 2008-08-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2013-06-21
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 qualify 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
Where it is running
- Study site — Artesia, California, United States
- Study site — Los Angeles, California, United States
- Study site — Santa Ana, California, United States
- Study site — Torrence, California, United States
- Study site — Walnut Creek, California, United States
- Study site — DeLand, Florida, United States
- Study site — Bloomingdale, Illinois, United States
- Study site — Grand Rapids, Michigan, United States
- Study site — St Louis, Missouri, United States
- Study site — Las Vegas, Nevada, United States
- Study site — Clifton, New Jersey, United States
- Study site — Asheboro, North Carolina, United States
- Study site — Wilmington, North Carolina, United States
- Study site — Bensalem, Pennsylvania, United States
- Study site — Athens, Tennessee, United States
- Study site — Corpus Christi, Texas, United States
- Study site — Dallas, Texas, United States
- Study site — Houston, Texas, United States
- Study site — Richmond, Texas, United States
- Study site — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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