Status:
COMPLETED
A Trial of TT223 in Patients With Type 2 Diabetes Who Are Taking Metformin and/or Thiazolidinedione
Lead Sponsor:
OPKO Health, Inc.
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 dail...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00743002
Start Date
August 1 2008
End Date
December 1 2009
Last Update
June 21 2013
Active Locations (20)
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1
Artesia, California, United States
2
Los Angeles, California, United States
3
Santa Ana, California, United States
4
Torrence, California, United States