A Trial of TT223 in Patients With Type 2 Diabetes Who Are Taking Metformin and/or Thiazolidinedione
NCT ID: NCT00743002
Last Updated: 2013-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
87 participants
INTERVENTIONAL
2008-08-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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TT223 with Metformin and/or TZD
TT223 as a treatment for Type 2 diabetes is administered by injection once daily at 1 mg, 2 mg and 3 mg patients currently treated with Metformin and/or Thiazolidinedione (TZD).
TT223 with Metformin and/or TZD
Daily subcutaneous injection: 1 mg for 1 week; followed by 2 mg for 1 week; followed by 3 mg for 10 weeks
Placebo with Metformin and/or TZD
Placebo as a comparator is administered by injection once daily at 1 mg, 2 mg and 3 mg patients currently treated with Metformin and/or Thiazolidinedione (TZD).
Placebo with Metformin and/or TZD
Daily subcutaneous injection: 1 mg for 1 week; followed by 2 mg for 1 week; followed by 3 mg for 10 weeks
Interventions
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TT223 with Metformin and/or TZD
Daily subcutaneous injection: 1 mg for 1 week; followed by 2 mg for 1 week; followed by 3 mg for 10 weeks
Placebo with Metformin and/or TZD
Daily subcutaneous injection: 1 mg for 1 week; followed by 2 mg for 1 week; followed by 3 mg for 10 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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OPKO Health, Inc.
INDUSTRY
Responsible Party
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Locations
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Artesia, California, United States
Los Angeles, California, United States
Santa Ana, California, United States
Torrence, California, United States
Walnut Creek, California, United States
DeLand, Florida, United States
Bloomingdale, Illinois, United States
Grand Rapids, Michigan, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Clifton, New Jersey, United States
Asheboro, North Carolina, United States
Wilmington, North Carolina, United States
Bensalem, Pennsylvania, United States
Athens, Tennessee, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Richmond, Texas, United States
San Antonio, Texas, United States
Countries
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Other Identifiers
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GIN-201
Identifier Type: -
Identifier Source: org_study_id
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