TT223 P ll Trial in Type2 NOW Recruiting.
Gastrin Phase ll Trial in Type2 Diabetes NOW Recruiting.
Study GIN-201 Baseline Studies are being performed right now. Watch for Transition to announce this Trial when the First Patient is Dosed.
There will be an Interim Look at the complete set of Safety Data from the 12 week Treatment Period. Lilly & Transition want this to help design the impending Phase ll GLP1+TT223 Trial in Type2 Diabetes. There will be no need to wait for the Efficacy Results from the TT223 Stand Alone Trial because the GLP1 Trial is going ahead regardless of the outcome of Gastrin Stand Alone........
Dr. Cruz is also planning an Interim Analysis for the Efficacy Data. Reasoning is that there is an expectation of Efficacy beginning right after the Treatment Period so they will extract Efficacy Data (probably at the 3 month point) in order to analyse it. It is undecided at this point whether or not the Interim Data will be made public at that time or if they will wait for completion of the trial.
Transitions Medical Officer Dr. Aleksandra Pastrak is in the Drivers Seat for this one and with Eli Lilly as Co-Pilot on this collaborative effort she is working along side some of the worlds best Diabetes Scientists. Good Job.
Upcoming Conference Call Q&A should answer some of the questions that have arisen.
https://clinicaltrials.gov/ct2/show/NCT00743002?term=tt223&rank=1
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Trial of TT223 in Patients With Type 2 Diabetes Who Are Taking Metformin and/or Thiazolidinedione
Verified by Transition Therapeutics, August 2008
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.
U.S. FDA Resources
Primary Outcome Measures:
- To evaluate the safety and tolerability of TT223 as a treatment for Type 2 diabetes at 1 mg, 2 mg and 3 mg. [ Time Frame: For the duration of the trial. ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To evaluate the efficacy of TT223 as a treatment for Type 2 diabetes by comparing the change in HbA1c value from baseline between the TT223 and placebo groups. [ Time Frame: For the duration of the trial. ] [ Designated as safety issue: No ]
- To evaluate the efficacy of TT223 on beta cell function by assessing additional outcome measures including fasting blood glucose levels, and meal tolerance testing. [ Time Frame: For the duration of the trial. ] [ Designated as safety issue: No ]
- To determine the pharmacokinetic (PK) parameter profile of TT223 in a subset of patients. [ Time Frame: Day 1 and Week 12 of treatment. ] [ Designated as safety issue: No ]
Inclusion Criteria:
- 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 Criteria:
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743002