Lilly $140 Million Deal...First Patient Dosed LY-G.
Safety Data for TT223 must be absolutely Exemplary Again, as they didn't even have to wait for ALL of the Patients in that Trial to be dosed. Recall this TT223/GLP1 Trial was waiting for the 12 week Dosing TT223-SA Safety Data.
There is a tremendous amount of Human Safety Data on TT223. Theres been what?..... 4 Phasel's conducted on Human subjects showing that Gastrin doesn't have any of the Nausea etc. so very common with all of the GLP-1's and even the other analogues like EGF.
For a Phaselb Trial............this TT223/GLP1 Trial is powered for Efficacy. The Primary Endpoint is Hb1Ac.
-----Also Note the Disease Modifying measures integrated into the Secondary Endpoints.
-----Note the new FDA Guidelines for CV Risk for New Diabetes Drugs is Integrated into the Trial as well.
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TORONTO, March 23 /PRNewswire-FirstCall/ - Transition Therapeutics Inc. ("Transition" or the "Company") (NASDAQ:TTHI, TSX:TTH) announced today that the first patient has been dosed in a clinical study of gastrin analogue TT-223 in combination with a proprietary Lilly GLP-1 analogue, in patients with type 2 diabetes. The study is a randomized, double-blind, placebo-controlled study in approximately 140 patients to evaluate the safety, tolerability and efficacy of daily TT-223 treatments in combination with weekly administrations of GLP-1 analogue, for a combination treatment period of 4 weeks with a 5-month follow-up.
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Primary Outcome Measures:
- Change in A1C [ Time Frame: baseline (-1 week), 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in A1C [ Time Frame: baseline, 0, 4 weeks, 2 months, 3.5 months, 5 months, 6 months ] [ Designated as safety issue: No ]
- Change in MMTT response (including postprandial glucose, glucose AUC, insulin/c-peptide secretory response, HOMA, GLP-1, glucagon) [ Time Frame: baseline, 0, 3 weeks, 3.5 months, 6 months ] [ Designated as safety issue: No ]
- Change in fasting blood glucose [ Time Frame: baseline, 0, 3 weeks, 4 weeks, 2 months, 3.5 months, 5 months, 6 months ] [ Designated as safety issue: No ]
- Change in A1C adjusted for baseline A1c, c-peptide level, homeostasis model assessment of insulin resistance, duration of diabetes and weight [ Time Frame: baseline, 0, 4 weeks, 2 months, 3.5 months, 5 months, 6 months ] [ Designated as safety issue: No ]
- Change in MMTT response (includes postprandial glucose, glucose AUC, insulin/c-peptide secretory response, HOMA, GLP-1, glucagon) adjusted for baseline A1c, C-peptide level, homeostasis model assessment of insulin resistance, duration of diabetes and weight [ Time Frame: baseline, 0, 3 weeks, 3.5 months, 6 months ] [ Designated as safety issue: No ]
- Change in fasting blood glucose adjusted for baseline A1c, c-peptide level, homeostasis model assessment of insulin resistance, duration of diabetes and weight [ Time Frame: baseline, 0, 3 weeks, 4 weeks, 2 months, 3.5 months, 5 months, 6 months ] [ Designated as safety issue: No ]
- Mean changes in weight [ Time Frame: baseline, 6 months ] [ Designated as safety issue: Yes ]
- Antibodies to LY2428757 [ Time Frame: Baseline, 4 weeks, 2 months, 6 months ] [ Designated as safety issue: Yes ]
- Antibodies to TT223 [ Time Frame: Baseline, 4 weeks, 2 months, 6 months ] [ Designated as safety issue: Yes ]
- Pharmacokinetics (PKs) of TT223, first dose [ Time Frame: 0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours ] [ Designated as safety issue: No ]
- Pharmacokinetics (PKs) of TT223, 3-week timepoint [ Time Frame: 0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours ] [ Designated as safety issue: No ]
- Pharmacokinetics (PKs) of LY2428757, 3 week timepoint [ Time Frame: 0 (pre-dose) ] [ Designated as safety issue: No ]
- Visual Analog Scale (VAS) for nausea [ Time Frame: baseline, 0, 1 week, 2 weeks, 3 weeks, 4 weeks, 6 months ] [ Designated as safety issue: No ]
- Change in waist circumference [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
- 7 point profile, self-monitored blood glucose values [ Time Frame: baseline, 4 weeks, 6 months ] [ Designated as safety issue: No ]
- Change in 7 point profile, self-monitored blood glucose [ Time Frame: baseline, 4 weeks, 6 months ] [ Designated as safety issue: No ]
- Change in Lipase [ Time Frame: baseline, after run-in treatment, 3 weeks, 4 weeks, 3.5 months, 6 months ] [ Designated as safety issue: Yes ]
- Change in Amylase [ Time Frame: baseline, after run-in treatment, 3 weeks, 4 weeks, 3.5 months, 6 months ] [ Designated as safety issue: Yes ]
- Percent with 2-fold elevation of lipase and/or amylase at any timepoint [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Rate of hypoglycemia [ Time Frame: -3 weeks, baseline, 0, 1 week, 2 week, 3 week, 4 week, 2 months, 3.5 months, 5 months, 6 months ] [ Designated as safety issue: Yes ]
- Incidence of hypoglycemia [ Time Frame: -3 weeks, baseline, 0, 1 week, 2 week, 3 week, 4 week, 2 months, 3.5 months, 5 months, 6 months ] [ Designated as safety issue: Yes ]
- Number of adjudicated and confirmed deaths and non-fatal CV events at any timepoint [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Change in fasting insulin and HOMA [ Time Frame: baseline, 0, 3 weeks, 4 weeks, 2 months, 3.5 months, 6 months ] [ Designated as safety issue: No ]