FREEDOM-1 and FREEDOM-1 High Baseline (HBL) study showed positive results when the continuous subcutaneous infusion of exenatide is added to standard oral diabetes medications….
ITCA 650 is a continuous subcutaneous infusion of exenatide through a pump for the treatment of type 2 diabetes. FREEDOM-1 is a double blinded, randomized, placebo-controlled, multicenter, phase 3 trial to assess efficacy and safety of ITCA 650 in type 2 diabetes patients with an HbA1c between 7.5% to 10%. A total of 460 patients were randomized evenly into three groups and patients were given doses of 40 or 60 mcg/d for 39 weeks. The primary endpoint was HbA1c reduction and secondary endpoint was changes in weight, and percentage of patients treated to HbA1c goal of <7%. This trial showed significant reduction in A1c level over the 39 weeks period, with mean of 1.4% to 1.7% across the majority of patients. Patients with baseline A1c above 8.5% had a mean reduction up to 2.1%. Overall, this trial demonstrated statistically significant results for 40mcg/d and 60mcg/d mini pumps compared to control groups.
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Patients meeting all the inclusion criteria for FREEDOM-1, but with very high baseline A1c of 10%-12% were enrolled into FREDOM-HBL (high baseline) trial. The results showed sustained HbA1c reduction of 3.4% in poorly controlled patients over 39 weeks period. It also demonstrated that 25% of these patients were able to reach a goal of an A1C <7%. Both of these trials also demonstrated good GI tolerability.
Both trials will be presented at the ADA annual meeting in June 2015 in Boston. If ITCA 650 is approved, it will be the first injection free GLP-1 agonist therapy to deliver 6-months and 12-months treatment with subcutaneous mini-pumps.
- Two phase 3 trials, FREEDOM-1 and FREEDOM-1 HBL, demonstrated positive results with ITCA 650 (Exenatide) when added to standard oral diabetes medications.
- FREEDOM- 1 included patients with an A1c between 7.5% to 10% and it showed reduction in A1c by 2.1%.
- FREEDOM-1 HBL included patients with an A1c between 10% to 12% and showed reduction in A1c by 3.4% and 25% of patients were able to reach an A1c below 7%.
Video on how ITCA 650 works: http://www.intarcia.com/pipeline-technology/
Robert Henry et.al. “Efficacy and Tolerability of ITCA 650 (continuous Subcutaneous Exenatide) in Poorly Controlled Type 2 Diabetes with Baseline A1C 10%”. Boston, MA: Intarcia Therapeutics, 2014. Print.
Intracia Therapeutics “Intarcia Announces Two Positive Phase 3 Trials for ITCA 650 in Type 2 Diabetes: FREEDOM-1 and FREEDOM-1 High Baseline (HBL) Study Results” October 1, 2014.