Exenatide via Osmotic Mini-Pump Improved A1c and Weight

ITCA 650 is Exenatide acetate powder,Exenatide powder in an osmotic mini-pump, a type 2 diabetes medication. It continually provides subcutaneous medication for 3 to 6 months.

Currently, exenatide is available as the brand name Byetta which is a liquid injection and also an extended release formulation marketed as Bydureon which comes in a powder that is mixed with liquid and then injected.

Researchers tested out ITCA 650 in two dose amounts and compared it to a placebo in patients with uncontrolled type 2 diabetes.

Over 39 weeks, this phase 3, double-blind, placebo-controlled trial randomized 460 patients between the ages of 18 and 80 who had an A1c level between 7.5 and 10 % (58-86 mmol/mol). So a third of participants took a placebo, another third ITCA 650 40 μg per day and another third took ITCA 650 60 μg per day.

The researchers looked for any A1c changes after those 39 weeks.
Does Exenatide Help Lower A1c Levels?

Taking ITCA 650 showed to lower A1c levels when compared to the placebo dose. The researchers wrote in their abstract that “In a prespecified analysis, greater HbA1c reductions occurred in patients not receiving sulfonylureas (SUs) vs. those receiving SUs (−1.7% vs. −1.2% [−18.6 and −13.1 mmol/mol].”They add that on week 39 37% of those taking ITCA 650 40 μg per day had an A1c below 7% (53 mmol/mol)–44% of those taking 60 μg per day lowered their A1c under 7% (53 mmol/mol) and only 9% of the placebo group lowered their A1c under 7% (53 mmol/mol).

ITCA 650 users also showed more weight loss than those on the placebo. The higher the dose of ITCA 650, the more weight lost.As far as the most common adverse event, nausea was observed but also showed to go away with time. Of those taking ITCA, 7.2% stopped taking the medication because of gastrointestinal adverse effects while only 1.3% of patients stopped taking the placebo due to the same.

They concluded that “ITCA 650 significantly reduced HbA1c and weight compared with placebo and was well tolerated in patients with uncontrolled type 2 diabetes on oral antidiabetes medications.”