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

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 HbA_1creductions 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 HbA_1c and weight compared with placebo and was well tolerated in patients with uncontrolled type 2 diabetes on oral antidiabetes medications.”

Wait, How Does an Osmotic Mini-Pump Work?

Intarcia Therapeutics is the company behind the osmotic mini-pump for ITCA 650. Their website states that their Medici Drug Delivery System is made so a trained healthcare provider can insert it in a patient during a regular in-office visit.

First it is placed under the skin and then “water from the extracellular fluid enters the pump device at one end – by diffusing through a semi-permeable membrane directly into an osmotic engine – that expands to drive a piston at a controlled rate.” This action lets the drug inside the pump release continuously at the other end of the pump. These osmotic mini-pumps are created to carry “an appropriate volume of drug over different dosing intervals,” states the company’s website.

The company is currently awaiting FDA approval.

Regarding the insertion of this device, the study authors state that the adverse effects “associated with procedures to place and remove ITCA 650 were mild and transient”.