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Tiny pump may be diabetes care game changer

Issue: September 2015

ByEdward C. Chao, DO

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Could a delivery device for diabetes medication be the size of a matchstick? An investigational mini-pump may be one of the next potentially paradigm-changing developments in diabetes treatment. Two phase 3 studies presented at the recent 75th Scientific Sessions of the American Diabetes Association provided a glimpse of a possible future.

The osmotic mini-pump is a cylinder approximately 1 inch long that is implanted once subdermally. Also known as ITCA 650 (Intarcia Therapeutics), this device delivers exenatide (AstraZeneca) continuously. When the tiny pump is placed under the skin, water from the extracellular fluid enters the device at one end. The water then diffuses through a semipermeable membrane directly into a salt osmotic engine that expands to drive a piston at a controlled rate. The medication is then released from the device’s other end.

Edward C. Chao

Evidence promising

Patients using the pump in clinical trials experienced reduced HbA1c.

Researchers in the double blind, placebo-controlled FREEDOM-1 study randomly assigned 460 patients with type 2 diabetes and HbA1c between 7.5% and 10%, managing their disease with either diet and exercise or oral diabetes medications, to either ITCA 650 40 µg/day or 60 µg/day or to placebo. Baseline characteristics were similar across these three groups, with a diabetes duration of approximately 9 years, mean HbA1c of 8.5% and mean BMI of 33.5 kg/m2. The mean decline in HbA1c from baseline was 1.1% (97.5% CI, –1.29 to –0.71) for the 40-mcg/day group and 1.2% (97.5% CI, –1.37 to –0.8) for the 60 mcg/day cohort (P = .001 vs. placebo) at week 39. Adverse events were similar to those of glucagon-like peptide-1 receptor agonists, including nausea.

The FREEDOM-1 High Baseline (HBL) trial enrolled patients who did not meet criteria for FREEDOM-1 due to having an HbA1c greater than 10%. Open-label ITCA 650 was administered to each participant. At baseline, HbA1c was 10.8%, mean BMI was 32 kg/m2 and diabetes duration was 9 years. The mean reduction in HbA1c from baseline to week 39 (last observation carried forward) was 2.8% (P < .001), and 22% achieved HbA1c less than 7%. By week 6, the investigators noted significant HbA1c reductions.

Questions remain

Questions — such as whether patients and physicians will find this novel form of medication delivery appealing, as well as those of long-term safety — remain.

The lead investigator for the FREEDOM-HBL study, Robert Henry, MD, noted that the pump is positioned to change diabetes care. “I think these new data indicate clearly that the ITCA 650 method of delivery provides an uninterrupted, smooth and continuous dose that ensures adherence without the need for patient action or behavior modification, which we all know is extremely challenging for many patients,” Henry said in his presentation. “We desperately need new innovations like ITCA 650 that have the potential to positively affect the treatment of this devastating and growing epidemic worldwide.”