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Subcutaneous exenatide delivery lowers HbA1c in adults with type 2 diabetes
The GLP-1 receptor agonist exenatide delivered subcutaneously through an osmotic mini-pump significantly reduced HbA1c and weight compared with placebo in adults with type 2 diabetes inadequately controlled with oral antidiabetes medications, study data show.
The drug and device combination, ITCA 650, is an investigational product currently in development for the treatment of type 2 diabetes, according to study background.
Julio Rosenstock, MD, director of the Dallas Diabetes and Endocrine Center, and colleagues evaluated data from the FREEDOM-1 study on 460 adults with type 2 diabetes (mean HbA1c, 8.5%) uncontrolled with oral antidiabetes drugs randomly assigned to ITCA 650 40 µg per day (n = 153; mean age, 55.4 years; 41.8% women; 84.3% white; mean diabetes duration, 9.1 years), ITCA 650 60 µg per day (n = 153; mean age, 54.7 years; 40.5% women; 81.7% white; mean diabetes duration, 8.9 years) or placebo (n = 154; mean age, 54.7 years; 40.3% women; 81.8% white; mean diabetes duration, 8.6 years). Researchers sought to determine the efficacy and tolerability of the two doses of ITCA 650 compared with placebo. The treatment period was 39 weeks, and follow-up was conducted for 4 weeks after treatment.
More participants in the treatment groups achieved HbA1c less than 7% (40 µg, 37%; 60 µg, 44%; placebo, 9%) and HbA1c less than 6.5% (40 µg, 22%; 60 µg, 33%; placebo, 6%) compared with placebo.
From baseline to 39 weeks, the least squares (LS) mean change was significantly greater in the 40 µg (-1.1%) and 60 µg (-1.2%) groups compared with placebo (-0.1%; P < .001). Mean HbA1c at week 39 was 7.4% in the 40-µg group, 7.3% in the 60-µg group and 8.4% in the placebo group.
From baseline to 39 weeks, estimated mean change in body weight was greater in the 40-µg (-2.3 kg; P = .015) and 60-µg (-3 kg; P < .001) groups compared with placebo (-1 kg).
Rescue therapy was required in fewer participants in the treatment groups compared with placebo (40 µg, 15.6%; 60 µg, 11.3%; placebo, 39.2%).
Overall, at least one adverse event occurred in 8.2% of the 40-µg group, 85% of the 60-µg group and 71.4% of the placebo group. Discontinuation due to adverse events occurred more often in the treatment groups compared with placebo (40 µg, 11.8%; 60 µg, 8.5%; placebo 3.9%) with gastrointestinal disorders the most common reason for discontinuation.
“ITCA 650 is the first injection-free GLP-1 [receptor-agonist],” the researchers wrote. “This integrated drug-device combination maintains long-term effective blood concentrations of exenatide and has the ability to ensure medication adherence and lead to sustained glycemic control and weight loss. This report provides the first results from a large controlled study that demonstrates the efficacy and tolerability of ITCA 650 in patients with long-standing type 2 diabetes on a variety of background antidiabetes medications.” – by Amber Cox
Disclosures: Rosenstock reports he has served on scientific advisory boards and received honoraria or consulting fees from AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Eli Lilly, Intarcia Therapeutics Inc., Janssen, Novo Nordisk and Sanofi and has received grants/research support from Asahi Kasei, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, GlaxoSmithKline, Hanmi, Intarcia Therapeutics Inc., Janssen, Lexicon, Merck, Novo Nordisk, Pfizer, Sanofi and Takeda. Please see the study for all other authors’ relevant financial disclosures.