A1c results presented at EASD
To be included in this study, patients had to be 18-75 years old, have type 2 diabetes, a body mass index of 25-50 kg/m2, and hemoglobin A1c of 7%-10%, and be stable on metformin therapy.
The patients had a mean age of 57 years, and 57% were men. They had a mean A1c of 8.1%, a mean BMI of 34 kg/m2, and a mean waist circumference of 110 cm (43 inches).
“We just recently reported at the EASD conference last month, the effect of BI 456906 on A1c lowering,” Dr. Rosenstock said.
“It looks like the [drop in] A1c plateaus at 1.9%, which is pretty good when you consider the baseline A1c is around 8%. You get down to around 6%, which is what we regard as a very robust reduction in people with type 2 diabetes on metformin.”
The current analysis showed that patients who received doses of 0.3, 0.9, 1.8, and 2.7 mg/week of the novel drug lost 1.9%, 4.4%, 6.6%, and 6.7% of their initial body weight, respectively, after 16 weeks.
The patients who received 1.2 mg and 1.8 mg twice weekly lost even more weight, 7.2% and 9% of their initial weight, respectively.
At the highest dose, on average, patients lost 13 cm (5 inches) around their waist.
Adverse events were reported by 78% of the patients, most commonly nausea (34% of patients), vomiting (18%), and diarrhea (16%).
Only 1.3% of patients had a drug-related serious adverse event. A total of 16% of patients discontinued the therapy.
Most of the “gastrointestinal adverse events leading the treatment discontinuation were possibly dose and titration related,” Dr. Rosenstock said, “and it’s highly conceivable that for future studies a slower dose escalation may mitigate the occurrence of the gastrointestinal adverse events.”
BI 456906 was coinvented with Zealand Pharma. Under the licensing agreement, Boehringer Ingelheim funds all research, development, and commercialization.
A version of this article first appeared on Medscape.com.