ADO09, a coformulation of amylin analog pramlintide and A21G human insulin, is superior to insulin lispro for reducing postprandial blood glucose in patients with type 1 diabetes, according to study results presented at the 55th European Association for the Study of Diabetes Annual Meeting, held September 16 to 20, 2019, in Barcelona, Spain.

The study was performed at 3 dosing visits. At each visit, participants (N=24) received ADO09, separate injections of human insulin and pramlintide, or insulin lispro before consuming a mixed meal containing 618 calories and 53% carbohydrate. In addition to these therapies, all patients also received 1 g paracetamol to assess gastric emptying time. Using glucose and insulin infusions, blood glucose was adjusted to 126 mg/dL (±10%) before the meal.

Patients treated with ADO09 had reductions in postprandial blood glucose excursions by >95% in the first hour after the meal compared with insulin lispro (mean change in area under the curve [∆AUC] of blood glucose at 0-1 hours, 1.4±9.9 mg × hour/dL vs 43.5±15.3 mg × h/dL; P <.0001). Treatment with ADO09 was also associated with improvements in maximum postprandial blood glucose (change in maximum blood glucose, 87.0±35.5 mg/dL) compared with insulin lispro (change in maximum blood glucose, 109.2±31.1 mg/dL; P =.0133) and separate human insulin and pramlintide (change in maximum blood glucose, 109.4±44.3 mg/dL; P =.0357).

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Total postprandial blood glucose during an 8-hour period was numerically lower in patients who received ADO09 (∆AUC of blood glucose at 0-8 hours, 325±260 mg × hour/dL) compared with insulin lispro (∆AUC of blood glucose at 0-8 hours, 420±256 mg × hour/dL; P =.0726) and human insulin and pramlintide (∆AUC of blood glucose at 0-8 hours, 436±275 mg × hour/dL; P =.0535).


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ADO09 and human insulin and pramlintide were associated with similar rates of gastric emptying, and ADO09 resulted in significantly slower gastric emptying compared with insulin lispro (P <.0001). This led to a later maximum blood glucose occurrence (4.42±1.61 vs 3.44±2.98 hours; P =.0004).

The therapies were well tolerated in all groups. There were 3 adverse events in the ADO09 group and 2 adverse events in the human insulin and pramlintide group. Hypoglycemic events were rare during the meal test, with 2 occurring in both the ADO09 and human insulin and pramlintide treatment groups.

Disclosure: A study author declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

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Reference

Meiffren G, Andersen G, Seroussi C, et al. ADO09, a co-formulation of the amylin-analogue pramlintide and the A21G human insulin analogue, lowers postprandial blood glucose versus insulin lispro in type 1 diabetes. Presented at: European Association for the Study of Diabetes 55th Annual Meeting; September 16-20, 2019; Barcelona, Spain. Abstract 109.