Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2024 Oct;26(10):4639-4645.
doi: 10.1111/dom.15827. Epub 2024 Aug 7.

ADO09, a co-formulation of pramlintide and insulin A21G, lowers body weight versus insulin lispro in type 1 diabetes

Grit Andersen  1 , Rosy Eloy  2 , Tim Heise  1 , Martin Gaudier  2 , Claire Mégret  2 , Cyril Seroussi  2 , You-Ping Chan  2 , Olivier Soula  2 , Matthew Riddle  3 , J Hans DeVries  1
Affiliations
Randomized Controlled Trial

ADO09, a co-formulation of pramlintide and insulin A21G, lowers body weight versus insulin lispro in type 1 diabetes

Grit Andersen et al. Diabetes Obes Metab. 2024 Oct.

Abstract

Aim: To study safety, efficacy and weight loss with ADO09, a co-formulation of insulin A21G and pramlintide, in type 1 diabetes.

Materials and methods: A randomized, two-arm ambulatory 16-week study compared ADO09 with insulin lispro in 80 participants with type 1 diabetes. We compared changes of weight, glycated haemoglobin, glycaemic patterns during continuous glucose monitoring, and insulin doses at baseline and at the end of treatment.

Results: A significant and continuing weight loss, the primary endpoint, was observed with ADO09 compared with lispro as prandial insulin. In the whole group, the weight loss with ADO09 relative to lispro was 2.1 kg. Glycaemic control was relatively good (7.7% mean glycated haemoglobin) in both groups and did not change during treatment. Prandial insulin doses were reduced by 21% in the ADO09 group, whereas basal insulin dosage was not modified. Gastrointestinal symptoms were more frequent with ADO09, but no clear difference in hypoglycaemia was observed.

Conclusions: These results extend previous observations on the efficacy and safety of this insulin/pramlintide co-formulation. They show a beneficial effect on weight, using less mealtime insulin and without increased hypoglycaemia.

Keywords: insulin therapy; phase 2 study; randomized trial; subcutaneous injection; type 1 diabetes; weight control.

PubMed Disclaimer

References

REFERENCES

    1. Riddle MC. Basal glucose can be controlled, but the prandial problem persists—it's the next target. Diabetes Care. 2017;40:291‐300.
    1. Young AA. Amylin's physiology and its role in diabetes. Curr Opin Endocrinol Diabetes. 1997;4:282‐290.
    1. Edelman SV, Darsow T, Frias JP. Pramlintide in the treatment of diabetes. Int J Clin Pract. 2006;60:1647‐1653.
    1. Whitehouse F, Kruger DF, Fineman M, et al. A randomized study and open‐label extension evaluating the long‐term efficacy of pramlintide as an adjunct to insulin therapy in type 1 diabetes. Diabetes Care. 2002;25:724‐730.
    1. Ratner RE, Dickey R, Fineman M, et al. Amylin replacement with pramlintide as an adjunct to insulin therapy improves long‐term glycaemic and weight control in type 1 diabetes mellitus: a 1‐year, randomized controlled trial. Diabet Med. 2004;21:1204‐1212.

Publication types

MeSH terms

Grants and funding