A Trial to Assess the Efficacy and Safety of M1 Pram P037 Prandial Insulin in Subjects With Type 1 Diabetes (T1DM)

Summary

In this trial, the treatment of subjects with type 1 diabetes with M1 Pram P037 as co-formulation of pramlintide and A21G human insulin analogue product will be compared with a current standard treatment, insulin lispro. During a four months treatment period doses in both treatment arms may be adjusted and optimised under outpatient conditions to allow a meaningful comparison of both treatments with respect to their effects on body weight, achievable glycaemic control, safety and tolerability, treatment satisfaction and well-being.

Timeline

Start

2021-03-23

Primary completion

2022-02-24

Completion

2022-02-24

Publications

• Andersen G, Eloy R, Heise T, Gaudier M, Megret C, Seroussi C, Chan YP, Soula O, Riddle M, DeVries JH. ADO09, a co-formulation of pramlintide and insulin A21G, lowers body weight versus insulin lispro in type 1 diabetes. Diabetes Obes Metab. 2024 Oct;26(10):4639-4645. doi: 10.1111/dom.15827. Epub 2024 Aug 7.

Drugs

Indications