A Trial to Assess the Efficacy and Safety of M1 Pram P037 Prandial Insulin in Subjects With Type 1 Diabetes (T1DM)
Status:
Recruiting
Trial end date:
2022-03-15
Target enrollment:
Participant gender:
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.