NCT04816890

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

A Phase 2 Trial to Assess the Efficacy and Safety of M1 Pram P037 Prandial Insulin in T1DM Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Adocia · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed description

After a run in period in case of basal insulin switch or Continuous Glucose Monitoring (CGM) initiation, eligible subjects will enter a 3 weeks baseline recording period. Subjects will then be randomized to either M1 Pram P037 treatment or active comparator treatment (insulin lispro). Both investigator and enrolled subjects will be unblinded to treatment. Study participants will use CGM until follow-up visit. Treatment period will last 16 weeks. Throughout the 4-month treatment period, basal insulin and investigational products administration will be individually adjusted. Treatment Satisfaction Questionnaire and WHO-5 well-being index will be completed by subjects at day 0 and after 2 months (Visit 9) and 4 months (Visit 11) of treatment. A safety follow-up visit, 7 to 14 days after the last administration of IMP, will mark the end of the clinical trial for the subjects.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	M1 Pram P037	Subcutaneous administration of M1 Pram P037 in combination with a basal insulin.
DRUG	Insulin lispro	Subcutaneous administration of insulin lispro in combination with a basal insulin.

Timeline

• Start date: 2021-03-23
• Primary completion: 2022-02-24
• Completion: 2022-02-24
• First posted: 2021-03-25
• Last updated: 2022-06-24

Locations

2 sites across 1 country: Germany