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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Subcutaneous administration of M1 Pram P037 in combination with a basal insulin.
Subcutaneous administration of insulin lispro in combination with a basal insulin.
Profil Mainz GmbH & Co
Mainz, Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany
Body weight change from baseline to week 16 of treatment
Change in body weight after 16 weeks of treatment
Time frame: From week 0 to week 16
TIR [70-180] mg/dL.
Time In Range \[70-180\] mg/dL change from baseline to week 16 of treatment as measured by CGM.
Time frame: From week 0 to week 16
%TIR [70-180] mg/dL.
Percentage of Time In Range \[70-180\] mg/dL change from baseline to week 16 of treatment as measured by CGM.
Time frame: From week 0 to week 16
TIR [70-140] mg/dL.
Time In Range \[70-140\] mg/dL change from baseline to week 16 of treatment as measured by CGM.
Time frame: From week 0 to week 16
%TIR [70-140] mg/dL.
Percentage of Time In Range \[70-140\] mg/dL change from baseline to week 16 of treatment as measured by CGM.
Time frame: From week 0 to week 16
MeanG_24h
Average glucose over 24h change from baseline to week 16 of treatment
Time frame: From week 0 to week 16
CVG_24h
Coefficient Of Variation of glucose over 24h change from baseline to week 16 of treatment.
Time frame: From week 0 to week 16
DistG_24h
Distance travelled over 24h change from baseline to week 16 of treatment
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Time frame: From week 0 to week 16
SDG_24h
Standard Deviation of all glucose values over 24h change from baseline to week 16 of treatment
Time frame: From week 0 to week 16
HbA1c
HbA1c change from baseline to week 16 of treatment
Time frame: From week 0 to week 16
Total Insulin doses
Change from baseline of total insulin doses
Time frame: From week 0 to week 16
Prandial Insulin doses
Change from baseline of prandial (per meal), insulin doses
Time frame: From week 0 to week 16
Basal Insulin doses
Change from baseline of basal insulin doses
Time frame: From week 0 to week 16
Number of Adverse Events
Number of Adverse Events observed during the treatment period
Time frame: From week 0 to week 16
Duration of Adverse Events
Duration of Adverse Events observed during the treatment period
Time frame: From week 0 to week 16
Hypoglycaemic episodes
Number of Hypoglycemic episodes during the 16 weeks treatment period
Time frame: From week 0 to week 16