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

NCT04816890 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-06-24

No results posted yet for this study

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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

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.

Sponsors & Collaborators

  • Adocia

    lead INDUSTRY

Principal Investigators

  • Grit Andersen, MD · Profil Institut für Stoffwechselforschung GmbH

  • Eugen Baumgaertner, MD · Profil Institut für Stoffwechselforschung GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-23
Primary Completion
2022-02-24
Completion
2022-02-24

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04816890 on ClinicalTrials.gov