EUCTR2020-000444-58-DE
Active, not recruiting
Phase 1
A Phase 2 Trial to Assess the Efficacy and Safety of M1 Pram P037 prandial insulin in T1DM subjects
DrugsHumalog®
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Adocia
- Enrollment
- 80
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed and dated informed consent obtained before any trial\-related activities. Trial
- •related activities are any procedures that would not have been done during normal
- •management of the subject.
- •Male or female subject with type 1 diabetes mellitus.
- •Age between 18 and 64 years, both inclusive.
- •Body Mass Index (BMI) between 25\.0 and 35\.0 kg/m^2, both inclusive.
- •HbA1c between 7\.0 % and 9\.5 %, both inclusive
- •Diabetes duration of at least 12 months.
- •Using a multiple dosing insulin therapy (MDI) with a basal insulin and a rapid\-acting
- •insulin at at least two meals per day.
Exclusion Criteria
- •Known or suspected hypersensitivity to IMPs or any of the excipients or to any
- •component of the IMP formulation.
- •Type 2 diabetes mellitus.
- •Previous participation in this trial. Participation is defined as randomised.
- •Receipt of any medicinal product in clinical development within 3 months or at least 5
- •half\-lives of the related substances and their metabolites (whichever is longer) before
- •randomisation in this trial.
- •History of multiple and/or severe allergies to drugs or foods or a history of severe
- •anaphylactic reaction.
- •Any history or presence of cancer except basal cell skin cancer or squamous cell skin
Outcomes
Primary Outcomes
Not specified
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