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

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.
• •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 cancer as judged by the Investigator.
• •Clinically significant abnormal screening laboratory tests, as judged by the Investigator.
• •Systolic blood pressure \< 90 mmHg or \>139 mmHg and/or diastolic blood pressure \< 50 mmHg or \> 89 mmHg. One repeat test (on a different day, if necessary) will be acceptable in case of suspected white-coat hypertension.
• •Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening, as judged by the Investigator.
• •Proliferative retinopathy or maculopathy as judged by the Investigator based on a recent (\<1.5 years) ophthalmologic examination.
• •Severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator.
• •More than one episode of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months.
• •Hypoglycaemic unawareness as judged by the Investigator.
• •Hospitalisation for diabetic ketoacidosis during the previous 6 months.
• •Presence of clinically significant gastrointestinal symptoms (e.g., nausea, vomiting, heartburn or diarrhea), as judged by the Investigator.
• •Confirmed diagnosis of gastroparesis or requiring the use of drugs that alter gastrointestinal motility.
• •Unusual meal habits and special diet requirements that could constitute a risk for the subject when participating in the trial or interfere with the interpretation of data.
• •Use of oral antidiabetic drugs (OADs) and/or GLP-1 receptor agonists within 4 weeks prior to screening.
• •Use of systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intra-articular, or inhaled preparations) within 2 months prior to screening.
• •Use or planned use of drugs that promote weight loss (e.g. liraglutide, semaglutide, orlistat, lorcaserin, phentermine) within 2 months prior to screening.
• •If female, pregnancy or breast-feeding.
• •Women of childbearing potential who are not using a highly effective contraceptive method.
• •The Investigator considers a subject as unsuitable for inclusion in the study for any other reason.