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

• Status: Recruiting
• Trial end date: 2022-03-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Adocia
• Treatments: Insulin Lispro

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.

• Subjects with type 1 diabetes mellitus.

• 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.

• Using any CGM or Flash Glucose Monitoring (FGM) for at least 1 month or willing to use CGM during the trial.

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.