Status:
COMPLETED
A Trial to Assess the Efficacy and Safety of M1 Pram P037 Prandial Insulin in Subjects With Type 1 Diabetes (T1DM)
Lead Sponsor:
Adocia
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief 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 treatm...
Detailed Description
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 random...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04816890
Start Date
March 23 2021
End Date
February 24 2022
Last Update
June 24 2022
Active Locations (2)
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1
Profil Mainz GmbH & Co
Mainz, Germany, 55116
2
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, 41460