A Phase 2 Trial to Assess the Efficacy and Safety of M1 Pram P037 prandial insulin in T1DM subjects
- Conditions
- Type 1 diabetes mellitusMedDRA version: 21.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2020-000444-58-DE
- Lead Sponsor
- Adocia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
• 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.
• Using any CGM or FGM for at least 1 month or willing to use CGM during the trial.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• 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
cancer as judged by the Investigator.
• Clinically relevant comorbidity, capable of constituting a risk for the subject when
participating in the trial or of interfering with the interpretation of data.
• 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.
• Significant history of alcoholism or drug abuse as judged by the Investigator or
consuming more than 24.0 grams alcohol/day (for males), 12.0 grams alcohol/day (for
females) on average.
• A positive result in the alcohol and/or urine drug screen at the screening visit.
• Tested positive for Hepatitis Bs antigen.
• Tested positive for hepatitis C antibodies. (Presence of hepatitis C antibodies will not
lead to exclusion if liver function tests are normal and a hepatitis C polymerase chain
reaction is negative).
• Positive result to the test for HIV-1/2 antibodies or HIV-1 antigen.
• 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.
• Use or planned use of any other systemic medication that could interfere with the
safety of the subjects or interpretation of
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method