Type 1 diabetes mellitus MedDRA version: 21.1 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: P037 (M1 Pram)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PRAMLINTIDE
CAS Number: 151126-32-8
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type:
Sponsors
Adocia
Eligibility
Sex/Gender
All
Inclusion 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. • 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
Exclusion criteria
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 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 139 mmHg and/or diastolic blood pressure 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of prandial use of M1 Pram P037 with insulin lispro on body weight change after 16 weeks of optimised titration, in combination with a basal insulin.;Secondary Objective: To evaluate the efficacy and the safety of prandial use of M1 Pram P037 in comparison with insulin lispro after 16 weeks of treatment in combination with a basal insulin on: • Glycaemic control as assessed by continuous glucose monitoring (CGM)-derived parameters over the last 3 weeks of treatment: Time in range (TIR), time in tight range (TITR), time above range (TAR) and time below range (TBR) changes assessed from baseline to end of treatment and compared between each treatment, glycaemic variability • Safety, especially overall hypoglycaemia occurrence (number and duration), nocturnal hypoglycaemia (number and duration), and gastrointestinal events • Glycaemic control as assessed by change from baseline in HbA1c • Treatment satisfaction and well-being assessed by subjects • Change from baseline of total, prandial, and basal insulin doses after 16 weeks of treatment. ;Primary end point(s): Body weight change from baseline to week 16 of treatment;Timepoint(s) of evaluation of this end point: Data base release | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: For secondary efficacy endpoints, change will be assessed from baseline to end of treatment (last three weeks of treatment for CGMs endpoints, carbohydrate consumption and for insulin doses) and compared between treatments. CGM metrics will be assessed overall and separately for night-time (0.00-05.59) and daytime (06.00-23.59). Treatment satisfaction and well-being will be analysed as change from baseline and comparison between groups at the end of treatment. Secondary Efficacy Endpoints: • Percentage body weight change from baseline to week 16 of treatment • Time and percentage of time in range [70-180] mg/dL change from baseline to week 16 of treatment • Time and percentage of time in tight range [70-140] mg/dL change from baseline to week 16 of treatment • Time and percentage of time below range (TBR) defined as low [54-69 mg/dL] (TBR Level 1) and very low 250 mg/dL (TAR Level 2) change from baseline to week 16 of treatment • MeanG_24h: Average glucose over 24h change from baseline to week 16 of treatment • DistG_24h: Distance travelled over 24h change from baseline to week 16 of treatment • CVG_24h: coefficient of variation of glucose over 24h change from baseline to week 16 of treatment • SDG_24h: SD of all glucose values over 24h change from baseline to week 16 of treatment • HbA1c change from baseline to week 16 of treatment • Treatment satisfaction, using a treatment satisfaction questionnaire (TSQ) and the WHO-5 well-being index • Change from baseline of total, prandial per meal, and basal insulin doses (per time interval and correction dose) Secondary Safety Endpoints: Safety endpoints will be evaluated from the first administration of the IMP to the follow-up visit of subjects. • Adverse events (AEs) Number and duration of AEs during the first, second, third and fourth month of the treatment period, and during the whole treatment | — |
Countries
Germany
Contacts
Public ContactDeputy General Manager
Adocia
Outcome results
None listed