Type 1 Diabetes MedDRA version: 20.0 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: Insulin Human Soluble
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN HUMAN
CAS Number: 11061-68-0
Current Sponsor code: 570050
Other descriptive name: Recombina
Sponsors
Rechon Life Science AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patients have to meet all of the following criteria to be eligible to enter the study: 1) Willing and able to provide informed consent 2) Male or female diagnosed with T1DM diagnosed since at least 2 years 3) Ongoing daily treatment with insulin for at least 12 months 4) Current treatment with insulin below or equal to 1.2 U/kg/day 5) Age 18-75 (both inclusive) at the time of signing informed consent 6) BMI 18.0-32.0 kg/m2 (both inclusive) 7) HbA1c (glycosylated haemoglobin A1c) below or equal to 94 mmol/mol 8) Women must be: • postmenopausal, defined as above 45 years of age with amenorrhea for at least 18 months, or above 45 years of age with amenorrhea for at least 6 months and less than 18 months and a known serum follicle stimulating hormone (FSH) level above 40 IU/L, or • surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal occlusion), or otherwise be incapable of pregnancy, or • heterosexually active and practicing a highly effective method of birth control, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, or male partner sterilization, consistent with local regulations regarding use of birth control methods for patients participating in clinical trials, for the duration of their participation in the study, or • not heterosexually active. Note: patients who are not heterosexually active at screening must agree to utilize a highly effective method of birth control if they become heterosexually active during their participation in the study 9) Women of childbearing potential (i.e., those patients who do not meet the postmenopausal definition above, regardless of age) must have a negative urine pregnancy test at baseline (Day 1) and at screening if required by local regulations (Note: a serum pregnancy test is acceptable in lieu of a urine pregnancy test if required by local regulations) 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 281 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 94
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will not be permitted to enter the study: 1) Known allergies, hypersensitivity, or intolerance to the IMP or its excipients (see Section 9.1.2) 2) Renal disease that require treatment with immunosuppressive therapy or a history of chronic dialysis or renal transplant. Note: patients with a history of treated childhood renal disease without sequelae may participate 3) Myocardial infarction, unstable angina, revascularisation procedure, or cerebrovascular accident within 3 months before screening, or a planned revascularisation procedure, or history of New York Heart Association (NYHA) Class IV cardiac disease (The Criteria Committee of the New York Heart Association) 4) Known history of hepatitis B surface antigen or hepatitis C antibody positive (unless known to be associated with documented persistently stable/normal range aspartate aminotransferase [AST] and alanine aminotransferase [ALT] levels), or other clinically active liver disease 5) Female patients: pregnant or breast-feeding or planning to become pregnant or breast-feed during the study 6) History of malignancy within 5 years before screening (exceptions: squamous and basal cell carcinomas of the skin and carcinoma of the cervix in situ, or a malignancy that in the opinion of the Investigator, is considered cured with minimal risk of recurrence) 7) History of human immunodeficiency virus (HIV) antibody positive 8) History of one or more severe hypoglycaemic episodes within 6 months before screening Note: a severe hypoglycaemic episode is defined as an event that requires the help of another person. This refers to hypoglycaemic episodes which are correlated to the patients insulin sensitivitiy and not caused by incidents as for example medication error or acute in hospital treatment for other reasons. 9) Investigator’s assessment that the patient’s life expectancy is less than 1 year, or any condition, for example patients with severe co- diseases, that in the opinion of the Investigator would make participation not in the best interest of the patient, would interfere with the patients ability to participate in all study visits and complete the whole study, or could prevent, limit, or confound the protocol-specified safety or efficacy assessments 10) Major surgery (i.e. requiring general anaesthesia) within 3 months of the screening visit or any surgery planned during the patient’s expected participation in the study (except minor surgery, i.e. outpatient surgery under local anaesthesia) 11) Any condition that, in the opinion of the Investigator, would compromise the well-being of the patient or prevent the patient from meeting or performing study requirements 12) Current use of a corticosteroid medication or immunosuppressive agents, or likely to require treatment with a corticosteroid medication (for longer than 2 weeks in duration) or an immunosuppressive agent. Note: patients using inhaled, intranasal, intra-articular, or topical corticosteroids, or corticosteroids in therapeutic replacement doses may participate 13) Use of other antidiabetic therapy than insulin 14) Received an active investigational drug (including vaccines) or used an investigational medical device within 3 months before Day 1/baseline 15) Employees of the Investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that Investigator or study centre, as well as family members of the employees or the In
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To asses the long-term safety of Rechon Human Insulin Soluble as compared to Humulin® Regular in terms of immunogenicity and insulin tolerance.;Secondary Objective: To assess the long-term safety of Rechon Human Insulin Soluble as compared to Humulin® Regular in terms of general safety variables.;Primary end point(s): The proportion of patients having binding antibodies against human insulin.;Timepoint(s) of evaluation of this end point: From Visit 2 (baseline) to Visit 5. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in levels of insulin binding antibodies • Change in neutralizing capacity of anti-insulin antibodies • Change in insulin dose • Change in HbA1c • Change in fasting blood glucose • Hypoglycaemic episodes, classified according to American Diabetes Association (ADA), during the period • Change in levels of total circulating IgE antibodies • Incidents of local or systemic hypersensitivity during the period • Change in safety laboratory parameters • Change in body weight • Change in vital signs • Change in physical status • Number and type of AEs ;Timepoint(s) of evaluation of this end point: All secondary endpoints except Number and type of AEs: from Visit 2 (baseline) to Visit 5 Number and type of AEs: from first dose of IMP to the completion of Visit 5 | — |
Countries
Germany, Poland
Contacts
Public ContactClinical Development
Rechon Life Science AB
Outcome results
None listed