Patients suffering from diabetes mellitus type 1 or 2 with the indication for insulin treatment and dependent on insulin administration. MedDRA version: 9.1 Level: PT Classification code 10012608 Term: Diabetes mellitus insulin-dependent MedDRA version: 9.1 Level: PT Classification code 10018209 Term: Gestational diabetes MedDRA version: 9.1 Level: PT Classification code 10049746 Term: Insulin-requiring type II diabetes mellitus MedDRA version: 9.1 Level: PT Classification code 10051599 Term
Conditions
Interventions
Product Name: Soluble Insulin Injection, human 100 IU/ml in cartridge
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN HUMAN
CAS Number: 11061680
Concentration unit: IU/ml inte
Sponsors
Marvel Life Sciences Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [[1] male and female patients suffering from type 1 or type 2 diabetes mellitus for at least 6 months before randomization [2] negative screening assay for antibodies against insulin before the start of treatment [3] age 18-75 years [4] Body Mass Index (BMI) =35 kg/m2 [5] informed consent given in a written form after being provided with detailed information about the nature, risks, and scope of the clinical trial as well as the expected desirable and adverse effects of the drug 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: [1] known hypersensitivity against insulin or any of the inactive components of the formulations [2] known extreme resistance to insulin (daily dose of more than 200 IU) [3] severe renal failure (NKF stage 4-5) or patients on hemodialysis [4] severe cardiac failure (NYHA III-IV) [5] myocardial infarction within the last 6 months before randomization [6] unstable angina pectoris [7] stroke within the last 6 months before randomization [8] liver failure with ascites [9] severe peripheral vascular disease with ulceration or amputation [10] cancer [11] concomitant treatment with corticosteroids (except stable dose of inhaled corticosteroids) [12] concomitant treatment with immunosuppressive agents (e.g. cyclosporine A, methotrexate, etc.) [13] concomitant treatment with somatotropine [14] pregnancy or lactation period in female patients [15] severe physical or mental concomitant diseases that might hamper the realization of the trial according to protocol or the evaluation of efficacy or safety [16] anamnestic or current alcohol abuse i.e. consumption of more than 10 units of alcohol per week or a history of alcoholism or drug/chemical abuse (one unit of alcohol equals 250 ml of beer, 125 ml wine or 25 ml of spirits) [17] participation in another clinical trial within the last 12 weeks [18] legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study [19] unreliability or lack of cooperation [20] lack of a possibility to attend the visits required by protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To prove the non-inferiority of the test formulation containing recombinant human insulin to a reference product of the same type (Humulin®) regarding the incidence of newly developed antibodies against insulin.;Secondary Objective: ;Primary end point(s): PRIMARY ENDPOINT: Incidence of newly developed anti-insulin antibodies during the double-blind treatment phase as determined by a screening assay and confirmed by a confirmatory assay SECONDARY ENDPOINTS: - incidence of newly developed anti-insulin antibodies for the entire duration of treatment, - glycosylated hemoglobin (HbA1c) measured after 28 and 56 weeks of treatment, - dosage of insulin - incidence and severity of hypoglycemia, - changes in weight. | — |
Countries
Bulgaria, Germany
Outcome results
None listed