Health Condition 1: null- Type 1 Diabetes Mellitus
Conditions
Interventions
Intervention1: Insugen N: Doses will be individualized based on the requirements of the patients
Treatment will be given approximately for 1 year (Arm a) or 6 months (Arm B).
Intervention2: Insugen R: Doses will be individualized based on the requirements of the patients
Treatment will be given approximately for 1 year (Arm a) or 6 months (Arm B).
Control Intervention1: Insulatard: Doses will be individualized based on the requirements of the patients
Treatment will be given approximately for 6 months (Arm B).
Control Intervention2: Actrapid: Doses will be individualized based on the requirements of the patients
Treatment will be given approximately for 6 months (Arm B).
Sponsors
Biocon SA
Eligibility
Inclusion criteria
Inclusion criteria: 1. Provide written informed consent 2. Patients between the ages of 18 to 80 years 3. T1DM patients diagnosed with in the last 1 year. 4. Patients on basal-bolus insulin therapy 5. Body mass index of 18.5 to 34.99 kg/m2 6. Stable weight 7. Glycosylated haemoglobin of less than or equal to 11.0 percentage 8. Ability and willingness to comply with the protocol
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to any of the active or inactive ingredients of the test and/or reference products 2. Significant history of atopy or allergic drug reactions 3. Use of insulin pump therapy 4. Moderate insulin resistance 5. A clinically significant laboratory abnormality on the basis of which the Investigator advises against study inclusion 6. Clinically significant disease, except for well-controlled hypertension, hyperlipidaemia and thyroid disorders which as per the investigator makes the patient unsafe to be included in the study 7. Complications of abnormal glucose control and secondary complications of diabetes 8. An electrocardiogram abnormality considered clinically significant by the Investigator 9. History of drug or alcohol dependence or abuse within 6 months before Screening 10. Use of medications that can affect sugar control 11. Any electively planned surgery requiring hospitalization 12. Pregnancy, breastfeeding, or planned pregnancy during the study duration. Women of childbearing potential (any woman who is not surgically sterile or more than 2 years post menopause) must agree to use a reliable method of contraception (e.g., double-barrier, tubal ligation, or stable hormonal contraception) throughout the study period. Women who become pregnant during the study must be discontinued from the study and followed for pregnancy outcome 13. Hematological disorders 14. Receipt of another investigational drug within 6 weeks before Screening or within 5 half-lives of the drug, whichever is longer, or scheduled treatment of another investigational drug during the current study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in immunogenicity between Insugen R plus Insugen N and Actrapid plus Insulatard groupsTimepoint: From baseline to Week 24 and 48;Change in immunogenicity between Insugen R plus Insugen N and Actrapid plus Insulatard groupsTimepoint: From baseline to Week 24 and 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Diabetes Treatment Satisfaction QuestionnaireTimepoint: Between baseline and week 24;Efficacy parameters including HbA1c, FPG, 7-PCBG and insulin doseTimepoint: Between baseline and week 24;Partial correlation between allergic reactions and insulin antibodies, HbA1c and insulin antibodies, insulin dose and insulin antibodiesTimepoint: Between baseline and week 24;Safety parameters including Local and systemic reactions, hypoglycaemic events per 100 patients and other AEâ??sTimepoint: Between baseline, week 24 and 48 | — |
Countries
Germany, Hungary, India, Italy, Romania, Ukraine
Contacts
Public ContactRashika Suri
Biocon Research Limited
Outcome results
None listed