Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Recombinant insulin aspart mix 30: Dose 0.5 to 1.0 unit/kg/day Route of administration Subcutaneous(S.C.)
Duration of treatment 24 weeks Manufactured by BioGenomics Limited.
Control In
Sponsors
BioGenomics Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Type 2 DM patients willing to give written informed consent. 2. Type 2 DM patients who need insulin for their treatment and willing to take 1-3 injections daily. 3. Patients with T2DM, diagnosed since at least 6 months, who have been treated with premix human insulin or self-mixed human insulin with/without OADs (on stable dose for past 3 months). 4. HbA1c between 8.0% -10.0%, both inclusive. 5. Both sexes aged between 30 to 65 years, both inclusive. 6. Body Mass Index (BMI) =22kg/m2 and = 35 kg/m2, both inclusive. 7. Female patients who are not breastfeeding, and female patients of childbearing potential test negative for pregnancy, do not intend to become pregnant during the study, and agree to continue using a reliable method of birth control. 8. Willingness and ability to self-inject insulin, perform SMPG, and keep record in the patient diary.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from the study: 1. Known or suspected hypersensitivity to insulin or related product(s). 2. Patients exclusively on OADs for management of diabetes mellitus. 3. Previous participation in this trial (participation is defined as randomization). 4. Patients on insulin analogs 5. Patients who have participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to screening or are likely to simultaneously participate in another therapeutic clinical study. 6. History of severe hypoglycemic or hyperglycemic episodes in the last 6 months before screening. 7. Patients on any immunosuppressive medication like glucocorticoids, tacrolimus, cyclosporine, methotrexate, rituximab. 8. History of hematological disorders which can affect HbA1c levels (hemoglobinopathies, hemolytic anemia) 9. History of any medical condition which in opinion of investigator may embarrass glycemic control findings. 10. Patients with any other clinically significant disease(s) which, in the opinion of the investigator could compromise the patient’s safety, the patient’s involvement in the study or overall interpretation of the trial data. 11. Cardiovascular disease such as stroke, unstable angina pectoris, myocardial infarction, coronary arterial bypass graft or angioplasty, congestive heart failure class III or IV as per New York Heart Association, within 6 months prior to screening 12. In case of impaired liver function, defined as alanine transaminase =2.5 times upper limit of normal 13. Patients with eGFR below 60mL/min 14. Patients who have less than 5 years of remission history from any malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer). 15. Patients who are doubtful to comply with study procedures for mental, psychological or social reasons 16. Patients who have active proliferative retinopathy or macular edema 17. Known/screening seropositive patients of HIV or HBV or HCV 18. Women of child bearing potential who are not willing to follow a reliable and effective contraceptive measure during the course of the study and at least 1 week after the last visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of recombinant insulin aspart mix 30 (manufactured by BGL) with NovoMix® 30 (manufactured by Novo Nordisk) by measuring Mean change in glycated haemoglobin (A1C) from Baseline to end of 12 weeks & from Baseline to end of 24 weeksTimepoint: From baseline to end of 12 weeks & from baseline to end of 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in the fasting plasma glucose from baseline to end of 12 weeks & from baseline to end of 24 weeksTimepoint: From baseline to end of 12 weeks & from baseline to end of 24 weeks;Mean change in the post-prandial plasma glucose from baseline to end of 12 weeks & from baseline to end of 24 weeksTimepoint: From baseline to end of 12 weeks & from baseline to end of 24 weeks;To compare the immunogenicity of insulin aspart mix 30 (manufactured by BioGenomics Ltd.) with NovoMix® 30 (manufactured by Novo Nordisk) by measuring antibodies at baseline, end of 12 weeks & end of 24 weeks.Timepoint: From baseline to end of 12 weeks & from baseline to end of 24 weeks;To compare the rate of Treatment Emergent Adverse Events (TEAEs) during the study periodTimepoint: Entire study period | — |
Countries
India
Contacts
Public ContactDr Sachin Kadoo
BioGenomics Limited
Outcome results
None listed