Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Recombinant Insulin Glargine: 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 Intervent
Sponsors
BioGenomics Limited
Eligibility
Inclusion criteria
Inclusion criteria: A. Type 2 DM patients willing to give written informed consent and willing to take insulin injections daily. B. Patients on Lantus once daily with/without OADs at stable dose (plus or minus 15% variation in dose) for at least 3 months prior to screening C. HbA1c between 7.5% -10.5%, both inclusive. D. FPG more than 140mg/dL. E. Both sexes aged between 18 to 65 years, both inclusive. F. Body Mass Index (BMI) 18kg/m2 and 35 kg/m2, both inclusive. G. Stable weight, with no more than 5 kg gain or loss, in the 3 months prior to screening H. 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. I. Willingness and ability to self-inject insulin, perform SMPG, and keep record in the patient diary.
Exclusion criteria
Exclusion criteria: A. 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. B.FPG of patients more than 140mg/dl C. HbA1c of patients between 7.5% -10.5%,both inclusive D. Both sexes aged, between 18 to 65 years, both inclusive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of recombinant insulin glargine (manufactured by BioGenomics Limited) with Lantus? (manufactured by Sanofi) 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 average 7-point SMPG values from baseline to end of 12 weeks and from baseline to end of 24 weeks.Timepoint: From baseline to end of 12 weeks & from baseline to end of 24 weeks;To compare the immunogenicity of insulin glargine manufactured by BioGenomics Limited with Lantus? by measuring antibodies at baseline, end of 12 weeks and 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 period.Timepoint: From baseline to end of 12 weeks & from baseline to end of 24 weeks | — |
Countries
India
Contacts
Public ContactSneha Dongre
BioGenomics Limited
Outcome results
None listed