Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: VB70G - Insulin Glargine: Dose: 10 units/day
or 0.2 units /kg/day + OADs
Frequency: Daily once
ROA: subcutaneous
Total duration: 24 weeks
Control Intervention1: Lantus - Insulin Glargi
Sponsors
Virchow Biotech Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged between 18 â?? 65 years. 2. Patients with Type 2 diabetes mellitus based on the disease diagnostic criteria of World Health Organization (WHO) classification ([fasting plasma glucose >= 7.0mmol/l (>=126mg/dl) or 2â??h plasma glucose >= 11.1mmol/l (>=200mg/dl)].) 3. Patients who have been taking at least 2 types of oral diabetes medications [>= two drugs- AGI (α-Glucosidase inhibitors), DPP-4 (Dipeptidyl peptidase-4) inhibitors, MEG (Meglitinides), MET (metformin), SU (Sulfonylureas)] for at least 12 weeks prior to entering the study. 4. Patients with HbA1c >=7% and 5. Patients with a body mass index of less than or equal to 35 kg/m2.
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes mellitus patients. 2. Patients with significant liver, cardiac or gastrointestinal disease. 3. Patients with active cancer or have had cancer within the past 5 years (with the exception of basal cell carcinoma or carcinoma in situ) 4. Patients who are having an excessive resistance to insulin or hypersensitivity to insulin glargine. 5. Patients who had more than one episode of severe low blood sugar (defined as needing someone else to help because of very low blood sugar) within the 6 months before entering the study 6. Patients who have taken any other insulin other than insulin glargine within the past 30 days 7. Taking any other diabetes medicines that are not allowed in the study or not approved to be taken with insulin. 8. Patients on self-monitoring of blood glucose less than 6 months before screening visit; 9. Patients using pre-mix insulins, insulin detemir at 2 times or more a day, or GLP 1 receptor agonists in the last 3 months before screening visit; 10. Patients using mealtime insulin (rapid-acting insulin analogue and short-acting insulin) for more than 10 days in the last 3 months before screening visit; 11. Use of insulin pump in the last 6 months before screening visit; 12. Initiation of new glucose-lowering medications and/or weight loss drugs in the last 3 months before screening visit; 13. Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular oedema likely to require treatment (eg, laser, surgical treatment or injectable drugs) during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Hb1Ac from baseline to 24 weeksTimepoint: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in FPG from baseline to 24 weeks change in SMPG from baseline to 24 weeks percentage of participants with HbA1c lessthan 7 percent and lessthan 6.5 percent at week 4, 8, 12, 16 20 and 24 weeks Incidence of hypoglycemic eventsTimepoint: Week 24 Week 24 Week 4, 8, 12, 16, 20 and 24 | — |
Countries
India
Contacts
Public ContactDr Hemanth Nandigala
Virchow Biotech Private Limited
Outcome results
None listed