Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications
Conditions
Interventions
Intervention1: Insulin Basalog® - Basal Insulin. Insulin Glargine: Insulin Glargine, Given By Subcutaneous,Initial dose is 10IU,later on the Dose determined by treating physician with glucose values
Sponsors
Biocon Biologics India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Have been diagnosed (clinically) with T2DM, based on the World Health Organization (WHO) classification for at least 1 year prior to screening 2. Male or female 18 to 65 years of age 3. Insulin naïve T2DM subjects uncontrolled on OADs (OAD failure is defined as HbA1c >=7.5% after over 6 months of treatment with two or more OADs) 4. Subjects with OAD failure and initiated on Lantus in the past three months 5. Subjects having HbA1c >=7.5% and 6. Subject who have given written informed consent
Exclusion criteria
Exclusion criteria: 1. Have been diagnosed, at any time, with type 1 diabetes (T1D) or Latent Autoimmune Diabetes in adults 2. Subject who are/were on any insulin (premix, basal or bolus), 3. Subject needing prandial insulin in addition to basal insulin during study treatment 4. Have hypoglycaemia unawareness as judged by the investigator 5. Self-reported history of severe hypoglycaemia within 6 months prior to screening 6. Subject who are hypersensitive to insulin glargine or the excipients 7. Subject who are taking any alpha-glucosidase inhibitor (AGI) class medications for diabetes within three months of the screening visit 8. Subject who are taking corticosteroid therapy for more than 7 days 9. Subject with acute severe hyperglycaemia with any diabetes related complications 10. Pregnant or breastfeeding women and women planning pregnancy till next one year of study completion 11. Subject having any other contraindication as per prescribing information
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To demonstrate non-inferiority of switching reference insulin glargine (Lantus®) once daily to Bioconâ??s insulin Glargine (Basalog®) once daily, for HbA1c changeTimepoint: Mean change in HbA1c from 12 to 24 weeks in both the Lantus and Basalog arms. (Baseline, 3 Months and 6 months/ Baseline and 3 Months ) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in fasting plasma glucose from baseline to week 12 and week 12 to week 24 2. Number of hypoglycemic episodes during week 12 to week 24 between groups 3. Change in body weight and insulin dose from baseline to week 24 and week 12 to week 24 4. Number of treatment emergent adverse effects other than hypoglycaemia during the 24- week period Timepoint: from week 12 to week 24 | — |
Countries
India
Contacts
Public ContactDr Praveen Raj
Biocon Biologics India Limited
Outcome results
None listed