Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications
Conditions
Interventions
Intervention1: Basaglar: Biosimilar of insulin glargine
Control Intervention1: Not applicable: Not applicable- open label single arm study
Sponsors
Eli Lilly and Company India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Have T2DM based on the disease diagnostic criteria from the World Health Organization(WHO) classification for at least 6 months before screening. 2. Men or Non-pregnant women aged more than 18 years and less than 75 years at the time of screening. 3. Have been receiving GLP-1 RA or �2 OAMs at stable doses for 90 days prior to Visit 1. 4. Have an HbA1c level �7.0% and 5. Have never been treated with insulins except for short term treatment of acute conditions up to a maximum of 14 days. 6. Are able and willing to provide signed informed consent to participate in this study in accordance with local regulations.
Exclusion criteria
Exclusion criteria: 1. Have any form of diabetes other than T2DMH. 2. Have hypersensitivity to the active substance of Basaglar or to any of the excipients. 3. Have any clinically significant disorder,other than T2DM, that in the investigatorââ?¬•s opinion, would preclude participation in the trial. 4. Are receiving systemic glucocorticosteroids therapy or have excessive insulin resistance (total insulin dose >2 U/kg). 5. Have a history or diagnosis of human immunodeficiency virus infection, hepatitis B and C. 6. Have comorbidities of unstable angina, cardiac failure (Stage III or IV as per New York Heart Association guidelines) or renal failure (estimated glomerular filtration rate 7. Are pregnant or intend to become pregnant during the course of the study; or are sexually active women of child-bearing potential not actively practicing birth control by a medically acceptable method as determined by the investigator. 8. Is a woman who is breastfeeding. 9. Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as spouse, parent, child, or sibling, whether biological or legally adopted. 10. Are Lilly employees or are employees of third party organizations involved in the study who require exclusion of their employees.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess risk of hypoglycemia in adult subjects with T2DM in India who will be administered Basaglar.Timepoint: Incidence of total (symptomatic or asymptomatic with FBG level of ââ?°Â¤54 mg/dL [ââ?°Â¤3.0 mmol/L])hypoglycemic events at Week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess adverse events and other safety parameters in adult subjects with T2DM in India.Timepoint: 1. SAEs and TEAEs 2. Rates per 30 days and per subject year of total (symptomatic or asymptomatic) hypoglycemic events. 3. Incidence and rates per 30 days and per subject-year of nocturnal, severe, documented symptomatic and asymptomatic hypoglycemic events. 4. Basal insulin dose (U/day and U/kg/day). 5. Change in weight and BMI at Week 24 from baseline. | — |
Countries
India
Contacts
Public ContactDr Rajeev Sharan Shrivastava
Eli Lilly and Company (India) Pvt. Ltd.
Outcome results
None listed