A Multicenter, Open-Label, Single-Arm, Phase 4 Study toAssess the Safety of Basaglar in Subjects with Type 2Diabetes Mellitus in India

Eli Lilly and Company India Pvt Ltd0 个研究点目标入组 365 人开始时间: 待定最近更新: 2022年10月17日

研究概览

暂无简介。

•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 Ã¢â?°Â¥2 OAMs at stable doses for 90 days prior to Visit 1.
•4. Have an HbA1c level Ã¢â?°Â¥7.0% and <11.0%
•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.

•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 investigatorÃ¢â?¬•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
•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 <30 mL/min/m2.
•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.

发起方

Eli Lilly and Company India Pvt Ltd