A Study of Insulin Glargine (LY2963016) in Adult Participants With Type 2 Diabetes in India

• Status: Completed
• Trial end date: 2021-07-30
• Target enrollment: 0
• Participant gender: All

Summary

The reason for this study is to see if insulin glargine is safe in participants with type 2 diabetes mellitus (T2DM) in India.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Have T2DM based on the disease diagnostic criteria from the World Health Organization (WHO) classification for at least 6 months before screening.

• Have been receiving glucagon-like peptide-1 receptor agonist (GLP-1 RA) or ≥2 oral antihyperglycemic medication (OAMs) at stable doses for 90 days prior to screening.

• Have an HbA1c level ≥7.0% and <11.0%.

• Have never been treated with insulins except for short term treatment of acute conditions up to a maximum of 14 days.

Exclusion Criteria:

• Have any form of diabetes other than T2DM.

• Have hypersensitivity to the active substance of LY2963016 or to any of the excipients.

• Have any clinically significant disorder, other than T2DM, that in the investigator's opinion, would preclude participation in the trial.

• Are receiving systemic glucocorticosteroids therapy or have excessive insulin resistance (total insulin dose >2 units per kilogram).

• Have a history or diagnosis of human immunodeficiency virus infection, hepatitis B and C.

• 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 milliliters/minute/meter squared).

• 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.

• Is a woman who is breastfeeding.

• Have participated within the last 30 days in a clinical trial involving an investigational product other than the LY2963016. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed.

• Have previously completed or withdrawn from this study or any other study investigating LY2963016. This exclusion criterion does not apply to participants who are rescreened prior to baseline visit.

• Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.

• Are unwilling or unable to comply with the use of a glucometer.