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

Lilly

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Insulin Glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04153981

I4L-IN-ABEX (Other Identifier)

17225

Details and patient eligibility

About

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

Enrollment: 304 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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• Have previously completed or withdrawn from this study or any other study investigating LY2963016.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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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304 participants in 1 patient group

Insulin Glargine

Experimental group

Description:

Participants received insulin glargine once a day (QD) subcutaneously (SC) with a starting dose of 10 units. Participants self-titrated once or twice weekly until fasting blood glucose level was lowered to \<100 milligrams per deciliter (mg/dL). Dose was reduced by 4 units in case of hypoglycemia.

Treatment:

Drug: Insulin Glargine