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

NCT ID: NCT04153981

Last Updated: 2024-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 304 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-16
• Study Completion Date: 2021-07-30

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulin Glargine

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.

Group Type: EXPERIMENTAL

Insulin Glargine

Intervention Type: DRUG

Administered SC

Interventions

Insulin Glargine

Administered SC

Intervention Type: DRUG

Other Intervention Names

LY2963016; Basaglar

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

DIACARE

Ahemdabad, Gujarat, India

Gujarat Endocrine Center

Ahmedabad, Gujarat, India

Nirmal Hospital Private Limited

Surat, Gujarat, India

Government Medical College & Sir Sayajirao General Hospital

Vadodara, Gujarat, India

Sumandeep Vidhyapeeth & Dhiraj General Hospital

Vadodara, Gujarat, India

Bangalore Diabetes Center

Bangalore, Karnataka, India

Supe Heart & Diabetes Hospital & Research Centre

Nashik, Maharashtra, India

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, India

GSVM Medical College

Kanpur, Uttar Pradesh, India

Popular Hospital

Varanasi, Uttar Pradesh, India

Maharaja Agrasen Hospital

New Delhi, , India

Countries

India

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

I4L-IN-ABEX

Identifier Type: OTHER

Identifier Source: secondary_id

17225

Identifier Type: -

Identifier Source: org_study_id