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

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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Insulin Glargine

• Study Type: Interventional
• Enrollment (Actual): 304
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • New Delhi, India, 110026
    • Maharaja Agrasen Hospital
  • Delhi
    • New Delhi, Delhi, India, 110060
      • Sir Ganga Ram Hospital
  • Gujarat
    • Ahemdabad, Gujarat, India, 380015
      • DIACARE
    • Ahmedabad, Gujarat, India, 380006
      • Gujarat Endocrine Center
    • Surat, Gujarat, India, 395002
      • Nirmal Hospital Private Limited
    • Vadodara, Gujarat, India, 390001
      • Government Medical College & Sir Sayajirao General Hospital
    • Vadodara, Gujarat, India, 391760
      • Sumandeep Vidhyapeeth & Dhiraj General Hospital
  • Karnataka
    • Bangalore, Karnataka, India, 560043
      • Bangalore Diabetes Center
  • Maharashtra
    • Nasik, Maharashtra, India, 422002
      • Supe Heart & Diabetes Hospital & Research Centre
  • Uttar Pradesh
    • Kanpur, Uttar Pradesh, India, 208002
      • GSVM Medical College
    • Varanasi, Uttar Pradesh, India, 221004
      • Popular Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Insulin Glargine; Administered SC; Other Names: LY2963016; Basaglar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number or Participants With Hypoglycemic Events	Hypoglycemic event is when the fasting blood glucose (FBG) level is ≤ 54 milligrams per deciliter (mg/dL) [≤ 3.0 millimoles per liter (mmol/L)].	Baseline to Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Basal Insulin Dose	Basal Insulin Dose at Week 24.	Week 24
Change From Baseline in Body Weight	Change from baseline in body weight was evaluated. Least Square (LS) mean was calculated using generalized linear model with the analysis variable as outcome, and the baseline of the analysis variable as covariate.	Baseline, Week 24
Change From Baseline in Hemoglobin A1c (HbA1c)	HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. LS mean was calculated using generalized linear model with the analysis variable as outcome, and the baseline of analysis variable as covariate.	Baseline, Week 12 and Week 24
Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values	Seven-point SMBG was completed at the following timepoints: Before Breakfast, 2 Hours After Morning Meal, Before Mid-Day Meal, 2 Hours After Mid-Day Meal, Before Evening Meal, 2 Hours After Evening Meal and at 3 AM (± 1 hour). LS mean was calculated using generalized linear model with the analysis variable as outcome, and the baseline of analysis variable as covariate.	Baseline, Week 24
Change From Week 4 in Insulin Treatment Satisfaction Questionnaire (ITSQ)	The ITSQ is a 22-item questionnaire that assesses treatment satisfaction for participants taking insulin, under 5 domains: Inconvenience of Regimen [(IR) - 5 items], Lifestyle Flexibility [(LF) - 3 items], Glycemic Control [(GC) - 3 items], Hypoglycemic Control [(HC) - 5 items], Insulin Delivery Device [(IDD) - 6 items]. Each Item is measured on a 7-point scale, with scores ranging for IR from 5 to 35, LF from 3 to 21, GC from 3 to 21, HC from 5 to 35, IDD from 6 to 42. Lower scores reflect better outcomes. LS mean was calculated using generalized linear model with the analysis variable as outcome, and the baseline of analysis variable as covariate. ITSQ was not evaluated at Week 0. For this outcome, Week 4 was considered as baseline.	Baseline (Week 4), Week 24

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2019
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): July 30, 2021

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Glargine
• Other Study ID Numbers: 17225; I4L-IN-ABEX (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No