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

June 22, 2023 updated by: Eli Lilly and Company

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
304

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number or Participants With Hypoglycemic Events
Time Frame: Baseline to Week 24
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Basal Insulin Dose
Time Frame: Week 24
Basal Insulin Dose at Week 24.
Week 24
Change From Baseline in Body Weight
Time Frame: Baseline, Week 24
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)
Time Frame: Baseline, Week 12 and Week 24
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
Time Frame: Baseline, Week 24
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)
Time Frame: Baseline (Week 4), Week 24
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 16, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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