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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04153981
Recruitment Status : Suspended (Enrollment on hold due to COVID-19 pandemic.)
First Posted : November 6, 2019
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Insulin Glargine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Single-Arm, Phase 4 Study to Assess the Safety of Basaglar in Subjects With Type 2 Diabetes Mellitus in India
Actual Study Start Date : December 16, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Insulin Glargine
Insulin glargine administered subcutaneously (SC).
Drug: Insulin Glargine
Administered SC
Other Names:
  • LY2963016
  • Basaglar




Primary Outcome Measures :
  1. Number or Participants with Hypoglycemic Events [ Time Frame: Week 24 ]
    Hypoglycemic event defined as fasting blood glucose (FBG) level of ≤54 milligrams per deciliter (mg/dL) [≤3.0 millimoles per liter]


Secondary Outcome Measures :
  1. Basal Insulin Dose [ Time Frame: Week 24 ]
    Basal Insulin Dose

  2. Change from Baseline in Body Weight [ Time Frame: Baseline, Week 24 ]
    Change from Baseline in Body Weight

  3. Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 24 ]
    Change from Baseline in HbA1c

  4. Change from Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values [ Time Frame: Baseline, Week 24 ]
    Change from Baseline in 7-Point SMBG Values

  5. Change from Week 4 in Insulin Treatment Satisfaction Questionnaire (ITSQ) [ Time Frame: Week 4, Week 24 ]
    Change from Week 4 in ITSQ



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04153981


Locations
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India
Sir Ganga Ram Hospital
New Delhi, Delhi, India, 110060
DIACARE
Ahemdabad, Gujarat, India, 380015
Gujarat Endocrine Center
Ahmedabad, Gujarat, India, 380006
Nirmal Hospital Private Limited
Surat, Gujarat, India, 395002
Government Medical College & Sir Sayajirao General Hospital
Vadodara, Gujarat, India, 390001
Sumandeep Vidhyapeeth & Dhiraj General Hospital
Vadodara, Gujarat, India, 391760
Bangalore Diabetes Center
Bangalore, Karnataka, India, 560043
Supe Heart & Diabetes Hospital & Research Centre
Nasik, Maharashtra, India, 422002
GSVM Medical College
Kanpur, Uttar Pradesh, India, 208002
Popular Hospital
Varanasi, Uttar Pradesh, India, 221004
Maharaja Agrasen Hospital
New Delhi, India, 110026
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04153981    
Other Study ID Numbers: 17225
I4L-IN-ABEX ( Other Identifier: Eli Lilly and Company )
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 15, 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs