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

NCT04153981 | Completed Phase 4 Results

• 2 other identifiers: 17225I4L-IN-ABEX
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 11

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Basal Insulin Dose

  Week 24

• Change From Baseline in Body Weight

  Baseline, Week 24

• Change From Baseline in Hemoglobin A1c (HbA1c)

  Baseline, Week 12 and Week 24

• Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values

  Baseline, Week 24

• Change From Week 4 in Insulin Treatment Satisfaction Questionnaire (ITSQ)

  Baseline (Week 4), Week 24

Study Arms (1)

Insulin Glargine

EXPERIMENTAL

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

Interventions

Insulin Glargine DRUG

Administered SC

Also known as: LY2963016, Basaglar

Insulin Glargine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (11)

DIACARE

Ahemdabad, Gujarat, 380015, India

Location

Gujarat Endocrine Center

Ahmedabad, Gujarat, 380006, India

Location

Nirmal Hospital Private Limited

Surat, Gujarat, 395002, India

Location

Government Medical College & Sir Sayajirao General Hospital

Vadodara, Gujarat, 390001, India

Location

Sumandeep Vidhyapeeth & Dhiraj General Hospital

Vadodara, Gujarat, 391760, India

Location

Bangalore Diabetes Center

Bangalore, Karnataka, 560043, India

Location

Supe Heart & Diabetes Hospital & Research Centre

Nashik, Maharashtra, 422002, India

Location

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

Location

GSVM Medical College

Kanpur, Uttar Pradesh, 208002, India

Location

Popular Hospital

Varanasi, Uttar Pradesh, 221004, India

Location

Maharaja Agrasen Hospital

New Delhi, 110026, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; LY2963016 insulin glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 6, 2019
• Study Start: December 16, 2019
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: February 15, 2024
• Results First Posted: February 15, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

IN (11)