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Type 2 Diabetes MellitusPhase 4NCT04153981

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

A Phase 4 study testing Insulin Glargine in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 11 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Insulin Glargine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
304 participants
Where
11 sitesIndia
Study dates
16 Dec 2019to 30 Jul 2021
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 12Show fewer
  • 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.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

India11 sites

  • DIACARE

    Ahemdabad, Gujarat, 380015

  • Gujarat Endocrine Center

    Ahmedabad, Gujarat, 380006

  • Bangalore Diabetes Center

    Bangalore, Karnataka, 560043

  • GSVM Medical College

    Kanpur, Uttar Pradesh, 208002

  • Supe Heart & Diabetes Hospital & Research Centre

    Nashik, Maharashtra, 422002

  • Sir Ganga Ram Hospital

    New Delhi, National Capital Territory of Delhi, 110060

  • Maharaja Agrasen Hospital

    New Delhi, 110026

  • Nirmal Hospital Private Limited

    Surat, Gujarat, 395002

  • Government Medical College & Sir Sayajirao General Hospital

    Vadodara, Gujarat, 390001

  • Sumandeep Vidhyapeeth & Dhiraj General Hospital

    Vadodara, Gujarat, 391760

  • Popular Hospital

    Varanasi, Uttar Pradesh, 221004

Other trials in India

About this study

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

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

Being tested
Insulin Glargine
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04153981
Study groupRoleWhat they receive
Insulin GlargineExperimentalParticipants 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.
Receives: Drug: Insulin Glargine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)].

    Measured: Baseline to Week 24

Secondary outcomes (5)

  1. Basal Insulin Dose

    Basal Insulin Dose at Week 24.

    Measured: Week 24

  2. 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.

    Measured: Baseline, Week 24

  3. 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.

    Measured: Baseline, Week 12 and Week 24

  4. 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.

    Measured: Baseline, Week 24

  5. 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.

    Measured: Baseline (Week 4), Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2019
  2. Study start16 Dec 2019
  3. Primary completion30 Jul 2021
  4. Study completion30 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
304 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04153981
Sponsor's protocol ID
17225
Other IDs
I4L-IN-ABEX
Status last verified
Jun 2023
First submitted
5 Nov 2019
Last updated
15 Feb 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Insulin Glargine in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 11 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number or Participants With Hypoglycemic Events (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04153981.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.

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