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Completed

NCT Number: NCT04153981

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

DIACARE, Ahemdabad, Gujarat, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

insulin glargine

Drug

Administered SC

Other names: LY2963016, Basaglar

Primary outcomes

  1. 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)].

Secondary outcomes

  1. Basal Insulin Dose

    Time frame: Week 24

    Basal Insulin Dose at Week 24.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 6, 2019
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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