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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04153981
• Other study ID #: 17225
• Secondary ID: I4L-IN-ABEX
• Status: Completed
• Phase: Phase 4
• Start date: December 16, 2019
• Est. completion date: July 30, 2021

Study information

• Verified date: June 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Insulin Glargine
Administered SC

Locations

Country	Name	City	State
India	DIACARE	Ahemdabad	Gujarat
India	Gujarat Endocrine Center	Ahmedabad	Gujarat
India	Bangalore Diabetes Center	Bangalore	Karnataka
India	GSVM Medical College	Kanpur	Uttar Pradesh
India	Supe Heart & Diabetes Hospital & Research Centre	Nasik	Maharashtra
India	Maharaja Agrasen Hospital	New Delhi
India	Sir Ganga Ram Hospital	New Delhi	Delhi
India	Nirmal Hospital Private Limited	Surat	Gujarat
India	Government Medical College & Sir Sayajirao General Hospital	Vadodara	Gujarat
India	Sumandeep Vidhyapeeth & Dhiraj General Hospital	Vadodara	Gujarat
India	Popular Hospital	Varanasi	Uttar Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Basal Insulin Dose	Basal Insulin Dose at Week 24.	Week 24
Secondary	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.	Baseline, Week 24
Secondary	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.	Baseline, Week 12 and Week 24
Secondary	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.	Baseline, Week 24
Secondary	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.	Baseline (Week 4), Week 24