Clinical trial NCT04153981: A Study of Insulin Glargine (LY2963016) in Adult Participants With Type 2 Diabetes in India
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-11-06
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number or Participants With Hypoglycemic Events
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Basal Insulin Dose
timeFrame: Week 24
measure: Change From Baseline in Body Weight
timeFrame: Baseline, Week 24
measure: Change From Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 12 and Week 24
measure: Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values
timeFrame: Baseline, Week 24
measure: Change From Week 4 in Insulin Treatment Satisfaction Questionnaire (ITSQ)
timeFrame: Baseline (Week 4), Week 24
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
state: Delhi
city: Ahemdabad
country: India
facility: DIACARE
state: Gujarat
city: Ahmedabad
country: India
facility: Gujarat Endocrine Center
state: Gujarat
city: Surat
country: India
facility: Nirmal Hospital Private Limited
state: Gujarat
city: Vadodara
country: India
facility: Government Medical College & Sir Sayajirao General Hospital
state: Gujarat
city: Vadodara
country: India
facility: Sumandeep Vidhyapeeth & Dhiraj General Hospital
state: Gujarat
city: Bangalore
country: India
facility: Bangalore Diabetes Center
state: Karnataka
city: Nasik
country: India
facility: Supe Heart & Diabetes Hospital & Research Centre
state: Maharashtra
city: Kanpur
country: India
facility: GSVM Medical College
state: Uttar Pradesh
city: Varanasi
country: India
facility: Popular Hospital
state: Uttar Pradesh
city: New Delhi
country: India
facility: Maharaja Agrasen Hospital
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: