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

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

Official Title
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A Multicenter, Open-Label, Single-Arm, Phase 4 Study to Assess the Safety of Basaglar in Subjects With Type 2 Diabetes Mellitus in India

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Insulin Glargine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin Glargine<br>Insulin glargine administered subcutaneously (SC). | Drug: Insulin Glargine<br>* Administered SC<br>* Other names: Basaglar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number or Participants with Hypoglycemic Events | Hypoglycemic event defined as fasting blood glucose (FBG) level of ≤54 milligrams per deciliter (mg/dL) [≤3.0 millimoles per liter] | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Basal Insulin Dose | Basal Insulin Dose | Week 24 | 
| Change from Baseline in Body Weight | Change from Baseline in Body Weight | Baseline, Week 24 | 
| Change from Baseline in Hemoglobin A1c (HbA1c) | Change from Baseline in HbA1c | Baseline, Week 24 | 
| Change from Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values | Change from Baseline in 7-Point SMBG Values | Baseline, Week 24 | 
| Change from Week 4 in Insulin Treatment Satisfaction Questionnaire (ITSQ) | Change from Week 4 in ITSQ | Week 4, Week 24 |