A Study Evaluating Safety and Efficacy of BIOD-123 Compared to Insulin Lispro (Humalog®)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of BIOD-123 compared to insulin lispro (Humalog®) when used as part of a basal-bolus regimen in patients with type 1 diabetes.

Official Title
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A Randomized, Parallel Group Trial Evaluating Safety and Efficacy of BIOD-123 Compared to Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes Using Basal-bolus Insulin Injection Therapy

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Drug: BIOD-123
* Drug: Lispro (Humalog)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Established clinical diagnosis of type 1 diabetes, consistent with ADA classification criteria (Diabetes Care 35: S64-S71, 2012), for more than 1 year. Age: 18 years old, or older. Body Mass Index: between 18 and 35 kg/m2, inclusive. Willing to use insulin glargine as the only basal insulin throughout the duration of the trial. Willingness not to use insulin pump treatment and only use the study glucose meter and CGM devices during the duration of the trial. Exclusion Criteria: History of known hypersensitivity to any of the components in the study medication Treatment with pramlintide or GLP-1 analogs within 30 days of screening or anticipated use of these medications during the course of the study. Treatment with oral or intravenous corticosteroids in the last 3 months prior to screening. Standard doses of inhalational corticosteroid used as part of a long term treatment regimen are allowed. Consistent recent hypoglycemic unawareness within the last six months History of more than two severe hypoglycemic events within six months prior to screening

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIOD-123<br>BIOD-123 used as prandial insulin | Drug: BIOD-123<br> <br> |
| Active Comparator: Lispro (Humalog)<br>Lispro (Humalog) used as prandial insulin | Drug: Lispro (Humalog)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1C |  | Baseline and 18 week treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemic event rates |  | Baseline and 18 week treatment period | 
| Insulin dose |  | Baseline and 18 week treatment period | 
| Daily blood glucose measures |  | Baseline and 18 week treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mealtime insulin, Ultra-rapid acting insulin, Prandial insulin