A Study of Insulin Peglispro and Glargine on Fats in Participants With Type 1 Diabetes

Study Overview
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Brief Summary
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This study has two parts. Each participant will receive a daily injection of insulin peglispro during one treatment period and a daily injection of insulin glargine during the other treatment period. Each treatment period is 3 to 4 weeks and is followed by procedures to look at how the body uses or stores fats while taking each study drug.

Official Title
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Assessment of the Effects of LY2605541 on Triglyceride Metabolism, Compared to Insulin Glargine, in Patients With Type 1 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Biological: Insulin Peglispro
* Biological: Insulin Glargine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetic for more than 1 year with glycated hemoglobin (HbA1c) of less than 8.5% Otherwise fit and healthy Non smoker Exclusion Criteria: Taking medication or supplements other than insulin to control diabetes. Suffered a hypoglycemic event in the last 12 months that required hospitalization or have poor awareness of hypoglycemia Taking fibrates, thyroid replacement therapy, testosterone, beta blockers or systemic corticosteroids

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin Peglispro<br>Stable dose of insulin peglispro (0.2 - 0.8 units per kilogram [U/kg]) administered subcutaneously (SC) once daily for at least 21 days in one of two treatment periods. Dose based on prestudy basal insulin dosing regimen. | Biological: Insulin Peglispro<br>* Daily doses administered SC.<br>* Other names: LY2605541;|
| Active Comparator: Insulin Glargine<br>Stable dose of insulin glargine (0.2 - 0.8 U/kg) administered SC once daily for at least 21 days in one of two treatment periods. Dose based on prestudy basal insulin dosing regimen. | Biological: Insulin Glargine<br>* Daily doses administered SC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Very Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentrations | VLDL-TG average total concentration calculated at steady state from 240 to 420 minutes during dosing with insulin peglispro and insulin glargine. | Day 22: 240 minutes (min) to 420 min | 
| VLDL-TG Secretion Rate | VLDL-TG secretion rates are calculated at steady state during dosing with insulin peglispro and insulin glargine. | Day 22: 240 min to 420 min | 
| VLDL-TG Oxidation Rate | VLDL-TG oxidation rates are calculated at steady state during dosing with insulin peglispro and insulin glargine. | Day 22: 240 min to 420 min | 
| VLDL-TG Clearance Rate | VLDL-TG clearance rates are calculated at steady state during dosing with insulin peglispro and insulin glargine. | Day 22: 240 min to 420 min |