A Study of How Insulin Peglispro (LY2605541) and Insulin Glargine Affect the Breakdown of Fat and Sugar in Type 1 Diabetics

Phase 1

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Biological: Insulin Glargine; Biological: LY2605541

• Registration Number: NCT01925989
• Lead Sponsor: Eli Lilly and Company

Brief Summary

This is a two-period study of participants with type 1 diabetes mellitus (T1DM). In each period, participants will receive once daily injections of stable dose LY2605541 or insulin glargine for 28 to 35 days followed by procedures to look at how the body uses or stores fats and sugars. Participants will continue to use meal time insulin throughout the study. Healthy participants will also enroll in the study. They will not receive any study medication.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-16
• Study First Submitted QC: 2013-08-16
• Study First Posted: 2013-08-20
• Study Start: 2013-11
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Results First Submitted: 2018-03-17
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-29
• Last Update Submitted: 2018-10-29
• Results First Posted: 2019-03-01
• Last Update Posted: 2019-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Type 1 Diabetics:

• T1DM for more than 1 year with Hemoglobin A1c (HbA1c) of less than 9.5%

All Participants:

• Otherwise fit and healthy
• Non smoker

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Exclusion Criteria

Type 1 Diabetics:

• 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

All Participants:

• Taking fibrates, thyroid replacement therapy, testosterone, beta blockers or systemic corticosteroids

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Insulin Glargine/Insulin Peglispro	Insulin Glargine	Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen. Participants continue to use mealtime insulin. Insulin peglispro (LY2605541) administered to participants with T1DM subcutaneously (SQ) once daily (QD) for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen.
Insulin Peglispro/Insulin Glargine	LY2605541	Insulin peglispro (LY2605541) administered to participants with T1DM subcutaneously (SQ) once daily (QD) for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen. Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen. Participants continue to use mealtime insulin.

Primary Outcome Measures

Name	Time	Method
Sleep Respiratory Quotient (RQ) in Type 1 Diabetes Mellitus (T1DM)	Day 30 post dose, overnight period (0000 to 0600 hours)	Lipid or glucose metabolism was assessed by the measurement of respiratory quotient (RQ) during sleep using whole room calorimetry. RQ is a calculation of basal metabolic rate (BMR) when estimated from carbon dioxide production. It is calculated from the ratio of carbon dioxide produced by the body to oxygen consumed by the body using whole room calorimetry (WRC).

Secondary Outcome Measures

Name	Time	Method
Total Number of Minutes of Lipid Oxidation (RQ Below 7.6) in T1DM and Healthy Participants	Day 5, every minute through 23 hour period	The respiratory quotient (or RQ or respiratory coefficient), is a number used in calculations of basal metabolic rate (BMR) when estimated from carbon dioxide production. It is calculated from the ratio of carbon dioxide produced by the body to oxygen consumed by the body using whole room calorimetry.It is calculated from the ratio of carbon dioxide produced by the body to oxygen consumed by the body using whole data based on all 1-minutes interval measurements for the duration of the overnight period.
Lipid Oxidation in T1DM and Healthy Participants	Day 30 post dose, overnight period (0000 to 0600 hours)	Lipid oxidation is derived from RQ, basal metabolic rate and urinary nitrogen, a value of 0.7 indicates that lipids are being metabolized.
Basal Metabolic Rate (BMR) for T1DM	Day 30 post dose, overnight period (0000 to 0600 hours)	BMR is the metabolic rate determined at rest 12 to 14 hours after the last meal.
Sleep Respiratory Quotient (RQ) of Untreated Healthy Participants	Day 5, overnight period (0000 to 0600 hours)	The respiratory quotient (or RQ or respiratory coefficient), is a number used in calculations of basal metabolic rate (BMR) when estimated from carbon dioxide production. It is calculated from the ratio of carbon dioxide produced by the body to oxygen consumed by the body using whole room calorimetry. The overnight period was averaged based on all 1-minutes interval measurements for the duration of the overnight period.
Change in RQ, Pre-breakfast to Post-breakfast Meal, in T1DM	Day 30 0830 to 0854 hours, Day 30 1000 to 1054 hours	The respiratory quotient (or RQ or respiratory coefficient), is a number used in calculations of basal metabolic rate (BMR) when estimated from carbon dioxide production. It is calculated from the ratio of carbon dioxide produced by the body to oxygen consumed by the body using whole room calorimetry.

Trial Locations

Locations (1)

Translational Research Institute for Metabolism and Diabetes; 🇺🇸 Orlando, Florida, United States