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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Evaluation of the Effects of Insulin Peglispro (LY2605541) on Respiratory Quotient During Sleep and Response to Hyperinsulinemia Compared With That of Insulin Glargine in Patients With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01925989
• Other study ID #: 14872
• Secondary ID: I2R-MC-BIDO
• Status: Completed
• Phase: Phase 1
• Start date: November 2013
• Est. completion date: October 2015

Study information

• Verified date: October 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT02211586

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Biological:
• LY2605541
Administered SQ
• Insulin Glargine
Administered SQ

Locations

Country	Name	City	State
United States	Translational Research Institute for Metabolism and Diabetes	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Respiratory Quotient (RQ) in Type 1 Diabetes Mellitus (T1DM)	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).	Day 30 post dose, overnight period (0000 to 0600 hours)
Secondary	Lipid Oxidation in T1DM and Healthy Participants	Lipid oxidation is derived from RQ, basal metabolic rate and urinary nitrogen, a value of 0.7 indicates that lipids are being metabolized.	Day 30 post dose, overnight period (0000 to 0600 hours)
Secondary	Basal Metabolic Rate (BMR) for T1DM	BMR is the metabolic rate determined at rest 12 to 14 hours after the last meal.	Day 30 post dose, overnight period (0000 to 0600 hours)
Secondary	Sleep Respiratory Quotient (RQ) of Untreated Healthy Participants	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.	Day 5, overnight period (0000 to 0600 hours)
Secondary	Total Number of Minutes of Lipid Oxidation (RQ Below 7.6) in T1DM and Healthy Participants	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.	Day 5, every minute through 23 hour period
Secondary	Change in RQ, Pre-breakfast to Post-breakfast Meal, in T1DM	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.	Day 30 0830 to 0854 hours, Day 30 1000 to 1054 hours