Back to resultsA Study of How Insulin Peglispro (LY2605541) and Insulin Glargine Affect the Breakdown of Fat and Sugar in Type 1 Diabetics
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY2605541
Insulin Glargine
Sponsored by
About this trial
This is an interventional basic science trial for Type 1 Diabetes Mellitus
Eligibility Criteria
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
Sites / Locations
- Translational Research Institute for Metabolism and Diabetes
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Insulin Peglispro/Insulin Glargine
Insulin Glargine/Insulin Peglispro
Control
Arm Description
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.
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.
Control Arm. Untreated healthy participants.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Basal Metabolic Rate (BMR) for T1DM
BMR is the metabolic rate determined at rest 12 to 14 hours after the last meal.
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.
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.
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.
Full Information
NCT ID
NCT01925989
First Posted
August 16, 2013
Last Updated
October 29, 2018
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT01925989
Brief Title
A Study of How Insulin Peglispro (LY2605541) and Insulin Glargine Affect the Breakdown of Fat and Sugar in Type 1 Diabetics
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insulin Peglispro/Insulin Glargine
Arm Type
Experimental
Arm Description
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.
Arm Title
Insulin Glargine/Insulin Peglispro
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control Arm. Untreated healthy participants.
Intervention Type
Biological
Intervention Name(s)
LY2605541
Intervention Description
Administered SQ
Intervention Type
Biological
Intervention Name(s)
Insulin Glargine
Intervention Description
Administered SQ
Primary Outcome Measure Information:
Title
Sleep Respiratory Quotient (RQ) in Type 1 Diabetes Mellitus (T1DM)
Description
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).
Time Frame
Day 30 post dose, overnight period (0000 to 0600 hours)
Secondary Outcome Measure Information:
Title
Lipid Oxidation in T1DM and Healthy Participants
Description
Lipid oxidation is derived from RQ, basal metabolic rate and urinary nitrogen, a value of 0.7 indicates that lipids are being metabolized.
Time Frame
Day 30 post dose, overnight period (0000 to 0600 hours)
Title
Basal Metabolic Rate (BMR) for T1DM
Description
BMR is the metabolic rate determined at rest 12 to 14 hours after the last meal.
Time Frame
Day 30 post dose, overnight period (0000 to 0600 hours)
Title
Sleep Respiratory Quotient (RQ) of Untreated Healthy Participants
Description
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.
Time Frame
Day 5, overnight period (0000 to 0600 hours)
Title
Total Number of Minutes of Lipid Oxidation (RQ Below 7.6) in T1DM and Healthy Participants
Description
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.
Time Frame
Day 5, every minute through 23 hour period
Title
Change in RQ, Pre-breakfast to Post-breakfast Meal, in T1DM
Description
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.
Time Frame
Day 30 0830 to 0854 hours, Day 30 1000 to 1054 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Translational Research Institute for Metabolism and Diabetes
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of How Insulin Peglispro (LY2605541) and Insulin Glargine Affect the Breakdown of Fat and Sugar in Type 1 Diabetics
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