Trial Outcomes & Findings for A Study of How Insulin Peglispro (LY2605541) and Insulin Glargine Affect the Breakdown of Fat and Sugar in Type 1 Diabetics (NCT NCT01925989)
NCT ID: NCT01925989
Last Updated: 2019-03-01
Results Overview
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).
COMPLETED
PHASE1
27 participants
Day 30 post dose, overnight period (0000 to 0600 hours)
2019-03-01
Participant Flow
Participant milestones
| Measure |
Sequence Insulin Peglispro/Insulin Glargine
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 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 based on participant's prestudy basal insulin dosing regimen. Participants continue to use mealtime insulin.
|
Sequence Insulin Glargine/Insulin Peglispro
Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose 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 based on participant's prestudy basal insulin dosing regimen.
|
Control
Untreated healthy participants who received no study drug.
|
|---|---|---|---|
|
Period 1
STARTED
|
7
|
8
|
12
|
|
Period 1
Received at Least 1 Dose of Study Drug
|
7
|
8
|
0
|
|
Period 1
COMPLETED
|
6
|
6
|
12
|
|
Period 1
NOT COMPLETED
|
1
|
2
|
0
|
|
Period 2
STARTED
|
6
|
6
|
12
|
|
Period 2
COMPLETED
|
6
|
6
|
12
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence Insulin Peglispro/Insulin Glargine
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 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 based on participant's prestudy basal insulin dosing regimen. Participants continue to use mealtime insulin.
|
Sequence Insulin Glargine/Insulin Peglispro
Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose 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 based on participant's prestudy basal insulin dosing regimen.
|
Control
Untreated healthy participants who received no study drug.
|
|---|---|---|---|
|
Period 1
Sponsor Decision
|
1
|
1
|
0
|
|
Period 1
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
A Study of How Insulin Peglispro (LY2605541) and Insulin Glargine Affect the Breakdown of Fat and Sugar in Type 1 Diabetics
Baseline characteristics by cohort
| Measure |
All T1DM
n=15 Participants
Participants with T1DM who received Insulin peglispro (LY260551) and insulin glargine SQ in either sequence group.
|
Control
n=12 Participants
Untreated healthy participants who received no study drug.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.5 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
36.9 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
36.7 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 30 post dose, overnight period (0000 to 0600 hours)Population: All randomized participants with T1DM that received at least 1 dose of study drug. Data from 2 participants could not be used: one due to uncontrolled blood glucose and one due to an increase in thyroid medication.
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).
Outcome measures
| Measure |
Insulin Peglispro
n=13 Participants
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 based on participant's prestudy basal insulin dosing regimen.
|
Insulin Glargine
n=12 Participants
Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose based on participant's prestudy basal insulin dosing regimen.
|
Control
Untreated healthy participants who received no study drug.
|
|---|---|---|---|
|
Sleep Respiratory Quotient (RQ) in Type 1 Diabetes Mellitus (T1DM)
|
0.822 ratio
Standard Deviation 0.026
|
0.846 ratio
Standard Deviation 0.033
|
—
|
SECONDARY outcome
Timeframe: Day 30 post dose, overnight period (0000 to 0600 hours)Population: All randomized participants.
Lipid oxidation is derived from RQ, basal metabolic rate and urinary nitrogen, a value of 0.7 indicates that lipids are being metabolized.
Outcome measures
| Measure |
Insulin Peglispro
n=13 Participants
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 based on participant's prestudy basal insulin dosing regimen.
|
Insulin Glargine
n=12 Participants
Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose based on participant's prestudy basal insulin dosing regimen.
|
Control
n=12 Participants
Untreated healthy participants who received no study drug.
|
|---|---|---|---|
|
Lipid Oxidation in T1DM and Healthy Participants
|
0.892 grams per day (g/day)
Standard Deviation 0.024
|
0.900 grams per day (g/day)
Standard Deviation 0.024
|
0.906 grams per day (g/day)
Standard Deviation 0.020
|
SECONDARY outcome
Timeframe: Day 30 post dose, overnight period (0000 to 0600 hours)Population: All randomized participants with T1DM that received at least 1 dose of study drug. Data from 2 participants could not be used: one due to uncontrolled blood glucose and one due to an increase in thyroid medication.
BMR is the metabolic rate determined at rest 12 to 14 hours after the last meal.
Outcome measures
| Measure |
Insulin Peglispro
n=13 Participants
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 based on participant's prestudy basal insulin dosing regimen.
|
Insulin Glargine
n=12 Participants
Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose based on participant's prestudy basal insulin dosing regimen.
|
Control
Untreated healthy participants who received no study drug.
|
|---|---|---|---|
|
Basal Metabolic Rate (BMR) for T1DM
|
1511.0 kcal/day
Standard Deviation 228.3
|
1403.6 kcal/day
Standard Deviation 207.7
|
—
|
SECONDARY outcome
Timeframe: Day 5, overnight period (0000 to 0600 hours)Population: All randomized, health participant who received no study drug.
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.
Outcome measures
| Measure |
Insulin Peglispro
n=12 Participants
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 based on participant's prestudy basal insulin dosing regimen.
|
Insulin Glargine
Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose based on participant's prestudy basal insulin dosing regimen.
|
Control
Untreated healthy participants who received no study drug.
|
|---|---|---|---|
|
Sleep Respiratory Quotient (RQ) of Untreated Healthy Participants
|
0.848 ratio
Standard Deviation 0.020
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5, every minute through 23 hour periodPopulation: All randomized participants: T1DM participants that received at least 1 dose of study drug, Data from 2 participants could not be used:one due to uncontrolled blood glucose and one due to an increase in thyroid medication,data from 2 participants could not be used: 1 due to uncontrolled blood glucose and 1 due to an increase in thyroid medication.
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.
Outcome measures
| Measure |
Insulin Peglispro
n=13 Participants
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 based on participant's prestudy basal insulin dosing regimen.
|
Insulin Glargine
n=12 Participants
Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose based on participant's prestudy basal insulin dosing regimen.
|
Control
n=12 Participants
Untreated healthy participants who received no study drug.
|
|---|---|---|---|
|
Total Number of Minutes of Lipid Oxidation (RQ Below 7.6) in T1DM and Healthy Participants
|
22 minutes
Interval 3.0 to 205.0
|
8 minutes
Interval 0.0 to 61.0
|
4.5 minutes
Interval 0.0 to 84.0
|
SECONDARY outcome
Timeframe: Day 30 0830 to 0854 hours, Day 30 1000 to 1054 hoursPopulation: All randomized participants with T1DM that received at least 1 dose of study drug. Data from 2 participants could not be used: one due to uncontrolled blood glucose and one due to an increase in thyroid medication.
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.
Outcome measures
| Measure |
Insulin Peglispro
n=11 Participants
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 based on participant's prestudy basal insulin dosing regimen.
|
Insulin Glargine
n=12 Participants
Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose based on participant's prestudy basal insulin dosing regimen.
|
Control
Untreated healthy participants who received no study drug.
|
|---|---|---|---|
|
Change in RQ, Pre-breakfast to Post-breakfast Meal, in T1DM
|
0.836 ratio
Standard Deviation 0.055
|
0.874 ratio
Standard Deviation 0.033
|
—
|
Adverse Events
Insulin Peglispro
Insulin Glargine
Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Insulin Peglispro
n=13 participants at risk
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. Participants continue to use mealtime insulin.
|
Insulin Glargine
n=15 participants at risk
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.
|
Control
n=12 participants at risk
Control Arm. Untreated healthy participants.
|
|---|---|---|---|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/13
One participant in the Insulin Glargine/Insulin Peglispro arm withdrew consent prior to being dosed with study drug and is included in the AE section.
|
6.7%
1/15 • Number of events 1
One participant in the Insulin Glargine/Insulin Peglispro arm withdrew consent prior to being dosed with study drug and is included in the AE section.
|
0.00%
0/12
One participant in the Insulin Glargine/Insulin Peglispro arm withdrew consent prior to being dosed with study drug and is included in the AE section.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/13
One participant in the Insulin Glargine/Insulin Peglispro arm withdrew consent prior to being dosed with study drug and is included in the AE section.
|
6.7%
1/15 • Number of events 1
One participant in the Insulin Glargine/Insulin Peglispro arm withdrew consent prior to being dosed with study drug and is included in the AE section.
|
0.00%
0/12
One participant in the Insulin Glargine/Insulin Peglispro arm withdrew consent prior to being dosed with study drug and is included in the AE section.
|
|
General disorders
Injection site erythema
|
23.1%
3/13 • Number of events 3
One participant in the Insulin Glargine/Insulin Peglispro arm withdrew consent prior to being dosed with study drug and is included in the AE section.
|
0.00%
0/15
One participant in the Insulin Glargine/Insulin Peglispro arm withdrew consent prior to being dosed with study drug and is included in the AE section.
|
0.00%
0/12
One participant in the Insulin Glargine/Insulin Peglispro arm withdrew consent prior to being dosed with study drug and is included in the AE section.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/13
One participant in the Insulin Glargine/Insulin Peglispro arm withdrew consent prior to being dosed with study drug and is included in the AE section.
|
0.00%
0/15
One participant in the Insulin Glargine/Insulin Peglispro arm withdrew consent prior to being dosed with study drug and is included in the AE section.
|
8.3%
1/12 • Number of events 1
One participant in the Insulin Glargine/Insulin Peglispro arm withdrew consent prior to being dosed with study drug and is included in the AE section.
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Number of events 1
One participant in the Insulin Glargine/Insulin Peglispro arm withdrew consent prior to being dosed with study drug and is included in the AE section.
|
6.7%
1/15 • Number of events 1
One participant in the Insulin Glargine/Insulin Peglispro arm withdrew consent prior to being dosed with study drug and is included in the AE section.
|
0.00%
0/12
One participant in the Insulin Glargine/Insulin Peglispro arm withdrew consent prior to being dosed with study drug and is included in the AE section.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.7%
1/13 • Number of events 3
One participant in the Insulin Glargine/Insulin Peglispro arm withdrew consent prior to being dosed with study drug and is included in the AE section.
|
0.00%
0/15
One participant in the Insulin Glargine/Insulin Peglispro arm withdrew consent prior to being dosed with study drug and is included in the AE section.
|
0.00%
0/12
One participant in the Insulin Glargine/Insulin Peglispro arm withdrew consent prior to being dosed with study drug and is included in the AE section.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60