Trial Outcomes & Findings for A Study of Insulin Peglispro and Glargine on Fats in Participants With Type 1 Diabetes (NCT NCT01771250)
NCT ID: NCT01771250
Last Updated: 2019-03-11
Results Overview
VLDL-TG average total concentration calculated at steady state from 240 to 420 minutes during dosing with insulin peglispro and insulin glargine.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Day 22: 240 minutes (min) to 420 min
Results posted on
2019-03-11
Participant Flow
Insulin treatments were transitioned by gradual tapering/titration as required at the start of each period and the end of Period 2 based on the participants individual randomization and pre-study therapy.
Participant milestones
| Measure |
Insulin Peglispro (LY2605541) Then Insulin Glargine
Participants took a stable dose of insulin peglispro (0.2 - 0.8 Units per kilogram \[U/kg\]) in Period 1 and then insulin glargine (0.2 - 0.8 U/kg) in Period 2 administered subcutaneously (SC).
|
Insulin Glargine Then Insulin Peglispro
Participants took a stable dose of insulin glargine (0.2 - 0.8 U/kg) in Period 1 and then insulin peglispro (0.2 - 0.8 U/kg) in Period 2 administered subcutaneously (SC).
|
|---|---|---|
|
Period 1
STARTED
|
8
|
7
|
|
Period 1
Received at Least One Dose of Study Drug
|
7
|
7
|
|
Period 1
COMPLETED
|
7
|
7
|
|
Period 1
NOT COMPLETED
|
1
|
0
|
|
Period 2
STARTED
|
7
|
7
|
|
Period 2
COMPLETED
|
7
|
7
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Insulin Peglispro (LY2605541) Then Insulin Glargine
Participants took a stable dose of insulin peglispro (0.2 - 0.8 Units per kilogram \[U/kg\]) in Period 1 and then insulin glargine (0.2 - 0.8 U/kg) in Period 2 administered subcutaneously (SC).
|
Insulin Glargine Then Insulin Peglispro
Participants took a stable dose of insulin glargine (0.2 - 0.8 U/kg) in Period 1 and then insulin peglispro (0.2 - 0.8 U/kg) in Period 2 administered subcutaneously (SC).
|
|---|---|---|
|
Period 1
Met exclusion criteria
|
1
|
0
|
Baseline Characteristics
A Study of Insulin Peglispro and Glargine on Fats in Participants With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
All Study Participants
n=14 Participants
Participants were randomized to receive daily stable doses of either insulin peglispro or insulin glargine (0.2 -0.8 U/kg) administered SC for at least 21 days, in one of two treatment periods.
|
|---|---|
|
Age, Continuous
|
35.3 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 22: 240 minutes (min) to 420 minPopulation: All participants who were randomized and received at least one dose of study drug.
VLDL-TG average total concentration calculated at steady state from 240 to 420 minutes during dosing with insulin peglispro and insulin glargine.
Outcome measures
| Measure |
Insulin Peglispro
n=14 Participants
Participants took a stable dose of Insulin Peglispro (0.2 - 0.8 U/kg) administered SC once daily for at least 21 days in one of two treatment periods.
|
Insulin Glargine
n=14 Participants
Participants took a 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.
|
|---|---|---|
|
Very Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentrations
|
0.27 micromole per Liter (μmol/L)
Geometric Coefficient of Variation 55
|
0.17 micromole per Liter (μmol/L)
Geometric Coefficient of Variation 66
|
PRIMARY outcome
Timeframe: Day 22: 240 min to 420 minPopulation: All participants who were randomized and took at least one dose of study drug.
VLDL-TG secretion rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.
Outcome measures
| Measure |
Insulin Peglispro
n=14 Participants
Participants took a stable dose of Insulin Peglispro (0.2 - 0.8 U/kg) administered SC once daily for at least 21 days in one of two treatment periods.
|
Insulin Glargine
n=14 Participants
Participants took a 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.
|
|---|---|---|
|
VLDL-TG Secretion Rate
|
38.79 μmol/min
Geometric Coefficient of Variation 42
|
25.61 μmol/min
Geometric Coefficient of Variation 58
|
PRIMARY outcome
Timeframe: Day 22: 240 min to 420 minPopulation: All participants who were randomized and received at least one dose of study drug.
VLDL-TG oxidation rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.
Outcome measures
| Measure |
Insulin Peglispro
n=14 Participants
Participants took a stable dose of Insulin Peglispro (0.2 - 0.8 U/kg) administered SC once daily for at least 21 days in one of two treatment periods.
|
Insulin Glargine
n=14 Participants
Participants took a 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.
|
|---|---|---|
|
VLDL-TG Oxidation Rate
|
20.13 μmol/min
Geometric Coefficient of Variation 40
|
15.34 μmol/min
Geometric Coefficient of Variation 59
|
PRIMARY outcome
Timeframe: Day 22: 240 min to 420 minPopulation: All participants who were randomized and received at least one dose of study drug.
VLDL-TG clearance rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.
Outcome measures
| Measure |
Insulin Peglispro
n=14 Participants
Participants took a stable dose of Insulin Peglispro (0.2 - 0.8 U/kg) administered SC once daily for at least 21 days in one of two treatment periods.
|
Insulin Glargine
n=14 Participants
Participants took a 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.
|
|---|---|---|
|
VLDL-TG Clearance Rate
|
142.16 milliliters per minute (mL/min)
Geometric Coefficient of Variation 47
|
155.11 milliliters per minute (mL/min)
Geometric Coefficient of Variation 49
|
Adverse Events
Insulin Peglispro
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Insulin Glargine
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Insulin Peglispro
n=14 participants at risk
Participants took a stable dose of Insulin Peglispro (0.2 - 0.8 U/kg) administered SC once daily for at least 21 days in one of two treatment periods.
|
Insulin Glargine
n=14 participants at risk
Participants took a 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.
|
|---|---|---|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.00%
0/14
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Insulin Peglispro
n=14 participants at risk
Participants took a stable dose of Insulin Peglispro (0.2 - 0.8 U/kg) administered SC once daily for at least 21 days in one of two treatment periods.
|
Insulin Glargine
n=14 participants at risk
Participants took a 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.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/14
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.1%
1/14 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
7.1%
1/14 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
7.1%
1/14 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
7.1%
1/14 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
14.3%
2/14 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
1/14 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
7.1%
1/14 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood glucose increased
|
7.1%
1/14 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/14
All randomized participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
7.1%
1/14 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/14
All randomized participants who received at least one dose of study drug.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place