Trial Outcomes & Findings for Study of LY2409021 in Participants With Type 1 Diabetes (NCT NCT01640834)
NCT ID: NCT01640834
Last Updated: 2018-10-29
Results Overview
The mean absolute change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Baseline (Day 1), Day 2
Results posted on
2018-10-29
Participant Flow
Participant milestones
| Measure |
100 mg LY2409021
LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.
Placebo: 2 capsules, administered as a single oral dose on Day 2.
Glucagon: 1 mg administered via intramuscular injection on Day 3.
|
300 mg LY2409021
LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.
Glucagon: 1 mg administered via intramuscular injection on Day 3.
|
Placebo
Placebo: 3 capsules administered as a single oral dose on Day 2.
Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
4
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
8
|
8
|
4
|
|
Overall Study
COMPLETED
|
8
|
8
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of LY2409021 in Participants With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
100 mg LY2409021
n=8 Participants
LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.
Placebo: 2 capsules, administered as a single oral dose on Day 2.
Glucagon: 1 mg administered via intramuscular injection on Day 3.
|
300 mg LY2409021
n=8 Participants
LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.
Glucagon: 1 mg administered via intramuscular injection on Day 3.
|
Placebo
n=4 Participants
Placebo: 3 capsules administered as a single oral dose on Day 2.
Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.6 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
47.1 years
STANDARD_DEVIATION 5.7 • n=7 Participants
|
43.3 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
43.0 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 2Population: All participants who received a dose of LY2409021 or placebo and had evaluable 24-hour insulin data.
The mean absolute change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported.
Outcome measures
| Measure |
100 mg LY2409021
n=8 Participants
LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.
Placebo: 2 capsules, administered as a single oral dose on Day 2.
Glucagon: 1 mg administered via intramuscular injection on Day 3.
|
300 mg LY2409021
n=8 Participants
LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.
Glucagon: 1 mg administered via intramuscular injection on Day 3.
|
Placebo
n=4 Participants
Placebo: 3 capsules administered as a single oral dose on Day 2.
Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.
|
|---|---|---|---|
|
Pharmacodynamics: Change From Baseline to Day 2 in 24-hour Insulin Dose
|
1.85 insulin units
Standard Deviation 7.15
|
0.80 insulin units
Standard Deviation 9.63
|
7.69 insulin units
Standard Deviation 2.99
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 2Population: All participants who received a dose of LY2409021 or placebo and had evaluable 24-hour insulin data.
The percentage change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported.
Outcome measures
| Measure |
100 mg LY2409021
n=8 Participants
LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.
Placebo: 2 capsules, administered as a single oral dose on Day 2.
Glucagon: 1 mg administered via intramuscular injection on Day 3.
|
300 mg LY2409021
n=8 Participants
LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.
Glucagon: 1 mg administered via intramuscular injection on Day 3.
|
Placebo
n=4 Participants
Placebo: 3 capsules administered as a single oral dose on Day 2.
Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.
|
|---|---|---|---|
|
Pharmacodynamics: Percentage Change From Baseline to Day 2 in 24-hour Insulin
|
5.71 percentage of insulin units
Standard Deviation 19.90
|
3.12 percentage of insulin units
Standard Deviation 18.34
|
22.75 percentage of insulin units
Standard Deviation 22.20
|
SECONDARY outcome
Timeframe: Predose (Day 2) through 120 hours postdose (Day 7)Population: All participants who received a dose of LY2409021 and had evaluable pharmacokinetic data.
Outcome measures
| Measure |
100 mg LY2409021
n=8 Participants
LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.
Placebo: 2 capsules, administered as a single oral dose on Day 2.
Glucagon: 1 mg administered via intramuscular injection on Day 3.
|
300 mg LY2409021
n=8 Participants
LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.
Glucagon: 1 mg administered via intramuscular injection on Day 3.
|
Placebo
Placebo: 3 capsules administered as a single oral dose on Day 2.
Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.
|
|---|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021
|
2620 nanograms per milliliter
Geometric Coefficient of Variation 23
|
6090 nanograms per milliliter
Geometric Coefficient of Variation 23
|
—
|
SECONDARY outcome
Timeframe: Predose (Day 2) through 120 hours postdose (Day 7)Population: All participants who received a dose of LY2409021 and had evaluable pharmacokinetic data.
Exposure in terms of AUC of LY2409021 from time 0 extrapolated to infinity (AUCinf) is reported.
Outcome measures
| Measure |
100 mg LY2409021
n=8 Participants
LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.
Placebo: 2 capsules, administered as a single oral dose on Day 2.
Glucagon: 1 mg administered via intramuscular injection on Day 3.
|
300 mg LY2409021
n=8 Participants
LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.
Glucagon: 1 mg administered via intramuscular injection on Day 3.
|
Placebo
Placebo: 3 capsules administered as a single oral dose on Day 2.
Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.
|
|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021
|
209000 nanograms * hours per milliliter
Geometric Coefficient of Variation 30
|
506000 nanograms * hours per milliliter
Geometric Coefficient of Variation 22
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 3 up to Day 6Population: This outcome measure was not analyzed.
Data were not captured, and, therefore, this outcome measure was not analyzed. Zero participants were included in the analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 3 up to Day 6Population: This outcome measure was not analyzed.
Data were not captured, and, therefore, this outcome measure was not analyzed. Zero participants were included in the analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 3Population: All participants who received a dose of LY2409021 or placebo and had evaluable post-glucagon injection glucose concentration data.
The Cmax of glucose following a single dose of glucagon (1 mg) administered via an intramuscular injection is reported.
Outcome measures
| Measure |
100 mg LY2409021
n=8 Participants
LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.
Placebo: 2 capsules, administered as a single oral dose on Day 2.
Glucagon: 1 mg administered via intramuscular injection on Day 3.
|
300 mg LY2409021
n=8 Participants
LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.
Glucagon: 1 mg administered via intramuscular injection on Day 3.
|
Placebo
n=4 Participants
Placebo: 3 capsules administered as a single oral dose on Day 2.
Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.
|
|---|---|---|---|
|
Pharmacodynamics: Maximum Concentration (Cmax) of Glucose Concentration After 1 Milligram (mg) Glucagon Injection on Day 3
|
154.9 milligrams per deciliter
Geometric Coefficient of Variation 19
|
141.3 milligrams per deciliter
Geometric Coefficient of Variation 19
|
201.8 milligrams per deciliter
Geometric Coefficient of Variation 11
|
SECONDARY outcome
Timeframe: Day 3Population: All participants who received a dose of LY2409021 or placebo and had evaluable post-glucagon injection glucose concentration data.
Area under the glucose concentration curve from time 0 through 2 hours after a single dose of glucagon (1 milligram) administered via an intramuscular injection is reported.
Outcome measures
| Measure |
100 mg LY2409021
n=8 Participants
LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.
Placebo: 2 capsules, administered as a single oral dose on Day 2.
Glucagon: 1 mg administered via intramuscular injection on Day 3.
|
300 mg LY2409021
n=8 Participants
LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.
Glucagon: 1 mg administered via intramuscular injection on Day 3.
|
Placebo
n=4 Participants
Placebo: 3 capsules administered as a single oral dose on Day 2.
Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.
|
|---|---|---|---|
|
Pharmacodynamics: Area Under the Glucose Concentration Curve After a Single Dose of Glucagon on Day 3
|
15534.3 milligrams * minutes per deciliter
Geometric Coefficient of Variation 21
|
14885.5 milligrams * minutes per deciliter
Geometric Coefficient of Variation 16
|
20189.7 milligrams * minutes per deciliter
Geometric Coefficient of Variation 9
|
Adverse Events
100 mg LY2409021
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
300 mg LY2409021
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
100 mg LY2409021
n=8 participants at risk
LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.
Placebo: 2 capsules, administered as a single oral dose on Day 2.
Glucagon: 1 mg administered via intramuscular injection on Day 3.
|
300 mg LY2409021
n=8 participants at risk
LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.
Glucagon: 1 mg administered via intramuscular injection on Day 3.
|
Placebo
n=4 participants at risk
Placebo: 3 capsules administered as a single oral dose on Day 2.
Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/4
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/4
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/4
|
|
General disorders
Discomfort
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
75.0%
6/8 • Number of events 19
|
75.0%
6/8 • Number of events 13
|
75.0%
3/4 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8
|
0.00%
0/8
|
25.0%
1/4 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/4
|
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
Restriction type: GT60