Trial Outcomes & Findings for A Study of Multiple Doses of LY2922470 in Participants With Diabetes (NCT NCT01867216)
NCT ID: NCT01867216
Last Updated: 2018-07-26
Results Overview
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
66 participants
Primary outcome timeframe
Baseline through Study Completion (up to 56 days)
Results posted on
2018-07-26
Participant Flow
Participant milestones
| Measure |
Placebo QD or BID
Placebo administered orally once daily (QD) or twice daily (BID) for up to 28 days.
|
60 mg LY2922470 QD
60 mg LY2922470 administered orally QD for up to 28 days.
|
200 mg LY2922470 QD
200 mg LY2922470 administered orally QD for up to 28 days.
|
500 mg LY2922470 QD
500 mg LY2922470 administered orally QD for up to 28 days.
|
1200 mg LY2922470 QD
1200 mg LY2922470 administered orally QD for up to 28 days.
|
150 mg LY2922470 BID
150 mg LY2922470 administered orally BID for up to 28 days.
|
400 mg LY2922470 BID
400 mg LY2922470 administered orally BID for up to 28 days.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
8
|
8
|
8
|
9
|
8
|
9
|
|
Overall Study
Received Study Drug
|
14
|
8
|
8
|
8
|
9
|
8
|
9
|
|
Overall Study
COMPLETED
|
12
|
8
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
0
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo QD or BID
Placebo administered orally once daily (QD) or twice daily (BID) for up to 28 days.
|
60 mg LY2922470 QD
60 mg LY2922470 administered orally QD for up to 28 days.
|
200 mg LY2922470 QD
200 mg LY2922470 administered orally QD for up to 28 days.
|
500 mg LY2922470 QD
500 mg LY2922470 administered orally QD for up to 28 days.
|
1200 mg LY2922470 QD
1200 mg LY2922470 administered orally QD for up to 28 days.
|
150 mg LY2922470 BID
150 mg LY2922470 administered orally BID for up to 28 days.
|
400 mg LY2922470 BID
400 mg LY2922470 administered orally BID for up to 28 days.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Unable to Place Catheter for Blood Draws
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of Multiple Doses of LY2922470 in Participants With Diabetes
Baseline characteristics by cohort
| Measure |
Placebo QD or BID
n=14 Participants
Placebo administered orally QD or BID for up to 28 days.
|
60 mg LY2922470 QD
n=8 Participants
60 mg LY2922470 administered orally QD for up to 28 days.
|
200 mg LY2922470 QD
n=8 Participants
200 mg LY2922470 administered orally QD for up to 28 days.
|
500 mg LY2922470 QD
n=8 Participants
500 mg LY2922470 administered orally QD for up to 28 days.
|
1200 mg LY2922470 QD
n=9 Participants
1200 mg LY2922470 administered orally QD for up to 28 days.
|
150 mg LY2922470 BID
n=8 Participants
150 mg LY2922470 administered orally BID for up to 28 days.
|
400 mg LY2922470 BID
n=9 Participants
400 mg LY2922470 administered orally BID for up to 28 days.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
51.4 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
59.9 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
52.8 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
58.6 years
STANDARD_DEVIATION 7.8 • n=4 Participants
|
59.8 years
STANDARD_DEVIATION 7.6 • n=21 Participants
|
54.0 years
STANDARD_DEVIATION 6.4 • n=8 Participants
|
50.2 years
STANDARD_DEVIATION 9.3 • n=8 Participants
|
54.9 years
STANDARD_DEVIATION 8.7 • n=24 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
22 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
42 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
27 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
37 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
25 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
38 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
64 Participants
n=24 Participants
|
|
Body Mass Index (BMI)
|
31.00 kilograms per square meter (kg/m²)
STANDARD_DEVIATION 4.86 • n=5 Participants
|
28.10 kilograms per square meter (kg/m²)
STANDARD_DEVIATION 3.19 • n=7 Participants
|
30.76 kilograms per square meter (kg/m²)
STANDARD_DEVIATION 3.74 • n=5 Participants
|
31.08 kilograms per square meter (kg/m²)
STANDARD_DEVIATION 3.40 • n=4 Participants
|
30.20 kilograms per square meter (kg/m²)
STANDARD_DEVIATION 6.56 • n=21 Participants
|
34.36 kilograms per square meter (kg/m²)
STANDARD_DEVIATION 4.04 • n=8 Participants
|
32.90 kilograms per square meter (kg/m²)
STANDARD_DEVIATION 6.08 • n=8 Participants
|
31.19 kilograms per square meter (kg/m²)
STANDARD_DEVIATION 4.89 • n=24 Participants
|
|
Hemoglobin A1c (HbA1c)
|
8.29 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.08 • n=5 Participants
|
8.58 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.48 • n=7 Participants
|
7.74 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.29 • n=5 Participants
|
7.91 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.69 • n=4 Participants
|
7.24 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.49 • n=21 Participants
|
8.09 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.25 • n=8 Participants
|
7.96 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.21 • n=8 Participants
|
7.99 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.24 • n=24 Participants
|
|
Fasting Blood Glucose
|
145.92 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 50.50 • n=5 Participants
|
128.45 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 39.38 • n=7 Participants
|
132.39 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 37.09 • n=5 Participants
|
140.19 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 49.53 • n=4 Participants
|
137.11 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 26.19 • n=21 Participants
|
149.50 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 38.40 • n=8 Participants
|
149.56 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 44.21 • n=8 Participants
|
141.05 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 40.99 • n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline through Study Completion (up to 56 days)Population: All participants who received at least one dose of study drug.
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Placebo QD or BID
n=14 Participants
Placebo administered orally QD or BID for up to 28 days.
|
60 mg LY2922470 QD
n=8 Participants
60 mg LY2922470 administered orally QD for up to 28 days.
|
200 mg LY2922470 QD
n=8 Participants
200 mg LY2922470 administered orally QD for up to 28 days.
|
500 mg LY2922470 QD
n=8 Participants
500 mg LY2922470 administered orally QD for up to 28 days.
|
1200 mg LY2922470 QD
n=9 Participants
1200 mg LY2922470 administered orally QD for up to 28 days.
|
150 mg LY2922470 BID
n=8 Participants
150 mg LY2922470 administered orally BID for up to 28 days.
|
400 mg LY2922470 BID
n=9 Participants
400 mg LY2922470 administered orally BID for up to 28 days.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdosePopulation: All participants who received LY2922470 and had sufficient evaluable AUC(0-24) values.
Outcome measures
| Measure |
Placebo QD or BID
n=8 Participants
Placebo administered orally QD or BID for up to 28 days.
|
60 mg LY2922470 QD
n=8 Participants
60 mg LY2922470 administered orally QD for up to 28 days.
|
200 mg LY2922470 QD
n=8 Participants
200 mg LY2922470 administered orally QD for up to 28 days.
|
500 mg LY2922470 QD
n=8 Participants
500 mg LY2922470 administered orally QD for up to 28 days.
|
1200 mg LY2922470 QD
n=8 Participants
1200 mg LY2922470 administered orally QD for up to 28 days.
|
150 mg LY2922470 BID
n=9 Participants
150 mg LY2922470 administered orally BID for up to 28 days.
|
400 mg LY2922470 BID
400 mg LY2922470 administered orally BID for up to 28 days.
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470
Day 1
|
4220 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 52
|
11,600 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 27
|
25,100 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 30
|
81,400 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 34
|
21,000 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 47
|
50,700 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 45
|
—
|
|
Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470
Day 28
|
5660 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 31
|
15,300 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 43
|
25,000 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 47
|
65,300 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 49
|
21,300 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 51
|
44,800 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 38
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24, 48 hours postdosePopulation: All participants who received LY2922470 and had sufficient evaluable Cmax values. For BID arms, Cmax from time 0-6 hours.
Outcome measures
| Measure |
Placebo QD or BID
n=8 Participants
Placebo administered orally QD or BID for up to 28 days.
|
60 mg LY2922470 QD
n=8 Participants
60 mg LY2922470 administered orally QD for up to 28 days.
|
200 mg LY2922470 QD
n=8 Participants
200 mg LY2922470 administered orally QD for up to 28 days.
|
500 mg LY2922470 QD
n=8 Participants
500 mg LY2922470 administered orally QD for up to 28 days.
|
1200 mg LY2922470 QD
n=8 Participants
1200 mg LY2922470 administered orally QD for up to 28 days.
|
150 mg LY2922470 BID
n=9 Participants
150 mg LY2922470 administered orally BID for up to 28 days.
|
400 mg LY2922470 BID
400 mg LY2922470 administered orally BID for up to 28 days.
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470
Day 28
|
1070 ng/mL
Geometric Coefficient of Variation 32
|
1630 ng/mL
Geometric Coefficient of Variation 70
|
3410 ng/mL
Geometric Coefficient of Variation 33
|
7900 ng/mL
Geometric Coefficient of Variation 49
|
1540 ng/mL
Geometric Coefficient of Variation 42
|
2980 ng/mL
Geometric Coefficient of Variation 37
|
—
|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470
Day 1
|
723 ng/mL
Geometric Coefficient of Variation 39
|
1540 ng/mL
Geometric Coefficient of Variation 23
|
2750 ng/mL
Geometric Coefficient of Variation 42
|
8200 ng/mL
Geometric Coefficient of Variation 38
|
1510 ng/mL
Geometric Coefficient of Variation 54
|
3150 ng/mL
Geometric Coefficient of Variation 58
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24, 48 hours postdosePopulation: All participants who received LY2922470 and had sufficient evaluable Tmax values. For BID arms, Tmax from time 0-6 hours.
Outcome measures
| Measure |
Placebo QD or BID
n=8 Participants
Placebo administered orally QD or BID for up to 28 days.
|
60 mg LY2922470 QD
n=8 Participants
60 mg LY2922470 administered orally QD for up to 28 days.
|
200 mg LY2922470 QD
n=8 Participants
200 mg LY2922470 administered orally QD for up to 28 days.
|
500 mg LY2922470 QD
n=8 Participants
500 mg LY2922470 administered orally QD for up to 28 days.
|
1200 mg LY2922470 QD
n=8 Participants
1200 mg LY2922470 administered orally QD for up to 28 days.
|
150 mg LY2922470 BID
n=9 Participants
150 mg LY2922470 administered orally BID for up to 28 days.
|
400 mg LY2922470 BID
400 mg LY2922470 administered orally BID for up to 28 days.
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470
Day 1
|
1.50 hours
Interval 1.5 to 2.5
|
2.50 hours
Interval 1.5 to 4.0
|
2.75 hours
Interval 1.5 to 16.0
|
4.00 hours
Interval 1.5 to 6.0
|
2.00 hours
Interval 1.5 to 4.0
|
2.50 hours
Interval 1.5 to 4.0
|
—
|
|
Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470
Day 28
|
1.50 hours
Interval 1.5 to 1.5
|
3.92 hours
Interval 1.5 to 6.0
|
1.50 hours
Interval 1.5 to 2.5
|
2.50 hours
Interval 1.5 to 6.0
|
1.51 hours
Interval 1.5 to 4.0
|
1.50 hours
Interval 1.5 to 4.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 28Population: All participants who received study drug and had sufficient evaluable HbA1c values.
Outcome measures
| Measure |
Placebo QD or BID
n=12 Participants
Placebo administered orally QD or BID for up to 28 days.
|
60 mg LY2922470 QD
n=8 Participants
60 mg LY2922470 administered orally QD for up to 28 days.
|
200 mg LY2922470 QD
n=8 Participants
200 mg LY2922470 administered orally QD for up to 28 days.
|
500 mg LY2922470 QD
n=8 Participants
500 mg LY2922470 administered orally QD for up to 28 days.
|
1200 mg LY2922470 QD
n=8 Participants
1200 mg LY2922470 administered orally QD for up to 28 days.
|
150 mg LY2922470 BID
n=8 Participants
150 mg LY2922470 administered orally BID for up to 28 days.
|
400 mg LY2922470 BID
n=8 Participants
400 mg LY2922470 administered orally BID for up to 28 days.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) at Day 28
|
-0.38 percentage of glycosylated hemoglobin
Standard Deviation 0.45
|
-0.54 percentage of glycosylated hemoglobin
Standard Deviation 0.32
|
-0.43 percentage of glycosylated hemoglobin
Standard Deviation 0.58
|
-0.24 percentage of glycosylated hemoglobin
Standard Deviation 0.52
|
-0.16 percentage of glycosylated hemoglobin
Standard Deviation 0.67
|
-0.34 percentage of glycosylated hemoglobin
Standard Deviation 0.38
|
0.01 percentage of glycosylated hemoglobin
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: Day 28: Predose, 0.5,1.5, 2.5, 4, 6, 12, 16, 24 hours PostdosePopulation: All participants who received study drug and had sufficient evaluable blood glucose values.
Outcome measures
| Measure |
Placebo QD or BID
n=10 Participants
Placebo administered orally QD or BID for up to 28 days.
|
60 mg LY2922470 QD
n=5 Participants
60 mg LY2922470 administered orally QD for up to 28 days.
|
200 mg LY2922470 QD
n=8 Participants
200 mg LY2922470 administered orally QD for up to 28 days.
|
500 mg LY2922470 QD
n=8 Participants
500 mg LY2922470 administered orally QD for up to 28 days.
|
1200 mg LY2922470 QD
n=8 Participants
1200 mg LY2922470 administered orally QD for up to 28 days.
|
150 mg LY2922470 BID
n=8 Participants
150 mg LY2922470 administered orally BID for up to 28 days.
|
400 mg LY2922470 BID
n=8 Participants
400 mg LY2922470 administered orally BID for up to 28 days.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve (AUEC₀-₂₄) During Mixed Meal Tolerance Test at Day 28
|
21.7 mg*h/dL
Standard Deviation 724
|
-93 mg*h/dL
Standard Deviation 165
|
70.4 mg*h/dL
Standard Deviation 1160
|
-499 mg*h/dL
Standard Deviation 493
|
-205 mg*h/dL
Standard Deviation 583
|
-531 mg*h/dL
Standard Deviation 549
|
-621 mg*h/dL
Standard Deviation 943
|
SECONDARY outcome
Timeframe: Day 28: Predose, 0.5,1.5, 2.5, 4, 6, 12 hours PostdosePopulation: All participants who received study drug and had sufficient evaluable c-peptide values.
Outcome measures
| Measure |
Placebo QD or BID
n=12 Participants
Placebo administered orally QD or BID for up to 28 days.
|
60 mg LY2922470 QD
n=8 Participants
60 mg LY2922470 administered orally QD for up to 28 days.
|
200 mg LY2922470 QD
n=6 Participants
200 mg LY2922470 administered orally QD for up to 28 days.
|
500 mg LY2922470 QD
n=8 Participants
500 mg LY2922470 administered orally QD for up to 28 days.
|
1200 mg LY2922470 QD
n=7 Participants
1200 mg LY2922470 administered orally QD for up to 28 days.
|
150 mg LY2922470 BID
n=6 Participants
150 mg LY2922470 administered orally BID for up to 28 days.
|
400 mg LY2922470 BID
n=8 Participants
400 mg LY2922470 administered orally BID for up to 28 days.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in C-Peptide Area Under the Effective Concentration Curve (AUEC₀-₁₂) During Mixed Meal Tolerance Test at Day 28
|
665 picomoles*h per liter (pmol*h/L)
Standard Deviation 4970
|
147 picomoles*h per liter (pmol*h/L)
Standard Deviation 3560
|
793 picomoles*h per liter (pmol*h/L)
Standard Deviation 4220
|
-159 picomoles*h per liter (pmol*h/L)
Standard Deviation 3780
|
-740 picomoles*h per liter (pmol*h/L)
Standard Deviation 2890
|
1230 picomoles*h per liter (pmol*h/L)
Standard Deviation 1660
|
-2230 picomoles*h per liter (pmol*h/L)
Standard Deviation 2810
|
Adverse Events
Placebo QD or BID
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
60 mg LY2922470 QD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
200 mg LY2922470 QD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
500 mg LY2922470 QD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
1200 mg LY2922470 QD
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
150 mg LY2922470 BID
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
400 mg LY2922470 BID
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo QD or BID
n=14 participants at risk
Placebo administered orally QD or BID for up to 28 days.
|
60 mg LY2922470 QD
n=8 participants at risk
60 mg LY2922470 administered orally QD for up to 28 days.
|
200 mg LY2922470 QD
n=8 participants at risk
200 mg LY2922470 administered orally QD for up to 28 days.
|
500 mg LY2922470 QD
n=8 participants at risk
500 mg LY2922470 administered orally QD for up to 28 days.
|
1200 mg LY2922470 QD
n=9 participants at risk
1200 mg LY2922470 administered orally QD for up to 28 days.
|
150 mg LY2922470 BID
n=8 participants at risk
150 mg LY2922470 administered orally BID for up to 28 days.
|
400 mg LY2922470 BID
n=9 participants at risk
400 mg LY2922470 administered orally BID for up to 28 days.
|
|---|---|---|---|---|---|---|---|
|
Eye disorders
Asthenopia
|
0.00%
0/14
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/14
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/14
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/14
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
25.0%
2/8 • Number of events 2
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 2
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
22.2%
2/9 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/14
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Faeces discoloured
|
21.4%
3/14 • Number of events 3
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
25.0%
2/8 • Number of events 3
All participants who received at least one dose of study drug.
|
55.6%
5/9 • Number of events 5
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
33.3%
3/9 • Number of events 4
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Faeces pale
|
0.00%
0/14
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/14
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
0.00%
0/14
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/14
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
7.1%
1/14 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/14
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/14
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/14
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
25.0%
2/8 • Number of events 2
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Wound
|
7.1%
1/14 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/14
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/14
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/14
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 2
All participants who received at least one dose of study drug.
|
22.2%
2/9 • Number of events 2
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 2
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/14
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 2
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/14
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Nipple disorder
|
7.1%
1/14 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/14
All participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
7.1%
1/14 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.1%
1/14 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All participants who received at least one dose of study drug.
|
0.00%
0/8
All participants who received at least one dose of study drug.
|
0.00%
0/9
All 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
Restriction type: GT60