Trial Outcomes & Findings for Safety and Efficacy Study of EGT0001442 in Subjects With Type 2 Diabetes Mellitus (NCT NCT01029704)
NCT ID: NCT01029704
Last Updated: 2021-06-16
Results Overview
Fasting glucose levels were measured at four time points; At day -2, day 1, day 27 and day 29 (24-h after the last dose). Baseline is defined as the mean of FPG values on day -2 and day 1. End of treatment is defined as the mean of FPG values on day 27 and day 29. Changes in the FPG during the study period was calculated by subtracting the Baseline FPG from End of Treatment FPG.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
151 participants
Primary outcome timeframe
Baseline; Day -2 and Day 1. End of Treatment: Day 27 and Day 29
Results posted on
2021-06-16
Participant Flow
Participant milestones
| Measure |
Segment 1 (Dose Escalation): EGT0001442 5mg
Received 5mg of EGT0001442 once daily for 28 days
|
Segment 1 (Dose Escalation): EGT0001442 10mg
Received 10mg of EGT0001442 once daily for 28 days
|
Segment 1 (Dose Escalation): EGT0001442 20mg
Received 20mg of EGT0001442 once daily for 28 days
|
Segment 1 (Dose Escalation): EGT0001442 50mg
Received 50mg of EGT0001442 once daily for 28 days
|
Segment 2 (Double-blind): Placebo
Received placebo once daily for 28 days
|
Segment 2 (Double-blind): EGT0001442 5mg
Received 5mg of EGT0001442 once daily for 28 days
|
Segment 2 (Double-blind): EGT0001442 10mg
Received 10mg of EGT0001442 once daily for 28 days
|
Segment 2 (Double-blind): EGT0001442 20mg
Received 20mg of EGT0001442 once daily for 28 days
|
Segment 2 (Double-blind): EGT0001442 50mg
Received 50mg of EGT0001442 once daily for 28 days
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
5
|
28
|
24
|
23
|
28
|
26
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
5
|
23
|
20
|
19
|
22
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
5
|
4
|
4
|
6
|
1
|
Reasons for withdrawal
| Measure |
Segment 1 (Dose Escalation): EGT0001442 5mg
Received 5mg of EGT0001442 once daily for 28 days
|
Segment 1 (Dose Escalation): EGT0001442 10mg
Received 10mg of EGT0001442 once daily for 28 days
|
Segment 1 (Dose Escalation): EGT0001442 20mg
Received 20mg of EGT0001442 once daily for 28 days
|
Segment 1 (Dose Escalation): EGT0001442 50mg
Received 50mg of EGT0001442 once daily for 28 days
|
Segment 2 (Double-blind): Placebo
Received placebo once daily for 28 days
|
Segment 2 (Double-blind): EGT0001442 5mg
Received 5mg of EGT0001442 once daily for 28 days
|
Segment 2 (Double-blind): EGT0001442 10mg
Received 10mg of EGT0001442 once daily for 28 days
|
Segment 2 (Double-blind): EGT0001442 20mg
Received 20mg of EGT0001442 once daily for 28 days
|
Segment 2 (Double-blind): EGT0001442 50mg
Received 50mg of EGT0001442 once daily for 28 days
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
2
|
1
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
2
|
3
|
1
|
2
|
0
|
|
Overall Study
Withdrawn due to major protocol violation
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
Baseline characteristics by cohort
| Measure |
Segment 1 (Dose Escalation): EGT0001442 5mg
n=5 Participants
Received 5mg of EGT0001442 once daily for 28 days
|
Segment 1 (Dose Escalation): EGT0001442 10mg
n=5 Participants
Received 10mg of EGT0001442 once daily for 28 days
|
Segment 1 (Dose Escalation): EGT0001442 20mg
n=5 Participants
Received 20mg of EGT0001442 once daily for 28 days
|
Segment 1 (Dose Escalation): EGT0001442 50mg
n=5 Participants
Received 50mg of EGT0001442 once daily for 28 days
|
Segment 2 (Double-blind): Placebo
n=28 Participants
Received placebo once daily for 28 days
|
Segment 2 (Double-blind): EGT0001442 5mg
n=24 Participants
Received 5mg of EGT0001442 once daily for 28 days
|
Segment 2 (Double-blind): EGT0001442 10mg
n=23 Participants
Received 10mg of EGT0001442 once daily for 28 days
|
Segment 2 (Double-blind): EGT0001442 20mg
n=28 Participants
Received 20mg of EGT0001442 once daily for 28 days
|
Segment 2 (Double-blind): EGT0001442 50mg
n=26 Participants
Received 50mg of EGT0001442 once daily for 28 days
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
Segment 1
|
62.2 years
STANDARD_DEVIATION 7.9 • n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
49.4 years
STANDARD_DEVIATION 14.2 • n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
51.4 years
STANDARD_DEVIATION 11.7 • n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
53.2 years
STANDARD_DEVIATION 5.8 • n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
—
|
—
|
—
|
—
|
—
|
54.1 years
STANDARD_DEVIATION 10.8 • n=20 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
Age, Continuous
Segment 2
|
—
|
—
|
—
|
—
|
58.7 years
STANDARD_DEVIATION 7.3 • n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
57.8 years
STANDARD_DEVIATION 6.9 • n=24 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
54.9 years
STANDARD_DEVIATION 9 • n=23 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
59 years
STANDARD_DEVIATION 7.1 • n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
54.7 years
STANDARD_DEVIATION 6.7 • n=26 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
57.1 years
STANDARD_DEVIATION 7.5 • n=129 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
Sex: Female, Male
Segment 1 · Female
|
1 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
1 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
3 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
1 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
6 Participants
n=20 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
Sex: Female, Male
Segment 1 · Male
|
4 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
4 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
2 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
4 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
14 Participants
n=20 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
Sex: Female, Male
Segment 2 · Female
|
—
|
—
|
—
|
—
|
11 Participants
n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
9 Participants
n=24 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
12 Participants
n=23 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
12 Participants
n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
18 Participants
n=26 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
62 Participants
n=129 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
Sex: Female, Male
Segment 2 · Male
|
—
|
—
|
—
|
—
|
17 Participants
n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
15 Participants
n=24 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
11 Participants
n=23 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
16 Participants
n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
8 Participants
n=26 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
67 Participants
n=129 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
Ethnicity (NIH/OMB)
Segment 1 · Hispanic or Latino
|
4 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
4 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
3 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
4 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
15 Participants
n=20 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
Ethnicity (NIH/OMB)
Segment 1 · Not Hispanic or Latino
|
1 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
1 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
2 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
1 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
5 Participants
n=20 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
Ethnicity (NIH/OMB)
Segment 1 · Unknown or Not Reported
|
0 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=20 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
Ethnicity (NIH/OMB)
Segment 2 · Hispanic or Latino
|
—
|
—
|
—
|
—
|
20 Participants
n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
16 Participants
n=24 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
15 Participants
n=23 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
19 Participants
n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
19 Participants
n=26 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
89 Participants
n=129 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
Ethnicity (NIH/OMB)
Segment 2 · Not Hispanic or Latino
|
—
|
—
|
—
|
—
|
8 Participants
n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
8 Participants
n=24 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
8 Participants
n=23 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
9 Participants
n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
7 Participants
n=26 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
40 Participants
n=129 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
Ethnicity (NIH/OMB)
Segment 2 · Unknown or Not Reported
|
—
|
—
|
—
|
—
|
0 Participants
n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=24 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=23 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=26 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=129 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
Race (NIH/OMB)
Segment 1 · American Indian or Alaska Native
|
0 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=20 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
Race (NIH/OMB)
Segment 1 · Asian
|
0 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=20 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
Race (NIH/OMB)
Segment 1 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=20 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
Race (NIH/OMB)
Segment 1 · Black or African American
|
0 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
1 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
1 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
2 Participants
n=20 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
Race (NIH/OMB)
Segment 1 · White
|
5 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
5 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
4 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
4 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
18 Participants
n=20 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
Race (NIH/OMB)
Segment 1 · More than one race
|
0 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=20 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
Race (NIH/OMB)
Segment 1 · Unknown or Not Reported
|
0 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=20 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
Race (NIH/OMB)
Segment 2 · American Indian or Alaska Native
|
—
|
—
|
—
|
—
|
0 Participants
n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=24 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=23 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=26 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=129 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
Race (NIH/OMB)
Segment 2 · Asian
|
—
|
—
|
—
|
—
|
5 Participants
n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
2 Participants
n=24 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
3 Participants
n=23 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
4 Participants
n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
1 Participants
n=26 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
15 Participants
n=129 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
Race (NIH/OMB)
Segment 2 · Native Hawaiian or Other Pacific Islander
|
—
|
—
|
—
|
—
|
0 Participants
n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=24 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=23 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=26 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=129 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
Race (NIH/OMB)
Segment 2 · Black or African American
|
—
|
—
|
—
|
—
|
2 Participants
n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
2 Participants
n=24 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
1 Participants
n=23 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
1 Participants
n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=26 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
6 Participants
n=129 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
Race (NIH/OMB)
Segment 2 · White
|
—
|
—
|
—
|
—
|
21 Participants
n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
20 Participants
n=24 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
19 Participants
n=23 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
22 Participants
n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
24 Participants
n=26 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
106 Participants
n=129 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
Race (NIH/OMB)
Segment 2 · More than one race
|
—
|
—
|
—
|
—
|
0 Participants
n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=24 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=23 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
1 Participants
n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
1 Participants
n=26 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
2 Participants
n=129 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
Race (NIH/OMB)
Segment 2 · Unknown or Not Reported
|
—
|
—
|
—
|
—
|
0 Participants
n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=24 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=23 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=26 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
0 Participants
n=129 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
Height
Segment 1
|
172.04 cm
STANDARD_DEVIATION 11.49 • n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
167.34 cm
STANDARD_DEVIATION 11.42 • n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
163.74 cm
STANDARD_DEVIATION 9.10 • n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
172.80 cm
STANDARD_DEVIATION 9.00 • n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
—
|
—
|
—
|
—
|
—
|
168.98 cm
STANDARD_DEVIATION 10.20 • n=20 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
Height
Segment 2
|
—
|
—
|
—
|
—
|
167.76 cm
STANDARD_DEVIATION 11.09 • n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
170.15 cm
STANDARD_DEVIATION 9.32 • n=24 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
167.50 cm
STANDARD_DEVIATION 9.83 • n=23 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
166.71 cm
STANDARD_DEVIATION 9.60 • n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
164.92 cm
STANDARD_DEVIATION 10.98 • n=26 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
167.36 cm
STANDARD_DEVIATION 10.19 • n=129 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
Weight
Segment 1
|
91.04 kg
STANDARD_DEVIATION 14.48 • n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
83.72 kg
STANDARD_DEVIATION 9.86 • n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
92.18 kg
STANDARD_DEVIATION 16.65 • n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
87.22 kg
STANDARD_DEVIATION 12.81 • n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
—
|
—
|
—
|
—
|
—
|
88.54 kg
STANDARD_DEVIATION 13.01 • n=20 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
Weight
Segment 2
|
—
|
—
|
—
|
—
|
84.34 kg
STANDARD_DEVIATION 15.83 • n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
86.75 kg
STANDARD_DEVIATION 13.53 • n=24 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
81.40 kg
STANDARD_DEVIATION 15.03 • n=23 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
81.03 kg
STANDARD_DEVIATION 12.17 • n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
84.18 kg
STANDARD_DEVIATION 17.61 • n=26 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
83.51 kg
STANDARD_DEVIATION 14.86 • n=129 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
BMI
Segment 1
|
30.58 kg/m2
STANDARD_DEVIATION 1.85 • n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
30.00 kg/m2
STANDARD_DEVIATION 3.39 • n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
34.18 kg/m2
STANDARD_DEVIATION 3.58 • n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
29.14 kg/m2
STANDARD_DEVIATION 2.94 • n=5 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
—
|
—
|
—
|
—
|
—
|
30.98 kg/m2
STANDARD_DEVIATION 3.40 • n=20 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
|
BMI
Segment 2
|
—
|
—
|
—
|
—
|
29.77 kg/m2
STANDARD_DEVIATION 3.03 • n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
29.96 kg/m2
STANDARD_DEVIATION 3.98 • n=24 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
28.91 kg/m2
STANDARD_DEVIATION 4.02 • n=23 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
29.10 kg/m2
STANDARD_DEVIATION 3.30 • n=28 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
30.75 kg/m2
STANDARD_DEVIATION 4.47 • n=26 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
29.70 kg/m2
STANDARD_DEVIATION 3.77 • n=129 Participants • Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
|
PRIMARY outcome
Timeframe: Baseline; Day -2 and Day 1. End of Treatment: Day 27 and Day 29Population: Subjects participated in Segment 2 of the study were included in the analysis.
Fasting glucose levels were measured at four time points; At day -2, day 1, day 27 and day 29 (24-h after the last dose). Baseline is defined as the mean of FPG values on day -2 and day 1. End of treatment is defined as the mean of FPG values on day 27 and day 29. Changes in the FPG during the study period was calculated by subtracting the Baseline FPG from End of Treatment FPG.
Outcome measures
| Measure |
Placebo
n=28 Participants
Received no drug (EGT0001442) during 28 days
|
EGT0001442 5mg
n=24 Participants
Received 5mg of EGT0001442 per day for 28 days
|
EGT0001442 10mg
n=23 Participants
Received 10mg of EGT0001442 per day for 28 days
|
EGT0001442 20mg
n=28 Participants
Received 20mg of EGT0001442 per day for 28 days
|
EGT0001442 50mg
n=26 Participants
Received 50mg of EGT0001442 per day for 28 days
|
|---|---|---|---|---|---|
|
Changes in Fasting Plasma Glucose (FPG) From Baseline at Week 4 for Segment 2 of the Study
|
-12.595 mg/dL
Standard Error 7.025
|
-29.518 mg/dL
Standard Error 7.767
|
-30.429 mg/dL
Standard Error 8.386
|
-32.586 mg/dL
Standard Error 7.305
|
-44.605 mg/dL
Standard Error 7.299
|
PRIMARY outcome
Timeframe: Pre-dose to 48 h post-dosePopulation: 20 subjects in Segment 1 of the study were included in the analysis. The PK study was not included in Segment 2.
Blood samples were collected during Segment 1 at pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12 and 24 h (day 2), and 48 h (day 3) post dose for the determination of EGT0001442. Plasma concentrations of EGT0001442 were measured using a validated HPLC/MS-MS method and PK parameters were calculated by standard noncompartmental methods.
Outcome measures
| Measure |
Placebo
n=5 Participants
Received no drug (EGT0001442) during 28 days
|
EGT0001442 5mg
n=5 Participants
Received 5mg of EGT0001442 per day for 28 days
|
EGT0001442 10mg
n=5 Participants
Received 10mg of EGT0001442 per day for 28 days
|
EGT0001442 20mg
n=5 Participants
Received 20mg of EGT0001442 per day for 28 days
|
EGT0001442 50mg
Received 50mg of EGT0001442 per day for 28 days
|
|---|---|---|---|---|---|
|
Pharmacokinetics of EGT0001442 (Cmax) at 4 Dose Levels at Week 4
|
40.42 ng/mL
Standard Deviation 15.21
|
83.38 ng/mL
Standard Deviation 30.93
|
164.20 ng/mL
Standard Deviation 40.21
|
541.20 ng/mL
Standard Deviation 192.20
|
—
|
PRIMARY outcome
Timeframe: Pre-dose to 48 h post-dosePopulation: 20 subjects in Segment 1 of the study were included in the analysis. The PK study was not included in Segment 2. AUC0-24 values for two participants in 5 mg arm were not calculated.
Blood samples were collected during Segment 1 at pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12 and 24 h (day 2), and 48 h (day 3) post dose for the determination of EGT0001442. Plasma concentrations of EGT0001442 were measured using a validated HPLC/MS-MS method and PK parameters were calculated by standard noncompartmental methods.
Outcome measures
| Measure |
Placebo
n=5 Participants
Received no drug (EGT0001442) during 28 days
|
EGT0001442 5mg
n=5 Participants
Received 5mg of EGT0001442 per day for 28 days
|
EGT0001442 10mg
n=5 Participants
Received 10mg of EGT0001442 per day for 28 days
|
EGT0001442 20mg
n=5 Participants
Received 20mg of EGT0001442 per day for 28 days
|
EGT0001442 50mg
Received 50mg of EGT0001442 per day for 28 days
|
|---|---|---|---|---|---|
|
Pharmacokinetics of EGT0001442 (AUC 0-t and 0-24) at 4 Dose Levels at Week 4
AUC0-t
|
334.02 ng*h/mL
Standard Deviation 51.80
|
681.88 ng*h/mL
Standard Deviation 74.66
|
1312.36 ng*h/mL
Standard Deviation 487.28
|
3308.88 ng*h/mL
Standard Deviation 785.59
|
—
|
|
Pharmacokinetics of EGT0001442 (AUC 0-t and 0-24) at 4 Dose Levels at Week 4
AUC0-24
|
328.85 ng*h/mL
Standard Deviation 56.07
|
548.15 ng*h/mL
Standard Deviation 70.41
|
1076.39 ng*h/mL
Standard Deviation 373.15
|
2755.68 ng*h/mL
Standard Deviation 586.08
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 29Population: Subjects participated in Segment 2 of the study were included in the analysis.
Changes in the body weight during the study period was calculated by subtracting body weight on day 1 from body weight at the end of treatment on day 29.
Outcome measures
| Measure |
Placebo
n=28 Participants
Received no drug (EGT0001442) during 28 days
|
EGT0001442 5mg
n=24 Participants
Received 5mg of EGT0001442 per day for 28 days
|
EGT0001442 10mg
n=23 Participants
Received 10mg of EGT0001442 per day for 28 days
|
EGT0001442 20mg
n=28 Participants
Received 20mg of EGT0001442 per day for 28 days
|
EGT0001442 50mg
n=26 Participants
Received 50mg of EGT0001442 per day for 28 days
|
|---|---|---|---|---|---|
|
Change in the Body Weight From Baseline at Week 4
|
0.258 Kg
Standard Error 0.304
|
-1.176 Kg
Standard Error 0.345
|
-0.779 Kg
Standard Error 0.346
|
-1.796 Kg
Standard Error 0.324
|
-0.914 Kg
Standard Error 0.315
|
SECONDARY outcome
Timeframe: Baseline and Day 29Population: Subjects participated in Segment 2 of the study were included in the analysis.
HbA1c levels were measured at two time points; on day 1 and day 29 (end of treatment). Changes in the HbA1c level during the study period was calculated by subtracting HbA1c level on day 1 from HbA1c level at the end of treatment (day 29)
Outcome measures
| Measure |
Placebo
n=28 Participants
Received no drug (EGT0001442) during 28 days
|
EGT0001442 5mg
n=24 Participants
Received 5mg of EGT0001442 per day for 28 days
|
EGT0001442 10mg
n=23 Participants
Received 10mg of EGT0001442 per day for 28 days
|
EGT0001442 20mg
n=28 Participants
Received 20mg of EGT0001442 per day for 28 days
|
EGT0001442 50mg
n=26 Participants
Received 50mg of EGT0001442 per day for 28 days
|
|---|---|---|---|---|---|
|
Changes in Hemoglobin A1c (HbA1c) From Baseline at Week 4
|
0.178 percentage of HbA1c
Standard Error 0.107
|
-0.176 percentage of HbA1c
Standard Error 0.122
|
0.022 percentage of HbA1c
Standard Error 0.123
|
0.173 percentage of HbA1c
Standard Error 0.115
|
-0.167 percentage of HbA1c
Standard Error 0.112
|
SECONDARY outcome
Timeframe: Baseline, Day 1 and Day 28Population: Only number of subjects with data available in the specific treatment group is included
Urinary glucose levels were measured at three time points; on Day 0 (baseline), Day 1 and Day 28 (end of treatment). Changes in the urinary glucose level during the study period was calculated by reducing the baseline urinary glucose level (Day 1) from urinary glucose level at end of treatment (Day 28) (i.e urinary glucose level on Day 28 minus urinary glucose level on Day 1).
Outcome measures
| Measure |
Placebo
n=28 Participants
Received no drug (EGT0001442) during 28 days
|
EGT0001442 5mg
n=23 Participants
Received 5mg of EGT0001442 per day for 28 days
|
EGT0001442 10mg
n=22 Participants
Received 10mg of EGT0001442 per day for 28 days
|
EGT0001442 20mg
n=28 Participants
Received 20mg of EGT0001442 per day for 28 days
|
EGT0001442 50mg
n=26 Participants
Received 50mg of EGT0001442 per day for 28 days
|
|---|---|---|---|---|---|
|
Change in Urinary Glucose Excretion From Baseline to Day 1 and Day 28
Change in 24 h UGE from baseline to Day 1
|
-3.55 g/24h
Standard Deviation 13.05
|
26.21 g/24h
Standard Deviation 11.08
|
24.17 g/24h
Standard Deviation 16.89
|
25.13 g/24h
Standard Deviation 12.72
|
29.61 g/24h
Standard Deviation 20.00
|
|
Change in Urinary Glucose Excretion From Baseline to Day 1 and Day 28
Change in 24 h UGE from baseline to Day 28
|
-0.20 g/24h
Standard Deviation 14.98
|
22.57 g/24h
Standard Deviation 16.56
|
18.71 g/24h
Standard Deviation 20.46
|
21.01 g/24h
Standard Deviation 16.43
|
26.80 g/24h
Standard Deviation 19.36
|
SECONDARY outcome
Timeframe: Days 27/29 to Days 41/43Population: Subjects participated in Segment 2 of the study and had fasting plasma glucose (FPG) values at the end of treatment (mean FPG value on days 27 and 29) and at post-treatment (mean FPG values on days 41 and 43) are included in the analysis.
The mean change in FPG following cessation of treatment was obtained by calculating the difference between FPG values obtained on End of treatment (average of FPG values on days 27 and 29) and on Post Treatment (average of FPG values on days 41 and 43).
Outcome measures
| Measure |
Placebo
n=26 Participants
Received no drug (EGT0001442) during 28 days
|
EGT0001442 5mg
n=21 Participants
Received 5mg of EGT0001442 per day for 28 days
|
EGT0001442 10mg
n=19 Participants
Received 10mg of EGT0001442 per day for 28 days
|
EGT0001442 20mg
n=21 Participants
Received 20mg of EGT0001442 per day for 28 days
|
EGT0001442 50mg
n=25 Participants
Received 50mg of EGT0001442 per day for 28 days
|
|---|---|---|---|---|---|
|
Change in FPG Following Cessation of Treatment
|
0.058 mg/dL
Standard Error 8.256
|
17.746 mg/dL
Standard Error 8.896
|
17.148 mg/dL
Standard Error 10.421
|
24.437 mg/dL
Standard Error 7.989
|
20.807 mg/dL
Standard Error 8.021
|
Adverse Events
Segment 1 (Dose Escalation): EGT0001442 5mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Segment 1 (Dose Escalation): EGT0001442 10mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Segment 1 (Dose Escalation): EGT0001442 20mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Segment 1 (Dose Escalation): EGT0001442 50mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
EGT0001442 5mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
EGT0001442 10mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
EGT0001442 20mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
EGT0001442 50mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Segment 1 (Dose Escalation): EGT0001442 5mg
n=5 participants at risk
Received 5mg of EGT0001442 once daily for 28 days
|
Segment 1 (Dose Escalation): EGT0001442 10mg
n=5 participants at risk
Received 10mg of EGT0001442 once daily for 28 days
|
Segment 1 (Dose Escalation): EGT0001442 20mg
n=5 participants at risk
Received 20mg of EGT0001442 once daily for 28 days
|
Segment 1 (Dose Escalation): EGT0001442 50mg
n=5 participants at risk
Received 50mg of EGT0001442 once daily for 28 days
|
Placebo
n=28 participants at risk
Received no drug (EGT0001442) during 28 days
|
EGT0001442 5mg
n=24 participants at risk
Received 5mg of EGT0001442 per day for 28 days
|
EGT0001442 10mg
n=23 participants at risk
Received 10mg of EGT0001442 per day for 28 days
|
EGT0001442 20mg
n=28 participants at risk
Received 20mg of EGT0001442 per day for 28 days
|
EGT0001442 50mg
n=26 participants at risk
Received 50mg of EGT0001442 per day for 28 days
|
|---|---|---|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/24 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
4.3%
1/23 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/26 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
4.2%
1/24 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/23 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/26 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
Other adverse events
| Measure |
Segment 1 (Dose Escalation): EGT0001442 5mg
n=5 participants at risk
Received 5mg of EGT0001442 once daily for 28 days
|
Segment 1 (Dose Escalation): EGT0001442 10mg
n=5 participants at risk
Received 10mg of EGT0001442 once daily for 28 days
|
Segment 1 (Dose Escalation): EGT0001442 20mg
n=5 participants at risk
Received 20mg of EGT0001442 once daily for 28 days
|
Segment 1 (Dose Escalation): EGT0001442 50mg
n=5 participants at risk
Received 50mg of EGT0001442 once daily for 28 days
|
Placebo
n=28 participants at risk
Received no drug (EGT0001442) during 28 days
|
EGT0001442 5mg
n=24 participants at risk
Received 5mg of EGT0001442 per day for 28 days
|
EGT0001442 10mg
n=23 participants at risk
Received 10mg of EGT0001442 per day for 28 days
|
EGT0001442 20mg
n=28 participants at risk
Received 20mg of EGT0001442 per day for 28 days
|
EGT0001442 50mg
n=26 participants at risk
Received 50mg of EGT0001442 per day for 28 days
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leucopenia
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
20.0%
1/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/24 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/23 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/26 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.0%
1/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/24 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/23 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/26 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
20.0%
1/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
20.0%
1/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/24 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/23 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/26 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
20.0%
1/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/24 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/23 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/26 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
20.0%
1/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/24 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/23 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/26 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
|
General disorders
Fatigue
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
7.1%
2/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/24 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
4.3%
1/23 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
3.8%
1/26 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
|
Infections and infestations
Balanitis candida
|
20.0%
1/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/24 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/23 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
3.8%
1/26 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/24 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
8.7%
2/23 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/26 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
20.0%
1/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/24 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/23 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/26 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
20.0%
1/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/24 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/23 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/26 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
20.0%
1/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/24 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/23 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/26 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
20.0%
1/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/24 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/23 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/26 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
20.0%
1/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
3.6%
1/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
12.5%
3/24 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
4.3%
1/23 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
14.3%
4/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
11.5%
3/26 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/24 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
8.7%
2/23 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
3.6%
1/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
3.8%
1/26 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
3.6%
1/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/24 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/23 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
7.1%
2/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/26 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
20.0%
1/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/24 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/23 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/26 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
20.0%
1/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/24 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/23 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/26 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
20.0%
1/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/24 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/23 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/26 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
20.0%
1/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/24 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/23 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/26 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
20.0%
1/5 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/24 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/23 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
0.00%
0/28 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
7.7%
2/26 • Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator does not have the right to publish trial results.
- Publication restrictions are in place
Restriction type: OTHER