Trial Outcomes & Findings for 12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on Metformin (NCT NCT02647320)
NCT ID: NCT02647320
Last Updated: 2019-02-25
Results Overview
Glycated hemoglobin is a form of hemoglobin that is measured primarily to identify the three-month average glucose concentration in the blood. Target HbA1c for Type 2 diabetics was less than 7% at the time of this trial. Negative scores show improvement from baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
298 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2019-02-25
Participant Flow
A total of 654 subjects were recruited at multiple sites in the United States and Canada.
A total of 654 subjects were screened and 297 subjects passed the run-in screening period and were randomized. One subject failed screening but was randomized in error.
Participant milestones
| Measure |
DS-8500a 25mg
One DS-8500a 25 mg tablet, 2 placebo tablets, and one placebo capsule in a once-daily oral dose
|
DS-8500a 50 mg
Two DS-8500a 25 mg tablets, 1 placebo tablet, and one placebo capsule in a once-daily oral dose
|
DS-8500a 75 mg
Three DS-8500a 25 mg tablets and one placebo capsule in a once-daily oral dose
|
Sitagliptin 100 mg
Three placebo tablets and one sitagliptin 100 mg over-capsule in a once-daily oral dose
|
Placebo
Three placebo tablets and one placebo capsule in a once-daily oral dose
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
46
|
46
|
69
|
68
|
69
|
|
Overall Study
Inadvertently Randomized
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Safety Set
|
43
|
44
|
68
|
68
|
69
|
|
Overall Study
Modified Intent-to-Treat Set (mITT)
|
40
|
38
|
61
|
62
|
62
|
|
Overall Study
COMPLETED
|
34
|
35
|
54
|
58
|
52
|
|
Overall Study
NOT COMPLETED
|
12
|
11
|
15
|
10
|
17
|
Reasons for withdrawal
| Measure |
DS-8500a 25mg
One DS-8500a 25 mg tablet, 2 placebo tablets, and one placebo capsule in a once-daily oral dose
|
DS-8500a 50 mg
Two DS-8500a 25 mg tablets, 1 placebo tablet, and one placebo capsule in a once-daily oral dose
|
DS-8500a 75 mg
Three DS-8500a 25 mg tablets and one placebo capsule in a once-daily oral dose
|
Sitagliptin 100 mg
Three placebo tablets and one sitagliptin 100 mg over-capsule in a once-daily oral dose
|
Placebo
Three placebo tablets and one placebo capsule in a once-daily oral dose
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
3
|
2
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
3
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
4
|
2
|
2
|
7
|
|
Overall Study
Persistent hyperglycemia
|
0
|
1
|
1
|
1
|
1
|
|
Overall Study
Study terminated by sponsor
|
1
|
1
|
1
|
1
|
2
|
|
Overall Study
Reason not provided
|
0
|
0
|
1
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Develop anemia
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Disposition Missing Due to Fire at Site
|
2
|
3
|
4
|
3
|
4
|
Baseline Characteristics
Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
Baseline characteristics by cohort
| Measure |
DS-8500a 25mg
n=46 Participants
One DS-8500a 25 mg tablet, 2 placebo tablets, and one placebo capsule in a once-daily oral dose
|
DS-8500a 50 mg
n=46 Participants
Two DS-8500a 25 mg tablets, 1 placebo tablet, and one placebo capsule in a once-daily oral dose
|
DS-8500a 75 mg
n=69 Participants
Three DS-8500a 25 mg tablets and one placebo capsule in a once-daily oral dose
|
Sitagliptin 100 mg
n=68 Participants
Three placebo tablets and one sitagliptin 100 mg over-capsule in a once-daily oral dose
|
Placebo
n=69 Participants
Three placebo tablets and one placebo capsule in a once-daily oral dose
|
Total
n=298 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.4 years
STANDARD_DEVIATION 9.30 • n=46 Participants
|
57.0 years
STANDARD_DEVIATION 8.95 • n=46 Participants
|
57.0 years
STANDARD_DEVIATION 9.41 • n=69 Participants
|
57.4 years
STANDARD_DEVIATION 7.77 • n=68 Participants
|
55.6 years
STANDARD_DEVIATION 7.72 • n=69 Participants
|
56.7 years
STANDARD_DEVIATION 8.56 • n=298 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=46 Participants
|
22 Participants
n=46 Participants
|
38 Participants
n=69 Participants
|
28 Participants
n=68 Participants
|
30 Participants
n=69 Participants
|
140 Participants
n=298 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=46 Participants
|
24 Participants
n=46 Participants
|
31 Participants
n=69 Participants
|
40 Participants
n=68 Participants
|
39 Participants
n=69 Participants
|
158 Participants
n=298 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=46 Participants
|
0 Participants
n=46 Participants
|
2 Participants
n=69 Participants
|
0 Participants
n=68 Participants
|
1 Participants
n=69 Participants
|
4 Participants
n=298 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=46 Participants
|
3 Participants
n=46 Participants
|
3 Participants
n=69 Participants
|
4 Participants
n=68 Participants
|
13 Participants
n=69 Participants
|
26 Participants
n=298 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=46 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=298 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=46 Participants
|
7 Participants
n=46 Participants
|
10 Participants
n=69 Participants
|
10 Participants
n=68 Participants
|
10 Participants
n=69 Participants
|
44 Participants
n=298 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=46 Participants
|
36 Participants
n=46 Participants
|
54 Participants
n=69 Participants
|
53 Participants
n=68 Participants
|
45 Participants
n=69 Participants
|
222 Participants
n=298 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=46 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=298 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=46 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=69 Participants
|
1 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
2 Participants
n=298 Participants
|
|
Region of Enrollment
Canada
|
7 Participants
n=46 Participants
|
6 Participants
n=46 Participants
|
7 Participants
n=69 Participants
|
12 Participants
n=68 Participants
|
15 Participants
n=69 Participants
|
47 Participants
n=298 Participants
|
|
Region of Enrollment
United States
|
39 Participants
n=46 Participants
|
40 Participants
n=46 Participants
|
62 Participants
n=69 Participants
|
56 Participants
n=68 Participants
|
54 Participants
n=69 Participants
|
251 Participants
n=298 Participants
|
|
1. Glycated Hemoglobin
|
7.94 mmol/mol
STANDARD_DEVIATION 0.939 • n=40 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
8.09 mmol/mol
STANDARD_DEVIATION 0.910 • n=38 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
7.99 mmol/mol
STANDARD_DEVIATION 0.900 • n=61 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
7.78 mmol/mol
STANDARD_DEVIATION 0.790 • n=62 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
7.92 mmol/mol
STANDARD_DEVIATION 0.699 • n=62 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
7.93 mmol/mol
STANDARD_DEVIATION 0.852 • n=263 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
|
2. Total Cholesterol
|
177.1 mg/dL
STANDARD_DEVIATION 36.72 • n=40 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
180.3 mg/dL
STANDARD_DEVIATION 32.21 • n=38 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
178.0 mg/dL
STANDARD_DEVIATION 37.38 • n=61 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
172.6 mg/dL
STANDARD_DEVIATION 55.25 • n=62 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
182.8 mg/dL
STANDARD_DEVIATION 43.11 • n=62 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
178.1 mg/dL
STANDARD_DEVIATION 41.70 • n=263 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
|
3. Low Density Lipoprotein-C
|
96.6 mg/dL
STANDARD_DEVIATION 33.58 • n=40 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
96.9 mg/dL
STANDARD_DEVIATION 30.53 • n=38 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
96.6 mg/dL
STANDARD_DEVIATION 32.84 • n=61 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
95.1 mg/dL
STANDARD_DEVIATION 37.93 • n=62 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
99.8 mg/dL
STANDARD_DEVIATION 37.14 • n=62 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
97.0 mg/dL
STANDARD_DEVIATION 34.51 • n=263 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
|
4. High Density Lipoprotein-C
|
49.5 mg/dL
STANDARD_DEVIATION 12.80 • n=40 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
49.3 mg/dL
STANDARD_DEVIATION 13.20 • n=38 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
46.4 mg/dL
STANDARD_DEVIATION 11.77 • n=61 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
44.3 mg/dL
STANDARD_DEVIATION 12.17 • n=62 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
46.7 mg/dL
STANDARD_DEVIATION 10.93 • n=62 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
46.87 mg/dL
STANDARD_DEVIATION 12.19 • n=263 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
|
5. Non-High Density Lipoprotein-C
|
127.6 mg/dL
STANDARD_DEVIATION 38.13 • n=40 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
131.0 mg/dL
STANDARD_DEVIATION 32.54 • n=38 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
131.6 mg/dL
STANDARD_DEVIATION 35.93 • n=61 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
128.4 mg/dL
STANDARD_DEVIATION 44.46 • n=62 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
136.1 mg/dL
STANDARD_DEVIATION 40.69 • n=62 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
131.21 mg/dL
STANDARD_DEVIATION 38.56 • n=263 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
|
6. Triglycerides
|
165.3 mg/dL
STANDARD_DEVIATION 114.5 • n=40 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
174.9 mg/dL
STANDARD_DEVIATION 95.55 • n=38 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
179.6 mg/dL
STANDARD_DEVIATION 83.39 • n=61 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
169.8 mg/dL
STANDARD_DEVIATION 84.90 • n=62 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
184.2 mg/dL
STANDARD_DEVIATION 91.02 • n=62 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
175.5 mg/dL
STANDARD_DEVIATION 94.54 • n=263 Participants • Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.
Glycated hemoglobin is a form of hemoglobin that is measured primarily to identify the three-month average glucose concentration in the blood. Target HbA1c for Type 2 diabetics was less than 7% at the time of this trial. Negative scores show improvement from baseline.
Outcome measures
| Measure |
DS-8500a 25mg
n=35 Participants
One DS-8500a 25 mg tablets and placebo
|
DS-8500a 50 mg
n=33 Participants
Two DS-8500a 25 mg tablets and placebo
|
DS-8500a 75 mg
n=53 Participants
Three DS-8500a 25 mg tablets and placebo
|
Sitagliptin 100 mg
n=57 Participants
One sitagliptin 100 mg over-capsule and placebo
|
Placebo
n=53 Participants
Placebo tablets and capsule
|
|---|---|---|---|---|---|
|
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12
|
-0.24 percent of HbA1c
Standard Deviation 1.019
|
-0.16 percent of HbA1c
Standard Deviation 0.798
|
-0.35 percent of HbA1c
Standard Deviation 0.791
|
-0.66 percent of HbA1c
Standard Deviation 0.623
|
-0.23 percent of HbA1c
Standard Deviation 0.657
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT
Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the "bad" cholesterol, high-density lipoprotein cholesterol (HDL-C) - the "good" cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol.
Outcome measures
| Measure |
DS-8500a 25mg
n=34 Participants
One DS-8500a 25 mg tablets and placebo
|
DS-8500a 50 mg
n=33 Participants
Two DS-8500a 25 mg tablets and placebo
|
DS-8500a 75 mg
n=52 Participants
Three DS-8500a 25 mg tablets and placebo
|
Sitagliptin 100 mg
n=57 Participants
One sitagliptin 100 mg over-capsule and placebo
|
Placebo
n=51 Participants
Placebo tablets and capsule
|
|---|---|---|---|---|---|
|
Change From Baseline in Total Cholesterol (TC) at Week 12
|
-5.6 percent change in TC
Standard Deviation 11.95
|
-1.7 percent change in TC
Standard Deviation 22.30
|
-1.8 percent change in TC
Standard Deviation 12.58
|
-3.6 percent change in TC
Standard Deviation 14.34
|
-1.7 percent change in TC
Standard Deviation 13.57
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT
LDL-C is known as the "bad" cholesterol, so a lower score (negative change) means improvement.
Outcome measures
| Measure |
DS-8500a 25mg
n=33 Participants
One DS-8500a 25 mg tablets and placebo
|
DS-8500a 50 mg
n=33 Participants
Two DS-8500a 25 mg tablets and placebo
|
DS-8500a 75 mg
n=52 Participants
Three DS-8500a 25 mg tablets and placebo
|
Sitagliptin 100 mg
n=57 Participants
One sitagliptin 100 mg over-capsule and placebo
|
Placebo
n=50 Participants
Placebo tablets and capsule
|
|---|---|---|---|---|---|
|
Change From Baseline in LDL-C at Week 12
|
-6.7 percent change in LDL-C
Standard Deviation 17.34
|
2.8 percent change in LDL-C
Standard Deviation 46.18
|
-0.1 percent change in LDL-C
Standard Deviation 22.84
|
-2.4 percent change in LDL-C
Standard Deviation 23.20
|
0.9 percent change in LDL-C
Standard Deviation 20.12
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT
HDL-C is known as the "good" cholesterol, so a higher score (positive change) means improvement.
Outcome measures
| Measure |
DS-8500a 25mg
n=34 Participants
One DS-8500a 25 mg tablets and placebo
|
DS-8500a 50 mg
n=33 Participants
Two DS-8500a 25 mg tablets and placebo
|
DS-8500a 75 mg
n=52 Participants
Three DS-8500a 25 mg tablets and placebo
|
Sitagliptin 100 mg
n=57 Participants
One sitagliptin 100 mg over-capsule and placebo
|
Placebo
n=51 Participants
Placebo tablets and capsule
|
|---|---|---|---|---|---|
|
Change From Baseline in HDL-C at Week 12
|
3.0 percent change in HCL-C
Standard Deviation 11.48
|
1.1 percent change in HCL-C
Standard Deviation 10.18
|
2.2 percent change in HCL-C
Standard Deviation 11.59
|
1.1 percent change in HCL-C
Standard Deviation 13.17
|
1.2 percent change in HCL-C
Standard Deviation 11.41
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT
Non-HDL-C is the measure of "bad" cholesterol in the blood, including triglycerides and LDL-C, so a negative change means improvement. The equation for Non-HDL-C = LDL-C + (triglycerides/5).
Outcome measures
| Measure |
DS-8500a 25mg
n=34 Participants
One DS-8500a 25 mg tablets and placebo
|
DS-8500a 50 mg
n=33 Participants
Two DS-8500a 25 mg tablets and placebo
|
DS-8500a 75 mg
n=52 Participants
Three DS-8500a 25 mg tablets and placebo
|
Sitagliptin 100 mg
n=57 Participants
One sitagliptin 100 mg over-capsule and placebo
|
Placebo
n=51 Participants
Placebo tablets and capsule
|
|---|---|---|---|---|---|
|
Change From Baseline in Non-HDL-C at Week 12
|
-8.9 Percent change in Non-HDL-C
Standard Deviation 14.89
|
-2.5 Percent change in Non-HDL-C
Standard Deviation 31.68
|
-2.9 Percent change in Non-HDL-C
Standard Deviation 16.68
|
-4.7 Percent change in Non-HDL-C
Standard Deviation 19.10
|
-2.5 Percent change in Non-HDL-C
Standard Deviation 17.02
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT
Triglycerides are a type of fat found in the blood. The body uses them for energy. Some triglycerides are needed for good health. But high triglycerides might raise the risk of heart disease. Since Type 2 diabetics tend to have high triglycerides, a negative change means improvement.
Outcome measures
| Measure |
DS-8500a 25mg
n=34 Participants
One DS-8500a 25 mg tablets and placebo
|
DS-8500a 50 mg
n=33 Participants
Two DS-8500a 25 mg tablets and placebo
|
DS-8500a 75 mg
n=52 Participants
Three DS-8500a 25 mg tablets and placebo
|
Sitagliptin 100 mg
n=57 Participants
One sitagliptin 100 mg over-capsule and placebo
|
Placebo
n=51 Participants
Placebo tablets and capsule
|
|---|---|---|---|---|---|
|
Change From Baseline in Triglycerides at Week 12
|
-12.4 percent change in triglycerides
Standard Deviation 22.35
|
-1.9 percent change in triglycerides
Standard Deviation 78.27
|
-5.8 percent change in triglycerides
Standard Deviation 27.71
|
-7.0 percent change in triglycerides
Standard Deviation 27.90
|
-3.0 percent change in triglycerides
Standard Deviation 27.76
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: mITT with a measurement at baseline and Week 4
The MMTT requires a participant to drink a "mixed meal," such as Boost or Ensure, that contains protein, carbohydrates, and fat. The goal of the test is to find out how much insulin the pancreas makes in response to food by measuring the level of glucose in the blood. The lower the level of glucose in the blood during the first three hours after the test (AUC0-3h), the more insulin the body has made in response to the test. This would mean a negative change shows improvement.
Outcome measures
| Measure |
DS-8500a 25mg
n=37 Participants
One DS-8500a 25 mg tablets and placebo
|
DS-8500a 50 mg
n=35 Participants
Two DS-8500a 25 mg tablets and placebo
|
DS-8500a 75 mg
n=55 Participants
Three DS-8500a 25 mg tablets and placebo
|
Sitagliptin 100 mg
n=59 Participants
One sitagliptin 100 mg over-capsule and placebo
|
Placebo
n=57 Participants
Placebo tablets and capsule
|
|---|---|---|---|---|---|
|
Change From Baseline in Area-Under-the Curve 0-3 Hours (AUC0-3h) of Plasma Glucose (PG) in Response to the Mixed Meal Tolerance Test (MMTT) at Week 4
|
-4.32 (mg/dL)*hr
Standard Deviation 71.235
|
1.36 (mg/dL)*hr
Standard Deviation 67.661
|
-6.32 (mg/dL)*hr
Standard Deviation 83.597
|
-41.61 (mg/dL)*hr
Standard Deviation 73.971
|
-3.97 (mg/dL)*hr
Standard Deviation 87.625
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT with a measurement at baseline and Week 12
The MMTT requires a participant to drink a "mixed meal," such as Boost or Ensure, that contains protein, carbohydrates, and fat. The goal of the test is to find out how much insulin the pancreas makes in response to food by measuring the level of glucose in the blood. The lower the level of glucose in the blood during the first three hours after the test (AUC0-3h), the more insulin the body has made in response to the test. This would mean a negative change shows improvement.
Outcome measures
| Measure |
DS-8500a 25mg
n=28 Participants
One DS-8500a 25 mg tablets and placebo
|
DS-8500a 50 mg
n=31 Participants
Two DS-8500a 25 mg tablets and placebo
|
DS-8500a 75 mg
n=47 Participants
Three DS-8500a 25 mg tablets and placebo
|
Sitagliptin 100 mg
n=51 Participants
One sitagliptin 100 mg over-capsule and placebo
|
Placebo
n=49 Participants
Placebo tablets and capsule
|
|---|---|---|---|---|---|
|
Change From Baseline in AUC0-3h of PG in Response to the MMTT at Week 12
|
-18.77 (mg/dL)*hr
Standard Deviation 96.472
|
13.81 (mg/dL)*hr
Standard Deviation 67.025
|
-5.51 (mg/dL)*hr
Standard Deviation 104.992
|
-53.40 (mg/dL)*hr
Standard Deviation 74.803
|
-24.16 (mg/dL)*hr
Standard Deviation 101.016
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: mITT with a measurement at baseline and Week 4
Cmax measures the highest amount of glucose in the blood, so a negative change means improvement.
Outcome measures
| Measure |
DS-8500a 25mg
n=37 Participants
One DS-8500a 25 mg tablets and placebo
|
DS-8500a 50 mg
n=35 Participants
Two DS-8500a 25 mg tablets and placebo
|
DS-8500a 75 mg
n=56 Participants
Three DS-8500a 25 mg tablets and placebo
|
Sitagliptin 100 mg
n=59 Participants
One sitagliptin 100 mg over-capsule and placebo
|
Placebo
n=57 Participants
Placebo tablets and capsule
|
|---|---|---|---|---|---|
|
Change From Baseline in Maximum Concentration (Cmax) of PG in Response to MMTT at Week 4
|
-1.92 mg/dL
Standard Deviation 41.260
|
-7.35 mg/dL
Standard Deviation 39.645
|
-3.47 mg/dL
Standard Deviation 54.258
|
-28.44 mg/dL
Standard Deviation 45.327
|
-0.35 mg/dL
Standard Deviation 41.885
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT with a measurement at baseline and Week 12
Cmax measures the highest amount of glucose in the blood, so a negative change means improvement.
Outcome measures
| Measure |
DS-8500a 25mg
n=28 Participants
One DS-8500a 25 mg tablets and placebo
|
DS-8500a 50 mg
n=31 Participants
Two DS-8500a 25 mg tablets and placebo
|
DS-8500a 75 mg
n=47 Participants
Three DS-8500a 25 mg tablets and placebo
|
Sitagliptin 100 mg
n=51 Participants
One sitagliptin 100 mg over-capsule and placebo
|
Placebo
n=49 Participants
Placebo tablets and capsule
|
|---|---|---|---|---|---|
|
Change From Baseline in Cmax of PG in Response to MMTT at Week 12
|
-5.93 mg/dL
Standard Deviation 47.530
|
-1.10 mg/dL
Standard Deviation 53.045
|
-4.43 mg/dL
Standard Deviation 60.957
|
-28.29 mg/dL
Standard Deviation 42.184
|
1.11 mg/dL
Standard Deviation 58.731
|
SECONDARY outcome
Timeframe: Baseline, Week 2Population: mITT with a measurement at baseline and Week 2
Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.
Outcome measures
| Measure |
DS-8500a 25mg
n=40 Participants
One DS-8500a 25 mg tablets and placebo
|
DS-8500a 50 mg
n=36 Participants
Two DS-8500a 25 mg tablets and placebo
|
DS-8500a 75 mg
n=58 Participants
Three DS-8500a 25 mg tablets and placebo
|
Sitagliptin 100 mg
n=57 Participants
One sitagliptin 100 mg over-capsule and placebo
|
Placebo
n=58 Participants
Placebo tablets and capsule
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 2
|
4.3 mg/dL
Standard Deviation 25.98
|
-8.1 mg/dL
Standard Deviation 25.24
|
0.0 mg/dL
Standard Deviation 31.52
|
-16.2 mg/dL
Standard Deviation 26.11
|
10.7 mg/dL
Standard Deviation 32.38
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: mITT with a measurement at baseline and Week 4
Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.
Outcome measures
| Measure |
DS-8500a 25mg
n=40 Participants
One DS-8500a 25 mg tablets and placebo
|
DS-8500a 50 mg
n=38 Participants
Two DS-8500a 25 mg tablets and placebo
|
DS-8500a 75 mg
n=60 Participants
Three DS-8500a 25 mg tablets and placebo
|
Sitagliptin 100 mg
n=62 Participants
One sitagliptin 100 mg over-capsule and placebo
|
Placebo
n=62 Participants
Placebo tablets and capsule
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4
|
0.04 mg/dL
Standard Deviation 18.71
|
-12.7 mg/dL
Standard Deviation 30.82
|
-5.9 mg/dL
Standard Deviation 35.17
|
-11.1 mg/dL
Standard Deviation 31.81
|
2.4 mg/dL
Standard Deviation 32.01
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: mITT with a measurement at baseline and Week 8
Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.
Outcome measures
| Measure |
DS-8500a 25mg
n=36 Participants
One DS-8500a 25 mg tablets and placebo
|
DS-8500a 50 mg
n=33 Participants
Two DS-8500a 25 mg tablets and placebo
|
DS-8500a 75 mg
n=56 Participants
Three DS-8500a 25 mg tablets and placebo
|
Sitagliptin 100 mg
n=56 Participants
One sitagliptin 100 mg over-capsule and placebo
|
Placebo
n=55 Participants
Placebo tablets and capsule
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 8
|
2.3 mg/dL
Standard Deviation 27.57
|
-5.9 mg/dL
Standard Deviation 27.90
|
-7.1 mg/dL
Standard Deviation 37.51
|
-16.6 mg/dL
Standard Deviation 32.96
|
-1.0 mg/dL
Standard Deviation 31.63
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT with a measurement at baseline and Week 12
Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.
Outcome measures
| Measure |
DS-8500a 25mg
n=28 Participants
One DS-8500a 25 mg tablets and placebo
|
DS-8500a 50 mg
n=31 Participants
Two DS-8500a 25 mg tablets and placebo
|
DS-8500a 75 mg
n=47 Participants
Three DS-8500a 25 mg tablets and placebo
|
Sitagliptin 100 mg
n=52 Participants
One sitagliptin 100 mg over-capsule and placebo
|
Placebo
n=49 Participants
Placebo tablets and capsule
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
|
0.0 mg/dL
Standard Deviation 25.67
|
-9.1 mg/dL
Standard Deviation 34.89
|
-5.8 mg/dL
Standard Deviation 35.27
|
-5.7 mg/dL
Standard Deviation 46.29
|
8.1 mg/dL
Standard Deviation 32.72
|
SECONDARY outcome
Timeframe: Week 12Population: mITT
HbA1C less than 7% is the success goal for many Type 2 diabetics.
Outcome measures
| Measure |
DS-8500a 25mg
n=40 Participants
One DS-8500a 25 mg tablets and placebo
|
DS-8500a 50 mg
n=38 Participants
Two DS-8500a 25 mg tablets and placebo
|
DS-8500a 75 mg
n=61 Participants
Three DS-8500a 25 mg tablets and placebo
|
Sitagliptin 100 mg
n=62 Participants
One sitagliptin 100 mg over-capsule and placebo
|
Placebo
n=62 Participants
Placebo tablets and capsule
|
|---|---|---|---|---|---|
|
Count of Participants With HbA1c Less Than 7.0% at Week 12
|
6 Participants
|
8 Participants
|
15 Participants
|
28 Participants
|
10 Participants
|
Adverse Events
DS-8500a 25mg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
DS-8500a 50 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
DS-8500a 75 mg
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Sitagliptin 100 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DS-8500a 25mg
n=43 participants at risk
One DS-8500a 25 mg tablet, 2 placebo tablets, and one placebo capsule in a once-daily oral dose
|
DS-8500a 50 mg
n=44 participants at risk
Two DS-8500a 25 mg tablets, 1 placebo tablet, and one placebo capsule in a once-daily oral dose
|
DS-8500a 75 mg
n=68 participants at risk
Three DS-8500a 25 mg tablets and one placebo capsule in a once-daily oral dose
|
Sitagliptin 100 mg
n=68 participants at risk
Three placebo tablets and one sitagliptin 100 mg over-capsule in a once-daily oral dose
|
Placebo
n=69 participants at risk
Three placebo tablets and one placebo capsule in a once-daily oral dose
|
|---|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/43 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
0.00%
0/44 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
1.5%
1/68 • Number of events 1 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
0.00%
0/68 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/43 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
0.00%
0/44 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
0.00%
0/68 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
1.5%
1/68 • Number of events 1 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.3%
1/43 • Number of events 1 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
0.00%
0/44 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
0.00%
0/68 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
0.00%
0/68 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
2.3%
1/43 • Number of events 1 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
0.00%
0/44 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
0.00%
0/68 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
0.00%
0/68 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
|
Infections and infestations
Sepsis
|
2.3%
1/43 • Number of events 1 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
0.00%
0/44 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
0.00%
0/68 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
0.00%
0/68 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.3%
1/43 • Number of events 1 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
0.00%
0/44 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
0.00%
0/68 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
0.00%
0/68 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
0.00%
0/69 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
Other adverse events
| Measure |
DS-8500a 25mg
n=43 participants at risk
One DS-8500a 25 mg tablet, 2 placebo tablets, and one placebo capsule in a once-daily oral dose
|
DS-8500a 50 mg
n=44 participants at risk
Two DS-8500a 25 mg tablets, 1 placebo tablet, and one placebo capsule in a once-daily oral dose
|
DS-8500a 75 mg
n=68 participants at risk
Three DS-8500a 25 mg tablets and one placebo capsule in a once-daily oral dose
|
Sitagliptin 100 mg
n=68 participants at risk
Three placebo tablets and one sitagliptin 100 mg over-capsule in a once-daily oral dose
|
Placebo
n=69 participants at risk
Three placebo tablets and one placebo capsule in a once-daily oral dose
|
|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
4.7%
2/43 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
0.00%
0/44 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
5.9%
4/68 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
4.4%
3/68 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
1.4%
1/69 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/43 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
0.00%
0/44 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
1.5%
1/68 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
0.00%
0/68 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
5.8%
4/69 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
|
Gastrointestinal disorders
Nausea
|
7.0%
3/43 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
0.00%
0/44 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
5.9%
4/68 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
1.5%
1/68 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
2.9%
2/69 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.0%
3/43 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
4.5%
2/44 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
2.9%
2/68 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
2.9%
2/68 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
1.4%
1/69 • Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that first occurred or worsened in severity after initiation of double-blind treatment, were collected until the end of treatment (12 weeks), plus two weeks of follow-up.
|
Additional Information
Daiichi Sankyo Contact for Clinical Trial Information
Daiichi Sankyo
Phone: +81-3-6225-1111(M-F 9-5 JST)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60