Trial Outcomes & Findings for A Phase 4, Randomized, Double-blind, Parallel-group, Comparative Study and a Phase 4, Open-label, Long-term Study of SYR-472 (100 mg) in Combination With Insulin in Patients With Type 2 Diabetes (NCT NCT02324569)
NCT ID: NCT02324569
Last Updated: 2023-12-12
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
240 participants
Primary outcome timeframe
End of the screening period (Week 0) and End of Treatment Period I (Up to Week 12)
Results posted on
2023-12-12
Participant Flow
Participants took part in the study at 43 investigative sites in Japan, from 27 December 2014 to 28 December 2016.
Participants with a historical diagnosis of type 2 diabetes mellitus with inadequate glycemic control despite treatment with insulin therapy were enrolled in 1 of the 2 groups: Group I: 100 milligram (mg) SYR-472 in Period I followed by 100 mg SYR-472 in Period II, Group II: SYR-472 Placebo in Period I followed by 100 mg SYR-472 in Period II.
Participant milestones
| Measure |
Treatment Group I
SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
Treatment Group II
SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
|---|---|---|
|
Overall Study
STARTED
|
116
|
124
|
|
Overall Study
COMPLETED
|
100
|
103
|
|
Overall Study
NOT COMPLETED
|
16
|
21
|
Reasons for withdrawal
| Measure |
Treatment Group I
SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
Treatment Group II
SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
|---|---|---|
|
Overall Study
Pretreatment Event/Adverse Event
|
9
|
10
|
|
Overall Study
Voluntary Withdrawal
|
3
|
6
|
|
Overall Study
Lack of Efficacy
|
2
|
3
|
|
Overall Study
Change Insulin Dosage Exceeding Criteria
|
0
|
2
|
|
Overall Study
Inconvenient Schedule
|
2
|
0
|
Baseline Characteristics
A Phase 4, Randomized, Double-blind, Parallel-group, Comparative Study and a Phase 4, Open-label, Long-term Study of SYR-472 (100 mg) in Combination With Insulin in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Treatment Group I
n=116 Participants
SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
Treatment Group II
n=124 Participants
SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.9 Years
STANDARD_DEVIATION 10.89 • n=99 Participants
|
58.5 Years
STANDARD_DEVIATION 11.11 • n=107 Participants
|
58.2 Years
STANDARD_DEVIATION 10.99 • n=206 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=99 Participants
|
82 Participants
n=107 Participants
|
172 Participants
n=206 Participants
|
|
Region of Enrollment
Japan
|
116 Participants
n=99 Participants
|
124 Participants
n=107 Participants
|
240 Participants
n=206 Participants
|
|
BMI
|
25.39 kg/m^2
STANDARD_DEVIATION 3.593 • n=99 Participants
|
25.16 kg/m^2
STANDARD_DEVIATION 3.402 • n=107 Participants
|
25.27 kg/m^2
STANDARD_DEVIATION 3.490 • n=206 Participants
|
|
Duration of Diabetes
|
125.9 Months
STANDARD_DEVIATION 92.75 • n=99 Participants
|
143.6 Months
STANDARD_DEVIATION 90.23 • n=107 Participants
|
135.0 Months
STANDARD_DEVIATION 91.69 • n=206 Participants
|
|
Type of Insulin Preparation
Pre-Mixed
|
48 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Type of Insulin Preparation
Intermediate-Acting
|
3 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Type of Insulin Preparation
Long-Acting
|
65 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
133 Participants
n=206 Participants
|
|
Daily Dose of Insulin Preparation at Week -6
|
19.8 Unit
STANDARD_DEVIATION 9.32 • n=99 Participants
|
18.8 Unit
STANDARD_DEVIATION 8.88 • n=107 Participants
|
19.3 Unit
STANDARD_DEVIATION 9.09 • n=206 Participants
|
|
Creatinine Clearance (Ccr)
|
109.3 Milliliter (mL)/minute (min)
STANDARD_DEVIATION 36.09 • n=99 Participants
|
107.4 Milliliter (mL)/minute (min)
STANDARD_DEVIATION 40.28 • n=107 Participants
|
108.3 Milliliter (mL)/minute (min)
STANDARD_DEVIATION 38.24 • n=206 Participants
|
|
Haemoglobin A1c (HbA1c)
|
8.42 Percent
STANDARD_DEVIATION 0.677 • n=99 Participants
|
8.50 Percent
STANDARD_DEVIATION 0.675 • n=107 Participants
|
8.46 Percent
STANDARD_DEVIATION 0.675 • n=206 Participants
|
|
Fasting Plasma Glucose
|
160.6 Milligram (mg)/ Deciliter (dL)
STANDARD_DEVIATION 32.86 • n=99 Participants
|
167.3 Milligram (mg)/ Deciliter (dL)
STANDARD_DEVIATION 34.02 • n=107 Participants
|
164.1 Milligram (mg)/ Deciliter (dL)
STANDARD_DEVIATION 33.56 • n=206 Participants
|
|
2-hour (hr) Postprandial Plasma Glucose
|
290.0 mg/dL
STANDARD_DEVIATION 52.08 • n=99 Participants
|
286.1 mg/dL
STANDARD_DEVIATION 54.03 • n=107 Participants
|
288.0 mg/dL
STANDARD_DEVIATION 52.97 • n=206 Participants
|
|
Fasting C-Peptide
|
1.07 Nanogram (ng)/mL
STANDARD_DEVIATION 0.527 • n=99 Participants
|
1.16 Nanogram (ng)/mL
STANDARD_DEVIATION 0.647 • n=107 Participants
|
1.12 Nanogram (ng)/mL
STANDARD_DEVIATION 0.593 • n=206 Participants
|
|
Glycoalbumin
|
23.53 Percent
STANDARD_DEVIATION 3.343 • n=99 Participants
|
23.70 Percent
STANDARD_DEVIATION 3.290 • n=107 Participants
|
23.62 Percent
STANDARD_DEVIATION 3.310 • n=206 Participants
|
|
1,5-Anhydroglucitol
|
3.39 Microgram (μg)/mL
STANDARD_DEVIATION 2.349 • n=99 Participants
|
3.28 Microgram (μg)/mL
STANDARD_DEVIATION 2.978 • n=107 Participants
|
3.33 Microgram (μg)/mL
STANDARD_DEVIATION 2.688 • n=206 Participants
|
|
Insulinogenic Index
|
0.29 microunits*dL/mg*mL
STANDARD_DEVIATION 0.279 • n=99 Participants
|
0.38 microunits*dL/mg*mL
STANDARD_DEVIATION 0.687 • n=107 Participants
|
0.34 microunits*dL/mg*mL
STANDARD_DEVIATION 0.525 • n=206 Participants
|
PRIMARY outcome
Timeframe: End of the screening period (Week 0) and End of Treatment Period I (Up to Week 12)Population: Full Analysis Set: All randomized participants who received at least one dose of study drug.
Outcome measures
| Measure |
Treatment Group I
n=116 Participants
SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
Treatment Group II
n=124 Participants
SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
|---|---|---|
|
Change in HbA1c From Baseline at the End of Treatment Period I (End of Treatment Period I - End of the Screening Period)
|
-0.56 Percent
Standard Error 0.070
|
0.07 Percent
Standard Error 0.067
|
PRIMARY outcome
Timeframe: Up to Week 12Population: Safety Analysis Set: The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.
Reported data is the number of participants reporting one or more TEAEs that occurred before start of Treatment Period II in Treatment Group I and Treatment Group II.
Outcome measures
| Measure |
Treatment Group I
n=116 Participants
SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
Treatment Group II
n=124 Participants
SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
|---|---|---|
|
Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAEs) That Occurred Before Start of Treatment Period II
|
51 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, End of Treatment Period I (Up to Week 12) and End of Treatment Period II (Up to Week 52)Population: Full Analysis Set: All randomized participants who received at least one dose of study drug. The analyzed numbers for each arm were participants who were evaluable for this outcome measure at the given time point.
Reported data was the change from baseline in HbA1c at each time point.
Outcome measures
| Measure |
Treatment Group I
n=116 Participants
SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
Treatment Group II
n=124 Participants
SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
|---|---|---|
|
Change From Baseline in HbA1c
Week 44
|
-0.34 Percent
Standard Deviation 0.895
|
-0.67 Percent
Standard Deviation 0.772
|
|
Change From Baseline in HbA1c
Week 48
|
-0.44 Percent
Standard Deviation 0.804
|
-0.69 Percent
Standard Deviation 0.794
|
|
Change From Baseline in HbA1c
Week 52
|
-0.48 Percent
Standard Deviation 0.799
|
-0.70 Percent
Standard Deviation 0.711
|
|
Change From Baseline in HbA1c
Week 8
|
-0.50 Percent
Standard Deviation 0.573
|
-0.04 Percent
Standard Deviation 0.612
|
|
Change From Baseline in HbA1c
Week 12
|
-0.55 Percent
Standard Deviation 0.708
|
0.08 Percent
Standard Deviation 0.793
|
|
Change From Baseline in HbA1c
Week 16
|
-0.51 Percent
Standard Deviation 0.793
|
-0.16 Percent
Standard Deviation 0.840
|
|
Change From Baseline in HbA1c
Week 20
|
-0.42 Percent
Standard Deviation 0.836
|
-0.41 Percent
Standard Deviation 0.797
|
|
Change From Baseline in HbA1c
Week 24
|
-0.38 Percent
Standard Deviation 0.864
|
-0.49 Percent
Standard Deviation 0.812
|
|
Change From Baseline in HbA1c
Week 28
|
-0.42 Percent
Standard Deviation 0.884
|
-0.55 Percent
Standard Deviation 0.832
|
|
Change From Baseline in HbA1c
Week 32
|
-0.41 Percent
Standard Deviation 0.872
|
-0.57 Percent
Standard Deviation 0.791
|
|
Change From Baseline in HbA1c
Week 36
|
-0.42 Percent
Standard Deviation 0.817
|
-0.58 Percent
Standard Deviation 0.740
|
|
Change From Baseline in HbA1c
Week 40
|
-0.35 Percent
Standard Deviation 0.884
|
-0.62 Percent
Standard Deviation 0.779
|
|
Change From Baseline in HbA1c
End of Treatment Period I
|
-0.56 Percent
Standard Deviation 0.710
|
0.07 Percent
Standard Deviation 0.788
|
|
Change From Baseline in HbA1c
End of Treatment Period II
|
-0.43 Percent
Standard Deviation 0.827
|
-0.60 Percent
Standard Deviation 0.831
|
|
Change From Baseline in HbA1c
Week 2
|
-0.16 Percent
Standard Deviation 0.240
|
0.01 Percent
Standard Deviation 0.229
|
|
Change From Baseline in HbA1c
Week 4
|
-0.38 Percent
Standard Deviation 0.327
|
-0.06 Percent
Standard Deviation 0.396
|
SECONDARY outcome
Timeframe: Baseline and Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 53, End of Treatment Period I (Up to Week 12) and End of Treatment Period II (Up to Week 52)Population: Full Analysis Set: All randomized participants who received at least one dose of study drug. The analyzed numbers for each arm were participants who were evaluable for this outcome measure at the given time point.
Reported data was the change from baseline in fasting plasma glucose at each time point.
Outcome measures
| Measure |
Treatment Group I
n=116 Participants
SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
Treatment Group II
n=124 Participants
SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose
Week 12
|
-2.0 mg/dL
Standard Deviation 39.65
|
2.0 mg/dL
Standard Deviation 42.04
|
|
Change From Baseline in Fasting Plasma Glucose
Week 16
|
-1.4 mg/dL
Standard Deviation 41.31
|
-9.0 mg/dL
Standard Deviation 37.24
|
|
Change From Baseline in Fasting Plasma Glucose
Week 20
|
-3.1 mg/dL
Standard Deviation 39.65
|
-10.4 mg/dL
Standard Deviation 38.68
|
|
Change From Baseline in Fasting Plasma Glucose
Week 53
|
-1.3 mg/dL
Standard Deviation 45.44
|
-13.2 mg/dL
Standard Deviation 34.49
|
|
Change From Baseline in Fasting Plasma Glucose
End of Treatment Period I
|
-2.8 mg/dL
Standard Deviation 39.40
|
0.8 mg/dL
Standard Deviation 42.44
|
|
Change From Baseline in Fasting Plasma Glucose
Week 2
|
-10.3 mg/dL
Standard Deviation 29.73
|
0.1 mg/dL
Standard Deviation 28.98
|
|
Change From Baseline in Fasting Plasma Glucose
Week 4
|
-12.6 mg/dL
Standard Deviation 32.19
|
-4.0 mg/dL
Standard Deviation 36.49
|
|
Change From Baseline in Fasting Plasma Glucose
Week 8
|
-9.3 mg/dL
Standard Deviation 32.13
|
-0.9 mg/dL
Standard Deviation 39.37
|
|
Change From Baseline in Fasting Plasma Glucose
Week 24
|
-3.0 mg/dL
Standard Deviation 36.08
|
-10.3 mg/dL
Standard Deviation 39.79
|
|
Change From Baseline in Fasting Plasma Glucose
Week 28
|
-4.5 mg/dL
Standard Deviation 38.76
|
-10.5 mg/dL
Standard Deviation 37.50
|
|
Change From Baseline in Fasting Plasma Glucose
Week 32
|
-6.9 mg/dL
Standard Deviation 39.46
|
-12.9 mg/dL
Standard Deviation 35.75
|
|
Change From Baseline in Fasting Plasma Glucose
Week 36
|
-6.0 mg/dL
Standard Deviation 35.58
|
-14.9 mg/dL
Standard Deviation 33.97
|
|
Change From Baseline in Fasting Plasma Glucose
Week 40
|
-3.7 mg/dL
Standard Deviation 40.45
|
-14.7 mg/dL
Standard Deviation 36.34
|
|
Change From Baseline in Fasting Plasma Glucose
Week 44
|
-4.9 mg/dL
Standard Deviation 36.88
|
-18.0 mg/dL
Standard Deviation 38.43
|
|
Change From Baseline in Fasting Plasma Glucose
Week 48
|
-8.8 mg/dL
Standard Deviation 38.00
|
-19.8 mg/dL
Standard Deviation 35.38
|
|
Change From Baseline in Fasting Plasma Glucose
Week 52
|
-10.0 mg/dL
Standard Deviation 43.40
|
-21.0 mg/dL
Standard Deviation 33.99
|
|
Change From Baseline in Fasting Plasma Glucose
End of Treatment Period II
|
-8.1 mg/dL
Standard Deviation 42.48
|
-18.3 mg/dL
Standard Deviation 35.81
|
SECONDARY outcome
Timeframe: Pre-meal and 0.5, 1, and 2 hr after-meal at Week 0 and 0.5, 1, and 2 hr after-meal at the End of Treatment Period I (Up to Week 12)Population: Full Analysis Set: All randomized participants who received at least one dose of study drug. The analyzed numbers for each arm were participants who were evaluable for this outcome measure at the given time point.
Reported data was the change from pre-meal in plasma glucose measured by the meal tolerance test at each time point.
Outcome measures
| Measure |
Treatment Group I
n=116 Participants
SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
Treatment Group II
n=124 Participants
SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
|---|---|---|
|
Change From Baseline in Plasma Glucose Measured by the Meal Tolerance Test in Treatment Period I
2 hr at the End of Treatment Period I
|
-29.9 mg/dL
Standard Deviation 42.23
|
2.3 mg/dL
Standard Deviation 59.89
|
|
Change From Baseline in Plasma Glucose Measured by the Meal Tolerance Test in Treatment Period I
Pre-meal at the End of Treatment Period I
|
-9.5 mg/dL
Standard Deviation 34.13
|
0.5 mg/dL
Standard Deviation 45.17
|
|
Change From Baseline in Plasma Glucose Measured by the Meal Tolerance Test in Treatment Period I
0.5 hr at the End of Treatment Period I
|
-17.6 mg/dL
Standard Deviation 36.82
|
3.5 mg/dL
Standard Deviation 51.12
|
|
Change From Baseline in Plasma Glucose Measured by the Meal Tolerance Test in Treatment Period I
1 hr at the End of Treatment Period I
|
-28.6 mg/dL
Standard Deviation 43.08
|
-1.2 mg/dL
Standard Deviation 51.02
|
SECONDARY outcome
Timeframe: Up to Week 12Population: Safety Analysis Set: The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period. The analyzed numbers for each arm were participants who were evaluable for this outcome measure.
Here "mmHg" is Millimeter of mercury.
Outcome measures
| Measure |
Treatment Group I
n=116 Participants
SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
Treatment Group II
n=124 Participants
SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
|---|---|---|
|
Number of Participants With Markedly Abnormal Values of Vital Signs Before Start of Treatment Period II
Diastolic Blood Pressure <50 mmHg
|
1 Participants
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Values of Vital Signs Before Start of Treatment Period II
Pulse <50 Beats per minute(bpm)
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Week 12Population: Safety Analysis Set: The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period. The analyzed numbers for each arm were participants who were evaluable for this outcome measure.
Here "QTcF" is Corrected QT interval by Fridericia formula, and "msec" is millisecond.
Outcome measures
| Measure |
Treatment Group I
n=116 Participants
SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
Treatment Group II
n=124 Participants
SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
|---|---|---|
|
Number of Participants With Markedly Abnormal Values of ECG Parameters Before Start of Treatment Period II
QTcF Interval >450 msec
|
2 Participants
|
4 Participants
|
|
Number of Participants With Markedly Abnormal Values of ECG Parameters Before Start of Treatment Period II
Change from Baseline in QTcF Interval >30 msec
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Week 12Population: Safety Analysis Set: The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period. The analyzed numbers for each arm were participants who were evaluable for this outcome measure..
Outcome measures
| Measure |
Treatment Group I
n=116 Participants
SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
Treatment Group II
n=124 Participants
SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
|---|---|---|
|
Number of Participants With Markedly Abnormal Values of Laboratory Parameters (Total Bilirubin >2.0) Before Start of Treatment Period II
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Week 53Population: Safety Analysis Set: The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period. The analyzed numbers for each arm were participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Treatment Group I
n=116 Participants
SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
Treatment Group II
n=124 Participants
SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
|---|---|---|
|
Number of Participants With Total Hypoglycaemia After 1st Dose of Study Drug and Before Start of Treatment Period II
|
17 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Baseline and Day 2, 3, 4, 5, 6, 7, and 8 in each Treatment Period (I and II) (Totally up to Week 17)Population: Safety Analysis Set: The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period. The analyzed numbers for each arm were participants who were evaluable for this outcome measure at the given time point.
Reported data was the change from baseline in self-monitoring of blood glucose before breakfast.
Outcome measures
| Measure |
Treatment Group I
n=116 Participants
SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
Treatment Group II
n=124 Participants
SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
|---|---|---|
|
Change From Baseline in Self-Monitoring of Blood Glucose Before Breakfast
Day 4 on Treatment Period I
|
1.6 mg/dL
Standard Deviation 43.99
|
-3.0 mg/dL
Standard Deviation 41.55
|
|
Change From Baseline in Self-Monitoring of Blood Glucose Before Breakfast
Day 5 on Treatment Period I
|
-6.7 mg/dL
Standard Deviation 41.51
|
-0.9 mg/dL
Standard Deviation 38.22
|
|
Change From Baseline in Self-Monitoring of Blood Glucose Before Breakfast
Day 2 on Treatment Period I
|
9.7 mg/dL
Standard Deviation 41.21
|
5.6 mg/dL
Standard Deviation 39.02
|
|
Change From Baseline in Self-Monitoring of Blood Glucose Before Breakfast
Day 3 on Treatment Period I
|
4.3 mg/dL
Standard Deviation 35.22
|
-0.9 mg/dL
Standard Deviation 41.35
|
|
Change From Baseline in Self-Monitoring of Blood Glucose Before Breakfast
Day 6 on Treatment Period I
|
-7.0 mg/dL
Standard Deviation 33.79
|
2.2 mg/dL
Standard Deviation 43.78
|
|
Change From Baseline in Self-Monitoring of Blood Glucose Before Breakfast
Day 7 on Treatment Period I
|
-0.2 mg/dL
Standard Deviation 38.15
|
-0.3 mg/dL
Standard Deviation 37.55
|
|
Change From Baseline in Self-Monitoring of Blood Glucose Before Breakfast
Day 8 on Treatment Period I
|
-3.8 mg/dL
Standard Deviation 39.63
|
2.0 mg/dL
Standard Deviation 37.70
|
|
Change From Baseline in Self-Monitoring of Blood Glucose Before Breakfast
Day 2 on Treatment Period II
|
-6.8 mg/dL
Standard Deviation 41.98
|
7.1 mg/dL
Standard Deviation 51.90
|
|
Change From Baseline in Self-Monitoring of Blood Glucose Before Breakfast
Day 3 on Treatment Period II
|
-10.2 mg/dL
Standard Deviation 39.95
|
5.8 mg/dL
Standard Deviation 44.25
|
|
Change From Baseline in Self-Monitoring of Blood Glucose Before Breakfast
Day 4 on Treatment Period II
|
-5.7 mg/dL
Standard Deviation 45.52
|
-1.7 mg/dL
Standard Deviation 49.40
|
|
Change From Baseline in Self-Monitoring of Blood Glucose Before Breakfast
Day 5 on Treatment Period II
|
-5.2 mg/dL
Standard Deviation 41.24
|
-2.8 mg/dL
Standard Deviation 47.25
|
|
Change From Baseline in Self-Monitoring of Blood Glucose Before Breakfast
Day 6 on Treatment Period II
|
-8.5 mg/dL
Standard Deviation 39.04
|
-3.4 mg/dL
Standard Deviation 40.67
|
|
Change From Baseline in Self-Monitoring of Blood Glucose Before Breakfast
Day 7 on Treatment Period II
|
-7.7 mg/dL
Standard Deviation 35.93
|
-4.9 mg/dL
Standard Deviation 44.21
|
|
Change From Baseline in Self-Monitoring of Blood Glucose Before Breakfast
Day 8 on Treatment Period II
|
-9.4 mg/dL
Standard Deviation 35.91
|
-7.8 mg/dL
Standard Deviation 43.85
|
Adverse Events
Treatment Group I
Serious events: 16 serious events
Other events: 59 other events
Deaths: 0 deaths
Treatment Group II
Serious events: 9 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Group I
n=116 participants at risk
SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
Treatment Group II
n=119 participants at risk
SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.86%
1/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.00%
0/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Cardiac disorders
Atrial fibrillation
|
0.86%
1/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.00%
0/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.86%
1/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.00%
0/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Cardiac disorders
Coronary artery aneurysm
|
0.00%
0/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.84%
1/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.84%
1/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.86%
1/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.00%
0/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.84%
1/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Eye disorders
Cataract
|
1.7%
2/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.84%
1/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.86%
1/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.00%
0/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Gastrointestinal disorders
Enteritis
|
0.86%
1/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.00%
0/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.86%
1/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.00%
0/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.84%
1/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Gastrointestinal disorders
Pancreatolithiasis
|
0.00%
0/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.84%
1/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Injury, poisoning and procedural complications
Accident
|
0.86%
1/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.00%
0/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.86%
1/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.00%
0/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Injury, poisoning and procedural complications
Fall
|
0.86%
1/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.00%
0/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.86%
1/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.00%
0/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.86%
1/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.00%
0/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Injury, poisoning and procedural complications
Radial nerve injury
|
0.86%
1/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.00%
0/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Injury, poisoning and procedural complications
Spinal cord injury cervical
|
0.86%
1/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.00%
0/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.86%
1/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.00%
0/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.84%
1/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.86%
1/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.00%
0/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.86%
1/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.00%
0/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.86%
1/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.00%
0/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.86%
1/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.00%
0/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.84%
1/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.86%
1/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.00%
0/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.84%
1/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Medullary thyroid cancer
|
0.86%
1/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.00%
0/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.84%
1/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.86%
1/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.00%
0/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Nervous system disorders
Basilar artery stenosis
|
0.00%
0/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.84%
1/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.84%
1/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.84%
1/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Psychiatric disorders
Completed suicide
|
0.86%
1/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.00%
0/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.86%
1/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.00%
0/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Nervous system disorders
Cerebral Infarction
|
0.00%
0/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.84%
1/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
Other adverse events
| Measure |
Treatment Group I
n=116 participants at risk
SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
Treatment Group II
n=119 participants at risk
SYR-472 placebo, one tablet, orally before breakfast, weekly for up to Week 12 as Period I, followed by SYR-472 100 mg, one tablet, orally before breakfast, weekly for up to Week 52 as Period II of this study. Participants treated with insulin therapy throughout study.
|
|---|---|---|
|
Gastrointestinal disorders
Dental caries
|
6.0%
7/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
0.84%
1/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Infections and infestations
Nasopharyngitis
|
34.5%
40/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
26.1%
31/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
19.0%
22/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
15.1%
18/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
4/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
6.7%
8/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
6.0%
7/116 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
5.0%
6/119 • Baseline up to Week 53
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. On serious adverse events table, only events that occurred after 1st dose of SYR-472 were reported.
|
Additional Information
Medical Director
Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)
Phone: +1-877-825-3327
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER