Trial Outcomes & Findings for Omarigliptin (MK-3102) Clinical Trial - Add-on to Oral Antihyperglycemic Agent Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-3102-015) (NCT NCT01697592)
NCT ID: NCT01697592
Last Updated: 2018-09-10
Results Overview
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of \>240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG \>200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
585 participants
Primary outcome timeframe
Up to 24 weeks
Results posted on
2018-09-10
Participant Flow
Sixty-seven sites in Japan received IRB approval and were shipped clinical supplies in this study and randomized at least one participant. A total of 772 participants were screened of which 187 participants were excluded. The most common reason for participants not being randomized was screen failure (meeting exclusionary laboratory values).
In Phase A, participants were randomized to receive either omarigliptin (MK-3102) 25 mg once weekly or placebo for 24 weeks in a blinded manner. In Phase B, all participants received open-label omarigliptin 25 mg once weekly for 28 weeks.
Participant milestones
| Measure |
Omarigliptin 25 mg/Sulfonylureas (SU) (Phase A+B)
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
|
Omarigliptin 25 mg/Glinides (Gln) (Phase A+B)
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.
|
Omarigliptin 25 mg/Biguanides (BG) (Phase A+B)
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
|
Omarigliptin 25 mg/Thiazolidinediones (TZD) (Phase A+B)
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
|
Omarigliptin 25 mg/α-GI (Phase A+B)
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-glucosidase (α-GI) throughout the duration of the study.
|
Placebo/SU (Phase A) Switching to Omari. 25 mg/SU (Phase B)
Placebo to omarigliptin (omari.)administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SU throughout the duration of the study.
|
Placebo/Gln. (Phase A) Switching to Omari. 25 mg/Gln (Phase B)
Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of Gln throughout the duration of the study.
|
Placebo/BG (Phase A) Switching to Omari. 25 mg/BG (Phase B)
Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BG. throughout the duration of the study.
|
Placebo/TZD (Phase A) Switching to Omari. 25 mg/TZ (Phase B)
Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZD throughout the duration of the study.
|
Placebo/α-GI (Phase A) Switching to Omari. 25 mg/α-GI (Ph. B)
Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase A (Up to 24 Weeks)
STARTED
|
126
|
65
|
66
|
65
|
67
|
63
|
34
|
33
|
34
|
32
|
|
Phase A (Up to 24 Weeks)
COMPLETED
|
123
|
62
|
65
|
63
|
67
|
62
|
32
|
33
|
34
|
30
|
|
Phase A (Up to 24 Weeks)
NOT COMPLETED
|
3
|
3
|
1
|
2
|
0
|
1
|
2
|
0
|
0
|
2
|
|
Phase B (Week 25 to Week 52)
STARTED
|
123
|
62
|
65
|
63
|
67
|
62
|
32
|
33
|
34
|
30
|
|
Phase B (Week 25 to Week 52)
COMPLETED
|
118
|
61
|
64
|
60
|
67
|
60
|
31
|
32
|
32
|
30
|
|
Phase B (Week 25 to Week 52)
NOT COMPLETED
|
5
|
1
|
1
|
3
|
0
|
2
|
1
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
Omarigliptin 25 mg/Sulfonylureas (SU) (Phase A+B)
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
|
Omarigliptin 25 mg/Glinides (Gln) (Phase A+B)
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.
|
Omarigliptin 25 mg/Biguanides (BG) (Phase A+B)
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
|
Omarigliptin 25 mg/Thiazolidinediones (TZD) (Phase A+B)
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
|
Omarigliptin 25 mg/α-GI (Phase A+B)
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-glucosidase (α-GI) throughout the duration of the study.
|
Placebo/SU (Phase A) Switching to Omari. 25 mg/SU (Phase B)
Placebo to omarigliptin (omari.)administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SU throughout the duration of the study.
|
Placebo/Gln. (Phase A) Switching to Omari. 25 mg/Gln (Phase B)
Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of Gln throughout the duration of the study.
|
Placebo/BG (Phase A) Switching to Omari. 25 mg/BG (Phase B)
Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BG. throughout the duration of the study.
|
Placebo/TZD (Phase A) Switching to Omari. 25 mg/TZ (Phase B)
Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZD throughout the duration of the study.
|
Placebo/α-GI (Phase A) Switching to Omari. 25 mg/α-GI (Ph. B)
Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase A (Up to 24 Weeks)
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase A (Up to 24 Weeks)
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Phase A (Up to 24 Weeks)
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase A (Up to 24 Weeks)
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Phase A (Up to 24 Weeks)
Adverse Event
|
0
|
2
|
1
|
2
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Phase B (Week 25 to Week 52)
Physician Decision
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase B (Week 25 to Week 52)
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Phase B (Week 25 to Week 52)
Adverse Event
|
2
|
1
|
1
|
2
|
0
|
1
|
1
|
0
|
2
|
0
|
Baseline Characteristics
Omarigliptin (MK-3102) Clinical Trial - Add-on to Oral Antihyperglycemic Agent Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-3102-015)
Baseline characteristics by cohort
| Measure |
Omarigliptin 25 mg/SU (Phase A+B)
n=126 Participants
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
|
Omarigliptin 25 mg/Gln (Phase A+B)
n=65 Participants
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.
|
Omarigliptin 25 mg/BG (Phase A+B)
n=66 Participants
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
|
Omarigliptin 25 mg/TZD (Phase A+B)
n=65 Participants
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
|
Omarigliptin 25 mg/α-GI (Phase A+B)
n=67 Participants
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.
|
Placebo/SU (Phase A) Switching to Omari. 25 mg/SU (Phase B)
n=63 Participants
Placebo to omarigliptin (omari.)administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SU throughout the duration of the study.
|
Placebo/Gln (Phase A) Switching to Omari. 25 mg/Gln (Ph. B)
n=34 Participants
Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of Gln throughout the duration of the study.
|
Placebo/BG (Phase A) Switching to Omari. 25 mg/BG (Phase B)
n=33 Participants
Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BG throughout the duration of the study.
|
Placebo/TZD (Phase A) Switching to Omari. 25 mg/TZD (Phase B)
n=34 Participants
Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZD throughout the duration of the study.
|
Placebo/α-GI (Phase A) Switching to Omari. 25 mg/α-GI (Ph. B)
n=32 Participants
Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
|
Total
n=585 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
63 Years
STANDARD_DEVIATION 9 • n=5 Participants
|
59 Years
STANDARD_DEVIATION 11 • n=7 Participants
|
59 Years
STANDARD_DEVIATION 9 • n=5 Participants
|
61 Years
STANDARD_DEVIATION 10 • n=4 Participants
|
61 Years
STANDARD_DEVIATION 11 • n=21 Participants
|
63 Years
STANDARD_DEVIATION 11 • n=8 Participants
|
61 Years
STANDARD_DEVIATION 10 • n=8 Participants
|
57 Years
STANDARD_DEVIATION 9 • n=24 Participants
|
61 Years
STANDARD_DEVIATION 9 • n=42 Participants
|
61 Years
STANDARD_DEVIATION 11 • n=42 Participants
|
61 Years
STANDARD_DEVIATION 10 • n=42 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
169 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
45 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
23 Participants
n=24 Participants
|
27 Participants
n=42 Participants
|
23 Participants
n=42 Participants
|
416 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of \>240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG \>200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue).
Outcome measures
| Measure |
Omarigliptin 25 mg/SU (Phase A)
n=126 Participants
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
|
Omarigliptin 25 mg/Gln (Phase A)
n=65 Participants
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
|
Omarigliptin 25 mg/BG (Phase A)
n=66 Participants
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
|
Omarigliptin 25 mg/TZD (Phase A)
n=65 Participants
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
|
Omarigliptin 25 mg/α-GI (Phase A)
n=67 Participants
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
|
Placebo/SU (Phase A)
n=63 Participants
Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
|
Placebo/Gln. (Phase A)
n=34 Participants
Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
|
Placebo/BG (Phase A)
n=33 Participants
Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
|
Placebo/TZD (Phase A)
n=34 Participants
Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
|
Placebo/α-GI (Phase A)
n=32 Participants
Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During Phase A
|
59.5 Percentage of participants
|
53.8 Percentage of participants
|
54.5 Percentage of participants
|
60.0 Percentage of participants
|
50.7 Percentage of participants
|
60.3 Percentage of participants
|
52.9 Percentage of participants
|
63.6 Percentage of participants
|
52.9 Percentage of participants
|
53.1 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 52 weeksPopulation: The ASaT population was all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data. Data was unavailable for 5 participants who discontinued from the study in the placebo arm in Phase A.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of \>240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG \>200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.
Outcome measures
| Measure |
Omarigliptin 25 mg/SU (Phase A)
n=126 Participants
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
|
Omarigliptin 25 mg/Gln (Phase A)
n=65 Participants
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
|
Omarigliptin 25 mg/BG (Phase A)
n=66 Participants
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
|
Omarigliptin 25 mg/TZD (Phase A)
n=65 Participants
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
|
Omarigliptin 25 mg/α-GI (Phase A)
n=67 Participants
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
|
Placebo/SU (Phase A)
n=62 Participants
Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
|
Placebo/Gln. (Phase A)
n=32 Participants
Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
|
Placebo/BG (Phase A)
n=33 Participants
Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
|
Placebo/TZD (Phase A)
n=34 Participants
Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
|
Placebo/α-GI (Phase A)
n=30 Participants
Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During the Overall Study
|
76.2 Percentage of participants
|
75.4 Percentage of participants
|
80.3 Percentage of participants
|
84.6 Percentage of participants
|
68.7 Percentage of participants
|
56.5 Percentage of participants
|
59.4 Percentage of participants
|
66.7 Percentage of participants
|
58.8 Percentage of participants
|
53.3 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: The ASaT population was defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Outcome measures
| Measure |
Omarigliptin 25 mg/SU (Phase A)
n=126 Participants
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
|
Omarigliptin 25 mg/Gln (Phase A)
n=65 Participants
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
|
Omarigliptin 25 mg/BG (Phase A)
n=66 Participants
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
|
Omarigliptin 25 mg/TZD (Phase A)
n=65 Participants
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
|
Omarigliptin 25 mg/α-GI (Phase A)
n=67 Participants
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
|
Placebo/SU (Phase A)
n=63 Participants
Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
|
Placebo/Gln. (Phase A)
n=34 Participants
Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
|
Placebo/BG (Phase A)
n=33 Participants
Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
|
Placebo/TZD (Phase A)
n=34 Participants
Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
|
Placebo/α-GI (Phase A)
n=32 Participants
Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A
|
0 Percentage of Participants
|
3.1 Percentage of Participants
|
0 Percentage of Participants
|
3.1 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
2.9 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
3.1 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 52 weeksPopulation: The ASaT population was all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data. Data was unavailable for 5 participants who discontinued from the study in the placebo arm in Phase A.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of \>240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG \>200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.
Outcome measures
| Measure |
Omarigliptin 25 mg/SU (Phase A)
n=126 Participants
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
|
Omarigliptin 25 mg/Gln (Phase A)
n=65 Participants
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
|
Omarigliptin 25 mg/BG (Phase A)
n=66 Participants
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
|
Omarigliptin 25 mg/TZD (Phase A)
n=65 Participants
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
|
Omarigliptin 25 mg/α-GI (Phase A)
n=67 Participants
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
|
Placebo/SU (Phase A)
n=62 Participants
Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
|
Placebo/Gln. (Phase A)
n=32 Participants
Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
|
Placebo/BG (Phase A)
n=33 Participants
Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
|
Placebo/TZD (Phase A)
n=34 Participants
Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
|
Placebo/α-GI (Phase A)
n=30 Participants
Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study
|
0.8 Percentage of participants
|
4.6 Percentage of participants
|
1.5 Percentage of participants
|
6.2 Percentage of participants
|
0 Percentage of participants
|
1.6 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2.9 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Full Analysis Set (FAS), comprised of all participants who received at least one study drug and have a baseline or post-randomization measurement.
HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 HbA1c minus the Week 0 HbA1c.
Outcome measures
| Measure |
Omarigliptin 25 mg/SU (Phase A)
n=126 Participants
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
|
Omarigliptin 25 mg/Gln (Phase A)
n=65 Participants
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
|
Omarigliptin 25 mg/BG (Phase A)
n=66 Participants
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
|
Omarigliptin 25 mg/TZD (Phase A)
n=65 Participants
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
|
Omarigliptin 25 mg/α-GI (Phase A)
n=67 Participants
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
|
Placebo/SU (Phase A)
n=63 Participants
Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
|
Placebo/Gln. (Phase A)
n=34 Participants
Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
|
Placebo/BG (Phase A)
n=33 Participants
Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
|
Placebo/TZD (Phase A)
n=34 Participants
Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
|
Placebo/α-GI (Phase A)
n=32 Participants
Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
|
-0.84 Percent HbA1C
Interval -0.94 to -0.73
|
-0.68 Percent HbA1C
Interval -0.89 to -0.48
|
-0.94 Percent HbA1C
Interval -1.1 to -0.78
|
-0.88 Percent HbA1C
Interval -1.04 to -0.73
|
-0.74 Percent HbA1C
Interval -0.89 to -0.59
|
0.09 Percent HbA1C
Interval -0.06 to 0.24
|
0.30 Percent HbA1C
Interval -0.04 to 0.64
|
-0.02 Percent HbA1C
Interval -0.35 to 0.31
|
0.28 Percent HbA1C
Interval 0.03 to 0.53
|
0.06 Percent HbA1C
Interval -0.16 to 0.28
|
Adverse Events
Omarigliptin 25 mg/SU (Phase A)
Serious events: 3 serious events
Other events: 33 other events
Deaths: 0 deaths
Omarigliptin 25 mg/Gln (Phase A)
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Omarigliptin 25 mg/BG (Phase A)
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Omarigliptin 25 mg/TZD (Phase A)
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
Omarigliptin 25 mg/α-GI (Phase A)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo/ABM (Phase A)
Serious events: 4 serious events
Other events: 62 other events
Deaths: 0 deaths
Omarigliptin 25 mg/SU (Phase A+B)
Serious events: 6 serious events
Other events: 58 other events
Deaths: 0 deaths
Omarigliptin 25 mg/Gln (Phase A+B)
Serious events: 3 serious events
Other events: 29 other events
Deaths: 0 deaths
Omarigliptin 25 mg/BG (Phase A+B)
Serious events: 2 serious events
Other events: 33 other events
Deaths: 0 deaths
Omarigliptin 25 mg/TZD (Phase A+B)
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
Omarigliptin 25 mg/α-GI (Phase A+B)
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Omarigliptin 25mg/ABM (Phase B)
Serious events: 7 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Omarigliptin 25 mg/SU (Phase A)
n=126 participants at risk
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
|
Omarigliptin 25 mg/Gln (Phase A)
n=65 participants at risk
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
|
Omarigliptin 25 mg/BG (Phase A)
n=66 participants at risk
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
|
Omarigliptin 25 mg/TZD (Phase A)
n=65 participants at risk
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
|
Omarigliptin 25 mg/α-GI (Phase A)
n=67 participants at risk
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
|
Placebo/ABM (Phase A)
n=196 participants at risk
Placebo to omargliptin administered orally once weekly for 24 weeks during Phase A. Participants continued any pre-study basal medication (ABM)throughout the duration of the study.
|
Omarigliptin 25 mg/SU (Phase A+B)
n=126 participants at risk
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
|
Omarigliptin 25 mg/Gln (Phase A+B)
n=65 participants at risk
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.
|
Omarigliptin 25 mg/BG (Phase A+B)
n=66 participants at risk
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
|
Omarigliptin 25 mg/TZD (Phase A+B)
n=65 participants at risk
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
|
Omarigliptin 25 mg/α-GI (Phase A+B)
n=67 participants at risk
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.
|
Omarigliptin 25mg/ABM (Phase B)
n=191 participants at risk
Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.
Participants continued any prestudy basal medications throughout the duration of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Cataract
|
0.79%
1/126 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/196 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.6%
2/126 • Number of events 2 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/67 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/191 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Eye disorders
Macular hole
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/65 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/196 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/65 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/191 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/66 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/196 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/66 • Number of events 2 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/191 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/65 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/196 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/65 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/191 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/65 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/196 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/65 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/191 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/65 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/196 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/65 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/191 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/196 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/65 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.52%
1/191 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypopharyngeal cancer
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/65 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/196 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/65 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/191 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.79%
1/126 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/196 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.79%
1/126 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/191 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Nervous system disorders
Cerebral infarction
|
0.79%
1/126 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/196 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.79%
1/126 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/191 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/196 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.79%
1/126 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/191 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/196 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.52%
1/191 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/196 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.52%
1/191 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/196 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.52%
1/191 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/196 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.52%
1/191 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/196 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.52%
1/191 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/196 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.52%
1/191 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/196 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/66 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/191 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/196 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/65 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/191 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Investigations
Blood glucose increased
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/196 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.79%
1/126 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/191 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Investigations
Weight increased
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/196 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.79%
1/126 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/191 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.51%
1/196 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/191 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.51%
1/196 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/191 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.51%
1/196 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/191 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.51%
1/196 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/191 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/196 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/67 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/191 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
Other adverse events
| Measure |
Omarigliptin 25 mg/SU (Phase A)
n=126 participants at risk
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
|
Omarigliptin 25 mg/Gln (Phase A)
n=65 participants at risk
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
|
Omarigliptin 25 mg/BG (Phase A)
n=66 participants at risk
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
|
Omarigliptin 25 mg/TZD (Phase A)
n=65 participants at risk
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
|
Omarigliptin 25 mg/α-GI (Phase A)
n=67 participants at risk
Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
|
Placebo/ABM (Phase A)
n=196 participants at risk
Placebo to omargliptin administered orally once weekly for 24 weeks during Phase A. Participants continued any pre-study basal medication (ABM)throughout the duration of the study.
|
Omarigliptin 25 mg/SU (Phase A+B)
n=126 participants at risk
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
|
Omarigliptin 25 mg/Gln (Phase A+B)
n=65 participants at risk
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.
|
Omarigliptin 25 mg/BG (Phase A+B)
n=66 participants at risk
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
|
Omarigliptin 25 mg/TZD (Phase A+B)
n=65 participants at risk
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
|
Omarigliptin 25 mg/α-GI (Phase A+B)
n=67 participants at risk
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.
|
Omarigliptin 25mg/ABM (Phase B)
n=191 participants at risk
Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.
Participants continued any prestudy basal medications throughout the duration of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis
|
1.6%
2/126 • Number of events 2 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
6.1%
4/66 • Number of events 4 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/65 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
3/196 • Number of events 3 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.6%
2/126 • Number of events 2 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
6.1%
4/66 • Number of events 4 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/65 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/67 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.0%
2/191 • Number of events 2 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Infections and infestations
Nasopharyngitis
|
11.9%
15/126 • Number of events 17 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
21.5%
14/65 • Number of events 16 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
16.7%
11/66 • Number of events 14 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
16.9%
11/65 • Number of events 13 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
19.4%
13/67 • Number of events 14 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
22.4%
44/196 • Number of events 49 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
27.0%
34/126 • Number of events 44 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
35.4%
23/65 • Number of events 30 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
36.4%
24/66 • Number of events 34 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
29.2%
19/65 • Number of events 29 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
28.4%
19/67 • Number of events 25 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
18.8%
36/191 • Number of events 44 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.6%
7/126 • Number of events 10 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/65 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
4.5%
3/66 • Number of events 4 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/65 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
3/196 • Number of events 7 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
8.7%
11/126 • Number of events 14 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
3.1%
2/65 • Number of events 3 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
4.5%
3/66 • Number of events 7 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
3.1%
2/65 • Number of events 2 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
3.1%
6/191 • Number of events 7 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Gastrointestinal disorders
Constipation
|
2.4%
3/126 • Number of events 3 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
3.1%
2/65 • Number of events 2 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/66 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
3.0%
2/67 • Number of events 2 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
3/196 • Number of events 3 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
5.6%
7/126 • Number of events 8 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
7.7%
5/65 • Number of events 5 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/66 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/65 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
3.0%
2/67 • Number of events 2 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.6%
3/191 • Number of events 3 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Infections and infestations
Bronchitis
|
2.4%
3/126 • Number of events 3 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/65 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
3.0%
2/67 • Number of events 2 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
3.1%
6/196 • Number of events 6 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
7.9%
10/126 • Number of events 10 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/65 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
3.1%
2/65 • Number of events 2 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
4.5%
3/67 • Number of events 3 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
3.7%
7/191 • Number of events 10 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Infections and infestations
Influenza
|
1.6%
2/126 • Number of events 2 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
4.6%
3/65 • Number of events 3 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/67 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
2.0%
4/196 • Number of events 4 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
3.2%
4/126 • Number of events 4 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
6.2%
4/65 • Number of events 4 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/67 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/191 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/126 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
3.1%
2/65 • Number of events 2 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/66 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
4.6%
3/65 • Number of events 3 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/67 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.51%
1/196 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.79%
1/126 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
7.7%
5/65 • Number of events 5 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/66 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
4.6%
3/65 • Number of events 3 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/67 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.52%
1/191 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
3/126 • Number of events 3 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.5%
1/65 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
4.5%
3/66 • Number of events 3 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
3.1%
2/65 • Number of events 2 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
3.0%
2/67 • Number of events 2 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
2.0%
4/196 • Number of events 4 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
4.8%
6/126 • Number of events 6 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
6.2%
4/65 • Number of events 4 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
6.1%
4/66 • Number of events 4 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
7.7%
5/65 • Number of events 6 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
6.0%
4/67 • Number of events 4 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
5.2%
10/191 • Number of events 11 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
|
Nervous system disorders
Headache
|
0.79%
1/126 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
3.0%
2/66 • Number of events 2 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
3.1%
2/65 • Number of events 2 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
3.0%
2/67 • Number of events 2 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.51%
1/196 • Number of events 1 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.6%
2/126 • Number of events 3 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
0.00%
0/65 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
3.0%
2/66 • Number of events 2 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
6.2%
4/65 • Number of events 4 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
4.5%
3/67 • Number of events 3 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
1.6%
3/191 • Number of events 3 • Phase A (up to 24 weeks), Phase A+B (up to 52 weeks). Phase B (Up to 28 weeks [Week 25 to 52])
The ASaT Population was used for this analysis. AEs occuring after glycemic rescue were included in the analysis of SAEs but not for Non-SAEs. 5 participants in the placebo arm discontinued from the study in Phase A. The AEs for the various placebo arms were grouped into 1 placebo arm regardless of the antihyperglycemic basal medication received.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
- Publication restrictions are in place
Restriction type: OTHER