Trial Outcomes & Findings for A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes (SURPASS-CN-MONO) (NCT NCT05963022)
NCT ID: NCT05963022
Last Updated: 2025-10-21
Results Overview
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using ANCOVA model with Baseline + Prior Antihyperglycemic Use + Treatment (Type III sum of squares) as variables.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
206 participants
Primary outcome timeframe
Baseline, Week 40
Results posted on
2025-10-21
Participant Flow
Participant milestones
| Measure |
5 Milligram (mg) Tirzepatide
Participants received 5 mg of tirzepatide administered as subcutaneous (SC) injection via a single-dose pen (SDP) once weekly (QW) for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
|
10 mg Tirzepatide
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
52
|
51
|
52
|
51
|
|
Overall Study
Received at Least One Dose of Study Drug
|
52
|
51
|
52
|
51
|
|
Overall Study
COMPLETED
|
52
|
46
|
48
|
47
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
4
|
4
|
Reasons for withdrawal
| Measure |
5 Milligram (mg) Tirzepatide
Participants received 5 mg of tirzepatide administered as subcutaneous (SC) injection via a single-dose pen (SDP) once weekly (QW) for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
|
10 mg Tirzepatide
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
3
|
0
|
0
|
|
Overall Study
Pregnancy
|
0
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
Overall Study
Subject Required long-term Initiation of Rescue Antihyperglycemic Medication
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes (SURPASS-CN-MONO)
Baseline characteristics by cohort
| Measure |
5 mg Tirzepatide
n=52 Participants
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached
|
10 mg Tirzepatide
n=51 Participants
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=52 Participants
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
n=51 Participants
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
Total
n=206 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46.30 years
STANDARD_DEVIATION 11.37 • n=5 Participants
|
50.70 years
STANDARD_DEVIATION 10.79 • n=7 Participants
|
50.60 years
STANDARD_DEVIATION 12.11 • n=5 Participants
|
47.60 years
STANDARD_DEVIATION 11.56 • n=4 Participants
|
48.80 years
STANDARD_DEVIATION 11.54 • n=21 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
90 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
116 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
206 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
52 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
206 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
China
|
52 participants
n=5 Participants
|
51 participants
n=7 Participants
|
52 participants
n=5 Participants
|
51 participants
n=4 Participants
|
206 participants
n=21 Participants
|
|
Percentage of Hemoglobin A1c (HbA1c) at Baseline
|
8.07 Percentage of HbA1c
STANDARD_DEVIATION 0.77 • n=5 Participants
|
8.13 Percentage of HbA1c
STANDARD_DEVIATION 0.78 • n=7 Participants
|
7.97 Percentage of HbA1c
STANDARD_DEVIATION 0.81 • n=5 Participants
|
7.92 Percentage of HbA1c
STANDARD_DEVIATION 0.67 • n=4 Participants
|
8.02 Percentage of HbA1c
STANDARD_DEVIATION 0.76 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 40Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome, regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using ANCOVA model with Baseline + Prior Antihyperglycemic Use + Treatment (Type III sum of squares) as variables.
Outcome measures
| Measure |
5 mg Tirzepatide
n=52 Participants
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached
|
10 mg Tirzepatide
n=44 Participants
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=48 Participants
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
n=47 Participants
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c)
|
-2.19 percentage of HbA1c
Standard Error 0.121
|
-1.75 percentage of HbA1c
Standard Error 0.131
|
-2.03 percentage of HbA1c
Standard Error 0.124
|
-0.77 percentage of HbA1c
Standard Error 0.126
|
SECONDARY outcome
Timeframe: Week 40Population: All randomized participants who received at least one dose of study drug and had evaluable data for this outcome.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Percentage of participants with HbA1c \<7.0% (\<53 mmol/mol) is reported here.
Outcome measures
| Measure |
5 mg Tirzepatide
n=52 Participants
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached
|
10 mg Tirzepatide
n=44 Participants
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=48 Participants
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
n=47 Participants
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With HbA1c Target Values of <7.0% (<53 Millimole/Mole [mmol/Mol])
|
90.38 percentage of participants
|
86.36 percentage of participants
|
83.33 percentage of participants
|
38.30 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 40Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome, regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.
LS mean was calculated using ANCOVA model with Baseline + Prior Antihyperglycemic Use + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment (Type III sum of squares) as variables.
Outcome measures
| Measure |
5 mg Tirzepatide
n=51 Participants
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached
|
10 mg Tirzepatide
n=46 Participants
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=48 Participants
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
n=49 Participants
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Serum Glucose
|
-55.0 milligram per deciliter (mg/dL)
Standard Error 3.00
|
-54.8 milligram per deciliter (mg/dL)
Standard Error 3.16
|
-55.4 milligram per deciliter (mg/dL)
Standard Error 3.06
|
-30.2 milligram per deciliter (mg/dL)
Standard Error 3.07
|
SECONDARY outcome
Timeframe: Week 40Population: All randomized participants who received at least one dose of study drug and had evaluable data for this outcome.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Percentage of participants with HbA1c ≤6.5% (≤48 mmol/Mol) is reported here.
Outcome measures
| Measure |
5 mg Tirzepatide
n=52 Participants
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached
|
10 mg Tirzepatide
n=44 Participants
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=48 Participants
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
n=47 Participants
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With HbA1c Target Values of ≤6.5% (≤48 mmol/Mol)
|
88.46 percentage of participants
|
75.00 percentage of participants
|
81.25 percentage of participants
|
23.40 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 40Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome, regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.
LS mean was calculated using ANCOVA model with Baseline + Prior Antihyperglycemic Use + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment (Type III sum of squares) as variables.
Outcome measures
| Measure |
5 mg Tirzepatide
n=52 Participants
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached
|
10 mg Tirzepatide
n=46 Participants
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=48 Participants
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
n=49 Participants
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Body Weight
|
-6.1 kilograms (kg)
Standard Error 0.68
|
-5.5 kilograms (kg)
Standard Error 0.71
|
-8.7 kilograms (kg)
Standard Error 0.69
|
-1.3 kilograms (kg)
Standard Error 0.70
|
SECONDARY outcome
Timeframe: Week 40Population: All randomized participants who received at least one dose of study drug and had evaluable data for this outcome.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Percentage of participants with HbA1c \<5.7% (\<39 mmol/mol) is reported here.
Outcome measures
| Measure |
5 mg Tirzepatide
n=52 Participants
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached
|
10 mg Tirzepatide
n=44 Participants
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=48 Participants
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
n=47 Participants
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With HbA1c Target Values of <5.7% (<39 mmol/Mol)
|
40.38 percentage of participants
|
34.09 percentage of participants
|
56.25 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 40Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome regardless of adherence to study drug or initiation of rescue antihyperglycemic medication.
The SMBG data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Post meal, Midday Premeal, Midday 2-hour Post meal, Evening Premeal, Evening 2-hour Post meal and Bedtime. The daily average was calculated as the average of the 7 blood glucose values collected on a particular day. LS Mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Baseline + Baseline HbA1c (\<=8.5%, \>8.5%) + Prior Antihyperglycemic Use + Treatment + Time + Treatment\*Time(Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured.
Outcome measures
| Measure |
5 mg Tirzepatide
n=51 Participants
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached
|
10 mg Tirzepatide
n=45 Participants
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=43 Participants
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
n=27 Participants
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose Profiles (SMBG)
|
-78.4 milligram per deciliter (mg/dL)
Standard Error 3.959
|
-78.3 milligram per deciliter (mg/dL)
Standard Error 4.185
|
-80.8 milligram per deciliter (mg/dL)
Standard Error 4.186
|
-33.9 milligram per deciliter (mg/dL)
Standard Error 5.223
|
SECONDARY outcome
Timeframe: Week 40Population: All randomized participants who received at least one dose of study drug and had evaluable data for this outcome.
Percentage of Participants who Achieved Weight Loss ≥5% is reported here.
Outcome measures
| Measure |
5 mg Tirzepatide
n=51 Participants
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached
|
10 mg Tirzepatide
n=45 Participants
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=43 Participants
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
n=27 Participants
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved Weight Loss of ≥5%
|
54.90 percentage of participants
|
66.67 percentage of participants
|
88.37 percentage of participants
|
7.41 percentage of participants
|
SECONDARY outcome
Timeframe: Week 40Population: All randomized participants who received at least one dose of study drug and had evaluable data for this outcome.
Percentage of Participants who Achieved Weight Loss ≥10% is reported here.
Outcome measures
| Measure |
5 mg Tirzepatide
n=51 Participants
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached
|
10 mg Tirzepatide
n=45 Participants
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=43 Participants
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
n=27 Participants
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved Weight Loss of ≥10%
|
27.45 percentage of participants
|
33.33 percentage of participants
|
58.14 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 40Population: All randomized participants who received at least one dose of study drug and had evaluable data for this outcome.
Percentage of Participants who Achieved Weight Loss ≥15% is reported here.
Outcome measures
| Measure |
5 mg Tirzepatide
n=51 Participants
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached
|
10 mg Tirzepatide
n=45 Participants
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=43 Participants
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
n=27 Participants
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved Weight Loss of ≥15%
|
9.80 percentage of participants
|
13.33 percentage of participants
|
37.21 percentage of participants
|
0 percentage of participants
|
Adverse Events
5 mg Tirzepatide
Serious events: 5 serious events
Other events: 41 other events
Deaths: 0 deaths
10 mg Tirzepatide
Serious events: 6 serious events
Other events: 44 other events
Deaths: 0 deaths
15 mg Tirzepatide
Serious events: 3 serious events
Other events: 45 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
5 mg Tirzepatide
n=52 participants at risk
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
|
10 mg Tirzepatide
n=51 participants at risk
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=52 participants at risk
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
n=51 participants at risk
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Cataract
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
1/52 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
1.9%
1/52 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/52 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fracture
|
1.9%
1/52 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
3.8%
2/52 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/23 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/22 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
4.3%
1/23 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/22 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity mass
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
1.9%
1/52 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Other adverse events
| Measure |
5 mg Tirzepatide
n=52 participants at risk
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
|
10 mg Tirzepatide
n=51 participants at risk
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=52 participants at risk
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
n=51 participants at risk
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.9%
3/51 • Number of events 3 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Tachycardia
|
1.9%
1/52 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.9%
3/51 • Number of events 4 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal distension
|
15.4%
8/52 • Number of events 16 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
11.8%
6/51 • Number of events 9 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
11.5%
6/52 • Number of events 6 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.8%
3/52 • Number of events 3 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.9%
2/51 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.9%
2/51 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
7.7%
4/52 • Number of events 4 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.8%
4/51 • Number of events 5 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.8%
3/52 • Number of events 3 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.1%
12/52 • Number of events 19 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
23.5%
12/51 • Number of events 21 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
28.8%
15/52 • Number of events 41 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Eructation
|
1.9%
1/52 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.8%
4/51 • Number of events 13 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.8%
3/52 • Number of events 21 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
9.6%
5/52 • Number of events 9 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
21.6%
11/51 • Number of events 19 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
26.9%
14/52 • Number of events 34 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Regurgitation
|
5.8%
3/52 • Number of events 4 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.9%
3/51 • Number of events 4 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.6%
5/52 • Number of events 6 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
5.8%
3/52 • Number of events 3 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.8%
4/51 • Number of events 5 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
19.2%
10/52 • Number of events 17 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Fatigue
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.9%
2/51 • Number of events 6 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.8%
3/52 • Number of events 3 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site reaction
|
3.8%
2/52 • Number of events 7 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.9%
2/51 • Number of events 32 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.6%
5/52 • Number of events 27 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
3.8%
2/52 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.8%
3/52 • Number of events 3 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.9%
3/51 • Number of events 3 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Influenza
|
3.8%
2/52 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.9%
3/51 • Number of events 4 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.9%
2/51 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Respiratory tract infection
|
9.6%
5/52 • Number of events 6 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.9%
2/51 • Number of events 3 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
21.2%
11/52 • Number of events 14 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
17.6%
9/51 • Number of events 12 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
17.3%
9/52 • Number of events 13 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
19.6%
10/51 • Number of events 17 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/23 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.1%
2/22 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Amylase increased
|
3.8%
2/52 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.9%
2/51 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.6%
5/52 • Number of events 6 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Lipase increased
|
7.7%
4/52 • Number of events 4 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.9%
2/51 • Number of events 4 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
4/52 • Number of events 4 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
28.8%
15/52 • Number of events 18 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.5%
13/51 • Number of events 21 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
26.9%
14/52 • Number of events 19 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
3.8%
2/52 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.9%
2/51 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
2/52 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.8%
4/51 • Number of events 4 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.9%
1/52 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
2/52 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
33.3%
17/51 • Number of events 17 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
3.8%
2/52 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.8%
4/51 • Number of events 4 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.9%
2/51 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
9.6%
5/52 • Number of events 5 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.9%
3/51 • Number of events 3 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
4/52 • Number of events 4 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.9%
3/51 • Number of events 3 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.9%
3/51 • Number of events 3 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
1.9%
1/52 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.8%
3/52 • Number of events 3 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.8%
4/51 • Number of events 6 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
4.3%
1/23 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.5%
1/22 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.00%
0/23 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
1/20 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/22 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.8%
3/52 • Number of events 3 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.8%
3/52 • Number of events 3 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
5.8%
3/52 • Number of events 3 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.8%
4/51 • Number of events 4 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.8%
5/51 • Number of events 5 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hypotension
|
1.9%
1/52 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.8%
3/52 • Number of events 4 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue antihyperglycemic medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60