Trial Outcomes & Findings for A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes (NCT NCT02963766)
NCT ID: NCT02963766
Last Updated: 2022-07-01
Results Overview
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) mean in HbA1c was calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) and adjusted by, baseline + insulin Use + metformin Use + treatment + time + treatment\*time (Type III sum of squares). Variance-covariance structure = unstructured (for actual value) / unstructured (for change from baseline).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
154 participants
Primary outcome timeframe
Baseline, Week 26
Results posted on
2022-07-01
Participant Flow
Participant milestones
| Measure |
Placebo/0.75 Milligram (mg) Dulaglutide
Participants received placebo administered subcutaneously (SC) for 26 weeks during the double-blind period and open-label 0.75 mg/week dulaglutide for 26 weeks during the open Label Extension (OLE).
|
0.75 mg Dulaglutide
Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 0.75 mg/week for 26 weeks during the OLE.
|
1.5 mg Dulaglutide
Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 1.5 mg/week for 26 weeks during the OLE.
|
|---|---|---|---|
|
Double-Blind Period
STARTED
|
51
|
51
|
52
|
|
Double-Blind Period
Received at Least 1 Dose of Study Drug
|
51
|
51
|
52
|
|
Double-Blind Period
COMPLETED
|
47
|
49
|
50
|
|
Double-Blind Period
NOT COMPLETED
|
4
|
2
|
2
|
|
Open Label Extension (OLE)
STARTED
|
47
|
49
|
50
|
|
Open Label Extension (OLE)
COMPLETED
|
45
|
46
|
48
|
|
Open Label Extension (OLE)
NOT COMPLETED
|
2
|
3
|
2
|
Reasons for withdrawal
| Measure |
Placebo/0.75 Milligram (mg) Dulaglutide
Participants received placebo administered subcutaneously (SC) for 26 weeks during the double-blind period and open-label 0.75 mg/week dulaglutide for 26 weeks during the open Label Extension (OLE).
|
0.75 mg Dulaglutide
Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 0.75 mg/week for 26 weeks during the OLE.
|
1.5 mg Dulaglutide
Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 1.5 mg/week for 26 weeks during the OLE.
|
|---|---|---|---|
|
Double-Blind Period
Adverse Event
|
1
|
0
|
1
|
|
Double-Blind Period
Physician Decision
|
1
|
0
|
0
|
|
Double-Blind Period
Withdrawal by Subject
|
1
|
1
|
0
|
|
Double-Blind Period
Withdrawal by Parent or Guardian
|
0
|
0
|
1
|
|
Double-Blind Period
Protocol Violation
|
1
|
0
|
0
|
|
Double-Blind Period
Lost to Follow-up
|
0
|
1
|
0
|
|
Open Label Extension (OLE)
Physician Decision
|
1
|
2
|
2
|
|
Open Label Extension (OLE)
Withdrawal by Subject
|
1
|
1
|
0
|
Baseline Characteristics
A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Placebo/0.75 mg Dulaglutide
n=51 Participants
Participants received placebo administered SC for 26 weeks during the double-blind period and open-label 0.75 mg/week dulaglutide for 26 weeks during the OLE.
|
0.75 mg Dulaglutide
n=51 Participants
Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 0.75 mg/week for 26 weeks during the OLE.
|
1.5 mg Dulaglutide
n=52 Participants
Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 1.5 mg/week for 26 weeks during the OLE.
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
14.20 years
STANDARD_DEVIATION 2.08 • n=5 Participants
|
14.70 years
STANDARD_DEVIATION 2.21 • n=7 Participants
|
14.70 years
STANDARD_DEVIATION 1.81 • n=5 Participants
|
14.50 years
STANDARD_DEVIATION 2.04 • n=4 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
110 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
Brazil
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Region of Enrollment
France
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
India
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Region of Enrollment
Mexico
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Region of Enrollment
Puerto Rico
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
Saudi Arabia
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
Turkey
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Percentage of Hemoglobin A1c (HbA1c) at Baseline
|
8.14 Percentage of HbA1c
STANDARD_DEVIATION 1.12 • n=5 Participants
|
7.92 Percentage of HbA1c
STANDARD_DEVIATION 1.27 • n=7 Participants
|
8.16 Percentage of HbA1c
STANDARD_DEVIATION 1.39 • n=5 Participants
|
8.08 Percentage of HbA1c
STANDARD_DEVIATION 1.26 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c.
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) mean in HbA1c was calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) and adjusted by, baseline + insulin Use + metformin Use + treatment + time + treatment\*time (Type III sum of squares). Variance-covariance structure = unstructured (for actual value) / unstructured (for change from baseline).
Outcome measures
| Measure |
Placebo
n=45 Participants
Participants received placebo administered SC for 26 weeks.
|
Pooled Dulaglutide
n=100 Participants
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
1.5 mg Dulaglutide
Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
Pooled Dulaglutide
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26
|
0.5 percentage of HbA1C
Standard Error 0.24
|
-0.7 percentage of HbA1C
Standard Error 0.16
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c.
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean in HbA1c was calculated using a REML based MMRM and adjusted by, baseline + insulin use + metformin use + treatment + time + treatment\*time (Type III sum of squares). Variance-covariance structure = unstructured (for actual value) / unstructured (for change from baseline).
Outcome measures
| Measure |
Placebo
n=45 Participants
Participants received placebo administered SC for 26 weeks.
|
Pooled Dulaglutide
n=50 Participants
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
1.5 mg Dulaglutide
n=50 Participants
Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
Pooled Dulaglutide
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in HbA1c (Individual Doses) at Week 26
|
0.5 percentage of HbA1c
Standard Error 0.24
|
-0.5 percentage of HbA1c
Standard Error 0.22
|
-1.0 percentage of HbA1c
Standard Error 0.22
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants who received at least one dose of study drug and had evaluable fasting blood glucose data. Only pre-rescue measurements were used.
Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis and adjusted by baseline, strata, treatment, time, treatment\*time, (Type III sum of squares). Variance-Covariance structure = Unstructured (for actual value) / Unstructured (for change from baseline). Strata refer to: insulin use + metformin use + baseline HbA1c group \[ less than (\<) 8%, greater than or equal to (\>=) 8%).
Outcome measures
| Measure |
Placebo
n=43 Participants
Participants received placebo administered SC for 26 weeks.
|
Pooled Dulaglutide
n=49 Participants
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
1.5 mg Dulaglutide
n=50 Participants
Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
Pooled Dulaglutide
n=99 Participants
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (FBG) at Week 26
|
0.96 millimoles per liter (mmol/L)
Standard Error 0.45
|
-0.47 millimoles per liter (mmol/L)
Standard Error 0.41
|
-1.54 millimoles per liter (mmol/L)
Standard Error 0.41
|
-1.03 millimoles per liter (mmol/L)
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Week 26Population: All randomized participants who received at least 1 dose of study drug and had evaluable baseline and post-baseline HbA1c.
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.
Outcome measures
| Measure |
Placebo
n=45 Participants
Participants received placebo administered SC for 26 weeks.
|
Pooled Dulaglutide
n=50 Participants
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
1.5 mg Dulaglutide
n=50 Participants
Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
Pooled Dulaglutide
n=100 Participants
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With HbA1c ≤7.0%
|
18.42 percentage of participants
|
60.00 percentage of participants
|
53.19 percentage of participants
|
56.52 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants who received at least one dose of study drug and had evaluable BMI data.
BMI is an estimate of body fat based on body weight divided by height squared. LS mean were calculated using a MMRM analysis and adjusted by baseline, strata, treatment, time, treatment\*time, (Type III sum of squares). Variance-Covariance structure = Unstructured (for actual value) / Unstructured (for change from baseline). Strata refer to: insulin use + metformin use + baseline HbA1c group (\< 8%, \>= 8%).
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants received placebo administered SC for 26 weeks.
|
Pooled Dulaglutide
n=51 Participants
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
1.5 mg Dulaglutide
n=52 Participants
Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
Pooled Dulaglutide
n=103 Participants
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Body Mass Index (BMI) at Week 26
|
-0.0 kilograms/square meter (kg/m^2)
Standard Error 0.21
|
-0.2 kilograms/square meter (kg/m^2)
Standard Error 0.20
|
-0.1 kilograms/square meter (kg/m^2)
Standard Error 0.19
|
-0.1 kilograms/square meter (kg/m^2)
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Week 26Population: All randomized participants who received at least 1 dose of study drug.
Summary and analysis of Incidence of all hypoglycemia with Plasma Glucose \<54mg/dL.
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants received placebo administered SC for 26 weeks.
|
Pooled Dulaglutide
n=51 Participants
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
1.5 mg Dulaglutide
n=52 Participants
Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
Pooled Dulaglutide
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Self-Reported Events of Hypoglycemia
|
1.96 percentage of participants
|
3.92 percentage of participants
|
3.85 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 26Population: All randomized participants who received at least 1 dose of study drug.
Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia was summarized.
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants received placebo administered SC for 26 weeks.
|
Pooled Dulaglutide
n=51 Participants
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
1.5 mg Dulaglutide
n=52 Participants
Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
Pooled Dulaglutide
n=103 Participants
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia
|
17.6 percentage of participants
|
3.9 percentage of participants
|
1.9 percentage of participants
|
2.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 26Population: All randomized participants who received at least 1 dose of study drug.
The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants received placebo administered SC for 26 weeks.
|
Pooled Dulaglutide
n=51 Participants
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
1.5 mg Dulaglutide
n=52 Participants
Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
Pooled Dulaglutide
n=103 Participants
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Adjudicated Pancreatitis
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants who received at least one dose of study drug and had evaluable pancreatic enzymes data.
Serum Amylase (total and pancreas-derived) and lipase concentrations were measured.
Outcome measures
| Measure |
Placebo
n=47 Participants
Participants received placebo administered SC for 26 weeks.
|
Pooled Dulaglutide
n=51 Participants
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
1.5 mg Dulaglutide
n=52 Participants
Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
Pooled Dulaglutide
n=103 Participants
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Pancreatic Enzymes at Week 26
Serum Amylase
|
0.09 Units/Liter (U/L)
Standard Deviation 17.36
|
4.80 Units/Liter (U/L)
Standard Deviation 9.39
|
6.50 Units/Liter (U/L)
Standard Deviation 8.91
|
5.64 Units/Liter (U/L)
Standard Deviation 9.15
|
|
Change From Baseline in Pancreatic Enzymes at Week 26
Serum Amylase, Pancreatic
|
0.60 Units/Liter (U/L)
Standard Deviation 9.94
|
1.77 Units/Liter (U/L)
Standard Deviation 4.72
|
2.90 Units/Liter (U/L)
Standard Deviation 6.10
|
2.32 Units/Liter (U/L)
Standard Deviation 5.45
|
|
Change From Baseline in Pancreatic Enzymes at Week 26
Serum Lipase
|
2.23 Units/Liter (U/L)
Standard Deviation 31.99
|
4.37 Units/Liter (U/L)
Standard Deviation 8.28
|
3.88 Units/Liter (U/L)
Standard Deviation 6.63
|
4.12 Units/Liter (U/L)
Standard Deviation 7.47
|
SECONDARY outcome
Timeframe: Week 26Population: All randomized participants who received at least 1 dose of study drug.
Number of Participants with Thyroid Treatment-Emergent Adverse Events were summarized.
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants received placebo administered SC for 26 weeks.
|
Pooled Dulaglutide
n=51 Participants
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
1.5 mg Dulaglutide
n=52 Participants
Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
Pooled Dulaglutide
n=103 Participants
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Thyroid Treatment-Emergent Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants who received at least one dose of study drug and had evaluable serum calcitonin data.
Change from Baseline in Serum Calcitonin was evaluated.
Outcome measures
| Measure |
Placebo
n=47 Participants
Participants received placebo administered SC for 26 weeks.
|
Pooled Dulaglutide
n=48 Participants
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
1.5 mg Dulaglutide
n=48 Participants
Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
Pooled Dulaglutide
n=96 Participants
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Serum Calcitonin at Week 26
|
0.38 nanograms per liter (ng/L)
Standard Deviation 1.70
|
0.28 nanograms per liter (ng/L)
Standard Deviation 0.72
|
0.10 nanograms per liter (ng/L)
Standard Deviation 0.50
|
0.19 nanograms per liter (ng/L)
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: Week 26Population: All randomized participants who received at least one dose of study drug.
The percentage of Participants with Allergic and hypersensitivity reactions that were considered possibly related to study drug by the investigator are presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants received placebo administered SC for 26 weeks.
|
Pooled Dulaglutide
n=51 Participants
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
1.5 mg Dulaglutide
n=52 Participants
Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
Pooled Dulaglutide
n=103 Participants
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Allergic, Hypersensitivity Reactions
|
2.0 percentage of participants
|
3.9 percentage of participants
|
1.9 percentage of participants
|
2.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 26Population: All randomized participants who received at least one dose of study drug.
The percentage of participants with at least one treatment-emergent injection site reaction is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants received placebo administered SC for 26 weeks.
|
Pooled Dulaglutide
n=51 Participants
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
1.5 mg Dulaglutide
n=52 Participants
Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
Pooled Dulaglutide
n=103 Participants
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Injection Site Reactions
|
9.8 percentage of participants
|
9.8 percentage of participants
|
7.7 percentage of participants
|
8.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through Week 56Population: All randomized participants who received at least 1 dose of study drug and had at least one post-baseline Dulaglutide ADA test result.
Dulaglutide anti-drug antibodies (ADA) were assessed at baseline, Weeks 26 and 56. A participant was considered to have treatment-emergent (TE) dulaglutide ADAs if the participant had at least 1 titer that was TE relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.
Outcome measures
| Measure |
Placebo
n=46 Participants
Participants received placebo administered SC for 26 weeks.
|
Pooled Dulaglutide
n=51 Participants
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
1.5 mg Dulaglutide
n=52 Participants
Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
Pooled Dulaglutide
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Anti-Dulaglutide Antibodies
|
3 participants
|
3 participants
|
3 participants
|
—
|
SECONDARY outcome
Timeframe: Week 9: pre-dose,1 to 12 hours post dose and 24 to 96 hours post dose; Week 13: predose and 1 to 12 hours post dose; Week 26: predose; Week 39: up to 2 days postdose; Week 52 and Week 56: PK sample can be taken at any time during the visitPopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: Maximum Concentration of Dulaglutide at steady-state (Cmax,ss) was derived by a population pharmacokinetics approach. As part of addendum, additional PK samples were taken at week 9.
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants received placebo administered SC for 26 weeks.
|
Pooled Dulaglutide
n=52 Participants
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
1.5 mg Dulaglutide
Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
Pooled Dulaglutide
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration of Dulaglutide at Steady-state (Cmax,ss)
|
31 nanograms per milliliter (ng/mL)
Interval 28.4 to 33.5
|
62 nanograms per milliliter (ng/mL)
Interval 56.9 to 67.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 9: pre-dose,1 to 12 hours post dose and 24 to 96 hours post dose; Week 13: predose and 1 to 12 hours post dose; Week 26: predose; Week 39: up to 2 days postdose; Week 52 and Week 56: PK sample can be taken at any time during the visitPopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: Area Under the Concentration Time Curve over a 1-week interval of Dulaglutide at Steady-State \[AUC(0-168)ss\] was derived by a population pharmacokinetics approach. As part of addendum, additional PK samples were taken at week 9.
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants received placebo administered SC for 26 weeks.
|
Pooled Dulaglutide
n=52 Participants
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
1.5 mg Dulaglutide
Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
Pooled Dulaglutide
Participants received pooled: 0.75 mg/week dulaglutide and 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
|---|---|---|---|---|
|
PK: Area Under the Concentration Time Curve Over a 1-week Interval of Dulaglutide at Steady-State [AUC(0-168)ss]
|
4170 nanogram*hour per milliliter (ng*h/ mL)
Interval 3770.0 to 4510.0
|
8350 nanogram*hour per milliliter (ng*h/ mL)
Interval 7640.0 to 9070.0
|
—
|
—
|
Adverse Events
Placebo: Double-Blind Period
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
0.75 mg Dulaglutide: Double-Blind Period
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
1.5 mg Dulaglutide: Double-Blind Period
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Placebo/0.75 mg Dulaglutide: Open Label Extension (OLE)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
0.75 mg Dulaglutide: OLE
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
1.5 mg Dulaglutide: OLE
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo: Double-Blind Period
n=51 participants at risk
Participants received placebo administered SC for 26 weeks.
|
0.75 mg Dulaglutide: Double-Blind Period
n=51 participants at risk
Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks.
|
1.5 mg Dulaglutide: Double-Blind Period
n=52 participants at risk
Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
Placebo/0.75 mg Dulaglutide: Open Label Extension (OLE)
n=47 participants at risk
Participants who had received placebo during the double-blind period were given 0.75 mg/week dulaglutide administered SC for additional 26 weeks after the double-blind period.
|
0.75 mg Dulaglutide: OLE
n=49 participants at risk
Participants received 0.75 mg/week dulaglutide administered SC for additional 26 weeks after the double-blind period.
|
1.5 mg Dulaglutide: OLE
n=50 participants at risk
Participants received 1.5 mg/week dulaglutide administered SC for additional 26 weeks after the double-blind period.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Right ventricular failure
|
2.0%
1/51 • Number of events 1 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/51 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/52 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/47 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/49 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/50 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
|
Hepatobiliary disorders
Nonalcoholic fatty liver disease
|
0.00%
0/51 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/52 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/47 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/49 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/50 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
|
Infections and infestations
Genital herpes
|
2.0%
1/51 • Number of events 1 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/51 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/52 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/47 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/49 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/50 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/51 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/51 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/52 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/47 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
2.0%
1/49 • Number of events 1 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/50 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/51 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/51 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/52 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/47 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/49 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.00%
0/51 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/51 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/52 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/47 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/49 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/51 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/51 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/47 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/49 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/50 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
2.0%
1/51 • Number of events 1 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/51 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/52 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/47 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/49 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/50 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
|
Psychiatric disorders
Suicide attempt
|
2.0%
1/51 • Number of events 1 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/51 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/52 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/47 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/49 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/50 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.0%
1/51 • Number of events 1 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/51 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/52 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/47 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/49 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/50 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.0%
1/51 • Number of events 1 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/51 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/52 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/47 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/49 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/50 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
Other adverse events
| Measure |
Placebo: Double-Blind Period
n=51 participants at risk
Participants received placebo administered SC for 26 weeks.
|
0.75 mg Dulaglutide: Double-Blind Period
n=51 participants at risk
Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks.
|
1.5 mg Dulaglutide: Double-Blind Period
n=52 participants at risk
Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks.
|
Placebo/0.75 mg Dulaglutide: Open Label Extension (OLE)
n=47 participants at risk
Participants who had received placebo during the double-blind period were given 0.75 mg/week dulaglutide administered SC for additional 26 weeks after the double-blind period.
|
0.75 mg Dulaglutide: OLE
n=49 participants at risk
Participants received 0.75 mg/week dulaglutide administered SC for additional 26 weeks after the double-blind period.
|
1.5 mg Dulaglutide: OLE
n=50 participants at risk
Participants received 1.5 mg/week dulaglutide administered SC for additional 26 weeks after the double-blind period.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
3/51 • Number of events 3 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
7.8%
4/51 • Number of events 4 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
1.9%
1/52 • Number of events 4 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/47 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
6.1%
3/49 • Number of events 5 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
6.0%
3/50 • Number of events 3 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.8%
4/51 • Number of events 8 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
5.9%
3/51 • Number of events 3 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
9.6%
5/52 • Number of events 6 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
4.3%
2/47 • Number of events 2 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/49 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
10.0%
5/50 • Number of events 21 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.7%
7/51 • Number of events 9 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
15.7%
8/51 • Number of events 13 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
21.2%
11/52 • Number of events 19 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/47 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
2.0%
1/49 • Number of events 1 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
12.0%
6/50 • Number of events 21 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
7.8%
4/51 • Number of events 4 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
13.7%
7/51 • Number of events 16 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
15.4%
8/52 • Number of events 13 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
2.1%
1/47 • Number of events 2 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
6.1%
3/49 • Number of events 10 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
12.0%
6/50 • Number of events 12 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
3.9%
2/51 • Number of events 2 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
17.6%
9/51 • Number of events 10 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
13.5%
7/52 • Number of events 14 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
8.5%
4/47 • Number of events 6 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
8.2%
4/49 • Number of events 4 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
10.0%
5/50 • Number of events 8 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
|
General disorders
Pyrexia
|
3.9%
2/51 • Number of events 2 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
3.9%
2/51 • Number of events 3 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
3.8%
2/52 • Number of events 2 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
4.3%
2/47 • Number of events 3 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
6.1%
3/49 • Number of events 3 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
3.9%
2/51 • Number of events 3 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
5.8%
3/52 • Number of events 3 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
8.5%
4/47 • Number of events 5 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/49 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
6.0%
3/50 • Number of events 4 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
3/51 • Number of events 4 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
9.8%
5/51 • Number of events 6 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
3.8%
2/52 • Number of events 2 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
8.5%
4/47 • Number of events 4 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
2.0%
1/49 • Number of events 1 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
6.0%
3/50 • Number of events 3 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.8%
4/51 • Number of events 6 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
3.9%
2/51 • Number of events 3 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
11.5%
6/52 • Number of events 7 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
6.4%
3/47 • Number of events 4 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/49 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
3/51 • Number of events 3 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
3.9%
2/51 • Number of events 3 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/52 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
4.3%
2/47 • Number of events 2 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
2.0%
1/49 • Number of events 1 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/50 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/51 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
5.9%
3/51 • Number of events 3 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
3.8%
2/52 • Number of events 2 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/47 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/49 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/50 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
2.0%
1/51 • Number of events 1 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
7.8%
4/51 • Number of events 4 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
3.8%
2/52 • Number of events 2 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
2.1%
1/47 • Number of events 1 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
2.0%
1/49 • Number of events 1 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
2.0%
1/50 • Number of events 1 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
|
Nervous system disorders
Headache
|
9.8%
5/51 • Number of events 8 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
13.7%
7/51 • Number of events 7 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
15.4%
8/52 • Number of events 21 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
4.3%
2/47 • Number of events 2 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
10.2%
5/49 • Number of events 6 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
10.0%
5/50 • Number of events 6 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
2.4%
1/41 • Number of events 1 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
2.9%
1/35 • Number of events 1 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
5.9%
2/34 • Number of events 4 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/38 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/34 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
8.8%
3/34 • Number of events 3 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/41 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/35 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/38 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/34 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/34 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
1/51 • Number of events 1 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/51 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/52 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
6.4%
3/47 • Number of events 3 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/49 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
0.00%
0/50 • Up To 56 Weeks
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60