Trial Outcomes & Findings for A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes (NCT NCT02750410)
NCT ID: NCT02750410
Last Updated: 2019-09-24
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 HbA1c, treatment, visit, and treatment-by-visit insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin), where participant treated as a random effect.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
159 participants
Primary outcome timeframe
Baseline, Week 16
Results posted on
2019-09-24
Participant Flow
After 16 weeks of the primary double-blind treatment period, participants taking placebo were switched to dulaglutide for an additional 36 weeks of open-label extension treatment. Efficacy was assessed for 16 weeks based on hypoglycemic agent evaluation.
Participant milestones
| Measure |
Placebo
Placebo administered subcutaneously (SC) once weekly for 16 weeks. After 16-weeks, Dulaglutide 0.75 milligram (mg) administered SC once weekly for 36 weeks.
|
Dulaglutide
Dulaglutide administered SC once weekly for 16 weeks. After 16-weeks, Dulaglutide 0.75 mg administered SC once weekly for 36 weeks.
|
|---|---|---|
|
Double-Blind Treatment Period
STARTED
|
39
|
120
|
|
Double-Blind Treatment Period
Received at Least One Dose of Study Drug
|
39
|
120
|
|
Double-Blind Treatment Period
COMPLETED
|
37
|
117
|
|
Double-Blind Treatment Period
NOT COMPLETED
|
2
|
3
|
|
Open-Label Extension Period
STARTED
|
37
|
117
|
|
Open-Label Extension Period
COMPLETED
|
31
|
111
|
|
Open-Label Extension Period
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Placebo administered subcutaneously (SC) once weekly for 16 weeks. After 16-weeks, Dulaglutide 0.75 milligram (mg) administered SC once weekly for 36 weeks.
|
Dulaglutide
Dulaglutide administered SC once weekly for 16 weeks. After 16-weeks, Dulaglutide 0.75 mg administered SC once weekly for 36 weeks.
|
|---|---|---|
|
Double-Blind Treatment Period
Adverse Event
|
2
|
2
|
|
Double-Blind Treatment Period
Withdrawal by Subject
|
0
|
1
|
|
Open-Label Extension Period
Adverse Event
|
5
|
3
|
|
Open-Label Extension Period
Protocol Violation
|
0
|
1
|
|
Open-Label Extension Period
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Placebo
n=39 Participants
Placebo administered SC once weekly for 16 weeks. After 16-weeks, Dulaglutide 0.75 mg administered SC once weekly for 36 weeks.
|
Dulaglutide
n=120 Participants
Dulaglutide 0.75 mg administered SC once weekly for 16 weeks. After 16-weeks, Dulaglutide 0.75 mg administered SC once weekly for 36 weeks.
|
Total
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 10.68 • n=93 Participants
|
59.3 years
STANDARD_DEVIATION 10.23 • n=4 Participants
|
59.3 years
STANDARD_DEVIATION 10.31 • n=27 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
78 Participants
n=4 Participants
|
98 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=93 Participants
|
120 Participants
n=4 Participants
|
159 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
39 Participants
n=93 Participants
|
120 Participants
n=4 Participants
|
159 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Japan
|
39 Participants
n=93 Participants
|
120 Participants
n=4 Participants
|
159 Participants
n=27 Participants
|
|
Percentage of Hemoglobin A1c (HbA1c) at Baseline
|
8.64 Percentage of HbA1c
STANDARD_DEVIATION 0.72 • n=93 Participants
|
8.50 Percentage of HbA1c
STANDARD_DEVIATION 0.69 • n=4 Participants
|
8.53 Percentage of HbA1c
STANDARD_DEVIATION 0.70 • n=27 Participants
|
|
Percentage of Participants with Insulin regimen
Basal
|
43.6 percentage of insulin regimen
n=93 Participants
|
43.3 percentage of insulin regimen
n=4 Participants
|
43.4 percentage of insulin regimen
n=27 Participants
|
|
Percentage of Participants with Insulin regimen
Premixed
|
23.1 percentage of insulin regimen
n=93 Participants
|
21.7 percentage of insulin regimen
n=4 Participants
|
22.0 percentage of insulin regimen
n=27 Participants
|
|
Percentage of Participants with Insulin regimen
Basal/meal time
|
33.3 percentage of insulin regimen
n=93 Participants
|
35.0 percentage of insulin regimen
n=4 Participants
|
34.6 percentage of insulin regimen
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: 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 HbA1c, treatment, visit, and treatment-by-visit insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin), where participant treated as a random effect.
Outcome measures
| Measure |
Placebo
n=39 Participants
Placebo administered SC for 16 weeks.
|
Dulaglutide
n=120 Participants
Dulaglutide 0.75 mg administered SC once weekly for 16 weeks.
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c)
|
0.06 percentage of HbA1c
Standard Error 0.099
|
-1.45 percentage of HbA1c
Standard Error 0.057
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants who received at least one dose of study drug had evaluable post-baseline HbA1c data. HbA1c ≤6.5% had no results since model did not converge.
Percentage of participants whose HbA1c was \<7.0% or ≤6.5%. HbA1c \<7.0% is presented.
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo administered SC for 16 weeks.
|
Dulaglutide
n=116 Participants
Dulaglutide 0.75 mg administered SC once weekly for 16 weeks.
|
|---|---|---|
|
Percentage of Participants With HbA1c <7.0% or ≤6.5%
|
47.4 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants who received at least one dose of study drug and had evaluable post baseline data.
The LS mean change from baseline in FSG was calculated using a REML based MMRM and adjusted by, baseline value, treatment, visit, treatment-by-visit, baseline HbA1c Group (\<8.5%, \>=8.5%) + insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin), where participant treated as a random effect.
Outcome measures
| Measure |
Placebo
n=39 Participants
Placebo administered SC for 16 weeks.
|
Dulaglutide
n=118 Participants
Dulaglutide 0.75 mg administered SC once weekly for 16 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Serum Glucose (FSG)
|
-4.1 milligram/deciliter (mg/dL)
Standard Error 4.94
|
-34.2 milligram/deciliter (mg/dL)
Standard Error 2.78
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants who received at least one dose of study drug and had evaluable post baseline data.
The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: prebreakfast blood glucose (BG), breakfast 2-hour postprandial blood glucose (PPBG), prelunch BG, lunch 2-hour PPBG, predinner BG, dinner 2-hour PPBG, and bedtime BG. LS mean was calculated with fixed effect test of analysis of covariance (ANCOVA) model and adjusted by, baseline value, treatment, baseline HbA1c Group (\<8.5%, ≥8.5%), insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin).
Outcome measures
| Measure |
Placebo
n=39 Participants
Placebo administered SC for 16 weeks.
|
Dulaglutide
n=120 Participants
Dulaglutide 0.75 mg administered SC once weekly for 16 weeks.
|
|---|---|---|
|
Change From Baseline in Plasma Glucose From 7-Point Self-Monitored Blood Glucose Profiles (SMBG)
Dinner 2-hour PPBG
|
3.97 mg/dL
Standard Error 7.91
|
-30.99 mg/dL
Standard Error 4.48
|
|
Change From Baseline in Plasma Glucose From 7-Point Self-Monitored Blood Glucose Profiles (SMBG)
Prebreakfast BG
|
12.30 mg/dL
Standard Error 4.37
|
-14.28 mg/dL
Standard Error 2.52
|
|
Change From Baseline in Plasma Glucose From 7-Point Self-Monitored Blood Glucose Profiles (SMBG)
Breakfast 2-hour PPBG
|
13.15 mg/dL
Standard Error 7.35
|
-32.24 mg/dL
Standard Error 4.19
|
|
Change From Baseline in Plasma Glucose From 7-Point Self-Monitored Blood Glucose Profiles (SMBG)
Prelunch BG
|
8.08 mg/dL
Standard Error 5.56
|
-28.74 mg/dL
Standard Error 3.18
|
|
Change From Baseline in Plasma Glucose From 7-Point Self-Monitored Blood Glucose Profiles (SMBG)
Lunch 2-hour PPBG
|
10.74 mg/dL
Standard Error 7.39
|
-39.42 mg/dL
Standard Error 4.54
|
|
Change From Baseline in Plasma Glucose From 7-Point Self-Monitored Blood Glucose Profiles (SMBG)
Predinner BG
|
5.66 mg/dL
Standard Error 5.74
|
-25.61 mg/dL
Standard Error 3.28
|
|
Change From Baseline in Plasma Glucose From 7-Point Self-Monitored Blood Glucose Profiles (SMBG)
Bedtime BG
|
13.21 mg/dL
Standard Error 7.78
|
-28.24 mg/dL
Standard Error 4.45
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants who received at least one dose of study drug and had evaluable post baseline data.
LS mean change from baseline in body weight was calculated using a REML based MMRM and was adjusted by, baseline value, treatment, visit, treatment-by-visit, baseline HbA1c group (\<8.5%, \>=8.5%), insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin), where participant treated as a random effect.
Outcome measures
| Measure |
Placebo
n=39 Participants
Placebo administered SC for 16 weeks.
|
Dulaglutide
n=120 Participants
Dulaglutide 0.75 mg administered SC once weekly for 16 weeks.
|
|---|---|---|
|
Change From Baseline in Body Weight
|
-0.30 kilogram (kg)
Standard Error 0.302
|
-0.20 kilogram (kg)
Standard Error 0.171
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants who received at least one dose of study drug.
Mean change from baseline in total insulin dose was measured in each treatment groups.
Outcome measures
| Measure |
Placebo
n=39 Participants
Placebo administered SC for 16 weeks.
|
Dulaglutide
n=120 Participants
Dulaglutide 0.75 mg administered SC once weekly for 16 weeks.
|
|---|---|---|
|
Change From Baseline in Daily Total Insulin Dose
|
-0.3 International Units (IU)/Day
Standard Deviation 1.2
|
-1.1 International Units (IU)/Day
Standard Deviation 3.1
|
Adverse Events
Placebo Double-Blind (DB) Treatment Period
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Dulaglutide 0.75 mg DB Treatment Period
Serious events: 3 serious events
Other events: 47 other events
Deaths: 0 deaths
Placebo DB Treatment, Dulaglutide 0.75 mg Extension Period
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Dulaglutide 0.75 mg DB Treatment/Extension Period
Serious events: 6 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Double-Blind (DB) Treatment Period
n=39 participants at risk
Placebo administered SC once weekly for 16 weeks.
|
Dulaglutide 0.75 mg DB Treatment Period
n=120 participants at risk
Dulaglutide 0.75 mg administered SC once weekly for 16 weeks.
|
Placebo DB Treatment, Dulaglutide 0.75 mg Extension Period
n=39 participants at risk
Placebo administered SC once weekly for 16 weeks then Dulaglutide 0.75 mg administered SC once weekly for 36 weeks.
|
Dulaglutide 0.75 mg DB Treatment/Extension Period
n=120 participants at risk
Dulaglutide 0.75 mg administered SC once weekly for 52 weeks.
|
|---|---|---|---|---|
|
Eye disorders
Cataract
|
0.00%
0/39 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
0.00%
0/120 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
0.00%
0/39 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
0.83%
1/120 • Number of events 1 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/39 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
0.00%
0/120 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
0.00%
0/39 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
0.83%
1/120 • Number of events 1 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/39 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
0.83%
1/120 • Number of events 1 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
0.00%
0/39 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
0.83%
1/120 • Number of events 1 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/39 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
0.83%
1/120 • Number of events 1 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
0.00%
0/39 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
0.83%
1/120 • Number of events 1 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/39 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
0.83%
1/120 • Number of events 1 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
0.00%
0/39 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
0.83%
1/120 • Number of events 1 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/39 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
0.00%
0/120 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
0.00%
0/39 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
0.83%
1/120 • Number of events 1 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
|
Psychiatric disorders
Depression
|
0.00%
0/39 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
0.00%
0/120 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
2.6%
1/39 • Number of events 1 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
0.00%
0/120 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/39 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
0.00%
0/120 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
2.6%
1/39 • Number of events 1 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
0.00%
0/120 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
Other adverse events
| Measure |
Placebo Double-Blind (DB) Treatment Period
n=39 participants at risk
Placebo administered SC once weekly for 16 weeks.
|
Dulaglutide 0.75 mg DB Treatment Period
n=120 participants at risk
Dulaglutide 0.75 mg administered SC once weekly for 16 weeks.
|
Placebo DB Treatment, Dulaglutide 0.75 mg Extension Period
n=39 participants at risk
Placebo administered SC once weekly for 16 weeks then Dulaglutide 0.75 mg administered SC once weekly for 36 weeks.
|
Dulaglutide 0.75 mg DB Treatment/Extension Period
n=120 participants at risk
Dulaglutide 0.75 mg administered SC once weekly for 52 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
2.6%
1/39 • Number of events 1 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
0.83%
1/120 • Number of events 1 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
5.1%
2/39 • Number of events 3 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
1.7%
2/120 • Number of events 2 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.6%
1/39 • Number of events 1 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
8.3%
10/120 • Number of events 17 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
12.8%
5/39 • Number of events 5 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
9.2%
11/120 • Number of events 18 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
|
Gastrointestinal disorders
Constipation
|
10.3%
4/39 • Number of events 4 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
6.7%
8/120 • Number of events 8 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
12.8%
5/39 • Number of events 5 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
10.8%
13/120 • Number of events 13 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/39 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
4.2%
5/120 • Number of events 5 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
7.7%
3/39 • Number of events 6 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
8.3%
10/120 • Number of events 10 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.6%
1/39 • Number of events 1 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
1.7%
2/120 • Number of events 2 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
7.7%
3/39 • Number of events 4 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
1.7%
2/120 • Number of events 2 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
|
Gastrointestinal disorders
Nausea
|
5.1%
2/39 • Number of events 2 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
5.8%
7/120 • Number of events 8 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
5.1%
2/39 • Number of events 2 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
5.8%
7/120 • Number of events 8 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
2/39 • Number of events 2 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
2.5%
3/120 • Number of events 4 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
7.7%
3/39 • Number of events 3 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
5.0%
6/120 • Number of events 7 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
|
Infections and infestations
Influenza
|
0.00%
0/39 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
1.7%
2/120 • Number of events 2 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
7.7%
3/39 • Number of events 3 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
4.2%
5/120 • Number of events 6 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
|
Infections and infestations
Nasopharyngitis
|
17.9%
7/39 • Number of events 8 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
15.8%
19/120 • Number of events 22 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
30.8%
12/39 • Number of events 15 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
28.3%
34/120 • Number of events 49 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
|
Infections and infestations
Pharyngitis
|
5.1%
2/39 • Number of events 2 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
1.7%
2/120 • Number of events 3 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
5.1%
2/39 • Number of events 2 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
2.5%
3/120 • Number of events 4 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/39 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
6.7%
8/120 • Number of events 8 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
5.1%
2/39 • Number of events 2 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
7.5%
9/120 • Number of events 9 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.1%
2/39 • Number of events 2 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
0.00%
0/120 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
5.1%
2/39 • Number of events 2 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
0.00%
0/120 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.6%
1/39 • Number of events 1 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
0.83%
1/120 • Number of events 1 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
5.1%
2/39 • Number of events 2 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
0.83%
1/120 • Number of events 1 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
|
Nervous system disorders
Headache
|
0.00%
0/39 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
0.83%
1/120 • Number of events 1 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
5.1%
2/39 • Number of events 2 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
0.83%
1/120 • Number of events 1 • Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60