Trial Outcomes & Findings for Effect of Biphasic Insulin Aspart 50 on Blood Glucose Control in Subjects With Type 2 Diabetes (NCT NCT00627445)
NCT ID: NCT00627445
Last Updated: 2014-10-22
Results Overview
Change in glycosylated haemoglobin A1c (HbA1c) from week 0 (baseline) to end of treatment (week 16)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
441 participants
Primary outcome timeframe
week 0, week 16
Results posted on
2014-10-22
Participant Flow
15 sites in China
Eligible subjects were subjects with type 2 diabetes having an HbA1c (Glycosylated Haemoglobin A1c) between 7.5-12.0 %, and treated with premix human insulin twice daily with or without oral anti-diabetic drugs (OADs) for at least 3 months qualifying for an intensified insulin treatment.
Participant milestones
| Measure |
BIAsp 50-50-30
Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
|
BIAsp 30-30
Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
|
|---|---|---|
|
Overall Study
STARTED
|
219
|
222
|
|
Overall Study
Exposed to Study Drug
|
219
|
222
|
|
Overall Study
COMPLETED
|
210
|
210
|
|
Overall Study
NOT COMPLETED
|
9
|
12
|
Reasons for withdrawal
| Measure |
BIAsp 50-50-30
Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
|
BIAsp 30-30
Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Other
|
6
|
8
|
Baseline Characteristics
Effect of Biphasic Insulin Aspart 50 on Blood Glucose Control in Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
BIAsp 50-50-30
n=219 Participants
Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
|
BIAsp 30-30
n=222 Participants
Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
|
Total
n=441 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.5 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
55.5 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
55.5 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
131 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
244 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
|
BMI
|
26.06 kg/m2
STANDARD_DEVIATION 2.70 • n=5 Participants
|
26.27 kg/m2
STANDARD_DEVIATION 2.73 • n=7 Participants
|
26.17 kg/m2
STANDARD_DEVIATION 2.71 • n=5 Participants
|
|
Height
|
162.8 cm
STANDARD_DEVIATION 7.9 • n=5 Participants
|
163.7 cm
STANDARD_DEVIATION 8.4 • n=7 Participants
|
163.2 cm
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Weight
|
69.2 kg
STANDARD_DEVIATION 9.8 • n=5 Participants
|
70.5 kg
STANDARD_DEVIATION 9.7 • n=7 Participants
|
69.9 kg
STANDARD_DEVIATION 9.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: week 0, week 16Population: Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of trial product.
Change in glycosylated haemoglobin A1c (HbA1c) from week 0 (baseline) to end of treatment (week 16)
Outcome measures
| Measure |
BIAsp 50-50-30
n=216 Participants
Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
|
BIAsp 30-30
n=221 Participants
Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
|
|---|---|---|
|
Change in Glycosylated Haemoglobin A1c (HbA1c)
|
-1.790 percentage (%) of total haemoglobin
Standard Error 0.057
|
-1.517 percentage (%) of total haemoglobin
Standard Error 0.056
|
SECONDARY outcome
Timeframe: week 16Population: Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of trial product.
The percentage of subjects who after 16 weeks of treatment met the glycosylated haemoglobin A1c (HbA1c) treatment targets below 7%, or below or equal to 6.5%.
Outcome measures
| Measure |
BIAsp 50-50-30
n=219 Participants
Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
|
BIAsp 30-30
n=222 Participants
Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
|
|---|---|---|
|
The Percentage of Subjects Achieving HbA1c Treatment Targets
Achieving HbA1c <7.0%
|
65 percentage (%) of subjects
|
52 percentage (%) of subjects
|
|
The Percentage of Subjects Achieving HbA1c Treatment Targets
Achieving HbA1c <=6.5%
|
47 percentage (%) of subjects
|
29 percentage (%) of subjects
|
SECONDARY outcome
Timeframe: week 0, week 16Population: Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of trial product.
Change in 8-point plasma glucose from baseline (week 0) to at end of treatment (week 16). 8-point plasma glucose was measured at following time points: Before each meal, 120 minutes after the start of each meal, at bedtime, and at 3:00 AM in the morning. Daily average was calculated at the end of treatment.
Outcome measures
| Measure |
BIAsp 50-50-30
n=219 Participants
Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
|
BIAsp 30-30
n=222 Participants
Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
|
|---|---|---|
|
Change and Daily Average in 8-point Plasma Glucose
Before Breakfast, N= 213, 213
|
-2.52 mmol/L
Standard Error 0.10 • Interval -0.36 to 0.18
|
-2.43 mmol/L
Standard Error 0.10
|
|
Change and Daily Average in 8-point Plasma Glucose
2 hours After Breakfast, N= 213, 210
|
-3.92 mmol/L
Standard Error 0.17 • Interval -0.38 to 0.55
|
-4.00 mmol/L
Standard Error 0.17
|
|
Change and Daily Average in 8-point Plasma Glucose
Before Lunch, N= 213, 210
|
-2.80 mmol/L
Standard Error 0.13 • Interval -0.45 to 0.27
|
-2.71 mmol/L
Standard Error 0.13
|
|
Change and Daily Average in 8-point Plasma Glucose
2 hours After Lunch, N= 213, 211
|
-4.37 mmol/L
Standard Error 0.19 • Interval -1.72 to -0.72
|
-3.15 mmol/L
Standard Error 0.18
|
|
Change and Daily Average in 8-point Plasma Glucose
Before Dinner, N= 212, 212
|
-3.83 mmol/L
Standard Error 0.16 • Interval -1.41 to -0.58
|
-2.83 mmol/L
Standard Error 0.15
|
|
Change and Daily Average in 8-point Plasma Glucose
2 hours After Dinner, N= 211, 209
|
-3.46 mmol/L
Standard Error 0.18 • Interval -0.58 to 0.41
|
-3.37 mmol/L
Standard Error 0.18
|
|
Change and Daily Average in 8-point Plasma Glucose
Bedtime, N= 207, 207
|
-2.93 mmol/L
Standard Error 0.15 • Interval -0.24 to 0.55
|
-3.09 mmol/L
Standard Error 0.15
|
|
Change and Daily Average in 8-point Plasma Glucose
3:00 AM, N= 211, 210
|
-1.99 mmol/L
Standard Error 0.13 • Interval -0.44 to 0.24
|
-1.89 mmol/L
Standard Error 0.13
|
|
Change and Daily Average in 8-point Plasma Glucose
Average, N= 213, 212
|
-3.23 mmol/L
Standard Error 0.10 • Interval -0.55 to -0.03
|
-2.94 mmol/L
Standard Error 0.10
|
SECONDARY outcome
Timeframe: week 0, week 16Population: Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of trial product.
Change in prandial (mealtime) plasma glucose increment from baseline (week 0) to end of treatment (week 16). Daily average prandial plasma glucose increment was calculated at end of treatment.
Outcome measures
| Measure |
BIAsp 50-50-30
n=219 Participants
Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
|
BIAsp 30-30
n=222 Participants
Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
|
|---|---|---|
|
Change and Daily Average in Prandial Plasma Glucose Increment
At Breakfast, N= 213, 210
|
-1.41 mmol/L
Standard Error 0.16
|
-1.58 mmol/L
Standard Error 0.16
|
|
Change and Daily Average in Prandial Plasma Glucose Increment
At Lunch, N= 213, 210
|
-1.57 mmol/L
Standard Error 0.19
|
-0.44 mmol/L
Standard Error 0.19
|
|
Change and Daily Average in Prandial Plasma Glucose Increment
At Dinner, N= 210, 209
|
0.40 mmol/L
Standard Error 0.18
|
-0.53 mmol/L
Standard Error 0.18
|
|
Change and Daily Average in Prandial Plasma Glucose Increment
Average, N= 213, 211
|
-0.88 mmol/L
Standard Error 0.11
|
-0.84 mmol/L
Standard Error 0.11
|
SECONDARY outcome
Timeframe: week 0, week 16Population: Intention-to-Treat analysis set (ITT) is all randomised subjects exposed to at least one dose of trial product.
The total increase in total daily insulin dose per body weight from baseline (week 0) to end of treatment (week 16).
Outcome measures
| Measure |
BIAsp 50-50-30
n=210 Participants
Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
|
BIAsp 30-30
n=210 Participants
Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
|
|---|---|---|
|
The Total Increase in Total Daily Insulin Dose Per Body Weight
|
0.963 U/kg
Standard Error 0.016
|
0.820 U/kg
Standard Error 0.015
|
SECONDARY outcome
Timeframe: week 0, week 16Population: Intention-to-Treat analysis set (ITT) is all randomised subjects exposed to at least one dose of trial product.
Change in body weight from baseline (week 0) to end of treatment (week 16)
Outcome measures
| Measure |
BIAsp 50-50-30
n=210 Participants
Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
|
BIAsp 30-30
n=209 Participants
Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
|
|---|---|---|
|
Change in Body Weight
|
1.188 kg
Standard Error 0.157
|
0.817 kg
Standard Error 0.155
|
SECONDARY outcome
Timeframe: weeks 0-16Population: Intention-to-Treat analysis set (ITT) is all randomised subjects exposed to at least one dose of trial product.
Number of hypoglycaemic episodes occurring after baseline (week 0) to the end of treatment (week 16) in each treatment group. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.
Outcome measures
| Measure |
BIAsp 50-50-30
n=219 Participants
Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
|
BIAsp 30-30
n=222 Participants
Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
|
|---|---|---|
|
Number of Hypoglycaemic Episodes
All
|
728 episodes
|
679 episodes
|
|
Number of Hypoglycaemic Episodes
Major or Minor
|
158 episodes
|
198 episodes
|
|
Number of Hypoglycaemic Episodes
Minor
|
157 episodes
|
198 episodes
|
|
Number of Hypoglycaemic Episodes
Symptoms Only
|
570 episodes
|
481 episodes
|
SECONDARY outcome
Timeframe: weeks 0-16Population: Intention-to-Treat analysis set (ITT) is all randomised subjects exposed to at least one dose of trial product.
Number of nocturnal hypoglycaemic episodes occurring after baseline (week 0) to end of treatment (week 16) in each treatment group. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.
Outcome measures
| Measure |
BIAsp 50-50-30
n=219 Participants
Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
|
BIAsp 30-30
n=222 Participants
Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
|
|---|---|---|
|
Number of Nocturnal Hypoglycaemic Episodes
All
|
134 episodes
|
81 episodes
|
|
Number of Nocturnal Hypoglycaemic Episodes
Major or Minor
|
31 episodes
|
30 episodes
|
|
Number of Nocturnal Hypoglycaemic Episodes
Minor
|
31 episodes
|
30 episodes
|
|
Number of Nocturnal Hypoglycaemic Episodes
Symptons Only
|
103 episodes
|
51 episodes
|
Adverse Events
BIAsp 50-50-30
Serious events: 5 serious events
Other events: 74 other events
Deaths: 0 deaths
BIAsp 30-30
Serious events: 9 serious events
Other events: 68 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BIAsp 50-50-30
n=219 participants at risk
Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
|
BIAsp 30-30
n=222 participants at risk
Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
|
|---|---|---|
|
Nervous system disorders
Hypoglycaemic coma
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Nervous system disorders
Cerebral infarction
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.90%
2/222 • Number of events 2 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Vascular disorders
Hypertension
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
Other adverse events
| Measure |
BIAsp 50-50-30
n=219 participants at risk
Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
|
BIAsp 30-30
n=222 participants at risk
Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
|
|---|---|---|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.90%
2/222 • Number of events 2 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Skin and subcutaneous tissue disorders
Photodermatosis
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
11/219 • Number of events 11 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
4.5%
10/222 • Number of events 11 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
6.8%
15/219 • Number of events 15 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
5.9%
13/222 • Number of events 13 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Cardiac disorders
Angina pectoris
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Cardiac disorders
Palpitations
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Eye disorders
Vision blurred
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.90%
2/222 • Number of events 2 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Eye disorders
Visual impairment
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.91%
2/219 • Number of events 2 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Gastrointestinal disorders
Intestinal mucosal hypertrophy
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Gastrointestinal disorders
Nausea
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.90%
2/222 • Number of events 2 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.90%
2/222 • Number of events 2 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Gastrointestinal disorders
Toothache
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Gastrointestinal disorders
Vomiting
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
General disorders
Asthenia
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
General disorders
Chest discomfort
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 2 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
General disorders
Injection site nodule
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
General disorders
Oedema peripheral
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
General disorders
Pyrexia
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.90%
2/222 • Number of events 2 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.90%
2/222 • Number of events 2 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.4%
3/219 • Number of events 3 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Infections and infestations
Bronchitis
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.90%
2/222 • Number of events 2 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Infections and infestations
Influenza
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Infections and infestations
Localised infection
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Infections and infestations
Nasopharyngitis
|
2.3%
5/219 • Number of events 6 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
1.4%
3/222 • Number of events 4 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Infections and infestations
Pharyngitis
|
0.91%
2/219 • Number of events 2 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.7%
6/219 • Number of events 7 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
3.2%
7/222 • Number of events 7 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Infections and infestations
Urinary tract infection
|
0.46%
1/219 • Number of events 2 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Injury, poisoning and procedural complications
Vertebral injury
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Investigations
Alanine aminotransferase increased
|
0.91%
2/219 • Number of events 2 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
1.4%
3/222 • Number of events 3 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Investigations
Albumin urine present
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Investigations
Blood triglycerides increased
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Investigations
Low density lipoprotein increased
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Investigations
White blood cell count increased
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
2.3%
5/219 • Number of events 5 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
1.4%
3/222 • Number of events 3 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.90%
2/222 • Number of events 2 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.90%
2/222 • Number of events 3 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Periostitis
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.90%
2/222 • Number of events 2 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Nervous system disorders
Headache
|
1.4%
3/219 • Number of events 3 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
2.3%
5/222 • Number of events 5 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Nervous system disorders
Lacunar infarction
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Psychiatric disorders
Insomnia
|
0.91%
2/219 • Number of events 2 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/219 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.45%
1/222 • Number of events 2 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous nodule
|
0.46%
1/219 • Number of events 1 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
0.00%
0/222 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
|
Vascular disorders
Hypertension
|
0.91%
2/219 • Number of events 2 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
1.4%
3/222 • Number of events 3 • Adverse events were collected over a time span of 16 weeks.
Safety analysis set is all subjects exposed to at least one dose of trial product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Manuscripts for publication will be prepared in collaboration between Investigator(s) and Novo Nordisk. Novo Nordisk will not suppress or veto publications; however Novo Nordisk reserves the right to postpone publication and/or communication for a short time to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER