Trial Outcomes & Findings for Comparison of Biphasic Insulin Aspart 30 Individually Adjusted by the Subject and the Trial Physician, Both Combined With Metformin in Subjects With Type 2 Diabetes (NCT NCT01427920)
NCT ID: NCT01427920
Last Updated: 2017-02-24
Results Overview
Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in full analysis set (FAS).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
348 participants
Primary outcome timeframe
Week 0, week 20
Results posted on
2017-02-24
Participant Flow
A total of 33 sites in 5 countries enrolled subjects.
Participant milestones
| Measure |
Subject-driven
The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
|
Investigator-driven
The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
|
|---|---|---|
|
Overall Study
STARTED
|
174
|
174
|
|
Overall Study
Exposed
|
174
|
173
|
|
Overall Study
COMPLETED
|
165
|
157
|
|
Overall Study
NOT COMPLETED
|
9
|
17
|
Reasons for withdrawal
| Measure |
Subject-driven
The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
|
Investigator-driven
The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
3
|
|
Overall Study
Withdrawal Criteria
|
4
|
4
|
|
Overall Study
Unclassified
|
2
|
8
|
Baseline Characteristics
Comparison of Biphasic Insulin Aspart 30 Individually Adjusted by the Subject and the Trial Physician, Both Combined With Metformin in Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Subject-driven
n=174 Participants
The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
|
Investigator-driven
n=174 Participants
The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
|
Total
n=348 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.9 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
58.0 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
58.5 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Gender
Female
|
83 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Gender
Male
|
91 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
|
Body Weight
|
81.0 kg
STANDARD_DEVIATION 16.2 • n=5 Participants
|
78.0 kg
STANDARD_DEVIATION 15.0 • n=7 Participants
|
79.5 kg
STANDARD_DEVIATION 15.7 • n=5 Participants
|
|
Body Mass Index
|
29.7 kg/m^2
STANDARD_DEVIATION 4.8 • n=5 Participants
|
29.2 kg/m^2
STANDARD_DEVIATION 4.7 • n=7 Participants
|
29.4 kg/m^2
STANDARD_DEVIATION 4.7 • n=5 Participants
|
|
Glycosylated Haemoglobin (HbA1c)
|
8.3 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.9 • n=5 Participants
|
8.3 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.9 • n=7 Participants
|
8.3 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.9 • n=5 Participants
|
|
Fasting Plasma Glucose
|
9.1 mmol/L
STANDARD_DEVIATION 2.7 • n=5 Participants
|
8.8 mmol/L
STANDARD_DEVIATION 2.8 • n=7 Participants
|
9.0 mmol/L
STANDARD_DEVIATION 2.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0, week 20Population: Full analysis set (FAS) - analysis included endpoint derived after 20 Weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 13 subjects did not contribute to the statistical analysis after Week 20.
Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in full analysis set (FAS).
Outcome measures
| Measure |
Subject-driven
n=169 Participants
The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
|
Investigator-driven
n=166 Participants
The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
|
|---|---|---|
|
Change in HbA1c (Glycosylated Haemoglobin) - FAS
|
-0.72 percentage of glycosylated haemoglobin
Standard Error 0.08
|
-0.97 percentage of glycosylated haemoglobin
Standard Error 0.08
|
PRIMARY outcome
Timeframe: Week 0, week 20Population: Per protocol (PP) analysis set - analysis included subjects exposed to BIAsp 30 for more than 12 weeks without any major protocol violations. 24 subjects did not contribute to the statistical analysis after Week 20.
Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in per protocol (PP) analysis set.
Outcome measures
| Measure |
Subject-driven
n=164 Participants
The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
|
Investigator-driven
n=160 Participants
The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
|
|---|---|---|
|
Change in HbA1c (Glycosylated Haemoglobin) - PP
|
-0.71 percentage of glycosylated haemoglobin
Standard Error 0.08
|
-0.98 percentage of glycosylated haemoglobin
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Week 0, week 20Population: Full analysis set (FAS) - analysis included endpoint derived after 20 weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 13 subjects did not contribute to the statistical analysis after Week 20.
Estimated mean change from baseline in FPG after 20 Weeks of treatment
Outcome measures
| Measure |
Subject-driven
n=169 Participants
The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
|
Investigator-driven
n=166 Participants
The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
|
|---|---|---|
|
Change in Fasting Plasma Glucose (FPG) (Central Laboratory Values)
|
-0.94 mmol/L
Standard Error 0.21
|
-1.07 mmol/L
Standard Error 0.22
|
SECONDARY outcome
Timeframe: Week 0 to week 20Population: Safety analysis set included all subjects who received at least one dose of BIAsp 30. One subject did not contribute to data.
A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of trial product, and no later than one day after product administration. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Outcome measures
| Measure |
Subject-driven
n=174 Participants
The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
|
Investigator-driven
n=173 Participants
The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
|
|---|---|---|
|
Number of Treatment Emergent Hypoglycaemic Episodes
|
638 episodes
|
766 episodes
|
SECONDARY outcome
Timeframe: Week 0Population: Full analysis set (FAS) - analysis included endpoint derived after 20 weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 10 subjects did not contribute to data.
From the 20 TRIM-D items, an overall score was derived. The scores were transformed to a 0 - 100 scale with higher scores indicating a better health state.
Outcome measures
| Measure |
Subject-driven
n=169 Participants
The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
|
Investigator-driven
n=169 Participants
The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
|
|---|---|---|
|
Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score
|
67.2 scores on a scale
Standard Deviation 14.7
|
70.0 scores on a scale
Standard Deviation 15.3
|
SECONDARY outcome
Timeframe: Week 4Population: Full analysis set (FAS) - analysis included endpoint derived after 20 weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 20 subjects did not contribute to data.
From the 20 TRIM-D items, an overall score was derived. The scores were transformed to a 0 - 100 scale with higher scores indicating a better health state.
Outcome measures
| Measure |
Subject-driven
n=165 Participants
The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
|
Investigator-driven
n=163 Participants
The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
|
|---|---|---|
|
Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score
|
71.0 scores on a scale
Standard Deviation 13.1
|
71.8 scores on a scale
Standard Deviation 14.4
|
SECONDARY outcome
Timeframe: Week 20Population: Full analysis set (FAS) - analysis included endpoint derived after 20 weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 17 subjects did not contribute to data.
From the 20 TRIM-D items, an overall score was derived. The scores were transformed to a 0 - 100 scale with higher scores indicating a better health state.
Outcome measures
| Measure |
Subject-driven
n=167 Participants
The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
|
Investigator-driven
n=164 Participants
The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
|
|---|---|---|
|
Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score
|
73.9 scores on a scale
Standard Deviation 13.6
|
74.0 scores on a scale
Standard Deviation 15.4
|
Adverse Events
Subject-driven
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Investigator-driven
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Subject-driven
n=174 participants at risk
The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
|
Investigator-driven
n=173 participants at risk
The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject's previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/174 • Adverse events were captured from the time of consent until 20 weeks of treatment, and if needed, were followed-up after the final visit.
Safety analysis set included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set contributed to the evaluation "as treated".
|
0.58%
1/173 • Number of events 1 • Adverse events were captured from the time of consent until 20 weeks of treatment, and if needed, were followed-up after the final visit.
Safety analysis set included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Infections and infestations
Endophthalmitis
|
0.00%
0/174 • Adverse events were captured from the time of consent until 20 weeks of treatment, and if needed, were followed-up after the final visit.
Safety analysis set included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set contributed to the evaluation "as treated".
|
0.58%
1/173 • Number of events 1 • Adverse events were captured from the time of consent until 20 weeks of treatment, and if needed, were followed-up after the final visit.
Safety analysis set included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Infections and infestations
Pneumonia
|
0.00%
0/174 • Adverse events were captured from the time of consent until 20 weeks of treatment, and if needed, were followed-up after the final visit.
Safety analysis set included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set contributed to the evaluation "as treated".
|
0.58%
1/173 • Number of events 1 • Adverse events were captured from the time of consent until 20 weeks of treatment, and if needed, were followed-up after the final visit.
Safety analysis set included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.57%
1/174 • Number of events 1 • Adverse events were captured from the time of consent until 20 weeks of treatment, and if needed, were followed-up after the final visit.
Safety analysis set included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/173 • Adverse events were captured from the time of consent until 20 weeks of treatment, and if needed, were followed-up after the final visit.
Safety analysis set included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/174 • Adverse events were captured from the time of consent until 20 weeks of treatment, and if needed, were followed-up after the final visit.
Safety analysis set included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set contributed to the evaluation "as treated".
|
0.58%
1/173 • Number of events 1 • Adverse events were captured from the time of consent until 20 weeks of treatment, and if needed, were followed-up after the final visit.
Safety analysis set included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set contributed to the evaluation "as treated".
|
|
Nervous system disorders
Lacunar infarction
|
0.57%
1/174 • Number of events 1 • Adverse events were captured from the time of consent until 20 weeks of treatment, and if needed, were followed-up after the final visit.
Safety analysis set included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set contributed to the evaluation "as treated".
|
0.00%
0/173 • Adverse events were captured from the time of consent until 20 weeks of treatment, and if needed, were followed-up after the final visit.
Safety analysis set included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set contributed to the evaluation "as treated".
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Novo Nordisk maintains the right to be informed of any Investigator plans for publication and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Novo Nordisk reserves the right to prior review of such publications and to ask for delay of publication of individual site results until after the primary manuscript is accepted for publication.
- Publication restrictions are in place
Restriction type: OTHER