Trial Outcomes & Findings for A Study to Compare Insulin Intensification of Biphasic Insulin Aspart 30 and Insulin Analogues (Insulin Glargine and Insulin Aspart) in Insulin naïve Type 2 Diabetic Patients (NCT NCT02453685)
NCT ID: NCT02453685
Last Updated: 2019-02-08
Results Overview
Change in HbA1c from baseline (week 0) to week 32.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
335 participants
Primary outcome timeframe
Week 0, week 32
Results posted on
2019-02-08
Participant Flow
The trial was conducted at 41 sites in 9 countries, as follows: Australia: 4 sites; Bulgaria: 5 sites; Hungary: 3 sites; India: 7 sites; Korea, Republic of: 4 sites; Serbia: 5 sites; Thailand: 4 sites; Turkey: 5 sites; United Arab Emirates: 4 sites.
Participant milestones
| Measure |
BIAsp 30
Subjects received subcutaneous (s.c.) injection of biphasic insulin aspart 30 (BIAsp 30-a mixture of soluble insulin aspart \[IAsp\] 30% and protaminated IAsp 70%) during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started treatment with 1 daily injection of BIAsp 30 (starting dose 12 unit) with the largest meal. Insulin titration: Subjects underwent weekly insulin dose titration during entire treatment period in order to achieve the pre-meal self-measured plasma glucose (SMPG) target of 4.4-6.1 mmol/L (80-110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in stepwise manner by adding an additional injection of BIAsp 30 depending on whether subjects achieved the pre-defined glycaemic target (hemoglobin A1c \[HbA1c\] \<7.0%). Subjects had the possibility of receiving up to 3 daily injections of BIAsp 30. Subjects continued pre-trial treatment with metformin and sulphonylurea (SU) throughout the trial.
|
Basal-bolus
Subjects received s.c. injections of insulin glargine (IGlar) during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started with 1 daily injection of IGlar (administrated at same point of time every day) with starting dose of 10 units. Insulin titration: Subjects underwent a weekly insulin dose titration during the entire treatment period in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in a stepwise manner by adding an additional injection of IAsp depending on whether subjects achieved the pre-defined glycaemic target (HbA1c \<7.0%). Subjects had the possibility of receiving 1 daily injection of IGlar plus up to 3 daily injections of IAsp. Subjects continued their pre-trial treatment with metformin and SU throughout the trial.
|
|---|---|---|
|
Overall Study
STARTED
|
168
|
167
|
|
Overall Study
Exposed
|
166
|
166
|
|
Overall Study
COMPLETED
|
149
|
155
|
|
Overall Study
NOT COMPLETED
|
19
|
12
|
Reasons for withdrawal
| Measure |
BIAsp 30
Subjects received subcutaneous (s.c.) injection of biphasic insulin aspart 30 (BIAsp 30-a mixture of soluble insulin aspart \[IAsp\] 30% and protaminated IAsp 70%) during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started treatment with 1 daily injection of BIAsp 30 (starting dose 12 unit) with the largest meal. Insulin titration: Subjects underwent weekly insulin dose titration during entire treatment period in order to achieve the pre-meal self-measured plasma glucose (SMPG) target of 4.4-6.1 mmol/L (80-110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in stepwise manner by adding an additional injection of BIAsp 30 depending on whether subjects achieved the pre-defined glycaemic target (hemoglobin A1c \[HbA1c\] \<7.0%). Subjects had the possibility of receiving up to 3 daily injections of BIAsp 30. Subjects continued pre-trial treatment with metformin and sulphonylurea (SU) throughout the trial.
|
Basal-bolus
Subjects received s.c. injections of insulin glargine (IGlar) during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started with 1 daily injection of IGlar (administrated at same point of time every day) with starting dose of 10 units. Insulin titration: Subjects underwent a weekly insulin dose titration during the entire treatment period in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in a stepwise manner by adding an additional injection of IAsp depending on whether subjects achieved the pre-defined glycaemic target (HbA1c \<7.0%). Subjects had the possibility of receiving 1 daily injection of IGlar plus up to 3 daily injections of IAsp. Subjects continued their pre-trial treatment with metformin and SU throughout the trial.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Protocol Violation
|
7
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
8
|
4
|
|
Overall Study
Unclassified
|
4
|
2
|
Baseline Characteristics
A Study to Compare Insulin Intensification of Biphasic Insulin Aspart 30 and Insulin Analogues (Insulin Glargine and Insulin Aspart) in Insulin naïve Type 2 Diabetic Patients
Baseline characteristics by cohort
| Measure |
BIAsp 30
n=168 Participants
Subjects received s.c. injection of BIAsp 30 (a mixture of soluble IAsp 30% and protaminated IAsp 70%) during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started treatment with 1 daily injection of BIAsp 30 (starting dose 12 unit) with the largest meal. Insulin titration: Subjects underwent weekly insulin dose titration during entire treatment period in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in stepwise manner by adding an additional injection of BIAsp 30 depending on whether subjects achieved the pre-defined glycaemic target (HbA1c \<7.0%). Subjects had the possibility of receiving up to 3 daily injections of BIAsp 30. Subjects continued pre-trial treatment with metformin and SU throughout the trial.
|
Basal-bolus
n=167 Participants
Subjects received s.c. injections of IGlar during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started with 1 daily injection of IGlar (administrated at same point of time every day) with starting dose of 10 units. Insulin titration: Subjects underwent a weekly insulin dose titration during the entire treatment period in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in a stepwise manner by adding an additional injection of IAsp depending on whether subjects achieved the pre-defined glycaemic target (HbA1c \<7.0%). Subjects had the possibility of receiving 1 daily injection of IGlar plus up to 3 daily injections of IAsp. Subjects continued their pre-trial treatment with metformin and SU throughout the trial.
|
Total
n=335 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.6 Years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
56.5 Years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
56.6 Years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
HbA1c
|
8.31 Percentage of HbA1c
STANDARD_DEVIATION 0.73 • n=5 Participants
|
8.23 Percentage of HbA1c
STANDARD_DEVIATION 0.69 • n=7 Participants
|
8.27 Percentage of HbA1c
STANDARD_DEVIATION 0.71 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0, week 32Population: Full analysis set. Week 32 data are presented after application of Last observation carried forward; 164 subjects contributed in each arm.
Change in HbA1c from baseline (week 0) to week 32.
Outcome measures
| Measure |
BIAsp 30
n=164 Participants
Subjects received s.c. injection of BIAsp 30 (a mixture of soluble IAsp 30% and protaminated IAsp 70%) during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started treatment with 1 daily injection of BIAsp 30 (starting dose 12 unit) with the largest meal. Insulin titration: Subjects underwent weekly insulin dose titration during entire treatment period in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in stepwise manner by adding an additional injection of BIAsp 30 depending on whether subjects achieved the pre-defined glycaemic target (HbA1c \<7.0%). Subjects had the possibility of receiving up to 3 daily injections of BIAsp 30. Subjects continued pre-trial treatment with metformin and SU throughout the trial.
|
Basal-bolus
n=164 Participants
Subjects received s.c. injections of IGlar during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started with 1 daily injection of IGlar (administrated at same point of time every day) with starting dose of 10 units. Insulin titration: Subjects underwent a weekly insulin dose titration during the entire treatment period in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in a stepwise manner by adding an additional injection of IAsp depending on whether subjects achieved the pre-defined glycaemic target (HbA1c \<7.0%). Subjects had the possibility of receiving 1 daily injection of IGlar plus up to 3 daily injections of IAsp. Subjects continued their pre-trial treatment with metformin and SU throughout the trial.
|
|---|---|---|
|
Change in HbA1c (Glycosylated Haemoglobin)
|
-1.16 Percentage of HbA1c
Standard Deviation 0.98
|
-1.30 Percentage of HbA1c
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: After 32 weeks of treatment (yes/no)Population: Full analysis set.
Percentage of subjects with HbA1c below 7.0% after 32 weeks of randomised treatment without treatment emergent severe hypoglycaemic episodes during the last 12 weeks of treatment. Subjects withdrawn before 32 weeks were handled as non-responders. Severe hypoglycaemic episode was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG concentration.
Outcome measures
| Measure |
BIAsp 30
n=168 Participants
Subjects received s.c. injection of BIAsp 30 (a mixture of soluble IAsp 30% and protaminated IAsp 70%) during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started treatment with 1 daily injection of BIAsp 30 (starting dose 12 unit) with the largest meal. Insulin titration: Subjects underwent weekly insulin dose titration during entire treatment period in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in stepwise manner by adding an additional injection of BIAsp 30 depending on whether subjects achieved the pre-defined glycaemic target (HbA1c \<7.0%). Subjects had the possibility of receiving up to 3 daily injections of BIAsp 30. Subjects continued pre-trial treatment with metformin and SU throughout the trial.
|
Basal-bolus
n=167 Participants
Subjects received s.c. injections of IGlar during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started with 1 daily injection of IGlar (administrated at same point of time every day) with starting dose of 10 units. Insulin titration: Subjects underwent a weekly insulin dose titration during the entire treatment period in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in a stepwise manner by adding an additional injection of IAsp depending on whether subjects achieved the pre-defined glycaemic target (HbA1c \<7.0%). Subjects had the possibility of receiving 1 daily injection of IGlar plus up to 3 daily injections of IAsp. Subjects continued their pre-trial treatment with metformin and SU throughout the trial.
|
|---|---|---|
|
HbA1c Below 7.0% Without Severe Hypoglycaemic Episodes
Yes
|
42.3 Percentage of subjects
|
56.3 Percentage of subjects
|
|
HbA1c Below 7.0% Without Severe Hypoglycaemic Episodes
No
|
57.7 Percentage of subjects
|
43.7 Percentage of subjects
|
SECONDARY outcome
Timeframe: Weeks 0-32Population: The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator.
Hypoglycaemic episodes were classified as severe, Asymptomatic, Documented symptomatic, Pseudo, and Probable symptomatic as per ADA classification. As symptoms of hypoglycaemia occur below a PG level of 3.1 mmol/L, (56 mg/dL) Novo Nordisk classification included hypoglycaemia with plasma glucose (PG) levels below 3.1 mmol/L (56 mg/dL) in the definition of blood glucose confirmed hypoglycaemia. Hence, Novo Nordisk classification included following types of hypoglycaemia in addition to ADA classification: Severe hypoglycaemia, Symptomatic blood glucose confirmed hypoglycaemia, Asymptomatic blood glucose confirmed hypoglycaemia, Severe or blood glucose confirmed symptomatic hypoglycaemia, Blood glucose confirmed hypoglycaemia, and Severe or blood glucose confirmed hypoglycaemia. Reported data represents total of all hypoglycaemic episodes.
Outcome measures
| Measure |
BIAsp 30
n=166 Participants
Subjects received s.c. injection of BIAsp 30 (a mixture of soluble IAsp 30% and protaminated IAsp 70%) during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started treatment with 1 daily injection of BIAsp 30 (starting dose 12 unit) with the largest meal. Insulin titration: Subjects underwent weekly insulin dose titration during entire treatment period in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in stepwise manner by adding an additional injection of BIAsp 30 depending on whether subjects achieved the pre-defined glycaemic target (HbA1c \<7.0%). Subjects had the possibility of receiving up to 3 daily injections of BIAsp 30. Subjects continued pre-trial treatment with metformin and SU throughout the trial.
|
Basal-bolus
n=166 Participants
Subjects received s.c. injections of IGlar during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started with 1 daily injection of IGlar (administrated at same point of time every day) with starting dose of 10 units. Insulin titration: Subjects underwent a weekly insulin dose titration during the entire treatment period in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in a stepwise manner by adding an additional injection of IAsp depending on whether subjects achieved the pre-defined glycaemic target (HbA1c \<7.0%). Subjects had the possibility of receiving 1 daily injection of IGlar plus up to 3 daily injections of IAsp. Subjects continued their pre-trial treatment with metformin and SU throughout the trial.
|
|---|---|---|
|
Number of Treatment Emergent Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) and the Novo Nordisk Definitions
ADA classification
|
1650 Hypoglycaemic episodes
|
1841 Hypoglycaemic episodes
|
|
Number of Treatment Emergent Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) and the Novo Nordisk Definitions
Novo Nordisk classification
|
1650 Hypoglycaemic episodes
|
1841 Hypoglycaemic episodes
|
SECONDARY outcome
Timeframe: Weeks 0-32Population: Safety analysis set. Number analysed=number of subjects with available data for individual timepoints.
Total daily insulin dose in the basal bolus treatment group and in BIAsp 30 treatment group at each week of each treatment.
Outcome measures
| Measure |
BIAsp 30
n=166 Participants
Subjects received s.c. injection of BIAsp 30 (a mixture of soluble IAsp 30% and protaminated IAsp 70%) during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started treatment with 1 daily injection of BIAsp 30 (starting dose 12 unit) with the largest meal. Insulin titration: Subjects underwent weekly insulin dose titration during entire treatment period in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in stepwise manner by adding an additional injection of BIAsp 30 depending on whether subjects achieved the pre-defined glycaemic target (HbA1c \<7.0%). Subjects had the possibility of receiving up to 3 daily injections of BIAsp 30. Subjects continued pre-trial treatment with metformin and SU throughout the trial.
|
Basal-bolus
n=166 Participants
Subjects received s.c. injections of IGlar during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started with 1 daily injection of IGlar (administrated at same point of time every day) with starting dose of 10 units. Insulin titration: Subjects underwent a weekly insulin dose titration during the entire treatment period in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in a stepwise manner by adding an additional injection of IAsp depending on whether subjects achieved the pre-defined glycaemic target (HbA1c \<7.0%). Subjects had the possibility of receiving 1 daily injection of IGlar plus up to 3 daily injections of IAsp. Subjects continued their pre-trial treatment with metformin and SU throughout the trial.
|
|---|---|---|
|
Total Daily Insulin Dose
Week 1
|
0.157 U/kg
Standard Deviation 0.038
|
0.127 U/kg
Standard Deviation 0.026
|
|
Total Daily Insulin Dose
Week 2
|
0.187 U/kg
Standard Deviation 0.053
|
0.167 U/kg
Standard Deviation 0.042
|
|
Total Daily Insulin Dose
Week 3
|
0.214 U/kg
Standard Deviation 0.070
|
0.197 U/kg
Standard Deviation 0.061
|
|
Total Daily Insulin Dose
Week 4
|
0.238 U/kg
Standard Deviation 0.088
|
0.224 U/kg
Standard Deviation 0.076
|
|
Total Daily Insulin Dose
Week 5
|
0.259 U/kg
Standard Deviation 0.102
|
0.244 U/kg
Standard Deviation 0.088
|
|
Total Daily Insulin Dose
Week 6
|
0.280 U/kg
Standard Deviation 0.114
|
0.264 U/kg
Standard Deviation 0.100
|
|
Total Daily Insulin Dose
Week 13
|
0.456 U/kg
Standard Deviation 0.267
|
0.425 U/kg
Standard Deviation 0.214
|
|
Total Daily Insulin Dose
Week 14
|
0.472 U/kg
Standard Deviation 0.277
|
0.439 U/kg
Standard Deviation 0.228
|
|
Total Daily Insulin Dose
Week 15
|
0.487 U/kg
Standard Deviation 0.295
|
0.455 U/kg
Standard Deviation 0.237
|
|
Total Daily Insulin Dose
Week 30
|
0.692 U/kg
Standard Deviation 0.511
|
0.682 U/kg
Standard Deviation 0.497
|
|
Total Daily Insulin Dose
Week 31
|
0.703 U/kg
Standard Deviation 0.525
|
0.693 U/kg
Standard Deviation 0.515
|
|
Total Daily Insulin Dose
Week 7
|
0.296 U/kg
Standard Deviation 0.131
|
0.281 U/kg
Standard Deviation 0.110
|
|
Total Daily Insulin Dose
Week 8
|
0.308 U/kg
Standard Deviation 0.145
|
0.296 U/kg
Standard Deviation 0.119
|
|
Total Daily Insulin Dose
Week 9
|
0.369 U/kg
Standard Deviation 0.172
|
0.339 U/kg
Standard Deviation 0.137
|
|
Total Daily Insulin Dose
Week 10
|
0.397 U/kg
Standard Deviation 0.199
|
0.365 U/kg
Standard Deviation 0.160
|
|
Total Daily Insulin Dose
Week 11
|
0.421 U/kg
Standard Deviation 0.224
|
0.391 U/kg
Standard Deviation 0.182
|
|
Total Daily Insulin Dose
Week 12
|
0.443 U/kg
Standard Deviation 0.245
|
0.413 U/kg
Standard Deviation 0.202
|
|
Total Daily Insulin Dose
Week 16
|
0.501 U/kg
Standard Deviation 0.308
|
0.468 U/kg
Standard Deviation 0.248
|
|
Total Daily Insulin Dose
Week 17
|
0.528 U/kg
Standard Deviation 0.324
|
0.496 U/kg
Standard Deviation 0.270
|
|
Total Daily Insulin Dose
Week 18
|
0.546 U/kg
Standard Deviation 0.334
|
0.516 U/kg
Standard Deviation 0.294
|
|
Total Daily Insulin Dose
Week 19
|
0.557 U/kg
Standard Deviation 0.353
|
0.532 U/kg
Standard Deviation 0.316
|
|
Total Daily Insulin Dose
Week 20
|
0.569 U/kg
Standard Deviation 0.367
|
0.544 U/kg
Standard Deviation 0.320
|
|
Total Daily Insulin Dose
Week 21
|
0.588 U/kg
Standard Deviation 0.387
|
0.563 U/kg
Standard Deviation 0.347
|
|
Total Daily Insulin Dose
Week 22
|
0.602 U/kg
Standard Deviation 0.401
|
0.580 U/kg
Standard Deviation 0.359
|
|
Total Daily Insulin Dose
Week 23
|
0.607 U/kg
Standard Deviation 0.411
|
0.590 U/kg
Standard Deviation 0.373
|
|
Total Daily Insulin Dose
Week 24
|
0.615 U/kg
Standard Deviation 0.426
|
0.605 U/kg
Standard Deviation 0.386
|
|
Total Daily Insulin Dose
Week 25
|
0.628 U/kg
Standard Deviation 0.435
|
0.618 U/kg
Standard Deviation 0.398
|
|
Total Daily Insulin Dose
Week 26
|
0.643 U/kg
Standard Deviation 0.454
|
0.643 U/kg
Standard Deviation 0.434
|
|
Total Daily Insulin Dose
Week 27
|
0.661 U/kg
Standard Deviation 0.472
|
0.653 U/kg
Standard Deviation 0.452
|
|
Total Daily Insulin Dose
Week 28
|
0.671 U/kg
Standard Deviation 0.487
|
0.664 U/kg
Standard Deviation 0.466
|
|
Total Daily Insulin Dose
Week 29
|
0.688 U/kg
Standard Deviation 0.509
|
0.674 U/kg
Standard Deviation 0.484
|
|
Total Daily Insulin Dose
Week 32
|
0.700 U/kg
Standard Deviation 0.542
|
0.708 U/kg
Standard Deviation 0.537
|
Adverse Events
BIAsp 30
Serious events: 14 serious events
Other events: 37 other events
Deaths: 0 deaths
Basal-bolus
Serious events: 12 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BIAsp 30
n=166 participants at risk
Subjects received s.c. injection of BIAsp 30 (a mixture of soluble IAsp 30% and protaminated IAsp 70%) during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started treatment with 1 daily injection of BIAsp 30 (starting dose 12 unit) with the largest meal. Insulin titration: Subjects underwent weekly insulin dose titration during entire treatment period in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in stepwise manner by adding an additional injection of BIAsp 30 depending on whether subjects achieved the pre-defined glycaemic target (HbA1c \<7.0%). Subjects had the possibility of receiving up to 3 daily injections of BIAsp 30. Subjects continued pre-trial treatment with metformin and SU throughout the trial.
|
Basal-bolus
n=166 participants at risk
Subjects received s.c. injections of IGlar during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started with 1 daily injection of IGlar (administrated at same point of time every day) with starting dose of 10 units. Insulin titration: Subjects underwent a weekly insulin dose titration during the entire treatment period in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in a stepwise manner by adding an additional injection of IAsp depending on whether subjects achieved the pre-defined glycaemic target (HbA1c \<7.0%). Subjects had the possibility of receiving 1 daily injection of IGlar plus up to 3 daily injections of IAsp. Subjects continued their pre-trial treatment with metformin and SU throughout the trial.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.60%
1/166 • Number of events 1 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
0.00%
0/166 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Infections and infestations
Anal abscess
|
0.00%
0/166 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
0.60%
1/166 • Number of events 1 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Cardiac disorders
Angina pectoris
|
1.2%
2/166 • Number of events 2 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
0.00%
0/166 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Cardiac disorders
Atrial fibrillation
|
0.60%
1/166 • Number of events 1 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
0.00%
0/166 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Eye disorders
Cataract
|
0.60%
1/166 • Number of events 1 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
0.60%
1/166 • Number of events 1 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/166 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
0.60%
1/166 • Number of events 1 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/166 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
0.60%
1/166 • Number of events 1 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Hepatobiliary disorders
Cholangitis
|
0.60%
1/166 • Number of events 1 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
0.00%
0/166 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.60%
1/166 • Number of events 1 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
0.00%
0/166 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.60%
1/166 • Number of events 1 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
0.00%
0/166 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/166 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
0.60%
1/166 • Number of events 1 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/166 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
1.2%
2/166 • Number of events 2 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Nervous system disorders
Diabetic neuropathy
|
0.60%
1/166 • Number of events 1 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
0.00%
0/166 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/166 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
0.60%
1/166 • Number of events 1 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.60%
1/166 • Number of events 1 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
0.00%
0/166 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/166 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
0.60%
1/166 • Number of events 1 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/166 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
0.60%
1/166 • Number of events 1 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Vascular disorders
Hypertension
|
0.60%
1/166 • Number of events 1 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
0.00%
0/166 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.2%
2/166 • Number of events 2 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
0.00%
0/166 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Nervous system disorders
Hypoglycaemic seizure
|
0.00%
0/166 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
1.8%
3/166 • Number of events 8 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Nervous system disorders
Hypoglycaemic unconsciousness
|
0.00%
0/166 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
1.2%
2/166 • Number of events 3 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.60%
1/166 • Number of events 1 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
0.00%
0/166 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.60%
1/166 • Number of events 1 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
0.00%
0/166 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.60%
1/166 • Number of events 1 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
0.60%
1/166 • Number of events 1 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.60%
1/166 • Number of events 1 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
0.00%
0/166 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Restrictive pulmonary disease
|
0.60%
1/166 • Number of events 1 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
0.00%
0/166 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Eye disorders
Retinal detachment
|
0.60%
1/166 • Number of events 1 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
0.00%
0/166 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.60%
1/166 • Number of events 1 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
0.00%
0/166 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.60%
1/166 • Number of events 1 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
0.00%
0/166 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
Other adverse events
| Measure |
BIAsp 30
n=166 participants at risk
Subjects received s.c. injection of BIAsp 30 (a mixture of soluble IAsp 30% and protaminated IAsp 70%) during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started treatment with 1 daily injection of BIAsp 30 (starting dose 12 unit) with the largest meal. Insulin titration: Subjects underwent weekly insulin dose titration during entire treatment period in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in stepwise manner by adding an additional injection of BIAsp 30 depending on whether subjects achieved the pre-defined glycaemic target (HbA1c \<7.0%). Subjects had the possibility of receiving up to 3 daily injections of BIAsp 30. Subjects continued pre-trial treatment with metformin and SU throughout the trial.
|
Basal-bolus
n=166 participants at risk
Subjects received s.c. injections of IGlar during a 32-week treatment period (divided into 4 periods of 8 weeks each). Subjects started with 1 daily injection of IGlar (administrated at same point of time every day) with starting dose of 10 units. Insulin titration: Subjects underwent a weekly insulin dose titration during the entire treatment period in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Insulin intensification: At the end of each 8-week period, insulin treatment was intensified in a stepwise manner by adding an additional injection of IAsp depending on whether subjects achieved the pre-defined glycaemic target (HbA1c \<7.0%). Subjects had the possibility of receiving 1 daily injection of IGlar plus up to 3 daily injections of IAsp. Subjects continued their pre-trial treatment with metformin and SU throughout the trial.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.6%
11/166 • Number of events 16 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
3.6%
6/166 • Number of events 7 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.6%
11/166 • Number of events 13 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
4.8%
8/166 • Number of events 9 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Gastrointestinal disorders
Diarrhoea
|
6.0%
10/166 • Number of events 19 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
6.6%
11/166 • Number of events 12 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Nervous system disorders
Headache
|
7.2%
12/166 • Number of events 24 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
9.0%
15/166 • Number of events 27 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Infections and infestations
Nasopharyngitis
|
12.7%
21/166 • Number of events 31 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
10.8%
18/166 • Number of events 27 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
|
Infections and infestations
Upper respiratory tract infection
|
6.6%
11/166 • Number of events 15 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
6.6%
11/166 • Number of events 13 • From first randomised treatment (week 0) to last randomised treatment (week 32) + 7 days.
The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator. All adverse events mentioned here were treatment emergent (an event that has an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more manuscripts for publication will be prepared collaboratively between Investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for less than 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER