Trial Outcomes & Findings for Efficacy and Safety of FIAsp in a Basal-bolus Regimen Versus Basal Insulin Therapy, Both in Combination With Metformin in Adult Subjects With Type 2 Diabetes (NCT NCT01850615)
NCT ID: NCT01850615
Last Updated: 2019-06-12
Results Overview
For this endpoint, baseline (week 0) and week 18 data are presented, where week 18 data are the "end of trial" data containing last available measurements.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
323 participants
Primary outcome timeframe
Week 0, week 18
Results posted on
2019-06-12
Participant Flow
The trial was conducted at 51 sites in 6 countries as follows: Argentina: 4 sites; India: 8 sites; Mexico: 3 sites; Romania: 5 sites; Slovenia: 4 sites; United States: 27 sites.
A total of 555 subjects were screened, of which 232 subjects were screening failures and 323 subjects were enrolled and entered the run-in (pre-assignment) period. Of those, 87 subjects were run-in failures. Hence, 236 subjects were randomized to the 18 weeks of treatment period.
Participant milestones
| Measure |
Faster Aspart + Basal
During the 18-week treatment period, subjects received subcutaneous (s.c., under the skin) injection of faster aspart (bolus insulin) along with s.c. basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different plasma glucose (PG) levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. Faster aspart was administered 0-2 minutes before each main meal (i.e., breakfast, lunch and main evening meal). The basal insulin injection was to be given once daily (OD), in the evening, at approximately the same time each day.
|
Basal
During the 18-week treatment period, subjects received s.c. injection of basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different PG levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
|
|---|---|---|
|
Overall Study
STARTED
|
116
|
120
|
|
Overall Study
Exposed
|
115
|
120
|
|
Overall Study
COMPLETED
|
107
|
115
|
|
Overall Study
NOT COMPLETED
|
9
|
5
|
Reasons for withdrawal
| Measure |
Faster Aspart + Basal
During the 18-week treatment period, subjects received subcutaneous (s.c., under the skin) injection of faster aspart (bolus insulin) along with s.c. basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different plasma glucose (PG) levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. Faster aspart was administered 0-2 minutes before each main meal (i.e., breakfast, lunch and main evening meal). The basal insulin injection was to be given once daily (OD), in the evening, at approximately the same time each day.
|
Basal
During the 18-week treatment period, subjects received s.c. injection of basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different PG levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
4
|
1
|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Unclassified
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of FIAsp in a Basal-bolus Regimen Versus Basal Insulin Therapy, Both in Combination With Metformin in Adult Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Faster Aspart + Basal
n=116 Participants
During the 18-week treatment period, subjects received subcutaneous (s.c., under the skin) injection of faster aspart (bolus insulin) along with s.c. basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different PG levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. Faster aspart was administered 0-2 minutes before each main meal (i.e., breakfast, lunch and main evening meal). The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
|
Basal
n=120 Participants
During the 18-week treatment period, subjects received s.c. injection of basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different (PG) levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
|
Total
n=236 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.5 years
STANDARD_DEVIATION 9.9 • n=93 Participants
|
57.4 years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
57.4 years
STANDARD_DEVIATION 9.2 • n=27 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=93 Participants
|
61 Participants
n=4 Participants
|
122 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
114 Participants
n=27 Participants
|
|
Glycosylated haemoglobin (HbA1c)
|
7.93 Percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.69 • n=93 Participants
|
7.92 Percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.68 • n=4 Participants
|
7.93 Percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.69 • n=27 Participants
|
|
Body weight
|
82.2 Kg
STANDARD_DEVIATION 16.2 • n=93 Participants
|
85.1 Kg
STANDARD_DEVIATION 17.3 • n=4 Participants
|
83.7 Kg
STANDARD_DEVIATION 16.8 • n=27 Participants
|
PRIMARY outcome
Timeframe: Week 0, week 18Population: Full analysis set included all randomised subjects.
For this endpoint, baseline (week 0) and week 18 data are presented, where week 18 data are the "end of trial" data containing last available measurements.
Outcome measures
| Measure |
Faster Aspart + Basal
n=116 Participants
During the 18-week treatment period, subjects received subcutaneous (s.c., under the skin) injection of faster aspart (bolus insulin) along with s.c. basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different PG levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. Faster aspart was administered 0-2 minutes before each main meal (i.e., breakfast, lunch and main evening meal). The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
|
Basal
n=120 Participants
During the 18-week treatment period, subjects received s.c. injection of basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different (PG) levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
|
|---|---|---|
|
Change From Baseline in HbA1c
Week 18
|
6.78 Percentage of glycosylated haemoglobin
Standard Deviation 0.92
|
7.7 Percentage of glycosylated haemoglobin
Standard Deviation 0.93
|
|
Change From Baseline in HbA1c
Baseline
|
7.93 Percentage of glycosylated haemoglobin
Standard Deviation 0.69
|
7.92 Percentage of glycosylated haemoglobin
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: After 18 weeks of randomised treatmentPopulation: FAS included all randomised subjects. Number analysed for individual time-points = treatment wise number of subjects who contributed to analysis.
For this endpoint the "end of trial" data containing last available measurements are presented. PPG measurements were recorded by the subjects at 2 hours after each meal (breakfast, lunch and main evening meal) as part of three 7-point profiles (SMPG) prior to the visits. Individual mean meal PPG (post-breakfast, post-lunch, post-main evening meal) was derived from the three measurements.
Outcome measures
| Measure |
Faster Aspart + Basal
n=116 Participants
During the 18-week treatment period, subjects received subcutaneous (s.c., under the skin) injection of faster aspart (bolus insulin) along with s.c. basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different PG levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. Faster aspart was administered 0-2 minutes before each main meal (i.e., breakfast, lunch and main evening meal). The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
|
Basal
n=120 Participants
During the 18-week treatment period, subjects received s.c. injection of basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different (PG) levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
|
|---|---|---|
|
Self-measured Plasma Glucose (SMPG) 7-point Profile: Post Prandial Plasma Glucose (PPG), Overall 2-hour Mean (of Breakfast, Lunch, Main Evening Meal)
PPG breakfast; SMPG
|
7.2 mmol/L
Standard Deviation 1.8
|
9 mmol/L
Standard Deviation 2.4
|
|
Self-measured Plasma Glucose (SMPG) 7-point Profile: Post Prandial Plasma Glucose (PPG), Overall 2-hour Mean (of Breakfast, Lunch, Main Evening Meal)
PPG lunch; SMPG
|
7.1 mmol/L
Standard Deviation 1.9
|
9.7 mmol/L
Standard Deviation 2.6
|
|
Self-measured Plasma Glucose (SMPG) 7-point Profile: Post Prandial Plasma Glucose (PPG), Overall 2-hour Mean (of Breakfast, Lunch, Main Evening Meal)
PPG main evening meal; SMPG
|
7.4 mmol/L
Standard Deviation 1.9
|
10.1 mmol/L
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: After 18 weeks of randomised treatmentPopulation: FAS included all randomised subjects. Number analysed for individual time-points = treatment wise number of subjects who contributed to analysis.
For this endpoint the "end of trial" data containing last available measurements are presented. Prandial PG increment for each meal (breakfast, lunch, main evening meal) was derived from the 7-point profiles (SMPG) as the difference between the PPG value 2 hours after each meal and the PG value before each meal. Individual mean meal PPG (post-breakfast, post-lunch, post-main evening meal) was derived from the three measurements.
Outcome measures
| Measure |
Faster Aspart + Basal
n=116 Participants
During the 18-week treatment period, subjects received subcutaneous (s.c., under the skin) injection of faster aspart (bolus insulin) along with s.c. basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different PG levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. Faster aspart was administered 0-2 minutes before each main meal (i.e., breakfast, lunch and main evening meal). The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
|
Basal
n=120 Participants
During the 18-week treatment period, subjects received s.c. injection of basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different (PG) levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
|
|---|---|---|
|
Self-measured Plasma Glucose (SMPG) 7-point Profile: Prandial Plasma Glucose (PG) Increment, Overall 2-hour Mean (of Breakfast, Lunch, Main Evening Meal)
Breakfast increment; SMPG
|
1.2 mmol/L
Standard Deviation 1.8
|
2.9 mmol/L
Standard Deviation 2.4
|
|
Self-measured Plasma Glucose (SMPG) 7-point Profile: Prandial Plasma Glucose (PG) Increment, Overall 2-hour Mean (of Breakfast, Lunch, Main Evening Meal)
Lunch increment; SMPG
|
0.9 mmol/L
Standard Deviation 2.0
|
1.8 mmol/L
Standard Deviation 2.2
|
|
Self-measured Plasma Glucose (SMPG) 7-point Profile: Prandial Plasma Glucose (PG) Increment, Overall 2-hour Mean (of Breakfast, Lunch, Main Evening Meal)
Main evening meal increment; SMPG
|
0.7 mmol/L
Standard Deviation 1.7
|
1.4 mmol/L
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Week 0, week 18Population: FAS included all randomised subjects.
For this endpoint, baseline (week 0) and week 18 data are presented, where week 18 data are the "end of trial" data containing last available measurements.
Outcome measures
| Measure |
Faster Aspart + Basal
n=116 Participants
During the 18-week treatment period, subjects received subcutaneous (s.c., under the skin) injection of faster aspart (bolus insulin) along with s.c. basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different PG levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. Faster aspart was administered 0-2 minutes before each main meal (i.e., breakfast, lunch and main evening meal). The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
|
Basal
n=120 Participants
During the 18-week treatment period, subjects received s.c. injection of basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different (PG) levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
|
|---|---|---|
|
Change From Baseline in Body Weight
Baseline
|
82.2 Kg
Standard Deviation 16.2
|
85.1 Kg
Standard Deviation 17.3
|
|
Change From Baseline in Body Weight
Week 18
|
83.9 Kg
Standard Deviation 16.9
|
85.4 Kg
Standard Deviation 17.5
|
SECONDARY outcome
Timeframe: Weeks 0-18Population: The Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or its comparator.
Plasma glucose (PG) was measured and recorded when a hypoglycaemic episode was suspected. All PG values ≤3.9 mmol/L (70 mg/dL) or \>3.9 mmol/L (70 mg/dL) when they occurred in conjunction with hypoglycaemic symptoms were recorded by the subject. Numbers of treatment emergent hypoglycaemic episodes were recorded during 18 weeks of treatment.
Outcome measures
| Measure |
Faster Aspart + Basal
n=115 Participants
During the 18-week treatment period, subjects received subcutaneous (s.c., under the skin) injection of faster aspart (bolus insulin) along with s.c. basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different PG levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. Faster aspart was administered 0-2 minutes before each main meal (i.e., breakfast, lunch and main evening meal). The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
|
Basal
n=120 Participants
During the 18-week treatment period, subjects received s.c. injection of basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different (PG) levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
|
|---|---|---|
|
Number of Treatment Emergent Hypoglycaemic Episodes
|
1908 Number of episodes
|
347 Number of episodes
|
SECONDARY outcome
Timeframe: Weeks 0-18Population: The SAS included all subjects receiving at least one dose of the investigational product or its comparator.
All adverse events (AEs) described here refer to treatment emergent adverse events (TEAE). A TEAE was defined as an event that had 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, week 18.
Outcome measures
| Measure |
Faster Aspart + Basal
n=115 Participants
During the 18-week treatment period, subjects received subcutaneous (s.c., under the skin) injection of faster aspart (bolus insulin) along with s.c. basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different PG levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. Faster aspart was administered 0-2 minutes before each main meal (i.e., breakfast, lunch and main evening meal). The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
|
Basal
n=120 Participants
During the 18-week treatment period, subjects received s.c. injection of basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different (PG) levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
|
|---|---|---|
|
Number of Adverse Events
|
123 Number of events
|
121 Number of events
|
Adverse Events
Faster Aspart + Basal
Serious events: 6 serious events
Other events: 2 other events
Deaths: 0 deaths
Basal
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Faster Aspart + Basal
n=115 participants at risk
During the 18-week treatment period, subjects received subcutaneous (s.c., under the skin) injection of faster aspart (bolus insulin) along with s.c. basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different PG levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. Faster aspart was administered 0-2 minutes before each main meal (i.e., breakfast, lunch and main evening meal). The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
|
Basal
n=120 participants at risk
During the 18-week treatment period, subjects received s.c. injection of basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different (PG) levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/115 • During 18 weeks of randomised treatment period + 7 days of follow-up period.
All AEs described here refer to TEAEs. The SAS included all subjects receiving at least one dose of the investigational product or its comparator.
|
0.83%
1/120 • Number of events 1 • During 18 weeks of randomised treatment period + 7 days of follow-up period.
All AEs described here refer to TEAEs. The SAS included all subjects receiving at least one dose of the investigational product or its comparator.
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.00%
0/115 • During 18 weeks of randomised treatment period + 7 days of follow-up period.
All AEs described here refer to TEAEs. The SAS included all subjects receiving at least one dose of the investigational product or its comparator.
|
0.83%
1/120 • Number of events 1 • During 18 weeks of randomised treatment period + 7 days of follow-up period.
All AEs described here refer to TEAEs. The SAS included all subjects receiving at least one dose of the investigational product or its comparator.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.87%
1/115 • Number of events 1 • During 18 weeks of randomised treatment period + 7 days of follow-up period.
All AEs described here refer to TEAEs. The SAS included all subjects receiving at least one dose of the investigational product or its comparator.
|
0.00%
0/120 • During 18 weeks of randomised treatment period + 7 days of follow-up period.
All AEs described here refer to TEAEs. The SAS included all subjects receiving at least one dose of the investigational product or its comparator.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/115 • During 18 weeks of randomised treatment period + 7 days of follow-up period.
All AEs described here refer to TEAEs. The SAS included all subjects receiving at least one dose of the investigational product or its comparator.
|
0.83%
1/120 • Number of events 1 • During 18 weeks of randomised treatment period + 7 days of follow-up period.
All AEs described here refer to TEAEs. The SAS included all subjects receiving at least one dose of the investigational product or its comparator.
|
|
Injury, poisoning and procedural complications
Fall
|
1.7%
2/115 • Number of events 2 • During 18 weeks of randomised treatment period + 7 days of follow-up period.
All AEs described here refer to TEAEs. The SAS included all subjects receiving at least one dose of the investigational product or its comparator.
|
0.83%
1/120 • Number of events 1 • During 18 weeks of randomised treatment period + 7 days of follow-up period.
All AEs described here refer to TEAEs. The SAS included all subjects receiving at least one dose of the investigational product or its comparator.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.7%
2/115 • Number of events 2 • During 18 weeks of randomised treatment period + 7 days of follow-up period.
All AEs described here refer to TEAEs. The SAS included all subjects receiving at least one dose of the investigational product or its comparator.
|
0.00%
0/120 • During 18 weeks of randomised treatment period + 7 days of follow-up period.
All AEs described here refer to TEAEs. The SAS included all subjects receiving at least one dose of the investigational product or its comparator.
|
|
Nervous system disorders
Hypoglycaemic unconsciousness
|
0.00%
0/115 • During 18 weeks of randomised treatment period + 7 days of follow-up period.
All AEs described here refer to TEAEs. The SAS included all subjects receiving at least one dose of the investigational product or its comparator.
|
0.83%
1/120 • Number of events 1 • During 18 weeks of randomised treatment period + 7 days of follow-up period.
All AEs described here refer to TEAEs. The SAS included all subjects receiving at least one dose of the investigational product or its comparator.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/115 • During 18 weeks of randomised treatment period + 7 days of follow-up period.
All AEs described here refer to TEAEs. The SAS included all subjects receiving at least one dose of the investigational product or its comparator.
|
0.83%
1/120 • Number of events 1 • During 18 weeks of randomised treatment period + 7 days of follow-up period.
All AEs described here refer to TEAEs. The SAS included all subjects receiving at least one dose of the investigational product or its comparator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant respiratory tract neoplasm
|
0.00%
0/115 • During 18 weeks of randomised treatment period + 7 days of follow-up period.
All AEs described here refer to TEAEs. The SAS included all subjects receiving at least one dose of the investigational product or its comparator.
|
0.83%
1/120 • Number of events 1 • During 18 weeks of randomised treatment period + 7 days of follow-up period.
All AEs described here refer to TEAEs. The SAS included all subjects receiving at least one dose of the investigational product or its comparator.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.87%
1/115 • Number of events 1 • During 18 weeks of randomised treatment period + 7 days of follow-up period.
All AEs described here refer to TEAEs. The SAS included all subjects receiving at least one dose of the investigational product or its comparator.
|
0.00%
0/120 • During 18 weeks of randomised treatment period + 7 days of follow-up period.
All AEs described here refer to TEAEs. The SAS included all subjects receiving at least one dose of the investigational product or its comparator.
|
|
Infections and infestations
Respiratory tract infection
|
0.87%
1/115 • Number of events 1 • During 18 weeks of randomised treatment period + 7 days of follow-up period.
All AEs described here refer to TEAEs. The SAS included all subjects receiving at least one dose of the investigational product or its comparator.
|
0.00%
0/120 • During 18 weeks of randomised treatment period + 7 days of follow-up period.
All AEs described here refer to TEAEs. The SAS included all subjects receiving at least one dose of the investigational product or its comparator.
|
|
Injury, poisoning and procedural complications
Wrong drug administered
|
0.87%
1/115 • Number of events 1 • During 18 weeks of randomised treatment period + 7 days of follow-up period.
All AEs described here refer to TEAEs. The SAS included all subjects receiving at least one dose of the investigational product or its comparator.
|
0.00%
0/120 • During 18 weeks of randomised treatment period + 7 days of follow-up period.
All AEs described here refer to TEAEs. The SAS included all subjects receiving at least one dose of the investigational product or its comparator.
|
Other adverse events
| Measure |
Faster Aspart + Basal
n=115 participants at risk
During the 18-week treatment period, subjects received subcutaneous (s.c., under the skin) injection of faster aspart (bolus insulin) along with s.c. basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different PG levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. Faster aspart was administered 0-2 minutes before each main meal (i.e., breakfast, lunch and main evening meal). The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
|
Basal
n=120 participants at risk
During the 18-week treatment period, subjects received s.c. injection of basal insulin (insulin detemir or insulin glargine or NPH insulin) and metformin. Treatment recommendations were developed for the different trial products specifying the recommended dose adjustments at different (PG) levels. Trial products were titrated according to the insulin dosing recommendations provided during the study. No maximum dose of insulin was specified as doses were titrated individually. The basal insulin injection was to be given OD, in the evening, at approximately the same time each day.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
2/115 • Number of events 4 • During 18 weeks of randomised treatment period + 7 days of follow-up period.
All AEs described here refer to TEAEs. The SAS included all subjects receiving at least one dose of the investigational product or its comparator.
|
5.0%
6/120 • Number of events 6 • During 18 weeks of randomised treatment period + 7 days of follow-up period.
All AEs described here refer to TEAEs. The SAS included all subjects receiving at least one dose of the investigational product or its comparator.
|
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