Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (Soluble Insulin Analogue Combination \[SIAC\], insulin degludec/insulin aspart) formulations with each other and with biphasic insulin aspart 30, all in combination with metformin in insulin naive subjects with type 2 diabetes.
Interventions
DRUGinsulin degludec/insulin aspart
Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily
DRUGbiphasic insulin aspart
Treat-to-target dose titration scheme, injection s.c., twice daily
DRUGmetformin
Tablets, 1500-2000 mg/daily
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.) * Insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3 months (no previous insulin treatment or previous short term insulin treatment maximum 14 days within the last 3 months) * Treatment with one or two oral anti-diabetic drugs (OADs): metformin, sulfonylurea, other insulin secretagogue (e.g. repaglinide, nateglinide), alpha-glucosidase inhibitors for at least 2 months at a stable maximally tolerated dose or at least half maximally allowed dose according to locally approved summary of product characteristics (SPC) * HbA1c, 7.0-11.0 % (both inclusive) * Body Mass Index (BMI), 25.0-37.0 kg/m\^2 (both inclusive)
Exclusion criteria
* Metformin contraindication according to local practice * Thiazolidinedione (TZD) treatment within previous 3 months prior to Visit 1 * Any systemic treatment with products, which in the investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) within 3 months prior to randomisation * Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system (except for conditions associated with type 2 diabetes) that, in the opinion of the investigator, may confound the results of the trial or pose additional risk in administering trial product
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycosylated Haemoglobin (HbA1c) | Week 0, Week 16 | Change from baseline in HbA1c after 16 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) | Week 16 | Estimate of the overall mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, before bedtime, at 4 am and before breakfast. |
| Rate of Major and Minor Hypoglycaemic Episodes | Week 0 to Week 16 + 5 days follow up | Observed rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. |
| Rate of Nocturnal Major and Minor Hypoglycaemic Episodes | Week 0 to Week 16 + 5 days follow up | Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 05:59 (included). |
| Rate of Treatment Emergent Adverse Events (AEs) | Week 0 to Week 16 + 5 days follow up | Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. |
| Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) | Week -4, Week 16 | Laboratory values at screening (Week -4) and at Week 16 |
| Vital Signs: Diastolic Blood Pressure (BP) | Week 0, Week 16 | Values at baseline (Week 0) and at Week 16 |
| Laboratory Safety Parameters (Biochemistry): Serum Creatinine | Week -4, Week 16 | Laboratory values at screening (Week -4) and at Week 16 |
| Vital Signs: Systolic Blood Pressure (BP) | Week 0, Week 16 | Values at baseline (Week 0) and at Week 16 |
| Vital Signs: Pulse | Week 0, Week 16 | Values at baseline (Week 0) and at Week 16 |
| Physical Examination | Week -4, Week 8, Week 16 | Physical examination was performed at screening (week -4), and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed. |
| Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) | Week -4, Week 16 | Laboratory values at screening (Week -4) and at Week 16 |
Countries
Finland, France, Germany, Poland, Spain
Participant flow
Recruitment details
The trial was conducted at 27 sites in 5 countries: Finland (4), France (4), Germany (6), Poland (9) and Spain (4).
Pre-assignment details
Subjects underwent a run-in period of up to 3 weeks (including 1-week maintenance period) where metformin was up-titrated to 1500 or 2000 mg/day. Subjects who tolerated metformin dose for a week and had fasting plasma glucose ≥ 7.5 mmol/L were randomised to SIAC 30 (B), SIAC 45 (B) or BIAsp 30 twice daily.
Participants by arm
| Arm | Count |
|---|---|
| SIAC 30 (B) Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. | 61 |
| SIAC 45 (B) Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml \[1 dosing unit = 6 nmol\]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. | 59 |
| BIAsp 30 Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. | 62 |
| Total | 182 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 1 |
| Overall Study | Lack of Efficacy | 0 | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 1 | 1 |
| Overall Study | Unclassified | 5 | 3 | 2 |
Baseline characteristics
| Characteristic | SIAC 30 (B) | SIAC 45 (B) | BIAsp 30 | Total |
|---|---|---|---|---|
| Age, Continuous | 58.7 years STANDARD_DEVIATION 8.5 | 60.5 years STANDARD_DEVIATION 8.9 | 59.7 years STANDARD_DEVIATION 8 | 59.6 years STANDARD_DEVIATION 8.4 |
| Fasting plasma glucose (FPG) | 11.4 mmol/L STANDARD_DEVIATION 2.7 | 11.8 mmol/L STANDARD_DEVIATION 2.9 | 11.7 mmol/L STANDARD_DEVIATION 3.1 | 11.6 mmol/L STANDARD_DEVIATION 2.9 |
| Glycosylated haemoglobin (HbA1c) | 8.5 percentage of glycosylated haemoglobin STANDARD_DEVIATION 1.2 | 8.5 percentage of glycosylated haemoglobin STANDARD_DEVIATION 0.9 | 8.6 percentage of glycosylated haemoglobin STANDARD_DEVIATION 1 | 8.5 percentage of glycosylated haemoglobin STANDARD_DEVIATION 1.1 |
| Sex: Female, Male Female | 32 Participants | 30 Participants | 23 Participants | 85 Participants |
| Sex: Female, Male Male | 29 Participants | 29 Participants | 39 Participants | 97 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 14 / 60 | 13 / 59 | 13 / 62 |
| serious Total, serious adverse events | 0 / 60 | 0 / 59 | 2 / 62 |
Outcome results
Primary
Change in Glycosylated Haemoglobin (HbA1c)
Change from baseline in HbA1c after 16 weeks of treatment
Time frame: Week 0, Week 16
Population: The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). HbA1c values were missing for 2 subjects, hence did not contribute to the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SIAC 30 (B) | Change in Glycosylated Haemoglobin (HbA1c) | -1.79 percentage of glycosylated haemoglobin | Standard Deviation 1.11 |
| SIAC 45 (B) | Change in Glycosylated Haemoglobin (HbA1c) | -1.87 percentage of glycosylated haemoglobin | Standard Deviation 0.91 |
| BIAsp 30 | Change in Glycosylated Haemoglobin (HbA1c) | -1.84 percentage of glycosylated haemoglobin | Standard Deviation 0.93 |
Secondary
Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)
Laboratory values at screening (Week -4) and at Week 16
Time frame: Week -4, Week 16
Population: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. For 2 subjects the laboratory values were missing at week -4. From the SAS, 54 (SIAC 30), 57 (SIAC 45) and 53 (BIAsp 30) subjects contributed to the analysis at week 16.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIAC 30 (B) | Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) | Week -4, N=60, 57, 62 | 33.0 IU/L | Standard Deviation 16.6 |
| SIAC 30 (B) | Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) | Week 16, N=54, 57, 53 | 22.9 IU/L | Standard Deviation 9.2 |
| SIAC 45 (B) | Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) | Week -4, N=60, 57, 62 | 31.4 IU/L | Standard Deviation 16 |
| SIAC 45 (B) | Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) | Week 16, N=54, 57, 53 | 22.5 IU/L | Standard Deviation 11.1 |
| BIAsp 30 | Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) | Week -4, N=60, 57, 62 | 36.9 IU/L | Standard Deviation 23.4 |
| BIAsp 30 | Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) | Week 16, N=54, 57, 53 | 23.6 IU/L | Standard Deviation 11.3 |
Secondary
Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)
Laboratory values at screening (Week -4) and at Week 16
Time frame: Week -4, Week 16
Population: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. For 3 subjects the laboratory values were missing at week -4. From the SAS, 54 (SIAC 30), 57 (SIAC 45) and 53 (BIAsp 30) subjects contributed to the analysis at week 16.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIAC 30 (B) | Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) | Week -4, N=60, 56, 62 | 23.6 IU/L | Standard Deviation 11.2 |
| SIAC 30 (B) | Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) | Week 16, N=54, 57, 53 | 22.6 IU/L | Standard Deviation 8.7 |
| SIAC 45 (B) | Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) | Week -4, N=60, 56, 62 | 25.2 IU/L | Standard Deviation 12 |
| SIAC 45 (B) | Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) | Week 16, N=54, 57, 53 | 22.9 IU/L | Standard Deviation 11.4 |
| BIAsp 30 | Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) | Week -4, N=60, 56, 62 | 26.4 IU/L | Standard Deviation 16.1 |
| BIAsp 30 | Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) | Week 16, N=54, 57, 53 | 23.1 IU/L | Standard Deviation 11.2 |
Secondary
Laboratory Safety Parameters (Biochemistry): Serum Creatinine
Laboratory values at screening (Week -4) and at Week 16
Time frame: Week -4, Week 16
Population: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. For 2 subjects the laboratory values were missing at week -4. From the SAS, 56 (SIAC 30), 57 (SIAC 45) and 56 (BIAsp 30) subjects contributed to the analysis at week 16.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIAC 30 (B) | Laboratory Safety Parameters (Biochemistry): Serum Creatinine | Week -4, N=60, 57, 62 | 72.7 umol/L | Standard Deviation 14 |
| SIAC 30 (B) | Laboratory Safety Parameters (Biochemistry): Serum Creatinine | Week 16, N=56, 57, 56 | 73.6 umol/L | Standard Deviation 13.2 |
| SIAC 45 (B) | Laboratory Safety Parameters (Biochemistry): Serum Creatinine | Week -4, N=60, 57, 62 | 75.8 umol/L | Standard Deviation 14.8 |
| SIAC 45 (B) | Laboratory Safety Parameters (Biochemistry): Serum Creatinine | Week 16, N=56, 57, 56 | 76.3 umol/L | Standard Deviation 16.1 |
| BIAsp 30 | Laboratory Safety Parameters (Biochemistry): Serum Creatinine | Week 16, N=56, 57, 56 | 78.1 umol/L | Standard Deviation 15.5 |
| BIAsp 30 | Laboratory Safety Parameters (Biochemistry): Serum Creatinine | Week -4, N=60, 57, 62 | 74.8 umol/L | Standard Deviation 14.1 |
Secondary
Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
Estimate of the overall mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, before bedtime, at 4 am and before breakfast.
Time frame: Week 16
Population: The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). For 2 subjects, mean SMPG values were missing.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SIAC 30 (B) | Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) | 7.52 mmol/L | Standard Error 0.27 |
| SIAC 45 (B) | Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) | 7.44 mmol/L | Standard Error 0.28 |
| BIAsp 30 | Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) | 7.52 mmol/L | Standard Error 0.27 |
Secondary
Physical Examination
Physical examination was performed at screening (week -4), and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.
Time frame: Week -4, Week 8, Week 16
Secondary
Rate of Major and Minor Hypoglycaemic Episodes
Observed rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.
Time frame: Week 0 to Week 16 + 5 days follow up
Population: The full analysis set (FAS) included all randomised subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SIAC 30 (B) | Rate of Major and Minor Hypoglycaemic Episodes | Major | 0 Episodes/100 years of patient exposure |
| SIAC 30 (B) | Rate of Major and Minor Hypoglycaemic Episodes | Minor | 287 Episodes/100 years of patient exposure |
| SIAC 45 (B) | Rate of Major and Minor Hypoglycaemic Episodes | Major | 0 Episodes/100 years of patient exposure |
| SIAC 45 (B) | Rate of Major and Minor Hypoglycaemic Episodes | Minor | 679 Episodes/100 years of patient exposure |
| BIAsp 30 | Rate of Major and Minor Hypoglycaemic Episodes | Major | 0 Episodes/100 years of patient exposure |
| BIAsp 30 | Rate of Major and Minor Hypoglycaemic Episodes | Minor | 730 Episodes/100 years of patient exposure |
Secondary
Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 05:59 (included).
Time frame: Week 0 to Week 16 + 5 days follow up
Population: The full analysis set (FAS) included all randomised subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SIAC 30 (B) | Rate of Nocturnal Major and Minor Hypoglycaemic Episodes | Major | 0 Episodes/100 years of patient exposure |
| SIAC 30 (B) | Rate of Nocturnal Major and Minor Hypoglycaemic Episodes | Minor | 39 Episodes/100 years of patient exposure |
| SIAC 45 (B) | Rate of Nocturnal Major and Minor Hypoglycaemic Episodes | Major | 0 Episodes/100 years of patient exposure |
| SIAC 45 (B) | Rate of Nocturnal Major and Minor Hypoglycaemic Episodes | Minor | 79 Episodes/100 years of patient exposure |
| BIAsp 30 | Rate of Nocturnal Major and Minor Hypoglycaemic Episodes | Major | 0 Episodes/100 years of patient exposure |
| BIAsp 30 | Rate of Nocturnal Major and Minor Hypoglycaemic Episodes | Minor | 108 Episodes/100 years of patient exposure |
Secondary
Rate of Treatment Emergent Adverse Events (AEs)
Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.
Time frame: Week 0 to Week 16 + 5 days follow up
Population: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SIAC 30 (B) | Rate of Treatment Emergent Adverse Events (AEs) | Adverse events (AEs) | 298 Events/100 years of patient exposure |
| SIAC 30 (B) | Rate of Treatment Emergent Adverse Events (AEs) | Serious AEs | 0 Events/100 years of patient exposure |
| SIAC 30 (B) | Rate of Treatment Emergent Adverse Events (AEs) | Severe AEs | 0 Events/100 years of patient exposure |
| SIAC 30 (B) | Rate of Treatment Emergent Adverse Events (AEs) | Moderate AEs | 56 Events/100 years of patient exposure |
| SIAC 30 (B) | Rate of Treatment Emergent Adverse Events (AEs) | Mild AEs | 242 Events/100 years of patient exposure |
| SIAC 30 (B) | Rate of Treatment Emergent Adverse Events (AEs) | Fatal AEs | 0 Events/100 years of patient exposure |
| SIAC 45 (B) | Rate of Treatment Emergent Adverse Events (AEs) | Fatal AEs | 0 Events/100 years of patient exposure |
| SIAC 45 (B) | Rate of Treatment Emergent Adverse Events (AEs) | Adverse events (AEs) | 545 Events/100 years of patient exposure |
| SIAC 45 (B) | Rate of Treatment Emergent Adverse Events (AEs) | Moderate AEs | 67 Events/100 years of patient exposure |
| SIAC 45 (B) | Rate of Treatment Emergent Adverse Events (AEs) | Mild AEs | 477 Events/100 years of patient exposure |
| SIAC 45 (B) | Rate of Treatment Emergent Adverse Events (AEs) | Serious AEs | 0 Events/100 years of patient exposure |
| SIAC 45 (B) | Rate of Treatment Emergent Adverse Events (AEs) | Severe AEs | 0 Events/100 years of patient exposure |
| BIAsp 30 | Rate of Treatment Emergent Adverse Events (AEs) | Serious AEs | 11 Events/100 years of patient exposure |
| BIAsp 30 | Rate of Treatment Emergent Adverse Events (AEs) | Severe AEs | 5 Events/100 years of patient exposure |
| BIAsp 30 | Rate of Treatment Emergent Adverse Events (AEs) | Fatal AEs | 5 Events/100 years of patient exposure |
| BIAsp 30 | Rate of Treatment Emergent Adverse Events (AEs) | Moderate AEs | 38 Events/100 years of patient exposure |
| BIAsp 30 | Rate of Treatment Emergent Adverse Events (AEs) | Adverse events (AEs) | 379 Events/100 years of patient exposure |
| BIAsp 30 | Rate of Treatment Emergent Adverse Events (AEs) | Mild AEs | 335 Events/100 years of patient exposure |
Secondary
Vital Signs: Diastolic Blood Pressure (BP)
Values at baseline (Week 0) and at Week 16
Time frame: Week 0, Week 16
Population: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 58 (SIAC 30), 56 (SIAC 45) and 58 (BIAsp 30) subjects contributed to the analysis at week 16.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIAC 30 (B) | Vital Signs: Diastolic Blood Pressure (BP) | Week 0 (Baseline), N=60, 59, 62 | 80 mmHg | Standard Deviation 9 |
| SIAC 30 (B) | Vital Signs: Diastolic Blood Pressure (BP) | Week 16, N=58, 56, 58 | 78 mmHg | Standard Deviation 9 |
| SIAC 45 (B) | Vital Signs: Diastolic Blood Pressure (BP) | Week 0 (Baseline), N=60, 59, 62 | 81 mmHg | Standard Deviation 10 |
| SIAC 45 (B) | Vital Signs: Diastolic Blood Pressure (BP) | Week 16, N=58, 56, 58 | 79 mmHg | Standard Deviation 10 |
| BIAsp 30 | Vital Signs: Diastolic Blood Pressure (BP) | Week 0 (Baseline), N=60, 59, 62 | 81 mmHg | Standard Deviation 11 |
| BIAsp 30 | Vital Signs: Diastolic Blood Pressure (BP) | Week 16, N=58, 56, 58 | 76 mmHg | Standard Deviation 9 |
Secondary
Vital Signs: Pulse
Values at baseline (Week 0) and at Week 16
Time frame: Week 0, Week 16
Population: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 58 (SIAC 30), 56 (SIAC 45) and 58 (BIAsp 30) subjects contributed to the analysis at week 16.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIAC 30 (B) | Vital Signs: Pulse | Week 0 (Baseline), N=60, 59, 62 | 74 beats/minute | Standard Deviation 10 |
| SIAC 30 (B) | Vital Signs: Pulse | Week 16, N=58, 56, 58 | 73 beats/minute | Standard Deviation 10 |
| SIAC 45 (B) | Vital Signs: Pulse | Week 0 (Baseline), N=60, 59, 62 | 76 beats/minute | Standard Deviation 8 |
| SIAC 45 (B) | Vital Signs: Pulse | Week 16, N=58, 56, 58 | 73 beats/minute | Standard Deviation 8 |
| BIAsp 30 | Vital Signs: Pulse | Week 0 (Baseline), N=60, 59, 62 | 75 beats/minute | Standard Deviation 8 |
| BIAsp 30 | Vital Signs: Pulse | Week 16, N=58, 56, 58 | 77 beats/minute | Standard Deviation 9 |
Secondary
Vital Signs: Systolic Blood Pressure (BP)
Values at baseline (Week 0) and at Week 16
Time frame: Week 0, Week 16
Population: The safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 58 (SIAC 30), 56 (SIAC 45) and 58 (BIAsp 30) subjects contributed to the analysis at week 16.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIAC 30 (B) | Vital Signs: Systolic Blood Pressure (BP) | Week 0 (Baseline), N=60, 59, 62 | 134 mmHg | Standard Deviation 15 |
| SIAC 30 (B) | Vital Signs: Systolic Blood Pressure (BP) | Week 16, N=58, 56, 58 | 128 mmHg | Standard Deviation 13 |
| SIAC 45 (B) | Vital Signs: Systolic Blood Pressure (BP) | Week 0 (Baseline), N=60, 59, 62 | 138 mmHg | Standard Deviation 18 |
| SIAC 45 (B) | Vital Signs: Systolic Blood Pressure (BP) | Week 16, N=58, 56, 58 | 135 mmHg | Standard Deviation 17 |
| BIAsp 30 | Vital Signs: Systolic Blood Pressure (BP) | Week 0 (Baseline), N=60, 59, 62 | 137 mmHg | Standard Deviation 18 |
| BIAsp 30 | Vital Signs: Systolic Blood Pressure (BP) | Week 16, N=58, 56, 58 | 133 mmHg | Standard Deviation 15 |