Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (SIAC, insulin degludec/insulin aspart) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.
Interventions
DRUGinsulin degludec/insulin aspart
Formulation 1: Treat-to-target dose titration scheme, injection s.c., once daily
DRUGinsulin glargine
Treat-to-target dose titration scheme, injection s.c., once daily
DRUGmetformin
Tablets, 1500-2000 mg/day
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 month at a stable maximum tolerated dose or at least half maximum 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) treatments within the previous three 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 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 | 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, bedtime, at 4 am and before breakfast. |
| 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. |
| Rate of Major and Minor Hypoglycaemic Episodes | Week 0 to Week 16 + 5 days follow up | 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 06:00 (excluded). |
| Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) | Week -4, Week 16 | Values at screening (Week -4) and at Week 16 |
| Change in Fasting Plasma Glucose (FPG) | Week 0, Week 16 | Change from baseline in FPG after 16 weeks of treatment |
| Laboratory Safety Parameters (Biochemistry): Serum Creatinine | Week -4, Week 16 | 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 |
| 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 0, Week 8, Week 16 | Physical examination is performed at baseline (Week 0) 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 | Values at screening (Week -4) and at Week 16 |
Countries
France, Germany, Norway, Romania, Spain
Participant flow
Recruitment details
The trial was conducted at 22 sites in 5 countries: France (4 sites), Germany (5 sites), Norway (5 sites), Romania (3 sites) and Spain (5 sites).
Pre-assignment details
During a run-in period of 2 weeks, metformin was up-titrated to 1500/ 2000 mg/day, which was maintained for 1 week. Subjects who tolerated the metformin dose for a week and had a median of 3 self measured glucose values before breakfast, on 3 consecutive days before randomisation, of ≥ 7.5 mmol/l, were randomised to 1 of the 3 treatment groups
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; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. | 59 |
| 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; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. | 59 |
| Insulin Glargine Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. | 60 |
| Total | 178 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 |
| Overall Study | Lack of Efficacy | 0 | 0 | 2 |
| Overall Study | Protocol Violation | 2 | 2 | 1 |
| Overall Study | Unclassified | 1 | 4 | 2 |
Baseline characteristics
| Characteristic | SIAC 30 (B) | SIAC 45 (B) | Insulin Glargine | Total |
|---|---|---|---|---|
| Age, Continuous | 58.7 years STANDARD_DEVIATION 8.8 | 60.2 years STANDARD_DEVIATION 8.4 | 58.4 years STANDARD_DEVIATION 8.4 | 59.1 years STANDARD_DEVIATION 8.5 |
| Fasting plasma glucose (FPG) | 11.1 mmol/L STANDARD_DEVIATION 3.3 | 11.5 mmol/L STANDARD_DEVIATION 3.2 | 12.1 mmol/L STANDARD_DEVIATION 3.5 | 11.6 mmol/L STANDARD_DEVIATION 3.3 |
| Glycosylated haemoglobin (HbA1c) | 8.3 percentage of glycosylated haemoglobin STANDARD_DEVIATION 1.2 | 8.6 percentage of glycosylated haemoglobin STANDARD_DEVIATION 1.5 | 8.4 percentage of glycosylated haemoglobin STANDARD_DEVIATION 1.3 | 8.5 percentage of glycosylated haemoglobin STANDARD_DEVIATION 1.3 |
| Sex: Female, Male Female | 22 Participants | 25 Participants | 16 Participants | 63 Participants |
| Sex: Female, Male Male | 37 Participants | 34 Participants | 44 Participants | 115 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 | 23 / 59 | 16 / 59 | 13 / 60 |
| serious Total, serious adverse events | 2 / 59 | 1 / 59 | 0 / 60 |
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: Full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SIAC 30 (B) | Change in Glycosylated Haemoglobin (HbA1c) | -1.31 percentage of glycosylated haemoglobin | Standard Deviation 1.01 |
| SIAC 45 (B) | Change in Glycosylated Haemoglobin (HbA1c) | -1.46 percentage of glycosylated haemoglobin | Standard Deviation 1.39 |
| Insulin Glargine | Change in Glycosylated Haemoglobin (HbA1c) | -1.29 percentage of glycosylated haemoglobin | Standard Deviation 1.1 |
Secondary
Change in Fasting Plasma Glucose (FPG)
Change from baseline in FPG after 16 weeks of treatment
Time frame: Week 0, Week 16
Population: The FAS included all randomised subjects and missing data was imputed using LOCF.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SIAC 30 (B) | Change in Fasting Plasma Glucose (FPG) | -4.30 mmol/L | Standard Deviation 3.45 |
| SIAC 45 (B) | Change in Fasting Plasma Glucose (FPG) | -4.10 mmol/L | Standard Deviation 3.09 |
| Insulin Glargine | Change in Fasting Plasma Glucose (FPG) | -5.07 mmol/L | Standard Deviation 3.85 |
Secondary
Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)
Values at screening (Week -4) and at Week 16
Time frame: Week -4, Week 16
Population: The SAS included all subjects who received at least one dose of the investigational product or its comparator.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIAC 30 (B) | Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) | Week -4 , N=58, 59, 60 | 31.9 IU/L | Standard Deviation 18.3 |
| SIAC 30 (B) | Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) | Week 16 , N=54, 54, 57 | 23.9 IU/L | Standard Deviation 13.1 |
| SIAC 45 (B) | Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) | Week -4 , N=58, 59, 60 | 29.7 IU/L | Standard Deviation 15.3 |
| SIAC 45 (B) | Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) | Week 16 , N=54, 54, 57 | 23.2 IU/L | Standard Deviation 9.7 |
| Insulin Glargine | Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) | Week -4 , N=58, 59, 60 | 33.7 IU/L | Standard Deviation 23.1 |
| Insulin Glargine | Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) | Week 16 , N=54, 54, 57 | 22.3 IU/L | Standard Deviation 10.3 |
Secondary
Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)
Values at screening (Week -4) and at Week 16
Time frame: Week -4, Week 16
Population: The SAS included all subjects who received at least one dose of the investigational product or its comparator.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIAC 30 (B) | Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) | Week -4, N=58, 59, 60 | 24.8 IU/L | Standard Deviation 14.6 |
| SIAC 30 (B) | Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) | Week 16, N=54, 54, 57 | 21.1 IU/L | Standard Deviation 8.2 |
| SIAC 45 (B) | Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) | Week -4, N=58, 59, 60 | 22.0 IU/L | Standard Deviation 8.3 |
| SIAC 45 (B) | Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) | Week 16, N=54, 54, 57 | 20.0 IU/L | Standard Deviation 5.8 |
| Insulin Glargine | Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) | Week 16, N=54, 54, 57 | 19.2 IU/L | Standard Deviation 6.4 |
| Insulin Glargine | Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) | Week -4, N=58, 59, 60 | 24.0 IU/L | Standard Deviation 14.1 |
Secondary
Laboratory Safety Parameters (Biochemistry): Serum Creatinine
Values at screening (Week -4) and at Week 16
Time frame: Week -4, Week 16
Population: The SAS included all subjects who received at least one dose of the investigational product or its comparator.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIAC 30 (B) | Laboratory Safety Parameters (Biochemistry): Serum Creatinine | Week -4 , N=58, 59, 60 | 76.4 umol/L | Standard Deviation 15.4 |
| SIAC 30 (B) | Laboratory Safety Parameters (Biochemistry): Serum Creatinine | Week 16 , N=54, 54, 57 | 75.7 umol/L | Standard Deviation 15.4 |
| SIAC 45 (B) | Laboratory Safety Parameters (Biochemistry): Serum Creatinine | Week -4 , N=58, 59, 60 | 75.8 umol/L | Standard Deviation 14.4 |
| SIAC 45 (B) | Laboratory Safety Parameters (Biochemistry): Serum Creatinine | Week 16 , N=54, 54, 57 | 74.9 umol/L | Standard Deviation 15.6 |
| Insulin Glargine | Laboratory Safety Parameters (Biochemistry): Serum Creatinine | Week -4 , N=58, 59, 60 | 77.4 umol/L | Standard Deviation 13.9 |
| Insulin Glargine | Laboratory Safety Parameters (Biochemistry): Serum Creatinine | Week 16 , N=54, 54, 57 | 76.8 umol/L | Standard Deviation 14.6 |
Secondary
Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
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, bedtime, at 4 am and before breakfast.
Time frame: Week 16
Population: The FAS included all randomised subjects and missing data was imputed using LOCF.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SIAC 30 (B) | Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) | 8.34 mmol/L | Standard Error 0.75 |
| SIAC 45 (B) | Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) | 8.31 mmol/L | Standard Error 0.78 |
| Insulin Glargine | Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) | 8.42 mmol/L | Standard Error 0.78 |
Secondary
Physical Examination
Physical examination is performed at baseline (Week 0) 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 0, Week 8, Week 16
Secondary
Rate of Major and Minor Hypoglycaemic Episodes
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 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 | 115 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 | 240 Episodes/100 years of patient exposure |
| Insulin Glargine | Rate of Major and Minor Hypoglycaemic Episodes | Major | 0 Episodes/100 years of patient exposure |
| Insulin Glargine | Rate of Major and Minor Hypoglycaemic Episodes | Minor | 67 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 06:00 (excluded).
Time frame: Week 0 to Week 16 + 5 days follow up
Population: The FAS included all randomised subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SIAC 30 (B) | Rate of Nocturnal Major and Minor Hypoglycaemic Episodes | Minor | 6 Episodes/100 years of patient exposure |
| SIAC 30 (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 | 158 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 |
| Insulin Glargine | Rate of Nocturnal Major and Minor Hypoglycaemic Episodes | Major | 0 Episodes/100 years of patient exposure |
| Insulin Glargine | Rate of Nocturnal Major and Minor Hypoglycaemic Episodes | Minor | 17 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: Safety analysis set (SAS) 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) | Severe AEs | 6 Events/100 years of patient exposure |
| SIAC 30 (B) | Rate of Treatment Emergent Adverse Events (AEs) | Moderate AEs | 138 Events/100 years of patient exposure |
| SIAC 30 (B) | Rate of Treatment Emergent Adverse Events (AEs) | Serious AEs | 11 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 30 (B) | Rate of Treatment Emergent Adverse Events (AEs) | Mild AEs | 298 Events/100 years of patient exposure |
| SIAC 30 (B) | Rate of Treatment Emergent Adverse Events (AEs) | Adverse events (AEs) | 441 Events/100 years of patient exposure |
| SIAC 45 (B) | Rate of Treatment Emergent Adverse Events (AEs) | Serious AEs | 6 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 |
| SIAC 45 (B) | Rate of Treatment Emergent Adverse Events (AEs) | Adverse events (AEs) | 310 Events/100 years of patient exposure |
| SIAC 45 (B) | Rate of Treatment Emergent Adverse Events (AEs) | Moderate AEs | 123 Events/100 years of patient exposure |
| SIAC 45 (B) | Rate of Treatment Emergent Adverse Events (AEs) | Mild AEs | 187 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 |
| Insulin Glargine | Rate of Treatment Emergent Adverse Events (AEs) | Moderate AEs | 61 Events/100 years of patient exposure |
| Insulin Glargine | Rate of Treatment Emergent Adverse Events (AEs) | Fatal AEs | 0 Events/100 years of patient exposure |
| Insulin Glargine | Rate of Treatment Emergent Adverse Events (AEs) | Serious AEs | 0 Events/100 years of patient exposure |
| Insulin Glargine | Rate of Treatment Emergent Adverse Events (AEs) | Severe AEs | 0 Events/100 years of patient exposure |
| Insulin Glargine | Rate of Treatment Emergent Adverse Events (AEs) | Adverse events (AEs) | 295 Events/100 years of patient exposure |
| Insulin Glargine | Rate of Treatment Emergent Adverse Events (AEs) | Mild AEs | 234 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 SAS included all subjects who received at least one dose of the investigational product or its comparator.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIAC 30 (B) | Vital Signs: Diastolic Blood Pressure (BP) | Week 16, N=56, 53, 58 | 76 mmHg | Standard Deviation 8 |
| SIAC 30 (B) | Vital Signs: Diastolic Blood Pressure (BP) | Week 0 (Baseline), N=59, 59, 60 | 78 mmHg | Standard Deviation 8 |
| SIAC 45 (B) | Vital Signs: Diastolic Blood Pressure (BP) | Week 16, N=56, 53, 58 | 77 mmHg | Standard Deviation 9 |
| SIAC 45 (B) | Vital Signs: Diastolic Blood Pressure (BP) | Week 0 (Baseline), N=59, 59, 60 | 78 mmHg | Standard Deviation 8 |
| Insulin Glargine | Vital Signs: Diastolic Blood Pressure (BP) | Week 16, N=56, 53, 58 | 77 mmHg | Standard Deviation 7 |
| Insulin Glargine | Vital Signs: Diastolic Blood Pressure (BP) | Week 0 (Baseline), N=59, 59, 60 | 79 mmHg | Standard Deviation 8 |
Secondary
Vital Signs: Pulse
Values at baseline (Week 0) and at Week 16
Time frame: Week 0, Week 16
Population: The SAS included all subjects who received at least one dose of the investigational product or its comparator.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIAC 30 (B) | Vital Signs: Pulse | Week 16, N=56, 53, 58 | 71 beats/minute | Standard Deviation 10 |
| SIAC 30 (B) | Vital Signs: Pulse | Week 0 (Baseline), N=59, 59, 60 | 73 beats/minute | Standard Deviation 10 |
| SIAC 45 (B) | Vital Signs: Pulse | Week 0 (Baseline), N=59, 59, 60 | 75 beats/minute | Standard Deviation 10 |
| SIAC 45 (B) | Vital Signs: Pulse | Week 16, N=56, 53, 58 | 69 beats/minute | Standard Deviation 9 |
| Insulin Glargine | Vital Signs: Pulse | Week 0 (Baseline), N=59, 59, 60 | 75 beats/minute | Standard Deviation 9 |
| Insulin Glargine | Vital Signs: Pulse | Week 16, N=56, 53, 58 | 71 beats/minute | Standard Deviation 11 |
Secondary
Vital Signs: Systolic Blood Pressure (BP)
Values at baseline (Week 0) and at Week 16
Time frame: Week 0, Week 16
Population: The SAS included all subjects who received at least one dose of the investigational product or its comparator.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIAC 30 (B) | Vital Signs: Systolic Blood Pressure (BP) | Week 0 (Baseline), N=59, 59, 60 | 135 mmHg | Standard Deviation 15 |
| SIAC 30 (B) | Vital Signs: Systolic Blood Pressure (BP) | Week 16, N=56, 53, 58 | 129 mmHg | Standard Deviation 13 |
| SIAC 45 (B) | Vital Signs: Systolic Blood Pressure (BP) | Week 0 (Baseline), N=59, 59, 60 | 133 mmHg | Standard Deviation 14 |
| SIAC 45 (B) | Vital Signs: Systolic Blood Pressure (BP) | Week 16, N=56, 53, 58 | 133 mmHg | Standard Deviation 12 |
| Insulin Glargine | Vital Signs: Systolic Blood Pressure (BP) | Week 0 (Baseline), N=59, 59, 60 | 135 mmHg | Standard Deviation 15 |
| Insulin Glargine | Vital Signs: Systolic Blood Pressure (BP) | Week 16, N=56, 53, 58 | 129 mmHg | Standard Deviation 12 |