Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted in Europe, Oceania and the United States of America (USA). The aim of this trial is to compare two NN1250 (insulin degludec) formulations with each other and with insulin glargine, all in combination with insulin aspart in subjects with type 1 diabetes.
Interventions
DRUGinsulin degludec
Formulation 1: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily
DRUGinsulin glargine
Treat-to-target dose titration scheme, injection s.c., once daily
DRUGinsulin aspart
Treat-to-target dose titration scheme, injection s.c. (under the skin), 3 times 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
* Type 1 diabetes for at least one year * HbA1c 7-11% (both inclusive) * Treated with insulin for at least six months - any regimen
Exclusion criteria
* Any systemic treatment with products which in the Investigator's opinion could interfere with glucose or lipid metabolism (eg systemic corticosteroids) 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 | Estimate of the overall mean of SMPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) 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 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). |
| 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 -1, Week 16 | Laboratory values at screening (Week -1) and at Week 16 |
| Change in Fasting Plasma Glucose (FPG) | Week 0, Week 16 | Change from baseline in FPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) after 16 weeks of treatment |
| Laboratory Safety Parameters (Biochemistry): Serum Creatinine | Week -1, Week 16 | Laboratory values at screening (Week -1) and at Week 16 |
| Vital Signs: Diastolic BP (Blood Pressure) | Week 0, Week 16 | Values at baseline (Week 0) and at Week 16 |
| Vital Signs: Systolic BP (Blood Pressure) | 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 -1, Week 8, Week 16 | Physical examination was performed at screening (week -1), 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 -1, Week 16 | Laboratory values at screening (Week -1) and at Week 16 |
Countries
Australia, Germany, Norway, Sweden, United States
Participant flow
Recruitment details
A total of 28 centres participated: Australia (5), Germany (6), Norway (6), Sweden (5) and United States (6).
Participants by arm
| Arm | Count |
|---|---|
| SIBA (D) Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted. | 60 |
| SIBA (E) Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted. | 59 |
| IGlar Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted. | 59 |
| Total | 178 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 | 1 |
| Overall Study | Lack of Efficacy | 2 | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 2 | 1 |
| Overall Study | Unclassified | 2 | 2 | 5 |
Baseline characteristics
| Characteristic | SIBA (D) | SIBA (E) | IGlar | Total |
|---|---|---|---|---|
| Age, Continuous | 45.6 years STANDARD_DEVIATION 12.5 | 44.5 years STANDARD_DEVIATION 12.7 | 47.2 years STANDARD_DEVIATION 13.5 | 45.8 years STANDARD_DEVIATION 12.8 |
| Fasting plasma glucose (FPG) | 10.3 mmol/L STANDARD_DEVIATION 4.8 | 9.9 mmol/L STANDARD_DEVIATION 3.3 | 9.5 mmol/L STANDARD_DEVIATION 3.8 | 9.9 mmol/L STANDARD_DEVIATION 4 |
| Gender Female | 23 Participants | 22 Participants | 27 Participants | 72 Participants |
| Gender Male | 37 Participants | 37 Participants | 32 Participants | 106 Participants |
| Glycosylated haemoglobin (HbA1c) | 8.5 percentage of glycosylated haemoglobin STANDARD_DEVIATION 1 | 8.4 percentage of glycosylated haemoglobin STANDARD_DEVIATION 0.9 | 8.3 percentage of glycosylated haemoglobin STANDARD_DEVIATION 0.8 | 8.4 percentage of glycosylated haemoglobin STANDARD_DEVIATION 0.9 |
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 | 31 / 60 | 42 / 59 | 31 / 59 |
| serious Total, serious adverse events | 1 / 60 | 2 / 59 | 1 / 59 |
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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SIBA (D) | Change in Glycosylated Haemoglobin (HbA1c) | -0.54 percentage of glycosylated haemoglobin | Standard Deviation 0.78 |
| SIBA (E) | Change in Glycosylated Haemoglobin (HbA1c) | -0.57 percentage of glycosylated haemoglobin | Standard Deviation 0.76 |
| IGlar | Change in Glycosylated Haemoglobin (HbA1c) | -0.62 percentage of glycosylated haemoglobin | Standard Deviation 0.68 |
Secondary
Change in Fasting Plasma Glucose (FPG)
Change from baseline in FPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SIBA (D) | Change in Fasting Plasma Glucose (FPG) | -2.06 mmol/L | Standard Deviation 5.17 |
| SIBA (E) | Change in Fasting Plasma Glucose (FPG) | -1.60 mmol/L | Standard Deviation 4.66 |
| IGlar | Change in Fasting Plasma Glucose (FPG) | -0.54 mmol/L | Standard Deviation 4.36 |
Secondary
Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)
Laboratory values at screening (Week -1) and at Week 16
Time frame: Week -1, Week 16
Population: The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 55 (SIBA D), 53 (SIBA E) and 54 (IGlar) subjects contributed to the analysis at week 16.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIBA (D) | Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) | Week -1 , N=60, 59, 59 | 25.5 IU/L | Standard Deviation 11.3 |
| SIBA (D) | Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) | Week 16 , N=55, 53, 54 | 25.0 IU/L | Standard Deviation 12 |
| SIBA (E) | Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) | Week -1 , N=60, 59, 59 | 22.7 IU/L | Standard Deviation 11.1 |
| SIBA (E) | Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) | Week 16 , N=55, 53, 54 | 21.2 IU/L | Standard Deviation 8 |
| IGlar | Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) | Week -1 , N=60, 59, 59 | 23.1 IU/L | Standard Deviation 10.2 |
| IGlar | Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) | Week 16 , N=55, 53, 54 | 23.1 IU/L | Standard Deviation 13 |
Secondary
Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)
Laboratory values at screening (Week -1) and at Week 16
Time frame: Week -1, 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, 55 (SIBA D), 53 (SIBA E) and 54 (IGlar) subjects contributed to the analysis at week 16.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIBA (D) | Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) | Week -1, N=60, 59, 59 | 22.8 IU/L | Standard Deviation 7.4 |
| SIBA (D) | Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) | Week 16, N=55, 53, 54 | 23.3 IU/L | Standard Deviation 8.8 |
| SIBA (E) | Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) | Week -1, N=60, 59, 59 | 21.7 IU/L | Standard Deviation 7 |
| SIBA (E) | Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) | Week 16, N=55, 53, 54 | 21.6 IU/L | Standard Deviation 8.5 |
| IGlar | Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) | Week -1, N=60, 59, 59 | 23.3 IU/L | Standard Deviation 11.3 |
| IGlar | Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) | Week 16, N=55, 53, 54 | 23.9 IU/L | Standard Deviation 9.4 |
Secondary
Laboratory Safety Parameters (Biochemistry): Serum Creatinine
Laboratory values at screening (Week -1) and at Week 16
Time frame: Week -1, 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, 55 (SIBA D), 53 (SIBA E) and 54 (IGlar) subjects contributed to the analysis at week 16.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIBA (D) | Laboratory Safety Parameters (Biochemistry): Serum Creatinine | Week -1 , N=60, 59, 59 | 77.2 umol/L | Standard Deviation 12.6 |
| SIBA (D) | Laboratory Safety Parameters (Biochemistry): Serum Creatinine | Week 16 , N=55, 53, 54 | 77.2 umol/L | Standard Deviation 14.1 |
| SIBA (E) | Laboratory Safety Parameters (Biochemistry): Serum Creatinine | Week -1 , N=60, 59, 59 | 76.6 umol/L | Standard Deviation 12.8 |
| SIBA (E) | Laboratory Safety Parameters (Biochemistry): Serum Creatinine | Week 16 , N=55, 53, 54 | 75.9 umol/L | Standard Deviation 13 |
| IGlar | Laboratory Safety Parameters (Biochemistry): Serum Creatinine | Week -1 , N=60, 59, 59 | 77.6 umol/L | Standard Deviation 13.3 |
| IGlar | Laboratory Safety Parameters (Biochemistry): Serum Creatinine | Week 16 , N=55, 53, 54 | 77.9 umol/L | Standard Deviation 14.5 |
Secondary
Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
Estimate of the overall mean of SMPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) 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 full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SIBA (D) | Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) | 9.27 mmol/L | Standard Error 0.3 |
| SIBA (E) | Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) | 9.56 mmol/L | Standard Error 0.3 |
| IGlar | Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) | 9.04 mmol/L | Standard Error 0.3 |
Secondary
Physical Examination
Physical examination was performed at screening (week -1), 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 -1, 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 full analysis set (FAS) included all randomised subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SIBA (D) | Rate of Major and Minor Hypoglycaemic Episodes | Major | 46 Episodes/100 years of patient exposure |
| SIBA (D) | Rate of Major and Minor Hypoglycaemic Episodes | Minor | 5838 Episodes/100 years of patient exposure |
| SIBA (E) | Rate of Major and Minor Hypoglycaemic Episodes | Major | 41 Episodes/100 years of patient exposure |
| SIBA (E) | Rate of Major and Minor Hypoglycaemic Episodes | Minor | 5305 Episodes/100 years of patient exposure |
| IGlar | Rate of Major and Minor Hypoglycaemic Episodes | Major | 36 Episodes/100 years of patient exposure |
| IGlar | Rate of Major and Minor Hypoglycaemic Episodes | Minor | 6637 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 full analysis set (FAS) included all randomised subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SIBA (D) | Rate of Nocturnal Major and Minor Hypoglycaemic Episodes | Major | 17 Episodes/100 years of patient exposure |
| SIBA (D) | Rate of Nocturnal Major and Minor Hypoglycaemic Episodes | Minor | 769 Episodes/100 years of patient exposure |
| SIBA (E) | Rate of Nocturnal Major and Minor Hypoglycaemic Episodes | Major | 12 Episodes/100 years of patient exposure |
| SIBA (E) | Rate of Nocturnal Major and Minor Hypoglycaemic Episodes | Minor | 546 Episodes/100 years of patient exposure |
| IGlar | Rate of Nocturnal Major and Minor Hypoglycaemic Episodes | Major | 18 Episodes/100 years of patient exposure |
| IGlar | Rate of Nocturnal Major and Minor Hypoglycaemic Episodes | Minor | 1082 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) |
|---|---|---|---|
| SIBA (D) | Rate of Treatment Emergent Adverse Events (AEs) | Adverse events (AEs) | 653 Events/100 years of patient exposure |
| SIBA (D) | Rate of Treatment Emergent Adverse Events (AEs) | Serious AEs | 6 Events/100 years of patient exposure |
| SIBA (D) | Rate of Treatment Emergent Adverse Events (AEs) | Severe AEs | 6 Events/100 years of patient exposure |
| SIBA (D) | Rate of Treatment Emergent Adverse Events (AEs) | Moderate AEs | 202 Events/100 years of patient exposure |
| SIBA (D) | Rate of Treatment Emergent Adverse Events (AEs) | Mild AEs | 445 Events/100 years of patient exposure |
| SIBA (D) | Rate of Treatment Emergent Adverse Events (AEs) | Fatal AEs | 0 Events/100 years of patient exposure |
| SIBA (E) | Rate of Treatment Emergent Adverse Events (AEs) | Fatal AEs | 0 Events/100 years of patient exposure |
| SIBA (E) | Rate of Treatment Emergent Adverse Events (AEs) | Adverse events (AEs) | 874 Events/100 years of patient exposure |
| SIBA (E) | Rate of Treatment Emergent Adverse Events (AEs) | Moderate AEs | 246 Events/100 years of patient exposure |
| SIBA (E) | Rate of Treatment Emergent Adverse Events (AEs) | Mild AEs | 599 Events/100 years of patient exposure |
| SIBA (E) | Rate of Treatment Emergent Adverse Events (AEs) | Serious AEs | 12 Events/100 years of patient exposure |
| SIBA (E) | Rate of Treatment Emergent Adverse Events (AEs) | Severe AEs | 29 Events/100 years of patient exposure |
| IGlar | Rate of Treatment Emergent Adverse Events (AEs) | Serious AEs | 6 Events/100 years of patient exposure |
| IGlar | Rate of Treatment Emergent Adverse Events (AEs) | Severe AEs | 6 Events/100 years of patient exposure |
| IGlar | Rate of Treatment Emergent Adverse Events (AEs) | Fatal AEs | 0 Events/100 years of patient exposure |
| IGlar | Rate of Treatment Emergent Adverse Events (AEs) | Moderate AEs | 397 Events/100 years of patient exposure |
| IGlar | Rate of Treatment Emergent Adverse Events (AEs) | Adverse events (AEs) | 914 Events/100 years of patient exposure |
| IGlar | Rate of Treatment Emergent Adverse Events (AEs) | Mild AEs | 511 Events/100 years of patient exposure |
Secondary
Vital Signs: Diastolic BP (Blood Pressure)
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, 57 (SIBA E) and 57 (IGlar) subjects contributed to the analysis at week 16.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIBA (D) | Vital Signs: Diastolic BP (Blood Pressure) | Week 0 (Baseline), N=60, 59, 59 | 76 mmHg | Standard Deviation 8 |
| SIBA (D) | Vital Signs: Diastolic BP (Blood Pressure) | Week 16, N=60, 57, 57 | 76 mmHg | Standard Deviation 10 |
| SIBA (E) | Vital Signs: Diastolic BP (Blood Pressure) | Week 0 (Baseline), N=60, 59, 59 | 75 mmHg | Standard Deviation 10 |
| SIBA (E) | Vital Signs: Diastolic BP (Blood Pressure) | Week 16, N=60, 57, 57 | 75 mmHg | Standard Deviation 10 |
| IGlar | Vital Signs: Diastolic BP (Blood Pressure) | Week 0 (Baseline), N=60, 59, 59 | 74 mmHg | Standard Deviation 9 |
| IGlar | Vital Signs: Diastolic BP (Blood Pressure) | Week 16, N=60, 57, 57 | 74 mmHg | Standard Deviation 7 |
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, 57 (SIBA E) and 57 (IGlar) subjects contributed to the analysis at week 16.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIBA (D) | Vital Signs: Pulse | Week 0 (Baseline), N=60, 59, 59 | 74 beats/minute | Standard Deviation 10 |
| SIBA (D) | Vital Signs: Pulse | Week 16, N=60, 57, 57 | 74 beats/minute | Standard Deviation 12 |
| SIBA (E) | Vital Signs: Pulse | Week 0 (Baseline), N=60, 59, 59 | 72 beats/minute | Standard Deviation 9 |
| SIBA (E) | Vital Signs: Pulse | Week 16, N=60, 57, 57 | 72 beats/minute | Standard Deviation 11 |
| IGlar | Vital Signs: Pulse | Week 0 (Baseline), N=60, 59, 59 | 73 beats/minute | Standard Deviation 10 |
| IGlar | Vital Signs: Pulse | Week 16, N=60, 57, 57 | 72 beats/minute | Standard Deviation 12 |
Secondary
Vital Signs: Systolic BP (Blood Pressure)
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, 57 (SIBA E) and 57 (IGlar) subjects contributed to the analysis at week 16.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SIBA (D) | Vital Signs: Systolic BP (Blood Pressure) | Week 0 (Baseline), N=60, 59, 59 | 124 mmHg | Standard Deviation 15 |
| SIBA (D) | Vital Signs: Systolic BP (Blood Pressure) | Week 16, N=60, 57, 57 | 122 mmHg | Standard Deviation 14 |
| SIBA (E) | Vital Signs: Systolic BP (Blood Pressure) | Week 0 (Baseline), N=60, 59, 59 | 126 mmHg | Standard Deviation 16 |
| SIBA (E) | Vital Signs: Systolic BP (Blood Pressure) | Week 16, N=60, 57, 57 | 125 mmHg | Standard Deviation 14 |
| IGlar | Vital Signs: Systolic BP (Blood Pressure) | Week 0 (Baseline), N=60, 59, 59 | 124 mmHg | Standard Deviation 16 |
| IGlar | Vital Signs: Systolic BP (Blood Pressure) | Week 16, N=60, 57, 57 | 123 mmHg | Standard Deviation 15 |