Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
The trial was conducted in Germany, The Republic of Macedonia, Russian Federation, Serbia and South Africa. The aim of this trial was to make a safety comparison of insulin detemir produced by a new production method (NN729) with insulin detemir made by the previous production method (NN304). Subjects were treated with NN729 or NN304 for a period of 52 weeks at the same total daily dose and frequency of administration as their own pre-trial basal insulin . During the trial doses were individualised based on subject's plasma glucose measurements.
Interventions
DRUGinsulin detemir
NN304 injected s.c. (under the skin). Given as basal insulin.
DRUGinsulin aspart
Injected s.c. (under the skin). Given as bolus insulin.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes for at least 12 months * Basal-bolus treatment for at least 3 months * Body Mass Index (BMI) less than or equal to 35.0 kg/m\^2 * HbA1c (glycosylated haemoglobin) less than or equal to 12.0%
Exclusion criteria
* Known or suspected allergy to trial products or related products * Pregnancy, breast-feeding or the intention to become pregnant or not using adequate contraceptive measures * Receipt of any trial drug within 1 month prior to this trial * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation * Conditions that may interfere with trial participation as judged by Investigator: proliferative retinopathy or maculopathy requiring acute treatment within the last six months, recurrent major hypoglycaemia, impaired hepatic or renal function, cardiac problems, uncontrolled hypertension (treated and untreated)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Insulin Detemir - Human Insulin Cross-reacting Antibodies | week 0, week 52 | Measured change in concentrations of insulin detemir cross-reacting antibodies and the change ratio from baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycaemic Control Parameters (Change in HbA1c) | week 0, week 52 | HbA1c (Glycosylated haemoglobin). |
| Glycaemic Control Parameters (Change in Fasting Plasma Glucose [FPG]) | week 0, week 52 | — |
| Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | week 0, 26 and 52 | 1. point is Before Breakfast 2. point is 120 minutes after Breakfast 3. point is Before Lunch 4. point is 120 minutes after Lunch 5. point is Before Dinner 6. point is 120 minutes after Dinner 7. point is at Bedtime 8. point is At 03:00 A.M. 9. point is Before Breakfast the Following Day |
| Change From Baseline in Detemir Specific Antibodies | Week 0, week 52 | Measured change in concentrations of antibody values for insulin detemir specific antibodies and the change ratio from the baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio. |
| Change From Baseline in Total Antibodies | Week 0, week 52 | Measured change in concentrations of total insulin antibodies values (the sum of insulin detemir specific and insulin detemir - human insulin cross-reacting antibodies) and the change ratio from baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio. |
| Clinical Laboratory Values (Change in Haematology - Basophilis) | week 0, week 52 | Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory. |
| Clinical Laboratory Values (Change in Haematology - Eosinophils) | Week 0, week 52 | Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory. |
| Clinical Laboratory Values (Change in Haematology - Haemoglobin) | Week 0, week 52 | Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory. |
| Clinical Laboratory Values (Change in Haematology - Lymphocytes) | Week 0, week 52 | Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory. |
| Clinical Laboratory Values (Change in Haematology - Monocytes) | Week 0, week 52 | Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory. |
| Clinical Laboratory Values (Change in Haematology - Neutrophils) | Week 0, week 52 | Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory. |
| Hypoglycaemic Episodes | Weeks 0-52 | Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. Hypoglycaemic episodes occurring in the time frame between 23:00 hours (included) and 06:00 hours (excluded) were defined as nocturnal. |
| Clinical Laboratory Values (Change in Haematology - Leucocytes) | Week 0, week 52 | Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory. |
| Clinical Laboratory Values (Change in Biochemistry - Albumin) | Week 0, week 52 | Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory |
| Clinical Laboratory Values (Change in Biochemistry - Alanine Aminotransferase [ALAT]) | Week 0, week 52 | Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory. (ALAT = alanine aminotransferase) |
| Clinical Laboratory Values (Change in Biochemistry - Alkaline Phosphatase [ALP]) | Week 0, week 52 | Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory. (ALP = alkaline phosphatase) |
| Clinical Laboratory Values (Change in Biochemistry - Creatinine) | Week 0, week 52 | Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory |
| Clinical Laboratory Values (Change in Biochemistry - Lactate Dehydrogenase [LDH]) | Week 0, week 52 | Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory (LDH = lactate dehydrogenase) |
| Clinical Laboratory Values (Change in Biochemistry - Potassium) | Week 0, week 52 | Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory |
| Clinical Laboratory Values (Change in Biochemistry - Sodium) | Week 0, week 52 | Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory |
| Clinical Laboratory Values (Change in Biochemistry - Total Protein) | Week 0, week 52 | Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory |
| Adverse Events | Weeks 0-52 | — |
| Clinical Laboratory Values (Change in Haematology - Thrombocytes) | Week 0, week 52 | Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory. |
Countries
Germany, North Macedonia, Russia, Serbia and Montenegro, South Africa
Participant flow
Recruitment details
Twenty four sites in five countries: Germany (12), The Republic of Macedonia (1), Russian Federation (4), Serbia (3) and South Africa (4)
Pre-assignment details
Eligible subjects were adults with type 1 diabetes treated with a basal-bolus regimen for at least 3 months prior to the study, who had a BMI (Body Mass Index) no greater than 35.0 kg/m\^2 and HbA1c no greater than 12.0%.
Participants by arm
| Arm | Count |
|---|---|
| NN304 Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks | 164 |
| NN729 Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks | 166 |
| Total | 330 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lack of Efficacy | 1 | 0 |
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | Unclassified | 2 | 5 |
Baseline characteristics
| Characteristic | NN729 | Total | NN304 |
|---|---|---|---|
| Age, Continuous | 38.6 years STANDARD_DEVIATION 13.6 | 39.3 years STANDARD_DEVIATION 14.2 | 39.9 years STANDARD_DEVIATION 14.9 |
| BMI (Body Mass Index) | 25.23 kg/m^2 STANDARD_DEVIATION 3.59 | 25.45 kg/m^2 STANDARD_DEVIATION 3.83 | 25.68 kg/m^2 STANDARD_DEVIATION 4.05 |
| Body weight | 75.1 kg STANDARD_DEVIATION 14.9 | 76.4 kg STANDARD_DEVIATION 14.7 | 77.6 kg STANDARD_DEVIATION 14.6 |
| Diabetes History | 13.66 years STANDARD_DEVIATION 10.3 | 14.07 years STANDARD_DEVIATION 10.8 | 14.48 years STANDARD_DEVIATION 11.2 |
| HbA1c (Glycosylated haemoglobin) | 7.99 Percent (%) glycosylated haemoglobin STANDARD_DEVIATION 1.38 | 7.96 Percent (%) glycosylated haemoglobin STANDARD_DEVIATION 1.35 | 7.93 Percent (%) glycosylated haemoglobin STANDARD_DEVIATION 1.31 |
| Height | 1.72 meter STANDARD_DEVIATION 0.1 | 1.73 meter STANDARD_DEVIATION 0.1 | 1.74 meter STANDARD_DEVIATION 0.09 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 18 Participants | 9 Participants |
| Race (NIH/OMB) White | 152 Participants | 304 Participants | 152 Participants |
| Sex: Female, Male Female | 79 Participants | 145 Participants | 66 Participants |
| Sex: Female, Male Male | 87 Participants | 185 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 56 / 164 | 70 / 166 |
| serious Total, serious adverse events | 19 / 164 | 8 / 166 |
Outcome results
Primary
Change From Baseline in Insulin Detemir - Human Insulin Cross-reacting Antibodies
Measured change in concentrations of insulin detemir cross-reacting antibodies and the change ratio from baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio.
Time frame: week 0, week 52
Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NN304 | Change From Baseline in Insulin Detemir - Human Insulin Cross-reacting Antibodies | 1.81 ratio | Standard Error 0.07 |
| NN729 | Change From Baseline in Insulin Detemir - Human Insulin Cross-reacting Antibodies | 1.89 ratio | Standard Error 0.07 |
Comparison: Null hypothesis:Treatment with detemir produced with the NN729 process result in a similar change in cross reacting antibody levels as the NN304 process. Alternative hypothesis: change in antibody levels differ after treatment with detemir produced by the two manufacturing processes.~The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA.p-value: 0.64995% CI: [0.86, 1.26]ANOVA
Secondary
Adverse Events
Time frame: Weeks 0-52
Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NN304 | Adverse Events | Serious Adverse Events | 25 events |
| NN304 | Adverse Events | Non-Serious Adverse Events | 259 events |
| NN729 | Adverse Events | Serious Adverse Events | 10 events |
| NN729 | Adverse Events | Non-Serious Adverse Events | 346 events |
Secondary
Change From Baseline in Detemir Specific Antibodies
Measured change in concentrations of antibody values for insulin detemir specific antibodies and the change ratio from the baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio.
Time frame: Week 0, week 52
Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NN304 | Change From Baseline in Detemir Specific Antibodies | 1.14 ratio | Standard Error 0.04 |
| NN729 | Change From Baseline in Detemir Specific Antibodies | 1.06 ratio | Standard Error 0.04 |
Comparison: The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA. The analysis was based on an assumption of a log-normal distribution for antibody data and was thus built on log-transformed data.p-value: 0.1595% CI: [0.84, 1.03]ANOVA
Secondary
Change From Baseline in Total Antibodies
Measured change in concentrations of total insulin antibodies values (the sum of insulin detemir specific and insulin detemir - human insulin cross-reacting antibodies) and the change ratio from baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio.
Time frame: Week 0, week 52
Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NN304 | Change From Baseline in Total Antibodies | 1.55 ratio | Standard Error 0.05 |
| NN729 | Change From Baseline in Total Antibodies | 1.55 ratio | Standard Error 0.05 |
Comparison: The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA. The analysis was based on an assumption of a log-normal distribution for antibody data and was thus built on log-transformed data.p-value: 0.96695% CI: [0.87, 1.15]ANOVA
Secondary
Clinical Laboratory Values (Change in Biochemistry - Alanine Aminotransferase [ALAT])
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory. (ALAT = alanine aminotransferase)
Time frame: Week 0, week 52
Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NN304 | Clinical Laboratory Values (Change in Biochemistry - Alanine Aminotransferase [ALAT]) | Week 52 | 30.72 U/L | Standard Deviation 25.48 |
| NN304 | Clinical Laboratory Values (Change in Biochemistry - Alanine Aminotransferase [ALAT]) | Change from Baseline to week 52 | 1.34 U/L | Standard Deviation 17.8 |
| NN304 | Clinical Laboratory Values (Change in Biochemistry - Alanine Aminotransferase [ALAT]) | Baseline | 29.21 U/L | Standard Deviation 22.12 |
| NN729 | Clinical Laboratory Values (Change in Biochemistry - Alanine Aminotransferase [ALAT]) | Baseline | 25.98 U/L | Standard Deviation 13.65 |
| NN729 | Clinical Laboratory Values (Change in Biochemistry - Alanine Aminotransferase [ALAT]) | Week 52 | 27.81 U/L | Standard Deviation 16.05 |
| NN729 | Clinical Laboratory Values (Change in Biochemistry - Alanine Aminotransferase [ALAT]) | Change from Baseline to week 52 | 1.76 U/L | Standard Deviation 17.17 |
Secondary
Clinical Laboratory Values (Change in Biochemistry - Albumin)
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory
Time frame: Week 0, week 52
Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NN304 | Clinical Laboratory Values (Change in Biochemistry - Albumin) | Baseline | 4.30 g/dL | Standard Deviation 0.23 |
| NN304 | Clinical Laboratory Values (Change in Biochemistry - Albumin) | Week 52 | 4.28 g/dL | Standard Deviation 0.25 |
| NN304 | Clinical Laboratory Values (Change in Biochemistry - Albumin) | Change from Baseline to week 52 | -0.02 g/dL | Standard Deviation 0.21 |
| NN729 | Clinical Laboratory Values (Change in Biochemistry - Albumin) | Baseline | 4.27 g/dL | Standard Deviation 0.23 |
| NN729 | Clinical Laboratory Values (Change in Biochemistry - Albumin) | Week 52 | 4.30 g/dL | Standard Deviation 0.22 |
| NN729 | Clinical Laboratory Values (Change in Biochemistry - Albumin) | Change from Baseline to week 52 | 0.02 g/dL | Standard Deviation 0.2 |
Secondary
Clinical Laboratory Values (Change in Biochemistry - Alkaline Phosphatase [ALP])
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory. (ALP = alkaline phosphatase)
Time frame: Week 0, week 52
Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NN304 | Clinical Laboratory Values (Change in Biochemistry - Alkaline Phosphatase [ALP]) | Baseline | 75.40 U/L | Standard Deviation 23.26 |
| NN304 | Clinical Laboratory Values (Change in Biochemistry - Alkaline Phosphatase [ALP]) | Week 52 | 82.35 U/L | Standard Deviation 47.2 |
| NN304 | Clinical Laboratory Values (Change in Biochemistry - Alkaline Phosphatase [ALP]) | Change from Baseline to week 52 | 6.77 U/L | Standard Deviation 42.36 |
| NN729 | Clinical Laboratory Values (Change in Biochemistry - Alkaline Phosphatase [ALP]) | Baseline | 75.55 U/L | Standard Deviation 25.3 |
| NN729 | Clinical Laboratory Values (Change in Biochemistry - Alkaline Phosphatase [ALP]) | Week 52 | 80.42 U/L | Standard Deviation 23.98 |
| NN729 | Clinical Laboratory Values (Change in Biochemistry - Alkaline Phosphatase [ALP]) | Change from Baseline to week 52 | 4.53 U/L | Standard Deviation 15.88 |
Secondary
Clinical Laboratory Values (Change in Biochemistry - Creatinine)
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory
Time frame: Week 0, week 52
Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a postbaseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NN304 | Clinical Laboratory Values (Change in Biochemistry - Creatinine) | Baseline | 73.1 Umol/L | Standard Deviation 15.4 |
| NN304 | Clinical Laboratory Values (Change in Biochemistry - Creatinine) | Week 52 | 72.5 Umol/L | Standard Deviation 16.4 |
| NN304 | Clinical Laboratory Values (Change in Biochemistry - Creatinine) | Change from Baseline to week 52 | -0.5 Umol/L | Standard Deviation 11 |
| NN729 | Clinical Laboratory Values (Change in Biochemistry - Creatinine) | Baseline | 72.3 Umol/L | Standard Deviation 31.6 |
| NN729 | Clinical Laboratory Values (Change in Biochemistry - Creatinine) | Week 52 | 73.1 Umol/L | Standard Deviation 63.4 |
| NN729 | Clinical Laboratory Values (Change in Biochemistry - Creatinine) | Change from Baseline to week 52 | 0.8 Umol/L | Standard Deviation 33.7 |
Secondary
Clinical Laboratory Values (Change in Biochemistry - Lactate Dehydrogenase [LDH])
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory (LDH = lactate dehydrogenase)
Time frame: Week 0, week 52
Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NN304 | Clinical Laboratory Values (Change in Biochemistry - Lactate Dehydrogenase [LDH]) | Baseline | 161.1 U/L | Standard Deviation 47.8 |
| NN304 | Clinical Laboratory Values (Change in Biochemistry - Lactate Dehydrogenase [LDH]) | Week 52 | 164.9 U/L | Standard Deviation 62 |
| NN304 | Clinical Laboratory Values (Change in Biochemistry - Lactate Dehydrogenase [LDH]) | Change from Baseline to week 52 | 3.2 U/L | Standard Deviation 45 |
| NN729 | Clinical Laboratory Values (Change in Biochemistry - Lactate Dehydrogenase [LDH]) | Baseline | 159.4 U/L | Standard Deviation 57.4 |
| NN729 | Clinical Laboratory Values (Change in Biochemistry - Lactate Dehydrogenase [LDH]) | Week 52 | 162.7 U/L | Standard Deviation 37.5 |
| NN729 | Clinical Laboratory Values (Change in Biochemistry - Lactate Dehydrogenase [LDH]) | Change from Baseline to week 52 | 2.6 U/L | Standard Deviation 46.7 |
Secondary
Clinical Laboratory Values (Change in Biochemistry - Potassium)
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory
Time frame: Week 0, week 52
Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NN304 | Clinical Laboratory Values (Change in Biochemistry - Potassium) | Baseline | 4.46 mmol/L | Standard Deviation 0.44 |
| NN304 | Clinical Laboratory Values (Change in Biochemistry - Potassium) | Week 52 | 4.49 mmol/L | Standard Deviation 0.49 |
| NN304 | Clinical Laboratory Values (Change in Biochemistry - Potassium) | Change from Baseline to week 52 | 0.02 mmol/L | Standard Deviation 0.5 |
| NN729 | Clinical Laboratory Values (Change in Biochemistry - Potassium) | Baseline | 4.37 mmol/L | Standard Deviation 0.49 |
| NN729 | Clinical Laboratory Values (Change in Biochemistry - Potassium) | Week 52 | 4.43 mmol/L | Standard Deviation 0.44 |
| NN729 | Clinical Laboratory Values (Change in Biochemistry - Potassium) | Change from Baseline to week 52 | 0.06 mmol/L | Standard Deviation 0.49 |
Secondary
Clinical Laboratory Values (Change in Biochemistry - Sodium)
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory
Time frame: Week 0, week 52
Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NN304 | Clinical Laboratory Values (Change in Biochemistry - Sodium) | Baseline | 138.9 mmol/L | Standard Deviation 2.6 |
| NN304 | Clinical Laboratory Values (Change in Biochemistry - Sodium) | Week 52 | 140.3 mmol/L | Standard Deviation 2.4 |
| NN304 | Clinical Laboratory Values (Change in Biochemistry - Sodium) | Change from Baseline to week 52 | 1.4 mmol/L | Standard Deviation 2.8 |
| NN729 | Clinical Laboratory Values (Change in Biochemistry - Sodium) | Baseline | 139.2 mmol/L | Standard Deviation 2.4 |
| NN729 | Clinical Laboratory Values (Change in Biochemistry - Sodium) | Week 52 | 140.0 mmol/L | Standard Deviation 2.4 |
| NN729 | Clinical Laboratory Values (Change in Biochemistry - Sodium) | Change from Baseline to week 52 | 0.8 mmol/L | Standard Deviation 2.9 |
Secondary
Clinical Laboratory Values (Change in Biochemistry - Total Protein)
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory
Time frame: Week 0, week 52
Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NN304 | Clinical Laboratory Values (Change in Biochemistry - Total Protein) | Baseline | 7.23 g/dL | Standard Deviation 0.44 |
| NN304 | Clinical Laboratory Values (Change in Biochemistry - Total Protein) | Week 52 | 7.13 g/dL | Standard Deviation 0.44 |
| NN304 | Clinical Laboratory Values (Change in Biochemistry - Total Protein) | Change from Baseline to week 52 | -0.11 g/dL | Standard Deviation 0.38 |
| NN729 | Clinical Laboratory Values (Change in Biochemistry - Total Protein) | Change from Baseline to week 52 | -0.06 g/dL | Standard Deviation 0.37 |
| NN729 | Clinical Laboratory Values (Change in Biochemistry - Total Protein) | Baseline | 7.24 g/dL | Standard Deviation 0.44 |
| NN729 | Clinical Laboratory Values (Change in Biochemistry - Total Protein) | Week 52 | 7.19 g/dL | Standard Deviation 0.43 |
Secondary
Clinical Laboratory Values (Change in Haematology - Basophilis)
Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.
Time frame: week 0, week 52
Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NN304 | Clinical Laboratory Values (Change in Haematology - Basophilis) | Week 52 | 0.24 Percent (%) of white blood cells | Standard Deviation 0.56 |
| NN304 | Clinical Laboratory Values (Change in Haematology - Basophilis) | Change from Baseline to week 52 | -0.25 Percent (%) of white blood cells | Standard Deviation 0.5 |
| NN304 | Clinical Laboratory Values (Change in Haematology - Basophilis) | Baseline | 0.30 Percent (%) of white blood cells | Standard Deviation 0.67 |
| NN729 | Clinical Laboratory Values (Change in Haematology - Basophilis) | Baseline | 0.36 Percent (%) of white blood cells | Standard Deviation 0.5 |
| NN729 | Clinical Laboratory Values (Change in Haematology - Basophilis) | Week 52 | 0.33 Percent (%) of white blood cells | Standard Deviation 0.49 |
| NN729 | Clinical Laboratory Values (Change in Haematology - Basophilis) | Change from Baseline to week 52 | 0.00 Percent (%) of white blood cells | Standard Deviation 0 |
Secondary
Clinical Laboratory Values (Change in Haematology - Eosinophils)
Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.
Time frame: Week 0, week 52
Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NN304 | Clinical Laboratory Values (Change in Haematology - Eosinophils) | Baseline | 2.50 Percent (%) of white blood cells | Standard Deviation 1.27 |
| NN304 | Clinical Laboratory Values (Change in Haematology - Eosinophils) | Week 52 | 2.47 Percent (%) of white blood cells | Standard Deviation 2.1 |
| NN304 | Clinical Laboratory Values (Change in Haematology - Eosinophils) | Change from Baseline to week 52 | -0.25 Percent (%) of white blood cells | Standard Deviation 2.22 |
| NN729 | Clinical Laboratory Values (Change in Haematology - Eosinophils) | Baseline | 1.82 Percent (%) of white blood cells | Standard Deviation 1.4 |
| NN729 | Clinical Laboratory Values (Change in Haematology - Eosinophils) | Week 52 | 2.08 Percent (%) of white blood cells | Standard Deviation 2.35 |
| NN729 | Clinical Laboratory Values (Change in Haematology - Eosinophils) | Change from Baseline to week 52 | 0.00 Percent (%) of white blood cells | Standard Deviation 3.61 |
Secondary
Clinical Laboratory Values (Change in Haematology - Haemoglobin)
Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.
Time frame: Week 0, week 52
Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NN304 | Clinical Laboratory Values (Change in Haematology - Haemoglobin) | Baseline | 8.85 mmol/L | Standard Deviation 0.92 |
| NN304 | Clinical Laboratory Values (Change in Haematology - Haemoglobin) | Week 52 | 8.54 mmol/L | Standard Deviation 0.91 |
| NN304 | Clinical Laboratory Values (Change in Haematology - Haemoglobin) | Change from Baseline to week 52 | -0.30 mmol/L | Standard Deviation 0.52 |
| NN729 | Clinical Laboratory Values (Change in Haematology - Haemoglobin) | Baseline | 8.80 mmol/L | Standard Deviation 0.79 |
| NN729 | Clinical Laboratory Values (Change in Haematology - Haemoglobin) | Week 52 | 8.47 mmol/L | Standard Deviation 0.76 |
| NN729 | Clinical Laboratory Values (Change in Haematology - Haemoglobin) | Change from Baseline to week 52 | -0.31 mmol/L | Standard Deviation 0.5 |
Secondary
Clinical Laboratory Values (Change in Haematology - Leucocytes)
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.
Time frame: Week 0, week 52
Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NN304 | Clinical Laboratory Values (Change in Haematology - Leucocytes) | Baseline | 6.22 Percent (%) of white blood cells | Standard Deviation 1.91 |
| NN304 | Clinical Laboratory Values (Change in Haematology - Leucocytes) | Week 52 | 6.24 Percent (%) of white blood cells | Standard Deviation 1.85 |
| NN304 | Clinical Laboratory Values (Change in Haematology - Leucocytes) | Change from Baseline to week 52 | 0.03 Percent (%) of white blood cells | Standard Deviation 1.77 |
| NN729 | Clinical Laboratory Values (Change in Haematology - Leucocytes) | Baseline | 6.3 Percent (%) of white blood cells | Standard Deviation 1.71 |
| NN729 | Clinical Laboratory Values (Change in Haematology - Leucocytes) | Week 52 | 5.96 Percent (%) of white blood cells | Standard Deviation 1.55 |
| NN729 | Clinical Laboratory Values (Change in Haematology - Leucocytes) | Change from Baseline to week 52 | -0.32 Percent (%) of white blood cells | Standard Deviation 1.69 |
Secondary
Clinical Laboratory Values (Change in Haematology - Lymphocytes)
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.
Time frame: Week 0, week 52
Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NN304 | Clinical Laboratory Values (Change in Haematology - Lymphocytes) | Baseline | 33.80 Percent (%) of white blood cells | Standard Deviation 6.94 |
| NN304 | Clinical Laboratory Values (Change in Haematology - Lymphocytes) | Week 52 | 28.12 Percent (%) of white blood cells | Standard Deviation 9.17 |
| NN304 | Clinical Laboratory Values (Change in Haematology - Lymphocytes) | Change from Baseline to week 52 | -3.25 Percent (%) of white blood cells | Standard Deviation 9.18 |
| NN729 | Clinical Laboratory Values (Change in Haematology - Lymphocytes) | Baseline | 37.45 Percent (%) of white blood cells | Standard Deviation 7.66 |
| NN729 | Clinical Laboratory Values (Change in Haematology - Lymphocytes) | Week 52 | 36.67 Percent (%) of white blood cells | Standard Deviation 9.3 |
| NN729 | Clinical Laboratory Values (Change in Haematology - Lymphocytes) | Change from Baseline to week 52 | 5.33 Percent (%) of white blood cells | Standard Deviation 6.66 |
Secondary
Clinical Laboratory Values (Change in Haematology - Monocytes)
Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.
Time frame: Week 0, week 52
Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NN304 | Clinical Laboratory Values (Change in Haematology - Monocytes) | Baseline | 3.40 Percent (%) of white blood cells | Standard Deviation 2.17 |
| NN304 | Clinical Laboratory Values (Change in Haematology - Monocytes) | Week 52 | 3.59 Percent (%) of white blood cells | Standard Deviation 2.92 |
| NN304 | Clinical Laboratory Values (Change in Haematology - Monocytes) | Change from Baseline to week 52 | -2.50 Percent (%) of white blood cells | Standard Deviation 1.91 |
| NN729 | Clinical Laboratory Values (Change in Haematology - Monocytes) | Baseline | 4.00 Percent (%) of white blood cells | Standard Deviation 2.61 |
| NN729 | Clinical Laboratory Values (Change in Haematology - Monocytes) | Week 52 | 3.42 Percent (%) of white blood cells | Standard Deviation 2.15 |
| NN729 | Clinical Laboratory Values (Change in Haematology - Monocytes) | Change from Baseline to week 52 | 0.67 Percent (%) of white blood cells | Standard Deviation 0.58 |
Secondary
Clinical Laboratory Values (Change in Haematology - Neutrophils)
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.
Time frame: Week 0, week 52
Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NN304 | Clinical Laboratory Values (Change in Haematology - Neutrophils) | Baseline | 60.00 Percent (%) of white blood cells | Standard Deviation 7.51 |
| NN304 | Clinical Laboratory Values (Change in Haematology - Neutrophils) | Week 52 | 65.59 Percent (%) of white blood cells | Standard Deviation 10.75 |
| NN304 | Clinical Laboratory Values (Change in Haematology - Neutrophils) | Change from Baseline to week 52 | 6.25 Percent (%) of white blood cells | Standard Deviation 10.37 |
| NN729 | Clinical Laboratory Values (Change in Haematology - Neutrophils) | Baseline | 56.36 Percent (%) of white blood cells | Standard Deviation 7.46 |
| NN729 | Clinical Laboratory Values (Change in Haematology - Neutrophils) | Week 52 | 57.50 Percent (%) of white blood cells | Standard Deviation 9.6 |
| NN729 | Clinical Laboratory Values (Change in Haematology - Neutrophils) | Change from Baseline to week 52 | -6.00 Percent (%) of white blood cells | Standard Deviation 8.66 |
Secondary
Clinical Laboratory Values (Change in Haematology - Thrombocytes)
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.
Time frame: Week 0, week 52
Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NN304 | Clinical Laboratory Values (Change in Haematology - Thrombocytes) | Baseline | 254.0 10^9/L | Standard Deviation 65.5 |
| NN304 | Clinical Laboratory Values (Change in Haematology - Thrombocytes) | Week 52 | 242.2 10^9/L | Standard Deviation 58.3 |
| NN304 | Clinical Laboratory Values (Change in Haematology - Thrombocytes) | Change from Baseline to week 52 | -12.8 10^9/L | Standard Deviation 38.5 |
| NN729 | Clinical Laboratory Values (Change in Haematology - Thrombocytes) | Baseline | 267.1 10^9/L | Standard Deviation 59.5 |
| NN729 | Clinical Laboratory Values (Change in Haematology - Thrombocytes) | Week 52 | 247.2 10^9/L | Standard Deviation 51.3 |
| NN729 | Clinical Laboratory Values (Change in Haematology - Thrombocytes) | Change from Baseline to week 52 | -18.6 10^9/L | Standard Deviation 38.9 |
Secondary
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
1. point is Before Breakfast 2. point is 120 minutes after Breakfast 3. point is Before Lunch 4. point is 120 minutes after Lunch 5. point is Before Dinner 6. point is 120 minutes after Dinner 7. point is at Bedtime 8. point is At 03:00 A.M. 9. point is Before Breakfast the Following Day
Time frame: week 0, 26 and 52
Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NN304 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Baseline 4. point | 8.60 mmol/L | Standard Deviation 3.7 |
| NN304 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 26 change. 5. point | -0.36 mmol/L | Standard Deviation 4.22 |
| NN304 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Baseline 6. point | 8.43 mmol/L | Standard Deviation 3.37 |
| NN304 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 26 change. 6. point | -0.35 mmol/L | Standard Deviation 4.16 |
| NN304 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 52 change. 3. point | -0.36 mmol/L | Standard Deviation 3.96 |
| NN304 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 26 change. 7. point | -0.35 mmol/L | Standard Deviation 3.63 |
| NN304 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Baseline 7. point | 8.69 mmol/L | Standard Deviation 3.48 |
| NN304 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 26 change. 8. point | 0.18 mmol/L | Standard Deviation 4.05 |
| NN304 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Baseline 3. point | 7.66 mmol/L | Standard Deviation 3.36 |
| NN304 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 26 change. 9. point | -0.64 mmol/L | Standard Deviation 4.05 |
| NN304 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Baseline 8. point | 7.97 mmol/L | Standard Deviation 3.51 |
| NN304 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 52 change. 1. point | -0.60 mmol/L | Standard Deviation 4.08 |
| NN304 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Baseline 5. point | 8.29 mmol/L | Standard Deviation 3.37 |
| NN304 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 52 change. 2. point | -0.54 mmol/L | Standard Deviation 4.8 |
| NN304 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Baseline 9. point | 8.05 mmol/L | Standard Deviation 3.49 |
| NN304 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 52 change. 4. point | -0.78 mmol/L | Standard Deviation 3.98 |
| NN304 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 26 change. 4. point | -0.34 mmol/L | Standard Deviation 3.82 |
| NN304 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 52 change. 5. point | -0.41 mmol/L | Standard Deviation 3.8 |
| NN304 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 26 change. 1. point | -0.64 mmol/L | Standard Deviation 3.95 |
| NN304 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 52 change. 6. point | -0.31 mmol/L | Standard Deviation 4.13 |
| NN304 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 26 change. 2. point | -0.61 mmol/L | Standard Deviation 4.43 |
| NN304 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 52 change. 7. point | -0.34 mmol/L | Standard Deviation 3.92 |
| NN304 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Baseline 1. point | 8.17 mmol/L | Standard Deviation 3.26 |
| NN304 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 52 change. 8. point | -0.24 mmol/L | Standard Deviation 3.59 |
| NN304 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 26 change. 3. point | -0.49 mmol/L | Standard Deviation 3.64 |
| NN304 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 52 change. 9. point | -0.44 mmol/L | Standard Deviation 4.14 |
| NN304 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Baseline 2. point | 8.95 mmol/L | Standard Deviation 3.86 |
| NN729 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 52 change. 9. point | -0.09 mmol/L | Standard Deviation 3.49 |
| NN729 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Baseline 2. point | 9.03 mmol/L | Standard Deviation 3.81 |
| NN729 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Baseline 3. point | 7.34 mmol/L | Standard Deviation 3.51 |
| NN729 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Baseline 4. point | 8.18 mmol/L | Standard Deviation 3.74 |
| NN729 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 52 change. 2. point | -0.99 mmol/L | Standard Deviation 4.04 |
| NN729 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Baseline 1. point | 8.17 mmol/L | Standard Deviation 3.56 |
| NN729 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 26 change. 1. point | -0.44 mmol/L | Standard Deviation 4.38 |
| NN729 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 26 change. 3. point | 0.08 mmol/L | Standard Deviation 4.04 |
| NN729 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Baseline 5. point | 8.16 mmol/L | Standard Deviation 3.84 |
| NN729 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Baseline 6. point | 8.60 mmol/L | Standard Deviation 3.75 |
| NN729 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Baseline 7. point | 8.60 mmol/L | Standard Deviation 3.7 |
| NN729 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Baseline 8. point | 7.72 mmol/L | Standard Deviation 3.47 |
| NN729 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Baseline 9. point | 7.56 mmol/L | Standard Deviation 3.24 |
| NN729 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 26 change. 2. point | -0.61 mmol/L | Standard Deviation 4.81 |
| NN729 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 26 change. 4. point | -0.22 mmol/L | Standard Deviation 4.27 |
| NN729 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 26 change. 5. point | -0.00 mmol/L | Standard Deviation 4.32 |
| NN729 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 26 change. 6. point | 0.07 mmol/L | Standard Deviation 4.7 |
| NN729 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 26 change. 7. point | 0.20 mmol/L | Standard Deviation 4.37 |
| NN729 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 26 change. 8. point | 0.08 mmol/L | Standard Deviation 4.19 |
| NN729 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 26 change. 9. point | 0.24 mmol/L | Standard Deviation 3.54 |
| NN729 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 52 change. 1. point | -0.67 mmol/L | Standard Deviation 3.85 |
| NN729 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 52 change. 3. point | -0.28 mmol/L | Standard Deviation 4.06 |
| NN729 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 52 change. 4. point | -0.29 mmol/L | Standard Deviation 3.93 |
| NN729 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 52 change. 5. point | -0.59 mmol/L | Standard Deviation 4.33 |
| NN729 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 52 change. 6. point | -0.51 mmol/L | Standard Deviation 4.04 |
| NN729 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 52 change. 7. point | -0.47 mmol/L | Standard Deviation 3.68 |
| NN729 | Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) | Week 52 change. 8. point | -0.31 mmol/L | Standard Deviation 3.77 |
Secondary
Glycaemic Control Parameters (Change in Fasting Plasma Glucose [FPG])
Time frame: week 0, week 52
Population: FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NN304 | Glycaemic Control Parameters (Change in Fasting Plasma Glucose [FPG]) | Week 52 | 9.73 mmol/L | Standard Error 0.3 |
| NN304 | Glycaemic Control Parameters (Change in Fasting Plasma Glucose [FPG]) | Change from Baseline to week 52 | 0.07 mmol/L | Standard Error 0.3 |
| NN729 | Glycaemic Control Parameters (Change in Fasting Plasma Glucose [FPG]) | Week 52 | 9.64 mmol/L | Standard Error 0.3 |
| NN729 | Glycaemic Control Parameters (Change in Fasting Plasma Glucose [FPG]) | Change from Baseline to week 52 | -0.02 mmol/L | Standard Error 0.3 |
Comparison: The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA.p-value: 0.81295% CI: [-0.89, 0.7]ANOVA
Secondary
Glycaemic Control Parameters (Change in HbA1c)
HbA1c (Glycosylated haemoglobin).
Time frame: week 0, week 52
Population: All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NN304 | Glycaemic Control Parameters (Change in HbA1c) | Week 52 | 7.88 Percent (%) glycosylated haemoglobin | Standard Error 0.07 |
| NN304 | Glycaemic Control Parameters (Change in HbA1c) | Change from Baseline to week 52 | -0.08 Percent (%) glycosylated haemoglobin | Standard Error 0.07 |
| NN729 | Glycaemic Control Parameters (Change in HbA1c) | Week 52 | 7.85 Percent (%) glycosylated haemoglobin | Standard Error 0.07 |
| NN729 | Glycaemic Control Parameters (Change in HbA1c) | Change from Baseline to week 52 | -0.11 Percent (%) glycosylated haemoglobin | Standard Error 0.07 |
Comparison: The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA.p-value: 0.75895% CI: [-0.21, 0.15]ANOVA
Secondary
Hypoglycaemic Episodes
Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. Hypoglycaemic episodes occurring in the time frame between 23:00 hours (included) and 06:00 hours (excluded) were defined as nocturnal.
Time frame: Weeks 0-52
Population: All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NN304 | Hypoglycaemic Episodes | Daytime - Major | 9 episodes |
| NN304 | Hypoglycaemic Episodes | Daytime - Minor | 2741 episodes |
| NN304 | Hypoglycaemic Episodes | Daytime - Symptoms Only | 381 episodes |
| NN304 | Hypoglycaemic Episodes | Nocturnal - Major | 12 episodes |
| NN304 | Hypoglycaemic Episodes | Nocturnal - Minor | 472 episodes |
| NN304 | Hypoglycaemic Episodes | Nocturnal - Symptoms Only | 64 episodes |
| NN304 | Hypoglycaemic Episodes | All events - Major | 21 episodes |
| NN304 | Hypoglycaemic Episodes | All events - Minor | 3215 episodes |
| NN304 | Hypoglycaemic Episodes | All events - Symptoms Only | 445 episodes |
| NN304 | Hypoglycaemic Episodes | Unclassified - Minor | 2 episodes |
| NN729 | Hypoglycaemic Episodes | All events - Minor | 2996 episodes |
| NN729 | Hypoglycaemic Episodes | Daytime - Major | 15 episodes |
| NN729 | Hypoglycaemic Episodes | Nocturnal - Symptoms Only | 60 episodes |
| NN729 | Hypoglycaemic Episodes | Daytime - Minor | 2590 episodes |
| NN729 | Hypoglycaemic Episodes | Unclassified - Minor | 2 episodes |
| NN729 | Hypoglycaemic Episodes | Daytime - Symptoms Only | 258 episodes |
| NN729 | Hypoglycaemic Episodes | All events - Major | 21 episodes |
| NN729 | Hypoglycaemic Episodes | Nocturnal - Major | 6 episodes |
| NN729 | Hypoglycaemic Episodes | All events - Symptoms Only | 318 episodes |
| NN729 | Hypoglycaemic Episodes | Nocturnal - Minor | 404 episodes |