Trial Outcomes & Findings for Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart Twice Daily and Biphasic Insulin Aspart Twice Daily in Subjects With Type 2 Diabetes Mellitus Before, During and After Ramadan (NCT NCT02648217)
NCT ID: NCT02648217
Last Updated: 2018-09-11
Results Overview
Mean change in HbA1c was evaluated from baseline (week 0) to end of Ramadan (day 29 of Ramadan).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
263 participants
Primary outcome timeframe
From week 0 to end of Ramadan (day 29 of Ramadan)
Results posted on
2018-09-11
Participant Flow
The trial was conducted at 27 sites in 5 countries as follows: Algeria: 4 sites; India: 7 sites; Lebanon: 4 sites; Malaysia: 3 sites; South Africa: 9 sites.
Participant milestones
| Measure |
Insulin Degludec/Insulin Aspart
Subjects received insulin degludec/insulin aspart (IDegAsp) subcutaneously (s.c.; under the skin) in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period \[pre-Ramadan\], 4-week Ramadan treatment period, and 4 week post-Ramadan period). IDegAsp was administered twice daily (BID) during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID IDegAsp at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, IDegAsp dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan and 4 times daily during Ramadan.
|
Biphasic Insulin Aspart 30
Subjects received biphasic insulin aspart 30 (BIAsp 30) s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period \[pre-Ramadan\], 4-week Ramadan treatment period, and 4 week post-Ramadan period). BIAsp 30 was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without oral antidiabetic drugs (OADs). Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID BIAsp 30 at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, BIAsp 30 dose was adjusted based on the subjects' self-measured plasma glucose (SMPG) values, measured twice daily during pre-Ramadan and post-Ramadan, and 4 times daily during Ramadan
|
|---|---|---|
|
Overall Study
STARTED
|
131
|
132
|
|
Overall Study
Exposed
|
130
|
132
|
|
Overall Study
COMPLETED
|
121
|
127
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
Reasons for withdrawal
| Measure |
Insulin Degludec/Insulin Aspart
Subjects received insulin degludec/insulin aspart (IDegAsp) subcutaneously (s.c.; under the skin) in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period \[pre-Ramadan\], 4-week Ramadan treatment period, and 4 week post-Ramadan period). IDegAsp was administered twice daily (BID) during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID IDegAsp at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, IDegAsp dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan and 4 times daily during Ramadan.
|
Biphasic Insulin Aspart 30
Subjects received biphasic insulin aspart 30 (BIAsp 30) s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period \[pre-Ramadan\], 4-week Ramadan treatment period, and 4 week post-Ramadan period). BIAsp 30 was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without oral antidiabetic drugs (OADs). Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID BIAsp 30 at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, BIAsp 30 dose was adjusted based on the subjects' self-measured plasma glucose (SMPG) values, measured twice daily during pre-Ramadan and post-Ramadan, and 4 times daily during Ramadan
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
|
Overall Study
Unclassified
|
5
|
0
|
Baseline Characteristics
The number of subjects analysed specifies the number of subjects who contributed to the analysis.
Baseline characteristics by cohort
| Measure |
Insulin Degludec/Insulin Aspart
n=131 Participants
Subjects received IDegAsp s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period \[pre-Ramadan\], 4-week Ramadan treatment period, and 4 week post-Ramadan period). IDegAsp was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID IDegAsp at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, IDegAsp dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan and 4 times daily during Ramadan.
|
Biphasic Insulin Aspart 30
n=132 Participants
Subjects received BIAsp 30 s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period \[pre-Ramadan\], 4-week Ramadan treatment period, and 4 week post-Ramadan period). BIAsp 30 was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID BIAsp 30 at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, BIAsp 30 dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan, and 4 times daily during Ramadan.
|
Total
n=263 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.9 Years
STANDARD_DEVIATION 9.8 • n=131 Participants
|
55.3 Years
STANDARD_DEVIATION 9.2 • n=132 Participants
|
55.1 Years
STANDARD_DEVIATION 9.5 • n=263 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=131 Participants
|
80 Participants
n=132 Participants
|
147 Participants
n=263 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=131 Participants
|
52 Participants
n=132 Participants
|
116 Participants
n=263 Participants
|
|
Glycated haemoglobin (HbA1c)
|
8.5 Percentage of HbA1c
STANDARD_DEVIATION 0.9 • n=131 Participants
|
8.5 Percentage of HbA1c
STANDARD_DEVIATION 0.9 • n=132 Participants
|
8.5 Percentage of HbA1c
STANDARD_DEVIATION 0.9 • n=263 Participants
|
|
Fasting plasma glucose (FPG)
|
9.9 mmol/L
STANDARD_DEVIATION 10.4 • n=124 Participants • The number of subjects analysed specifies the number of subjects who contributed to the analysis.
|
10.6 mmol/L
STANDARD_DEVIATION 16.3 • n=122 Participants • The number of subjects analysed specifies the number of subjects who contributed to the analysis.
|
10.3 mmol/L
STANDARD_DEVIATION 13.6 • n=246 Participants • The number of subjects analysed specifies the number of subjects who contributed to the analysis.
|
PRIMARY outcome
Timeframe: From week 0 to end of Ramadan (day 29 of Ramadan)Population: Here, 'number of subjects analysed' specifies the number of subjects, who contributed to the analysis.
Mean change in HbA1c was evaluated from baseline (week 0) to end of Ramadan (day 29 of Ramadan).
Outcome measures
| Measure |
Insulin Degludec/Insulin Aspart
n=121 Participants
Subjects received IDegAsp s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period \[pre-Ramadan\], 4-week Ramadan treatment period, and 4 week post-Ramadan period). IDegAsp was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID IDegAsp at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, IDegAsp dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan and 4 times daily during Ramadan.
|
Biphasic Insulin Aspart 30
n=124 Participants
Subjects received BIAsp 30 s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period \[pre-Ramadan\], 4-week Ramadan treatment period, and 4 week post-Ramadan period). BIAsp 30 was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID BIAsp 30 at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, BIAsp 30 dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan, and 4 times daily during Ramadan.
|
|---|---|---|
|
Change in HbA1c (%) (Glycosylated Haemoglobin)
|
-1.11 Percentage (%) of HbA1c
Standard Error 0.13
|
-1.13 Percentage (%) of HbA1c
Standard Error 0.13
|
SECONDARY outcome
Timeframe: From week 0 to end of Ramadan (day 29 of Ramadan)Population: Analysis was based on the FAS, which included all randomised subjects. Here, 'number of subjects analysed' specifies the number of subjects with available data at specified time-point.
Mean change in FPG was evaluated from baseline (week 0) to end of Ramadan (day 29 of Ramadan).
Outcome measures
| Measure |
Insulin Degludec/Insulin Aspart
n=115 Participants
Subjects received IDegAsp s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period \[pre-Ramadan\], 4-week Ramadan treatment period, and 4 week post-Ramadan period). IDegAsp was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID IDegAsp at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, IDegAsp dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan and 4 times daily during Ramadan.
|
Biphasic Insulin Aspart 30
n=113 Participants
Subjects received BIAsp 30 s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period \[pre-Ramadan\], 4-week Ramadan treatment period, and 4 week post-Ramadan period). BIAsp 30 was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID BIAsp 30 at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, BIAsp 30 dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan, and 4 times daily during Ramadan.
|
|---|---|---|
|
Change in Fasting Plasma Glucose (FPG)
|
-2.0 mmol/L
Standard Deviation 12.4
|
-4.4 mmol/L
Standard Deviation 18.0
|
SECONDARY outcome
Timeframe: From week 0 to end of Ramadan (day 29 of Ramadan)Population: Analysis was based on the FAS, which included all randomised subjects. Here, 'number of subjects analysed' specifies the number of subjects with available data at specified time-point.
Mean change in fructosamine was evaluated from baseline (week 0) to end of Ramadan (day 29 of Ramadan).
Outcome measures
| Measure |
Insulin Degludec/Insulin Aspart
n=118 Participants
Subjects received IDegAsp s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period \[pre-Ramadan\], 4-week Ramadan treatment period, and 4 week post-Ramadan period). IDegAsp was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID IDegAsp at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, IDegAsp dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan and 4 times daily during Ramadan.
|
Biphasic Insulin Aspart 30
n=119 Participants
Subjects received BIAsp 30 s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period \[pre-Ramadan\], 4-week Ramadan treatment period, and 4 week post-Ramadan period). BIAsp 30 was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID BIAsp 30 at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, BIAsp 30 dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan, and 4 times daily during Ramadan.
|
|---|---|---|
|
Change in Fructosamine
|
-0.035 mmol/L
Standard Deviation 0.051
|
-0.035 mmol/L
Standard Deviation 0.048
|
SECONDARY outcome
Timeframe: End of Ramadan (day 29 of Ramadan)Population: Analysis was based on the FAS, which included all randomised subjects. Here, 'number of subjects analysed' specifies the number of subjects with available data at specified time-point.
Number of subjects who achieved HbA1c below 7% (53 mmol/mol; ADA target) at the end of Ramadan (day 29 of Ramadan).
Outcome measures
| Measure |
Insulin Degludec/Insulin Aspart
n=121 Participants
Subjects received IDegAsp s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period \[pre-Ramadan\], 4-week Ramadan treatment period, and 4 week post-Ramadan period). IDegAsp was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID IDegAsp at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, IDegAsp dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan and 4 times daily during Ramadan.
|
Biphasic Insulin Aspart 30
n=123 Participants
Subjects received BIAsp 30 s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period \[pre-Ramadan\], 4-week Ramadan treatment period, and 4 week post-Ramadan period). BIAsp 30 was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID BIAsp 30 at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, BIAsp 30 dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan, and 4 times daily during Ramadan.
|
|---|---|---|
|
Number of Subjects Who Achieve HbA1c Below 7% (53 mmol/Mol (American Diabetes Association (ADA) Target )
Subjects with HbA1c <7.0% (Yes)
|
38 Number of subjects
|
42 Number of subjects
|
|
Number of Subjects Who Achieve HbA1c Below 7% (53 mmol/Mol (American Diabetes Association (ADA) Target )
Subjects with HbA1c <7.0% (No)
|
83 Number of subjects
|
81 Number of subjects
|
SECONDARY outcome
Timeframe: End of Ramadan (day 29 of Ramadan)Population: Analysis was based on the FAS, which included all randomised subjects. Here, 'number of subjects analysed' specifies the number of subjects with available data at specified time-point.
Number of subjects who achieved FPG \<=7.2 mmol/L at the end of Ramadan (day 29 of Ramadan). The above written (in the endpoint title) 'ADA target' is not applicable for FPG.
Outcome measures
| Measure |
Insulin Degludec/Insulin Aspart
n=121 Participants
Subjects received IDegAsp s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period \[pre-Ramadan\], 4-week Ramadan treatment period, and 4 week post-Ramadan period). IDegAsp was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID IDegAsp at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, IDegAsp dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan and 4 times daily during Ramadan.
|
Biphasic Insulin Aspart 30
n=123 Participants
Subjects received BIAsp 30 s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period \[pre-Ramadan\], 4-week Ramadan treatment period, and 4 week post-Ramadan period). BIAsp 30 was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID BIAsp 30 at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, BIAsp 30 dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan, and 4 times daily during Ramadan.
|
|---|---|---|
|
Number of Subjects Who Achieve FPG Below or Equal to 7.2 mmol/L (ADA Target)
Subjects with FPG <=7.2 mmol/L (Yes)
|
65 Number of subjects.
|
83 Number of subjects.
|
|
Number of Subjects Who Achieve FPG Below or Equal to 7.2 mmol/L (ADA Target)
Subjects with FPG <=7.2 mmol/L (No)
|
56 Number of subjects.
|
40 Number of subjects.
|
SECONDARY outcome
Timeframe: From week 0 to 4 weeks post RamadanPopulation: Analysis was based on the safety analysis set (SAS), which included all subjects receiving at least 1 dose of the investigational product (IDegAsp) or its comparator (BIAsp 30).
Treatment-emergent hypoglycaemic episodes: If the onset of the episode occurred on or after the first day of investigational medicinal product (IMP; IDegAsp/BIAsp 30) administration, and no later than 1 day after the last day on IMP, before switching to or being treated with another insulin product. The above mentioned definitions (in endpoint title) should read as the following: Novo Nordisk definition; severe or blood glucose (BG) confirmed symptomatic hypoglycaemia: An episode that was severe according to ADA classification or BG confirmed by a plasma glucose (PG) value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. American Diabetes Association (ADA) definition; documented symptomatic hypoglycaemia: An episode, during which typical symptoms of hypoglycaemia were accompanied by a measured PG concentration ≤3.9 mmol/L (70 mg/dL). Due to character limitation, severe hypoglycaemia as per ADA classification is not defined here; see next outcome measure.
Outcome measures
| Measure |
Insulin Degludec/Insulin Aspart
n=130 Participants
Subjects received IDegAsp s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period \[pre-Ramadan\], 4-week Ramadan treatment period, and 4 week post-Ramadan period). IDegAsp was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID IDegAsp at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, IDegAsp dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan and 4 times daily during Ramadan.
|
Biphasic Insulin Aspart 30
n=132 Participants
Subjects received BIAsp 30 s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period \[pre-Ramadan\], 4-week Ramadan treatment period, and 4 week post-Ramadan period). BIAsp 30 was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID BIAsp 30 at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, BIAsp 30 dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan, and 4 times daily during Ramadan.
|
|---|---|---|
|
Number of Treatment Emergent Hypoglycaemic Episodes Both According to the Novo Nordisk Definition for Hypoglycaemic Episodes (Severe or BG Hypoglycaemia) as Well as According to the ADA definition1 Confirmed Symptomatic
Severe or BG confirmed symptomatic hypoglycaemia
|
93 Number of episodes.
|
389 Number of episodes.
|
|
Number of Treatment Emergent Hypoglycaemic Episodes Both According to the Novo Nordisk Definition for Hypoglycaemic Episodes (Severe or BG Hypoglycaemia) as Well as According to the ADA definition1 Confirmed Symptomatic
Documented symptomatic hypoglycaemia
|
521 Number of episodes.
|
775 Number of episodes.
|
SECONDARY outcome
Timeframe: From week 0 to 4 weeks post RamadanPopulation: Analysis was based on the SAS, which included all subjects receiving at least one dose of the investigational product or its comparator.
Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes, which occurred between 00:01 and 05:59 both inclusive. Novo Nordisk definition; severe or blood glucose (BG) confirmed symptomatic hypoglycaemia: An episode that was severe according to ADA classification or BG confirmed by a plasma glucose (PG) value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA classification: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.
Outcome measures
| Measure |
Insulin Degludec/Insulin Aspart
n=130 Participants
Subjects received IDegAsp s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period \[pre-Ramadan\], 4-week Ramadan treatment period, and 4 week post-Ramadan period). IDegAsp was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID IDegAsp at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, IDegAsp dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan and 4 times daily during Ramadan.
|
Biphasic Insulin Aspart 30
n=132 Participants
Subjects received BIAsp 30 s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period \[pre-Ramadan\], 4-week Ramadan treatment period, and 4 week post-Ramadan period). BIAsp 30 was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID BIAsp 30 at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, BIAsp 30 dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan, and 4 times daily during Ramadan.
|
|---|---|---|
|
Number of Treatment Emergent Nocturnal (00:01-05:59 am) Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
|
18 Number of episodes.
|
106 Number of episodes.
|
Adverse Events
Insulin Degludec/Insulin Aspart
Serious events: 5 serious events
Other events: 54 other events
Deaths: 0 deaths
Biphasic Insulin Aspart 30
Serious events: 3 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Insulin Degludec/Insulin Aspart
n=130 participants at risk
Subjects received IDegAsp s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period \[pre-Ramadan\], 4-week Ramadan treatment period, and 4 week post-Ramadan period). IDegAsp was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID IDegAsp at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, IDegAsp dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan and 4 times daily during Ramadan.
|
Biphasic Insulin Aspart 30
n=132 participants at risk
Subjects received BIAsp 30 s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period \[pre-Ramadan\], 4-week Ramadan treatment period, and 4 week post-Ramadan period). BIAsp 30 was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID BIAsp 30 at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, BIAsp 30 dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan, and 4 times daily during Ramadan.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/130 • From first day of exposure to randomised treatment (week 0) and no later than seven days after the last day of randomised treatment (i.e., after 16-28 weeks; 8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period).
All the adverse events mentioned below are treatment-emergent. A treatment-emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Analysis was based on the SAS, which included all subjects receiving at least one dose of the investigational product or its comparator.
|
0.76%
1/132 • Number of events 2 • From first day of exposure to randomised treatment (week 0) and no later than seven days after the last day of randomised treatment (i.e., after 16-28 weeks; 8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period).
All the adverse events mentioned below are treatment-emergent. A treatment-emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Analysis was based on the SAS, which included all subjects receiving at least one dose of the investigational product or its comparator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.77%
1/130 • Number of events 1 • From first day of exposure to randomised treatment (week 0) and no later than seven days after the last day of randomised treatment (i.e., after 16-28 weeks; 8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period).
All the adverse events mentioned below are treatment-emergent. A treatment-emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Analysis was based on the SAS, which included all subjects receiving at least one dose of the investigational product or its comparator.
|
0.00%
0/132 • From first day of exposure to randomised treatment (week 0) and no later than seven days after the last day of randomised treatment (i.e., after 16-28 weeks; 8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period).
All the adverse events mentioned below are treatment-emergent. A treatment-emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Analysis was based on the SAS, which included all subjects receiving at least one dose of the investigational product or its comparator.
|
|
Injury, poisoning and procedural complications
Fall
|
0.77%
1/130 • Number of events 1 • From first day of exposure to randomised treatment (week 0) and no later than seven days after the last day of randomised treatment (i.e., after 16-28 weeks; 8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period).
All the adverse events mentioned below are treatment-emergent. A treatment-emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Analysis was based on the SAS, which included all subjects receiving at least one dose of the investigational product or its comparator.
|
0.00%
0/132 • From first day of exposure to randomised treatment (week 0) and no later than seven days after the last day of randomised treatment (i.e., after 16-28 weeks; 8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period).
All the adverse events mentioned below are treatment-emergent. A treatment-emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Analysis was based on the SAS, which included all subjects receiving at least one dose of the investigational product or its comparator.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/130 • From first day of exposure to randomised treatment (week 0) and no later than seven days after the last day of randomised treatment (i.e., after 16-28 weeks; 8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period).
All the adverse events mentioned below are treatment-emergent. A treatment-emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Analysis was based on the SAS, which included all subjects receiving at least one dose of the investigational product or its comparator.
|
1.5%
2/132 • Number of events 7 • From first day of exposure to randomised treatment (week 0) and no later than seven days after the last day of randomised treatment (i.e., after 16-28 weeks; 8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period).
All the adverse events mentioned below are treatment-emergent. A treatment-emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Analysis was based on the SAS, which included all subjects receiving at least one dose of the investigational product or its comparator.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.77%
1/130 • Number of events 1 • From first day of exposure to randomised treatment (week 0) and no later than seven days after the last day of randomised treatment (i.e., after 16-28 weeks; 8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period).
All the adverse events mentioned below are treatment-emergent. A treatment-emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Analysis was based on the SAS, which included all subjects receiving at least one dose of the investigational product or its comparator.
|
0.00%
0/132 • From first day of exposure to randomised treatment (week 0) and no later than seven days after the last day of randomised treatment (i.e., after 16-28 weeks; 8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period).
All the adverse events mentioned below are treatment-emergent. A treatment-emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Analysis was based on the SAS, which included all subjects receiving at least one dose of the investigational product or its comparator.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.77%
1/130 • Number of events 1 • From first day of exposure to randomised treatment (week 0) and no later than seven days after the last day of randomised treatment (i.e., after 16-28 weeks; 8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period).
All the adverse events mentioned below are treatment-emergent. A treatment-emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Analysis was based on the SAS, which included all subjects receiving at least one dose of the investigational product or its comparator.
|
0.00%
0/132 • From first day of exposure to randomised treatment (week 0) and no later than seven days after the last day of randomised treatment (i.e., after 16-28 weeks; 8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period).
All the adverse events mentioned below are treatment-emergent. A treatment-emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Analysis was based on the SAS, which included all subjects receiving at least one dose of the investigational product or its comparator.
|
|
Cardiac disorders
Myocardial infarction
|
1.5%
2/130 • Number of events 2 • From first day of exposure to randomised treatment (week 0) and no later than seven days after the last day of randomised treatment (i.e., after 16-28 weeks; 8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period).
All the adverse events mentioned below are treatment-emergent. A treatment-emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Analysis was based on the SAS, which included all subjects receiving at least one dose of the investigational product or its comparator.
|
0.00%
0/132 • From first day of exposure to randomised treatment (week 0) and no later than seven days after the last day of randomised treatment (i.e., after 16-28 weeks; 8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period).
All the adverse events mentioned below are treatment-emergent. A treatment-emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Analysis was based on the SAS, which included all subjects receiving at least one dose of the investigational product or its comparator.
|
|
Infections and infestations
Pneumonia
|
0.77%
1/130 • Number of events 1 • From first day of exposure to randomised treatment (week 0) and no later than seven days after the last day of randomised treatment (i.e., after 16-28 weeks; 8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period).
All the adverse events mentioned below are treatment-emergent. A treatment-emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Analysis was based on the SAS, which included all subjects receiving at least one dose of the investigational product or its comparator.
|
0.00%
0/132 • From first day of exposure to randomised treatment (week 0) and no later than seven days after the last day of randomised treatment (i.e., after 16-28 weeks; 8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period).
All the adverse events mentioned below are treatment-emergent. A treatment-emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Analysis was based on the SAS, which included all subjects receiving at least one dose of the investigational product or its comparator.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.77%
1/130 • Number of events 1 • From first day of exposure to randomised treatment (week 0) and no later than seven days after the last day of randomised treatment (i.e., after 16-28 weeks; 8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period).
All the adverse events mentioned below are treatment-emergent. A treatment-emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Analysis was based on the SAS, which included all subjects receiving at least one dose of the investigational product or its comparator.
|
0.00%
0/132 • From first day of exposure to randomised treatment (week 0) and no later than seven days after the last day of randomised treatment (i.e., after 16-28 weeks; 8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period).
All the adverse events mentioned below are treatment-emergent. A treatment-emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Analysis was based on the SAS, which included all subjects receiving at least one dose of the investigational product or its comparator.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.77%
1/130 • Number of events 1 • From first day of exposure to randomised treatment (week 0) and no later than seven days after the last day of randomised treatment (i.e., after 16-28 weeks; 8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period).
All the adverse events mentioned below are treatment-emergent. A treatment-emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Analysis was based on the SAS, which included all subjects receiving at least one dose of the investigational product or its comparator.
|
0.00%
0/132 • From first day of exposure to randomised treatment (week 0) and no later than seven days after the last day of randomised treatment (i.e., after 16-28 weeks; 8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period).
All the adverse events mentioned below are treatment-emergent. A treatment-emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Analysis was based on the SAS, which included all subjects receiving at least one dose of the investigational product or its comparator.
|
Other adverse events
| Measure |
Insulin Degludec/Insulin Aspart
n=130 participants at risk
Subjects received IDegAsp s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period \[pre-Ramadan\], 4-week Ramadan treatment period, and 4 week post-Ramadan period). IDegAsp was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID IDegAsp at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, IDegAsp dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan and 4 times daily during Ramadan.
|
Biphasic Insulin Aspart 30
n=132 participants at risk
Subjects received BIAsp 30 s.c. in the thigh, upper arm or abdomen for a duration of 16-28 weeks (8-20 weeks treatment initiation period \[pre-Ramadan\], 4-week Ramadan treatment period, and 4 week post-Ramadan period). BIAsp 30 was administered BID during the entire treatment period with the breakfast/lunch meal and evening meal (during Ramadan Suhur and Iftar), with or without OADs. Subjects on pre-trial basal, premixed or self-mixed insulin therapy were converted unit-to-unit to trial insulin, BID BIAsp 30 at the same total insulin dose as the subject's pre-trial total daily insulin dose. Subjects used a fixed dose adjustment titration algorithm and there was no minimum or maximum dose for trial products. To optimise and maintain glycaemic control, BIAsp 30 dose was adjusted based on the subjects' SMPG values, measured twice daily during pre-Ramadan and post-Ramadan, and 4 times daily during Ramadan.
|
|---|---|---|
|
Investigations
Blood glucose decreased
|
35.4%
46/130 • Number of events 115 • From first day of exposure to randomised treatment (week 0) and no later than seven days after the last day of randomised treatment (i.e., after 16-28 weeks; 8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period).
All the adverse events mentioned below are treatment-emergent. A treatment-emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Analysis was based on the SAS, which included all subjects receiving at least one dose of the investigational product or its comparator.
|
30.3%
40/132 • Number of events 89 • From first day of exposure to randomised treatment (week 0) and no later than seven days after the last day of randomised treatment (i.e., after 16-28 weeks; 8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period).
All the adverse events mentioned below are treatment-emergent. A treatment-emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Analysis was based on the SAS, which included all subjects receiving at least one dose of the investigational product or its comparator.
|
|
General disorders
Pyrexia
|
3.1%
4/130 • Number of events 4 • From first day of exposure to randomised treatment (week 0) and no later than seven days after the last day of randomised treatment (i.e., after 16-28 weeks; 8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period).
All the adverse events mentioned below are treatment-emergent. A treatment-emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Analysis was based on the SAS, which included all subjects receiving at least one dose of the investigational product or its comparator.
|
5.3%
7/132 • Number of events 8 • From first day of exposure to randomised treatment (week 0) and no later than seven days after the last day of randomised treatment (i.e., after 16-28 weeks; 8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period).
All the adverse events mentioned below are treatment-emergent. A treatment-emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Analysis was based on the SAS, which included all subjects receiving at least one dose of the investigational product or its comparator.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
8/130 • Number of events 8 • From first day of exposure to randomised treatment (week 0) and no later than seven days after the last day of randomised treatment (i.e., after 16-28 weeks; 8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period).
All the adverse events mentioned below are treatment-emergent. A treatment-emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Analysis was based on the SAS, which included all subjects receiving at least one dose of the investigational product or its comparator.
|
2.3%
3/132 • Number of events 3 • From first day of exposure to randomised treatment (week 0) and no later than seven days after the last day of randomised treatment (i.e., after 16-28 weeks; 8-20 weeks treatment initiation period [pre-Ramadan], 4-week Ramadan treatment period, and 4 week post-Ramadan period).
All the adverse events mentioned below are treatment-emergent. A treatment-emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. Analysis was based on the SAS, which included all subjects receiving at least one dose of the investigational product or its comparator.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER