Trial Outcomes & Findings for A Research Study to Compare the Effect of Insulin Degludec and Insulin Glargine on Blood Sugar Levels in People With Type 2 Diabetes - the SWITCH PRO Study (NCT NCT03687827)
NCT ID: NCT03687827
Last Updated: 2021-01-12
Results Overview
The percentage of time spent in glycaemic target range was calculated as the number of recorded measurements in glycaemic target range (70-180 milligrams per deciliter \[mg/dL\] (3.9-10.0 millimoles per litre \[mmol/L\]), both inclusive) divided by the total number of recorded measurements. The endpoint is based on data recorded by FGM system. It was required that at least 70% of the planned FGM measurements during weeks 16-17 and weeks 34-35 were available for endpoint data to be included in the analysis.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
498 participants
Primary outcome timeframe
During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2)
Results posted on
2021-01-12
Participant Flow
The trial was conducted in 5 countries as follows: Canada: 10 sites, Poland: 5 sites, Slovakia: 10 sites, South Africa: 7 sites, United States of America: 34 sites
This was a cross-over trial. The trial included a 2-week run-in period (which was after the screening visit) for eligibility assessment in regard to adherence to FGM requirements. The participants were randomized into one of two treatment sequences.
Participant milestones
| Measure |
Sequence A: Insulin Degludec 100U/mL Then Insulin Glargine 100U/mL
Participants were to receive a subcutaneous (s.c.) injection of Insulin degludec 100U/mL (Units per milliliter) once daily (in treatment period 1), followed by a s.c. injection of Insulin glargine 100U/mL once daily (in treatment period 2) with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
|
Sequence B: Insulin Glargine 100U/mL Then Insulin Degludec 100U/mL
Participants were to receive a subcutaneous (s.c.) injection of Insulin glargine 100U/mL once daily (in treatment period 1), followed by a s.c. injection of Insulin degludec 100U/mL once daily (in treatment period 2) with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
|
|---|---|---|
|
Treatment Period 1
STARTED
|
249
|
249
|
|
Treatment Period 1
Full Analysis Set (FAS)
|
249
|
249
|
|
Treatment Period 1
Safety Analysis Set (SAS)
|
249
|
249
|
|
Treatment Period 1
Per Protocol Set
|
219
|
229
|
|
Treatment Period 1
COMPLETED
|
235
|
241
|
|
Treatment Period 1
NOT COMPLETED
|
14
|
8
|
|
Treatment Period 2
STARTED
|
235
|
241
|
|
Treatment Period 2
COMPLETED
|
230
|
238
|
|
Treatment Period 2
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
Sequence A: Insulin Degludec 100U/mL Then Insulin Glargine 100U/mL
Participants were to receive a subcutaneous (s.c.) injection of Insulin degludec 100U/mL (Units per milliliter) once daily (in treatment period 1), followed by a s.c. injection of Insulin glargine 100U/mL once daily (in treatment period 2) with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
|
Sequence B: Insulin Glargine 100U/mL Then Insulin Degludec 100U/mL
Participants were to receive a subcutaneous (s.c.) injection of Insulin glargine 100U/mL once daily (in treatment period 1), followed by a s.c. injection of Insulin degludec 100U/mL once daily (in treatment period 2) with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
|
|---|---|---|
|
Treatment Period 1
Death
|
0
|
1
|
|
Treatment Period 1
Lost to Follow-up
|
2
|
2
|
|
Treatment Period 1
Physician Decision
|
5
|
2
|
|
Treatment Period 1
Withdrawal by Subject
|
7
|
3
|
|
Treatment Period 2
Physician Decision
|
4
|
1
|
|
Treatment Period 2
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
A Research Study to Compare the Effect of Insulin Degludec and Insulin Glargine on Blood Sugar Levels in People With Type 2 Diabetes - the SWITCH PRO Study
Baseline characteristics by cohort
| Measure |
Overall Study
n=498 Participants
Participants were to receive subcutaneous (s.c.) injection of Insulin degludec 100U/mL once daily followed by a s.c. injection of Insulin glargine 100U/mL once daily in 2 treatment periods with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
|
|---|---|
|
Age, Continuous
|
62.8 Years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
259 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
239 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
100 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
398 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
415 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2)Population: Per protocol (PP) analysis set - The PP analysis set consisted of subjects that stayed on assigned treatment until and completed FGM assessment at visits 21 and 39 respectively. Complete FGM assessment was specified as subjects having at least 70% of 2 weeks FGM measurements per maintenance period (2 \* 960 measurements).
The percentage of time spent in glycaemic target range was calculated as the number of recorded measurements in glycaemic target range (70-180 milligrams per deciliter \[mg/dL\] (3.9-10.0 millimoles per litre \[mmol/L\]), both inclusive) divided by the total number of recorded measurements. The endpoint is based on data recorded by FGM system. It was required that at least 70% of the planned FGM measurements during weeks 16-17 and weeks 34-35 were available for endpoint data to be included in the analysis.
Outcome measures
| Measure |
Insulin Degludec 100U/mL
n=448 Participants
Participants were to receive a subcutaneous (s.c.) injection of insulin degludec 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
|
Insulin Glargine 100U/mL
n=448 Participants
Participants were to receive a subcutaneous (s.c.) injection of insulin glargine 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
|
|---|---|---|
|
Percentage of Time Spent in Glycaemic Target Range 70-180 mg/dL (3.9-10.0 mmol/L) Both Inclusive, Using Flash Glucose Monitoring (FGM)
|
72.11 Percentage of Time
Standard Error 0.74
|
70.68 Percentage of Time
Standard Error 0.74
|
SECONDARY outcome
Timeframe: During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).Population: Per protocol (PP) analysis set - The PP analysis set consisted of subjects that stayed on assigned treatment until and completed FGM assessment at visits 21 and 39 respectively.
The percentage of time spent in tight glycaemic target range 70-140 mg/dL (3.9-7.8 mmol/L) both inclusive, during the 2-week maintenance periods using FGM (visit 9-21 (week 16-17) and visit 37-39 (week 34-35)).
Outcome measures
| Measure |
Insulin Degludec 100U/mL
n=448 Participants
Participants were to receive a subcutaneous (s.c.) injection of insulin degludec 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
|
Insulin Glargine 100U/mL
n=448 Participants
Participants were to receive a subcutaneous (s.c.) injection of insulin glargine 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
|
|---|---|---|
|
Time Spent in Tight Glycaemic Target Range 70-140 mg/dL (3.9-7.8 mmol/L) Both Inclusive, Using Flash Glucose Monitoring
|
52.97 Percentage of Time
Standard Error 0.82
|
51.45 Percentage of Time
Standard Error 0.82
|
SECONDARY outcome
Timeframe: During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).Population: Per protocol (PP) analysis set - The PP analysis set consisted of subjects that stayed on assigned treatment until and completed FGM assessment at visits 21 and 39 respectively.
Percentage of time spent in nocturnal glycaemic target range 70-140 mg/dL (3.9-7.8 mmol/L) both inclusive, in the nocturnal period (00:01 am - 05:59 am both inclusive) during the 2-week maintenance periods using FGM (visit 19-21 (week 16-17) and visit 37-39 (week 34-35)).
Outcome measures
| Measure |
Insulin Degludec 100U/mL
n=448 Participants
Participants were to receive a subcutaneous (s.c.) injection of insulin degludec 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
|
Insulin Glargine 100U/mL
n=448 Participants
Participants were to receive a subcutaneous (s.c.) injection of insulin glargine 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
|
|---|---|---|
|
Time Spent in Nocturnal Glycaemic Target Range 70-140 mg/dL (3.9-7.8 mmol/L) Both Inclusive, in the Nocturnal Period (00:01 am - 05:59 am Both Inclusive) Using Flash Glucose Monitoring
|
15.15 Percentage of Time
Standard Error 0.26
|
14.91 Percentage of Time
Standard Error 0.26
|
SECONDARY outcome
Timeframe: After the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).Population: Per protocol (PP) analysis set - The PP analysis set consisted of subjects that stayed on assigned treatment until and completed FGM assessment at visits 21 and 39 respectively.
Level of HbA1c after two weeks of maintenance periods (Visit 19-21 (week 16-17) and Visit 37-39 (week 34-35)).
Outcome measures
| Measure |
Insulin Degludec 100U/mL
n=448 Participants
Participants were to receive a subcutaneous (s.c.) injection of insulin degludec 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
|
Insulin Glargine 100U/mL
n=448 Participants
Participants were to receive a subcutaneous (s.c.) injection of insulin glargine 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
|
|---|---|---|
|
Level of Glycated Haemoglobin (HbA1c) - Percentage
|
7.10 Percentage of glycated haemoglobin
Standard Error 0.04
|
7.16 Percentage of glycated haemoglobin
Standard Error 0.04
|
SECONDARY outcome
Timeframe: After the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).Population: Per protocol (PP) analysis set - The PP analysis set consisted of subjects that stayed on assigned treatment until and completed FGM assessment at visits 21 and 39 respectively.
Level of HbA1c after two weeks of maintenance periods (Visit 19-21 (week 16-17) and Visit 37-39 (week 34-35)).
Outcome measures
| Measure |
Insulin Degludec 100U/mL
n=448 Participants
Participants were to receive a subcutaneous (s.c.) injection of insulin degludec 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
|
Insulin Glargine 100U/mL
n=448 Participants
Participants were to receive a subcutaneous (s.c.) injection of insulin glargine 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
|
|---|---|---|
|
Level of Glycated Haemoglobin (HbA1c) - mmol/Mol
|
54.10 millimoles per mole (mmol/mol)
Standard Error 0.42
|
54.78 millimoles per mole (mmol/mol)
Standard Error 0.42
|
SECONDARY outcome
Timeframe: During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).Population: Per protocol (PP) analysis set - The PP analysis set consisted of subjects that stayed on assigned treatment until and completed FGM assessment at visits 21 and 39 respectively.
Mean glucose levels (mmol/L) during the 2-week maintenance periods using FGM (visit 19-21 (week 16-17) and visit 37-39 (week 34-35)).
Outcome measures
| Measure |
Insulin Degludec 100U/mL
n=448 Participants
Participants were to receive a subcutaneous (s.c.) injection of insulin degludec 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
|
Insulin Glargine 100U/mL
n=448 Participants
Participants were to receive a subcutaneous (s.c.) injection of insulin glargine 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
|
|---|---|---|
|
Mean Glucose Levels Using Flash Glucose Monitoring (FGM)
|
7.57 mmol/L
Standard Error 0.08
|
7.61 mmol/L
Standard Error 0.08
|
Adverse Events
Insulin Degludec 100U/mL
Serious events: 26 serious events
Other events: 0 other events
Deaths: 0 deaths
Insulin Glargine 100U/mL
Serious events: 23 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Insulin Degludec 100U/mL
n=490 participants at risk
Participants were to receive a subcutaneous (s.c.) injection of insulin degludec 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
|
Insulin Glargine 100U/mL
n=484 participants at risk
Participants were to receive a subcutaneous (s.c.) injection of insulin glargine 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
|
|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/490 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.41%
2/490 • Number of events 2 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.00%
0/484 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.20%
1/490 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.00%
0/484 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.20%
1/490 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.00%
0/484 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
0.00%
0/490 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.20%
1/490 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.00%
0/484 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Cardiac disorders
Atrial fibrillation
|
0.20%
1/490 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.20%
1/490 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.00%
0/484 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/490 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/490 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Cardiac disorders
Cardiac failure
|
0.20%
1/490 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.20%
1/490 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.00%
0/484 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.20%
1/490 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.00%
0/484 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.20%
1/490 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.00%
0/484 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.20%
1/490 • Number of events 2 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.00%
0/484 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/490 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.00%
0/490 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/490 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.20%
1/490 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.00%
0/484 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/490 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/490 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.20%
1/490 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.00%
0/484 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Nervous system disorders
Facial paralysis
|
0.20%
1/490 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.00%
0/484 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/490 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Vascular disorders
Haematoma
|
0.20%
1/490 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.00%
0/484 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Infections and infestations
Hepatitis A
|
0.20%
1/490 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.00%
0/484 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/490 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.20%
1/490 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.00%
0/484 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/490 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Nervous system disorders
Hypoglycaemic unconsciousness
|
0.20%
1/490 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.00%
0/484 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/490 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Nervous system disorders
Intercostal neuralgia
|
0.00%
0/490 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/490 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.20%
1/490 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.00%
0/484 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/490 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/490 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Nervous system disorders
Migraine
|
0.00%
0/490 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.20%
1/490 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.00%
0/484 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.20%
1/490 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.00%
0/484 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Cardiac disorders
Myocardial infarction
|
0.20%
1/490 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.00%
0/484 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.20%
1/490 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/490 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.20%
1/490 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.00%
0/484 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/490 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Infections and infestations
Osteomyelitis chronic
|
0.00%
0/490 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Cardiac disorders
Palpitations
|
0.20%
1/490 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.00%
0/484 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.20%
1/490 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.00%
0/484 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/490 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 3 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Vascular disorders
Peripheral ischaemia
|
0.20%
1/490 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.00%
0/484 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Infections and infestations
Pneumonia
|
0.61%
3/490 • Number of events 3 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.41%
2/484 • Number of events 2 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Infections and infestations
Pseudomonas infection
|
0.20%
1/490 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.00%
0/484 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/490 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/490 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Investigations
Scan myocardial perfusion abnormal
|
0.20%
1/490 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.00%
0/484 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Infections and infestations
Sepsis
|
0.00%
0/490 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/490 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/490 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Renal and urinary disorders
Urinary retention
|
0.20%
1/490 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.00%
0/484 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Infections and infestations
Urinary tract infection
|
0.20%
1/490 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.00%
0/484 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.00%
0/490 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
0.21%
1/484 • Number of events 1 • From the randomization (week 0) up to end of treatment (week 36) and follow up (week 37).
Safety Analysis Set was defined as all participants that were randomized and treated with at least one dose of trial drug after randomization.
|
Other adverse events
Adverse event data not reported
Additional Information
Clinical Reporting Anchor and Disclosure (1452)
Novo Nordisk A/S
Phone: (+1) 866-867-7178
Email: [email protected]
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