Trial Outcomes & Findings for MiniMed™ 670G System China Study for Type I Diabetic (NCT NCT04663295)
NCT ID: NCT04663295
Last Updated: 2022-08-30
Results Overview
The overall mean change in % of time in target range from run-in period to study period will be estimated and compared by a simple superiority paired test and a significance level of 0.025 (one-sided).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
74 participants
Primary outcome timeframe
Baseline to end of 1-month study
Results posted on
2022-08-30
Participant Flow
Recruitment started on 31Oct2020 and ended on 30Apr2021. Recruitment was conducted at four hospitals.
There were 74 participants screened in the study. Of the 74 participants, 8 participants failed screening, and 1 participant was withdrawn prior to run-in. Therefore, 65 participants started run-in period. A total of 3 participants were withdrawn during the run-in period. Therefore, a total of 62 participants were included in the Intention to Treat Population and started the study period.
Participant milestones
| Measure |
Participants With Type 1 Diabetes Wearing HCL Pump System
Participants 14-75 years of age who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system.
|
|---|---|
|
Run-in Period
STARTED
|
65
|
|
Run-in Period
COMPLETED
|
62
|
|
Run-in Period
NOT COMPLETED
|
3
|
|
Overall Study Period
STARTED
|
62
|
|
Overall Study Period
COMPLETED
|
60
|
|
Overall Study Period
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Participants With Type 1 Diabetes Wearing HCL Pump System
Participants 14-75 years of age who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system.
|
|---|---|
|
Run-in Period
Withdrawal by Subject
|
3
|
|
Overall Study Period
Pregnancy
|
1
|
|
Overall Study Period
Withdrawn by Parent/Guardian
|
1
|
Baseline Characteristics
MiniMed™ 670G System China Study for Type I Diabetic
Baseline characteristics by cohort
| Measure |
Participants With Type 1 Diabetes Wearing HCL Pump System
n=62 Participants
Participants 14-75 years of age who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
|---|---|
|
Age, Continuous
|
33.4 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Han Chinese
|
62 Participants
n=5 Participants
|
|
BMI
|
22.1 kg/m^2
STANDARD_DEVIATION 3.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of 1-month studyPopulation: Intention to Treat Population.
The overall mean change in % of time in target range from run-in period to study period will be estimated and compared by a simple superiority paired test and a significance level of 0.025 (one-sided).
Outcome measures
| Measure |
Participants With Type 1 Diabetes Wearing HCL Pump System
n=62 Participants
Participants 14-75 years of age who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline 7% ≤ HbA1c < 7.5%
Participants 14-75 years of age with baseline HbA1c \< 7.5% and ≥ 7%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline 7.5% ≤ HbA1c ≤ 8.0%
Participants 14-75 years of age with baseline HbA1c ≤ 8% and ≥ 7.5%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline HbA1c > 8.0%
Participants 14-75 years of age with baseline HbA1c \> 8%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
|---|---|---|---|---|
|
Change in Time in Target Range (% of Sensor Glucose (SG)): 70 mg/dL (3.9 mmol/L) ≤ SG ≤ 180 mg/dL (10 mmol/L)
Baseline
|
75.3 percentage of total readings
Standard Deviation 12.4
|
—
|
—
|
—
|
|
Change in Time in Target Range (% of Sensor Glucose (SG)): 70 mg/dL (3.9 mmol/L) ≤ SG ≤ 180 mg/dL (10 mmol/L)
1-month Study
|
80.9 percentage of total readings
Standard Deviation 7.5
|
—
|
—
|
—
|
|
Change in Time in Target Range (% of Sensor Glucose (SG)): 70 mg/dL (3.9 mmol/L) ≤ SG ≤ 180 mg/dL (10 mmol/L)
Change
|
5.6 percentage of total readings
Standard Deviation 9.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1-month studyPopulation: Intention to Treat Population
Time in hypoglycemic range (% of SG): SG \< 70 mg/dL (3.9 mmol/L), SG \< 60 mg/dL (3.3 mmol/L), SG \< 54 mg/dL (3.0 mmol/L) will be summarized.
Outcome measures
| Measure |
Participants With Type 1 Diabetes Wearing HCL Pump System
n=62 Participants
Participants 14-75 years of age who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline 7% ≤ HbA1c < 7.5%
Participants 14-75 years of age with baseline HbA1c \< 7.5% and ≥ 7%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline 7.5% ≤ HbA1c ≤ 8.0%
Participants 14-75 years of age with baseline HbA1c ≤ 8% and ≥ 7.5%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline HbA1c > 8.0%
Participants 14-75 years of age with baseline HbA1c \> 8%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
|---|---|---|---|---|
|
Time in Hypoglycemic Range
SG < 54 mg/dL (3.0 mmol/L)
|
0.4 percentage of total readings
Standard Deviation 0.4
|
—
|
—
|
—
|
|
Time in Hypoglycemic Range
SG < 60 mg/dL (3.3 mmol/L)
|
0.8 percentage of total readings
Standard Deviation 0.7
|
—
|
—
|
—
|
|
Time in Hypoglycemic Range
SG < 70 mg/dL (3.9 mmol/L)
|
2.2 percentage of total readings
Standard Deviation 1.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1-month studyPopulation: Intention to Treat Population.
Time in hyperglycemic range (SG \> 180 mg/dL (10 mmol/L), 250 mg/dL (13.9 mmol/L) and 350 mg/dL (19.4 mmol/L)) will be summarized.
Outcome measures
| Measure |
Participants With Type 1 Diabetes Wearing HCL Pump System
n=62 Participants
Participants 14-75 years of age who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline 7% ≤ HbA1c < 7.5%
Participants 14-75 years of age with baseline HbA1c \< 7.5% and ≥ 7%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline 7.5% ≤ HbA1c ≤ 8.0%
Participants 14-75 years of age with baseline HbA1c ≤ 8% and ≥ 7.5%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline HbA1c > 8.0%
Participants 14-75 years of age with baseline HbA1c \> 8%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
|---|---|---|---|---|
|
Time in Hyperglycemic Range: SG > 180 mg/dL (10 mmol/L), 250 mg/dL (13.9 mmol/L) and 350 mg/dL (19.4 mmol/L)
SG > 180 mg/dL (10 mmol/L)
|
16.9 percentage of total readings
Standard Deviation 7.5
|
—
|
—
|
—
|
|
Time in Hyperglycemic Range: SG > 180 mg/dL (10 mmol/L), 250 mg/dL (13.9 mmol/L) and 350 mg/dL (19.4 mmol/L)
SG > 250 mg/dL (13.9 mmol/L)
|
2.4 percentage of total readings
Standard Deviation 2.4
|
—
|
—
|
—
|
|
Time in Hyperglycemic Range: SG > 180 mg/dL (10 mmol/L), 250 mg/dL (13.9 mmol/L) and 350 mg/dL (19.4 mmol/L)
SG > 350 mg/dL (19.4 mmol/L)
|
0.1 percentage of total readings
Standard Deviation 0.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1-month studyPopulation: Intention to Treat Population.
In order to evaluate glucose variation, we calculated standard deviation. The standard deviation (SD) of SG will be summarized in the unit of mmol/L
Outcome measures
| Measure |
Participants With Type 1 Diabetes Wearing HCL Pump System
n=62 Participants
Participants 14-75 years of age who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline 7% ≤ HbA1c < 7.5%
Participants 14-75 years of age with baseline HbA1c \< 7.5% and ≥ 7%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline 7.5% ≤ HbA1c ≤ 8.0%
Participants 14-75 years of age with baseline HbA1c ≤ 8% and ≥ 7.5%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline HbA1c > 8.0%
Participants 14-75 years of age with baseline HbA1c \> 8%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
|---|---|---|---|---|
|
Standard Deviation (SD) of SG in mmol/L
|
2.4 mmol/L
Standard Deviation 0.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1-month studyPopulation: Intention to Treatment Population
In order to evaluate glucose variation, we calculated standard deviation. The standard deviation (SD) of SG will be summarized in the unit of mg/dL.
Outcome measures
| Measure |
Participants With Type 1 Diabetes Wearing HCL Pump System
n=62 Participants
Participants 14-75 years of age who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline 7% ≤ HbA1c < 7.5%
Participants 14-75 years of age with baseline HbA1c \< 7.5% and ≥ 7%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline 7.5% ≤ HbA1c ≤ 8.0%
Participants 14-75 years of age with baseline HbA1c ≤ 8% and ≥ 7.5%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline HbA1c > 8.0%
Participants 14-75 years of age with baseline HbA1c \> 8%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
|---|---|---|---|---|
|
Standard Deviation (SD) of SG in mg/dL
|
43.2 mg/dL
Standard Deviation 7.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1-month studyPopulation: Intention to Treat Population.
In order to evaluate glucose variation, we calculated coefficient of variation (CV) of SG. The glucose coefficient of variation (CV) will be summarized in percentage.
Outcome measures
| Measure |
Participants With Type 1 Diabetes Wearing HCL Pump System
n=62 Participants
Participants 14-75 years of age who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline 7% ≤ HbA1c < 7.5%
Participants 14-75 years of age with baseline HbA1c \< 7.5% and ≥ 7%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline 7.5% ≤ HbA1c ≤ 8.0%
Participants 14-75 years of age with baseline HbA1c ≤ 8% and ≥ 7.5%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline HbA1c > 8.0%
Participants 14-75 years of age with baseline HbA1c \> 8%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
|---|---|---|---|---|
|
Coefficient of Variation (CV) of SG
|
30.6 Percentage
Standard Deviation 4.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to end of 1-month studyPopulation: Intention to Treat Population.
Change of Total Daily Dose (TDD) of insulin from baseline to EOS will be summarized.
Outcome measures
| Measure |
Participants With Type 1 Diabetes Wearing HCL Pump System
n=62 Participants
Participants 14-75 years of age who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline 7% ≤ HbA1c < 7.5%
Participants 14-75 years of age with baseline HbA1c \< 7.5% and ≥ 7%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline 7.5% ≤ HbA1c ≤ 8.0%
Participants 14-75 years of age with baseline HbA1c ≤ 8% and ≥ 7.5%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline HbA1c > 8.0%
Participants 14-75 years of age with baseline HbA1c \> 8%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
|---|---|---|---|---|
|
Change of Total Daily Dose (TDD) of Insulin From Baseline to End of Study (EOS)
Baseline
|
42.8 Units/Day
Standard Deviation 19.8
|
—
|
—
|
—
|
|
Change of Total Daily Dose (TDD) of Insulin From Baseline to End of Study (EOS)
End of 1-month study
|
40.7 Units/Day
Standard Deviation 18.9
|
—
|
—
|
—
|
|
Change of Total Daily Dose (TDD) of Insulin From Baseline to End of Study (EOS)
Change
|
-2.1 Units/Day
Standard Deviation 9.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to end of 1-month studyPopulation: Intention to Treat Population with available data.
Change of weight from baseline to EOS will be summarized.
Outcome measures
| Measure |
Participants With Type 1 Diabetes Wearing HCL Pump System
n=60 Participants
Participants 14-75 years of age who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline 7% ≤ HbA1c < 7.5%
Participants 14-75 years of age with baseline HbA1c \< 7.5% and ≥ 7%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline 7.5% ≤ HbA1c ≤ 8.0%
Participants 14-75 years of age with baseline HbA1c ≤ 8% and ≥ 7.5%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline HbA1c > 8.0%
Participants 14-75 years of age with baseline HbA1c \> 8%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
|---|---|---|---|---|
|
Change of Weight From Baseline to EOS
Baseline
|
61.0 Kg
Standard Deviation 10.5
|
—
|
—
|
—
|
|
Change of Weight From Baseline to EOS
End of 1-month study
|
61.0 Kg
Standard Deviation 10.1
|
—
|
—
|
—
|
|
Change of Weight From Baseline to EOS
Change
|
0.1 Kg
Standard Deviation 1.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1-month studyPopulation: Intention to Treat Population.
Time spent in Auto Mode (HCL) and time spent in Manual Mode (open loop) will be summarized.
Outcome measures
| Measure |
Participants With Type 1 Diabetes Wearing HCL Pump System
n=62 Participants
Participants 14-75 years of age who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline 7% ≤ HbA1c < 7.5%
Participants 14-75 years of age with baseline HbA1c \< 7.5% and ≥ 7%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline 7.5% ≤ HbA1c ≤ 8.0%
Participants 14-75 years of age with baseline HbA1c ≤ 8% and ≥ 7.5%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline HbA1c > 8.0%
Participants 14-75 years of age with baseline HbA1c \> 8%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
|---|---|---|---|---|
|
Time Spent in Auto Mode (HCL) Versus Time Spent in Manual Mode (Open Loop)
Time spent in Auto Mode
|
93.5 percentage of time
Standard Deviation 8.2
|
—
|
—
|
—
|
|
Time Spent in Auto Mode (HCL) Versus Time Spent in Manual Mode (Open Loop)
Time spent in Manual Mode
|
6.5 percentage of time
Standard Deviation 8.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1-month studyPopulation: Intention to Treat Population at each subgroup.
Time in target range (% of SG): 70 mg/dL (3.9 mmol/L) ≤ SG ≤ 180 mg/dL (10 mmol/L) in study period Time in hypoglycemic range (% of SG): SG \< 70 mg/dL (3.9 mmol/L), 60 mg/dL (3.3 mmol/L) and 54 mg/dL (3.0 mmol/L) in study period Time in hyperglycemic range: SG \> 180 mg/dL (10 mmol/L), 250 mg/dL (13.9 mmol/L) and 350 mg/dL (19.4 mmol/L) in study period
Outcome measures
| Measure |
Participants With Type 1 Diabetes Wearing HCL Pump System
n=29 Participants
Participants 14-75 years of age who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline 7% ≤ HbA1c < 7.5%
n=12 Participants
Participants 14-75 years of age with baseline HbA1c \< 7.5% and ≥ 7%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline 7.5% ≤ HbA1c ≤ 8.0%
n=11 Participants
Participants 14-75 years of age with baseline HbA1c ≤ 8% and ≥ 7.5%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
Participants With Baseline HbA1c > 8.0%
n=10 Participants
Participants 14-75 years of age with baseline HbA1c \> 8%, who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
|---|---|---|---|---|
|
Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%)
SG < 54 mg/dL (3.0 mmol/L)
|
0.3 percentage of total readings
Standard Deviation 0.3
|
0.4 percentage of total readings
Standard Deviation 0.4
|
0.4 percentage of total readings
Standard Deviation 0.3
|
0.6 percentage of total readings
Standard Deviation 0.6
|
|
Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%)
SG < 60 mg/dL (3.3 mmol/L)
|
0.7 percentage of total readings
Standard Deviation 0.6
|
0.8 percentage of total readings
Standard Deviation 0.7
|
0.9 percentage of total readings
Standard Deviation 0.4
|
1.3 percentage of total readings
Standard Deviation 1.0
|
|
Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%)
SG < 70 mg/dL (3.9 mmol/L)
|
2.0 percentage of total readings
Standard Deviation 1.4
|
2.0 percentage of total readings
Standard Deviation 1.4
|
2.2 percentage of total readings
Standard Deviation 0.8
|
3.1 percentage of total readings
Standard Deviation 2.1
|
|
Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%)
70 mg/dL (3.9 mmol/L) ≤ SG ≤ 180 mg/dL (10 mmol/L)
|
85.1 percentage of total readings
Standard Deviation 5.6
|
78.1 percentage of total readings
Standard Deviation 5.6
|
80.0 percentage of total readings
Standard Deviation 5.2
|
72.8 percentage of total readings
Standard Deviation 8.6
|
|
Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%)
SG > 180 mg/dL (10 mmol/L)
|
12.9 percentage of total readings
Standard Deviation 5.4
|
19.9 percentage of total readings
Standard Deviation 5.4
|
17.9 percentage of total readings
Standard Deviation 5.1
|
24.1 percentage of total readings
Standard Deviation 9.8
|
|
Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%)
SG > 250 mg/dL (13.9 mmol/L)
|
1.2 percentage of total readings
Standard Deviation 1.1
|
2.9 percentage of total readings
Standard Deviation 1.9
|
2.6 percentage of total readings
Standard Deviation 1.5
|
4.9 percentage of total readings
Standard Deviation 3.9
|
|
Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%)
SG > 350 mg/dL (19.4 mmol/L)
|
0.0 percentage of total readings
Standard Deviation 0.1
|
0.1 percentage of total readings
Standard Deviation 0.2
|
0.1 percentage of total readings
Standard Deviation 0.1
|
0.3 percentage of total readings
Standard Deviation 0.3
|
Adverse Events
Subjects With Type 1 Diabetes Wearing HCL Pump System During Run in Period
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Subjects With Type 1 Diabetes Wearing HCL Pump System During Study Period
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Subjects With Type 1 Diabetes Wearing HCL Pump System During Run in Period
n=65 participants at risk
Subjects 14-75 years of age who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during Run in period.
|
Subjects With Type 1 Diabetes Wearing HCL Pump System During Study Period
n=62 participants at risk
Subjects 14-75 years of age who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period.
|
|---|---|---|
|
General disorders
Infusion site haemorrhage
|
0.00%
0/65 • 2-4 weeks run in period and 1-month study period
AE events prior run-in were not reported in this section.
|
1.6%
1/62 • Number of events 1 • 2-4 weeks run in period and 1-month study period
AE events prior run-in were not reported in this section.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/65 • 2-4 weeks run in period and 1-month study period
AE events prior run-in were not reported in this section.
|
6.5%
4/62 • Number of events 4 • 2-4 weeks run in period and 1-month study period
AE events prior run-in were not reported in this section.
|
|
Metabolism and nutrition disorders
Diabetic ketosis
|
0.00%
0/65 • 2-4 weeks run in period and 1-month study period
AE events prior run-in were not reported in this section.
|
3.2%
2/62 • Number of events 2 • 2-4 weeks run in period and 1-month study period
AE events prior run-in were not reported in this section.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.1%
2/65 • Number of events 2 • 2-4 weeks run in period and 1-month study period
AE events prior run-in were not reported in this section.
|
1.6%
1/62 • Number of events 1 • 2-4 weeks run in period and 1-month study period
AE events prior run-in were not reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/65 • 2-4 weeks run in period and 1-month study period
AE events prior run-in were not reported in this section.
|
1.6%
1/62 • Number of events 1 • 2-4 weeks run in period and 1-month study period
AE events prior run-in were not reported in this section.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/65 • 2-4 weeks run in period and 1-month study period
AE events prior run-in were not reported in this section.
|
1.6%
1/62 • Number of events 1 • 2-4 weeks run in period and 1-month study period
AE events prior run-in were not reported in this section.
|
|
Gastrointestinal disorders
Dental caries
|
1.5%
1/65 • Number of events 1 • 2-4 weeks run in period and 1-month study period
AE events prior run-in were not reported in this section.
|
0.00%
0/62 • 2-4 weeks run in period and 1-month study period
AE events prior run-in were not reported in this section.
|
|
Infections and infestations
Tonsillitis
|
1.5%
1/65 • Number of events 1 • 2-4 weeks run in period and 1-month study period
AE events prior run-in were not reported in this section.
|
0.00%
0/62 • 2-4 weeks run in period and 1-month study period
AE events prior run-in were not reported in this section.
|
|
Nervous system disorders
Headache
|
1.5%
1/65 • Number of events 1 • 2-4 weeks run in period and 1-month study period
AE events prior run-in were not reported in this section.
|
0.00%
0/62 • 2-4 weeks run in period and 1-month study period
AE events prior run-in were not reported in this section.
|
|
Psychiatric disorders
Insomnia
|
1.5%
1/65 • Number of events 1 • 2-4 weeks run in period and 1-month study period
AE events prior run-in were not reported in this section.
|
0.00%
0/62 • 2-4 weeks run in period and 1-month study period
AE events prior run-in were not reported in this section.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER