Trial Outcomes & Findings for Outpatient Study to Evaluate Safety and Effectiveness of the Low Glucose Suspend Feature (NCT NCT01497938)
NCT ID: NCT01497938
Last Updated: 2014-03-17
Results Overview
The first study objective is to demonstrate that home use of Low Glucose Suspend (LGS) is safe and is not associated with glycemic deterioration, as measured by change in A1C from baseline to end of study participation.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
247 participants
Primary outcome timeframe
5 months
Results posted on
2014-03-17
Participant Flow
Participant milestones
| Measure |
Low Glucose Suspend Feasure (LGS)
According to randomization, Low Glucose Suspend (LGS) will be turned ON in the treatment arm of the study
Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature : Automatic suspension of insulin delivery when glucose is low.
|
Control Arm
The Low Glucose Suspend feature will not be available to subjects in the control arm
Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump : No Automatic suspension of insulin delivery when glucose is low.
|
|---|---|---|
|
Overall Study
STARTED
|
121
|
126
|
|
Overall Study
COMPLETED
|
116
|
124
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Low Glucose Suspend Feasure (LGS)
According to randomization, Low Glucose Suspend (LGS) will be turned ON in the treatment arm of the study
Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature : Automatic suspension of insulin delivery when glucose is low.
|
Control Arm
The Low Glucose Suspend feature will not be available to subjects in the control arm
Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump : No Automatic suspension of insulin delivery when glucose is low.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
|
Overall Study
Device Violation
|
1
|
0
|
Baseline Characteristics
Outpatient Study to Evaluate Safety and Effectiveness of the Low Glucose Suspend Feature
Baseline characteristics by cohort
| Measure |
Low Glucose Suspend Feature (LGS)
n=121 Participants
According to randomization, Low Glucose Suspend (LGS) will be turned ON in the treatment arm of the study
Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature : Automatic suspension of insulin delivery when glucose is low.
|
Control Arm
n=126 Participants
The Low Glucose Suspend feature will not be available to subjects in the control arm
Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump : No Automatic suspension of insulin delivery when glucose is low.
|
Total
n=247 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
110 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Continuous
|
41.6 years
STANDARD_DEVIATION 12.83 • n=5 Participants
|
44.8 years
STANDARD_DEVIATION 13.82 • n=7 Participants
|
43.3 years
STANDARD_DEVIATION 13.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
121 participants
n=5 Participants
|
126 participants
n=7 Participants
|
247 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 monthsThe first study objective is to demonstrate that home use of Low Glucose Suspend (LGS) is safe and is not associated with glycemic deterioration, as measured by change in A1C from baseline to end of study participation.
Outcome measures
| Measure |
Group A With Low Glucose Suspend (LGS) Feature Turned 'ON'
n=116 Participants
|
Group B Without Low Glucose Suspend (LGS) Feature
n=124 Participants
|
|---|---|---|
|
Change in A1C From Baseline to End of Study Participation
|
0.00 Percent
Standard Deviation 0.44
|
-0.04 Percent
Standard Deviation 0.42
|
PRIMARY outcome
Timeframe: 5 monthsAn event is identified as: LGS feature in the correct setting; CGM values \<= 65 mg/dL continuously with starting time between 10pm - 8am; No evidence of patient intervention during the first 20 minutes when CGM value was \<= 65 mg/dL; The rate of change before reaching sensor glucose value of \<= 65 mg/dL was \<= 5 mg/dl/minutes; If the time between two successive events was less than 30 minutes, they will be combined as one event; An evaluable event is defined as any event with CGM value \<= 65 mg/dL of greater than 20 minutes and the LGS feature is on the correct setting; Event AUC analysis was performed based on logarithm of AUC data.
Outcome measures
| Measure |
Group A With Low Glucose Suspend (LGS) Feature Turned 'ON'
n=121 Participants
|
Group B Without Low Glucose Suspend (LGS) Feature
n=126 Participants
|
|---|---|---|
|
The Event Area Under the Curve (AUC) Was Used to Demonstrate the Reduction of Nocturnal Hypoglycemia With the Low Glucose Suspend (LGS) Feature (LGS ON)
|
980 mg/dL x min
Standard Deviation 1200.1
|
1568 mg/dL x min
Standard Deviation 1994.9
|
Adverse Events
Group A With Low Glucose Suspend (LGS) Feature Turned 'ON'
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Group B Without Low Glucose Suspend (LGS) Feature
Serious events: 2 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A With Low Glucose Suspend (LGS) Feature Turned 'ON'
n=121 participants at risk
|
Group B Without Low Glucose Suspend (LGS) Feature
n=126 participants at risk
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/121 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Infections and infestations
Pneumonia
|
0.00%
0/121 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
Other adverse events
| Measure |
Group A With Low Glucose Suspend (LGS) Feature Turned 'ON'
n=121 participants at risk
|
Group B Without Low Glucose Suspend (LGS) Feature
n=126 participants at risk
|
|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/121 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Eye disorders
Conjunctivitis
|
0.83%
1/121 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.00%
0/126 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/121 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Gastrointestinal disorders
Nausea
|
1.7%
2/121 • Number of events 2 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/121 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Gastrointestinal disorders
Vomit
|
0.83%
1/121 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
1.6%
2/126 • Number of events 2 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/121 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
General disorders
Dental bridge failure
|
0.00%
0/121 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
General disorders
Pyrexia
|
2.5%
3/121 • Number of events 3 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.00%
0/126 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
General disorders
Application site bleeding
|
0.00%
0/121 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Injury, poisoning and procedural complications
Contusion
|
0.83%
1/121 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
1.6%
2/126 • Number of events 2 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/121 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/121 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/121 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
1.6%
2/126 • Number of events 2 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.83%
1/121 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.00%
0/126 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.83%
1/121 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.00%
0/126 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.3%
4/121 • Number of events 4 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
2.4%
3/126 • Number of events 3 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/121 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/121 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.83%
1/121 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.00%
0/126 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.83%
1/121 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.00%
0/126 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Nervous system disorders
Migraine
|
1.7%
2/121 • Number of events 2 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
2.5%
3/121 • Number of events 3 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.5%
3/121 • Number of events 4 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.00%
0/126 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/121 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.83%
1/121 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
1.6%
2/126 • Number of events 2 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Surgical and medical procedures
Endodontic procedure
|
0.00%
0/121 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.83%
1/121 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 2 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Skin and subcutaneous tissue disorders
Nail hypertrophy
|
0.83%
1/121 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.00%
0/126 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.83%
1/121 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/121 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
1.6%
2/126 • Number of events 3 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.83%
1/121 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.00%
0/126 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.83%
1/121 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.00%
0/126 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Infections and infestations
Acute Sinusitis
|
0.00%
0/121 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Infections and infestations
Bacterial Infection
|
0.00%
0/121 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Infections and infestations
Bronchitis Acute
|
0.00%
0/121 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Infections and infestations
Cellulitis
|
0.83%
1/121 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Infections and infestations
Ear Infection
|
0.00%
0/121 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Infections and infestations
Gastroenteritis
|
0.83%
1/121 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.00%
0/126 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Infections and infestations
Gastroenteritis Viral
|
1.7%
2/121 • Number of events 2 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Infections and infestations
Infection
|
0.00%
0/121 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 2 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Infections and infestations
Influenza
|
0.83%
1/121 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
1.6%
2/126 • Number of events 2 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Infections and infestations
Infusion Site Infection
|
0.00%
0/121 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Infections and infestations
Kidney Infection
|
0.00%
0/121 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
1.6%
2/126 • Number of events 2 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Infections and infestations
Nasopharyngitis
|
2.5%
3/121 • Number of events 3 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
5.6%
7/126 • Number of events 7 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Infections and infestations
Otitis media
|
0.83%
1/121 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.00%
0/126 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Infections and infestations
Pharyngitis
|
0.83%
1/121 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.00%
0/126 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Infections and infestations
Respiratory Tract Infection
|
0.83%
1/121 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.00%
0/126 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Infections and infestations
Sinusitis
|
1.7%
2/121 • Number of events 2 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
1.6%
2/126 • Number of events 2 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Infections and infestations
Tonsillitis
|
0.83%
1/121 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.00%
0/126 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Infections and infestations
Tooth Abscess
|
0.83%
1/121 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.00%
0/126 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Infections and infestations
Upper Respiratory Track Infection
|
2.5%
3/121 • Number of events 4 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
4.0%
5/126 • Number of events 5 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Infections and infestations
Urinary Tract Infection
|
0.83%
1/121 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Infections and infestations
Vaginal Mycosis
|
1.7%
2/121 • Number of events 2 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.00%
0/126 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Infections and infestations
Gingival infection
|
0.00%
0/121 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Gastrointestinal disorders
Stomach Discomfort
|
0.00%
0/121 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
0.79%
1/126 • Number of events 1 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/121 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
2.4%
3/126 • Number of events 3 • Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse events during run-in (training) period are available upon request
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place