Trial Outcomes & Findings for FLuctuATion Reduction With inSULin and Glp-1 Added togetheR (FLAT-SUGAR) (NCT NCT01524705)
NCT ID: NCT01524705
Last Updated: 2023-12-29
Results Overview
The change in the coefficient of variation (CV) of continuous glucose readings, as assessed by Continuous Glucose Monitoring (CGM)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
102 participants
Primary outcome timeframe
At baseline, 6 months of intervention
Results posted on
2023-12-29
Participant Flow
Participant milestones
| Measure |
Insulin Glargine, Metformin, Exenatide
Drug: Insulin Glargine Glargine-injectable, variable, QD, 6 months Drug: Metformin Metformin-oral, up to 1000mg, BID, 6 months Drug: Exenatide Injectable, 5mcg, BID, 6 months
|
Insulin Glargine, Metformin, Prandial Insulin
Drug: Insulin Glargine Glargine-injectable, variable, QD, 6 months Drug: Metformin Metformin-oral, up to 1000mg, BID, 6 months Drug: Prandial insulin Aspart or glulisine or lispro
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
50
|
|
Overall Study
COMPLETED
|
49
|
47
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Insulin Glargine, Metformin, Exenatide
Drug: Insulin Glargine Glargine-injectable, variable, QD, 6 months Drug: Metformin Metformin-oral, up to 1000mg, BID, 6 months Drug: Exenatide Injectable, 5mcg, BID, 6 months
|
Insulin Glargine, Metformin, Prandial Insulin
Drug: Insulin Glargine Glargine-injectable, variable, QD, 6 months Drug: Metformin Metformin-oral, up to 1000mg, BID, 6 months Drug: Prandial insulin Aspart or glulisine or lispro
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Pancreatic Cancer
|
0
|
1
|
Baseline Characteristics
FLuctuATion Reduction With inSULin and Glp-1 Added togetheR (FLAT-SUGAR)
Baseline characteristics by cohort
| Measure |
Insulin Glargine, Metformin, Exenatide
n=52 Participants
Approximately 60 Type 2 DM participants will be instructed on an AHA/ADA meal plan. Insulin Glargine, metformin and exenatide will used as a combination strategy to control individual HBA1Cs between 6.7 and 7.3% throughout the trial.
"GLIPULIN:" \[insulin glargine, metformin, exenatide (GLP-1-agonist)\]: Glargine-injectable, variable, QD, 6 months Metformin-oral, up to 1000mg, BID, 6 months Exenatide-injectable, 5mcg, BID, 6 months
|
Glargine, Metformin, Prandial Insulin
n=50 Participants
Approximately 60 type 2 DM participants will be instructed in AHA/ADA meal plan. Insulin Glargine, metformin and one of 3 prandial insulins will be used as combination strategy to control individual HBA1Cs between 6.7 and 7.3%. Prandial Insulins (aspart, glulisine or lispro)
Insulin glargine, metformin, prandial insulin: Approximately 60 type 2 DM participants will be instructed in AHA/ADA meal plan. Insulin Glargine, metformin and one of 3 prandial insulins will be used as combination strategy to control individual HBA1Cs between 6.7 and 7.3%. Prandial Insulins (aspart, glulisine or lispro)
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
62 years
STANDARD_DEVIATION 8 • n=5 Participants
|
63 years
STANDARD_DEVIATION 7 • n=7 Participants
|
62 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
43 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, Non-Hispanic
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Glycosylated hemoglobin (HbA1C)
|
7.9 %
STANDARD_DEVIATION 0.3 • n=5 Participants
|
7.9 %
STANDARD_DEVIATION 0.3 • n=7 Participants
|
7.9 %
STANDARD_DEVIATION 0.4 • n=5 Participants
|
|
Median Duration of Diabetes
|
15 years
STANDARD_DEVIATION 9 • n=5 Participants
|
16 years
STANDARD_DEVIATION 7 • n=7 Participants
|
15 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Previous Cardiovascular (CV) Event
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Previous Congestive Heart Failure (CHF)
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Weight
|
101.3 kg
STANDARD_DEVIATION 14.2 • n=5 Participants
|
99.7 kg
STANDARD_DEVIATION 17.8 • n=7 Participants
|
100.5 kg
STANDARD_DEVIATION 16 • n=5 Participants
|
|
Body Mass Index (BMI)
|
34.2 kg/m^2
STANDARD_DEVIATION 5.0 • n=5 Participants
|
33.7 kg/m^2
STANDARD_DEVIATION 5.1 • n=7 Participants
|
33.9 kg/m^2
STANDARD_DEVIATION 5.1 • n=5 Participants
|
|
Waist Circumference
|
113.9 cm
STANDARD_DEVIATION 16.6 • n=5 Participants
|
112.8 cm
STANDARD_DEVIATION 14.1 • n=7 Participants
|
113.4 cm
STANDARD_DEVIATION 15.4 • n=5 Participants
|
|
Blood Pressure-
Systolic
|
131.7 mmHg
STANDARD_DEVIATION 13.6 • n=5 Participants
|
129.1 mmHg
STANDARD_DEVIATION 15.2 • n=7 Participants
|
130.4 mmHg
STANDARD_DEVIATION 14.4 • n=5 Participants
|
|
Blood Pressure-
Diastolic
|
73.5 mmHg
STANDARD_DEVIATION 11.3 • n=5 Participants
|
73.1 mmHg
STANDARD_DEVIATION 9.8 • n=7 Participants
|
73.3 mmHg
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Heart Rate
|
70.5 bpm
STANDARD_DEVIATION 10.5 • n=5 Participants
|
72.4 bpm
STANDARD_DEVIATION 10.4 • n=7 Participants
|
71.4 bpm
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
C-peptide
|
0.80 nmol/L
STANDARD_DEVIATION 0.07 • n=5 Participants
|
0.73 nmol/L
STANDARD_DEVIATION 0.10 • n=7 Participants
|
0.77 nmol/L
STANDARD_DEVIATION 0.77 • n=5 Participants
|
|
Creatinine
|
79.56 micro mol/L
STANDARD_DEVIATION 17.68 • n=5 Participants
|
79.56 micro mol/L
STANDARD_DEVIATION 17.68 • n=7 Participants
|
79.56 micro mol/L
STANDARD_DEVIATION 17.68 • n=5 Participants
|
|
Alanine Transaminase (ALT)
|
37.6 micro kat/L
STANDARD_DEVIATION 22.8 • n=5 Participants
|
32.4 micro kat/L
STANDARD_DEVIATION 14.8 • n=7 Participants
|
35.0 micro kat/L
STANDARD_DEVIATION 19.3 • n=5 Participants
|
|
Albumin/Creatinine Ratio
|
3.95 mg/gm
STANDARD_DEVIATION 7.83 • n=5 Participants
|
4.92 mg/gm
STANDARD_DEVIATION 16.94 • n=7 Participants
|
4.23 mg/gm
STANDARD_DEVIATION 13.05 • n=5 Participants
|
|
Glucose Lowering Medications (prescreening)
Insulin
|
52 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Glucose Lowering Medications (prescreening)
Basal insulin only
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Glucose Lowering Medications (prescreening)
Prandial Insulin only
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Glucose Lowering Medications (prescreening)
Basal + 1 or more Prandial insulin
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Glucose Lowering Medications (prescreening)
Premixed insulin 1 or 2 injections
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Glucose Lowering Medications (prescreening)
Metformin
|
46 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Glucose Lowering Medications (prescreening)
Secretagogue
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Glucose Lowering Medications (prescreening)
Thiazolidinedione
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Glucose Lowering Medications (prescreening)
Glucagon-like peptide-1 receptor agonist(GLP- 1RA)
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Glucose Lowering Medications (prescreening)
Dipeptidyl peptidase-4 (DPP-4) inhibitor
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Glucose coefficient of variation (CV)
|
31.9 percentage
STANDARD_DEVIATION 6.1 • n=5 Participants
|
30.0 percentage
STANDARD_DEVIATION 6.1 • n=7 Participants
|
31.0 percentage
STANDARD_DEVIATION 6.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: At baseline, 6 months of interventionThe change in the coefficient of variation (CV) of continuous glucose readings, as assessed by Continuous Glucose Monitoring (CGM)
Outcome measures
| Measure |
Insulin Glargine, Metformin, Exenatide
n=47 Participants
52 randomized, 49 completed, 47 had complete data collection for primary endpoint
|
Insulin Glargine, Metformin, Prandial Insulin
n=45 Participants
50 randomized, 47 completed protocol, 45 had complete data analyzed for primary endpoint.
|
|---|---|---|
|
Coefficient of Variation at 26 Weeks Minus Coefficient of Variation at Baseline
|
-2.43 percentage
Standard Deviation 7.89
|
0.44 percentage
Standard Deviation 5.50
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: All participants that completed were analyzed
Severe hypoglycemia-documented glucose \<50mg/dl (participant journal), and hypoglycemic attacks requiring hospitalization, or treatment by emergency personnel.
Outcome measures
| Measure |
Insulin Glargine, Metformin, Exenatide
n=49 Participants
52 randomized, 49 completed, 47 had complete data collection for primary endpoint
|
Insulin Glargine, Metformin, Prandial Insulin
n=47 Participants
50 randomized, 47 completed protocol, 45 had complete data analyzed for primary endpoint.
|
|---|---|---|
|
Number of Participants With Hypoglycemia
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline vs 26 weeksPopulation: Participants with valid weights at baseline and 26 weeks
Weight in kg at 26 weeks minus weight at baseline.
Outcome measures
| Measure |
Insulin Glargine, Metformin, Exenatide
n=45 Participants
52 randomized, 49 completed, 47 had complete data collection for primary endpoint
|
Insulin Glargine, Metformin, Prandial Insulin
n=45 Participants
50 randomized, 47 completed protocol, 45 had complete data analyzed for primary endpoint.
|
|---|---|---|
|
Weight Change During Trial
|
-4.8 kg
Standard Deviation 3.3
|
0.7 kg
Standard Deviation 3.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline vs 26 weeks% of glycosylated hemoglobin in whole blood at 26 weeks
Outcome measures
| Measure |
Insulin Glargine, Metformin, Exenatide
n=45 Participants
52 randomized, 49 completed, 47 had complete data collection for primary endpoint
|
Insulin Glargine, Metformin, Prandial Insulin
n=45 Participants
50 randomized, 47 completed protocol, 45 had complete data analyzed for primary endpoint.
|
|---|---|---|
|
HbA1C Levels
|
7.1 % of HbA1C
Standard Deviation 0.6
|
7.2 % of HbA1C
Standard Deviation 0.6
|
Adverse Events
Insulin Glargine, Metformin, Exenatide
Serious events: 4 serious events
Other events: 46 other events
Deaths: 1 deaths
Insulin Glargine, Metformin, Prandial Insulin
Serious events: 5 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Insulin Glargine, Metformin, Exenatide
n=52 participants at risk
Drug: Insulin Glargine Glargine-injectable, variable, QD, 6 months Drug: Metformin Metformin-oral, up to 1000mg, BID, 6 months Drug: Exenatide Injectable, 5mcg, BID, 6 months
|
Insulin Glargine, Metformin, Prandial Insulin
n=50 participants at risk
Drug: Insulin Glargine Glargine-injectable, variable, QD, 6 months Drug: Metformin Metformin-oral, up to 1000mg, BID, 6 months Drug: Prandial insulin Aspart or glulisine or lispro
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Cardiac disorders
Angina unstable
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Cardiac disorders
Atrioventricular block second degree
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Cardiac disorders
Coronary artery thrombosis
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Nervous system disorders
Spondylitic myelopathy
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Surgical and medical procedures
Stapedotomy
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Cardiac disorders
Cardiac discomfort
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Infections and infestations
Human anaplasmosis
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
Other adverse events
| Measure |
Insulin Glargine, Metformin, Exenatide
n=52 participants at risk
Drug: Insulin Glargine Glargine-injectable, variable, QD, 6 months Drug: Metformin Metformin-oral, up to 1000mg, BID, 6 months Drug: Exenatide Injectable, 5mcg, BID, 6 months
|
Insulin Glargine, Metformin, Prandial Insulin
n=50 participants at risk
Drug: Insulin Glargine Glargine-injectable, variable, QD, 6 months Drug: Metformin Metformin-oral, up to 1000mg, BID, 6 months Drug: Prandial insulin Aspart or glulisine or lispro
|
|---|---|---|
|
Cardiac disorders
Sinus arrest
|
0.00%
0/52 • 34- 36 weeks
|
8.0%
4/50 • Number of events 4 • 34- 36 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
3.8%
2/52 • Number of events 4 • 34- 36 weeks
|
4.0%
2/50 • Number of events 3 • 34- 36 weeks
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Cardiac disorders
Atrioventricular block
|
1.9%
1/52 • Number of events 3 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Cardiac disorders
Atrioventricular block second degree
|
3.8%
2/52 • Number of events 2 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Cardiac disorders
Palpitations
|
3.8%
2/52 • Number of events 2 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 2 • 34- 36 weeks
|
|
Cardiac disorders
Ventricular tachycardia
|
5.8%
3/52 • Number of events 4 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Endocrine disorders
Hyperthyroidism
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
5.8%
3/52 • Number of events 4 • 34- 36 weeks
|
4.0%
2/50 • Number of events 2 • 34- 36 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
9.6%
5/52 • Number of events 6 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
5.8%
3/52 • Number of events 3 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Gastrointestinal disorders
Nausea
|
38.5%
20/52 • Number of events 20 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Gastrointestinal disorders
Vomiting
|
9.6%
5/52 • Number of events 5 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
General disorders
Discomfort
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
General disorders
Fatigue
|
3.8%
2/52 • Number of events 2 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
General disorders
Local reaction
|
3.8%
2/52 • Number of events 2 • 34- 36 weeks
|
6.0%
3/50 • Number of events 3 • 34- 36 weeks
|
|
General disorders
Oedema peripheral
|
0.00%
0/52 • 34- 36 weeks
|
4.0%
2/50 • Number of events 3 • 34- 36 weeks
|
|
General disorders
Infusion site bruising
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
General disorders
Application site burn
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
General disorders
Device capturing issue
|
3.8%
2/52 • Number of events 2 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
General disorders
Circumstance or information capable of leading to device use error
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
General disorders
Administration site erythema
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Infections and infestations
Abcess
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Infections and infestations
Cojunctiviris
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Infections and infestations
Ear infection
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Infections and infestations
Influenza
|
11.5%
6/52 • Number of events 6 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Infections and infestations
Localised infection
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Infections and infestations
Lower respiratory tract infection
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
4/52 • Number of events 4 • 34- 36 weeks
|
10.0%
5/50 • Number of events 5 • 34- 36 weeks
|
|
Infections and infestations
Pneumonia
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Infections and infestations
Sinusitis
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Infections and infestations
Tooth abscess
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
5.8%
3/52 • Number of events 3 • 34- 36 weeks
|
4.0%
2/50 • Number of events 2 • 34- 36 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/52 • 34- 36 weeks
|
4.0%
2/50 • Number of events 2 • 34- 36 weeks
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Infections and infestations
Wound infection
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Infections and infestations
Respiratory tract infection viral
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Injury, poisoning and procedural complications
Conjunctival abrasion
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/52 • 34- 36 weeks
|
4.0%
2/50 • Number of events 2 • 34- 36 weeks
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Injury, poisoning and procedural complications
Compensatory sweating
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Investigations
Blood creatinine increased
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
4.0%
2/50 • Number of events 2 • 34- 36 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/52 • 34- 36 weeks
|
4.0%
2/50 • Number of events 2 • 34- 36 weeks
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/52 • 34- 36 weeks
|
4.0%
2/50 • Number of events 2 • 34- 36 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Nervous system disorders
Carpal tunnel syndrome
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Nervous system disorders
Dizziness
|
3.8%
2/52 • Number of events 3 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Nervous system disorders
Dysgeusia
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Nervous system disorders
Headache
|
5.8%
3/52 • Number of events 3 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Nervous system disorders
Paraesthesia
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Nervous system disorders
Cervical radiculopathy
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Reproductive system and breast disorders
Prostatitis
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Reproductive system and breast disorders
Menopausal disorder
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/52 • 34- 36 weeks
|
2.0%
1/50 • Number of events 1 • 34- 36 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
9.6%
5/52 • Number of events 7 • 34- 36 weeks
|
6.0%
3/50 • Number of events 3 • 34- 36 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/52 • 34- 36 weeks
|
4.0%
2/50 • Number of events 2 • 34- 36 weeks
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Surgical and medical procedures
Metatarsal excision
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Surgical and medical procedures
Antiinflammatory therapy
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Vascular disorders
Hypotension
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
|
Vascular disorders
Hot flush
|
1.9%
1/52 • Number of events 1 • 34- 36 weeks
|
0.00%
0/50 • 34- 36 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place