Trial Outcomes & Findings for The Effect of Dolutegravir on Whole-body Insulin Sensitivity, Lipid and Endocrine Profile in Healthy Volunteers (NCT NCT04771754)
NCT ID: NCT04771754
Last Updated: 2025-12-02
Results Overview
Change in insulin sensitivity will be determined by peripheral glucose uptake using a euglycaemic clamp.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Baseline, day 28 and 72 for both groups.
Results posted on
2025-12-02
Participant Flow
Participant milestones
| Measure |
Arm 1
* Dolutegravir - 50 mg once daily, orally administered for the first 28 days of the study.
* No treatment for the last 44 days of the study.
Dolutegravir: 50 mg once daily orally
|
Arm 2
* No treatment for the first 28 days of the study.
* Dolutegravir - 50 mg once daily, orally administered for the last 28 days of the study (day 44-72).
Dolutegravir: 50 mg once daily orally
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Participant lost to follow up/ dropout
Baseline characteristics by cohort
| Measure |
Arm 1
n=7 Participants
* Dolutegravir - 50 mg once daily, orally administered for the first 28 days of the study.
* No treatment for the last 44 days of the study.
Dolutegravir: 50 mg once daily orally
|
Arm 2
n=8 Participants
* No treatment for the first 28 days of the study.
* Dolutegravir - 50 mg once daily, orally administered for the last 28 days of the study (day 44-72).
Dolutegravir: 50 mg once daily orally
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=121 Participants • Participant lost to follow up/ dropout
|
0 Participants
n=122 Participants • Participant lost to follow up/ dropout
|
0 Participants
n=243 Participants • Participant lost to follow up/ dropout
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=121 Participants • Participant lost to follow up/ dropout
|
8 Participants
n=122 Participants • Participant lost to follow up/ dropout
|
15 Participants
n=243 Participants • Participant lost to follow up/ dropout
|
|
Age, Categorical
>=65 years
|
0 Participants
n=121 Participants • Participant lost to follow up/ dropout
|
0 Participants
n=122 Participants • Participant lost to follow up/ dropout
|
0 Participants
n=243 Participants • Participant lost to follow up/ dropout
|
|
Sex: Female, Male
Female
|
4 Participants
n=121 Participants
|
4 Participants
n=122 Participants
|
8 Participants
n=243 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=121 Participants
|
4 Participants
n=122 Participants
|
7 Participants
n=243 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=121 Participants
|
8 Participants
n=122 Participants
|
15 Participants
n=243 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
PRIMARY outcome
Timeframe: Baseline, day 28 and 72 for both groups.Population: Dolutegravir versus No Treatment Two sample Wilcoxon rank sum (Mann Whitney) test
Change in insulin sensitivity will be determined by peripheral glucose uptake using a euglycaemic clamp.
Outcome measures
| Measure |
Arm 2
n=8 Participants
* No treatment for the first 28 days of the study.
* Dolutegravir - 50 mg once daily, orally administered for the last 28 days of the study (day 44-72).
Dolutegravir: 50 mg once daily orally
|
Arm 1
n=7 Participants
* Dolutegravir - 50 mg once daily, orally administered for the first 28 days of the study.
* No treatment for the last 44 days of the study.
Dolutegravir: 50 mg once daily orally
|
|---|---|---|
|
Change in Insulin Sensitivity in Participants From Baseline to End of Study Between Two Crossover Groups.
Baseline
|
6.286017 (mg/kg/min)
Standard Deviation 2.072026
|
7.749985 (mg/kg/min)
Standard Deviation 3.520332
|
|
Change in Insulin Sensitivity in Participants From Baseline to End of Study Between Two Crossover Groups.
Day 28
|
6.815305 (mg/kg/min)
Standard Deviation 2.404083
|
8.716221 (mg/kg/min)
Standard Deviation 2.600469
|
|
Change in Insulin Sensitivity in Participants From Baseline to End of Study Between Two Crossover Groups.
Day 72
|
7.684051 (mg/kg/min)
Standard Deviation 2.516086
|
10.62598 (mg/kg/min)
Standard Deviation 5.250227
|
SECONDARY outcome
Timeframe: Baseline, day 28 and 72 for both groups.Population: Dolutegravir versus No Treatment Two sample Wilcoxon rank sum (Mann Whitney) test
Fasting adiponectin levels in blood.
Outcome measures
| Measure |
Arm 2
n=8 Participants
* No treatment for the first 28 days of the study.
* Dolutegravir - 50 mg once daily, orally administered for the last 28 days of the study (day 44-72).
Dolutegravir: 50 mg once daily orally
|
Arm 1
n=7 Participants
* Dolutegravir - 50 mg once daily, orally administered for the first 28 days of the study.
* No treatment for the last 44 days of the study.
Dolutegravir: 50 mg once daily orally
|
|---|---|---|
|
Effect of Dolutegravir on Adipocytokines.
Adiponectin Baseline
|
7555.781 ng/mL
Standard Deviation 4201.587
|
7066.733 ng/mL
Standard Deviation 4002.151
|
|
Effect of Dolutegravir on Adipocytokines.
Adiponectin Day 28
|
8294.638 ng/mL
Standard Deviation 5464.168
|
7573.153 ng/mL
Standard Deviation 4832.789
|
|
Effect of Dolutegravir on Adipocytokines.
Adiponectin Day 72
|
9220.179 ng/mL
Standard Deviation 5437.189
|
6531.739 ng/mL
Standard Deviation 3687.814
|
SECONDARY outcome
Timeframe: Baseline, day 28 and 72 for both groups.Cortisol
Outcome measures
| Measure |
Arm 2
n=8 Participants
* No treatment for the first 28 days of the study.
* Dolutegravir - 50 mg once daily, orally administered for the last 28 days of the study (day 44-72).
Dolutegravir: 50 mg once daily orally
|
Arm 1
n=7 Participants
* Dolutegravir - 50 mg once daily, orally administered for the first 28 days of the study.
* No treatment for the last 44 days of the study.
Dolutegravir: 50 mg once daily orally
|
|---|---|---|
|
Effect of Dolutegravir on Pituitary Hormones
Baseline
|
307.25 nmol /L
Standard Deviation 116.4643
|
229.7143 nmol /L
Standard Deviation 106.6173
|
|
Effect of Dolutegravir on Pituitary Hormones
Day 28
|
304 nmol /L
Standard Deviation 102.0868
|
290.8571 nmol /L
Standard Deviation 116.7325
|
|
Effect of Dolutegravir on Pituitary Hormones
Day 72
|
272.8889 nmol /L
Standard Deviation 116.7994
|
233.375 nmol /L
Standard Deviation 102.841
|
SECONDARY outcome
Timeframe: Baseline, day 28 and 72 for both groups.Indirect calorimetry by ventilated hood expires gas analysis will be used to determine energy expenditure during the course of the clamp procedures.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, day 28 & 72 for both groups.Population: Dolutegravir versus No Treatment Two sample Wilcoxon rank sum (Mann Whitney) test
Fasting Leptin levels in blood.
Outcome measures
| Measure |
Arm 2
n=8 Participants
* No treatment for the first 28 days of the study.
* Dolutegravir - 50 mg once daily, orally administered for the last 28 days of the study (day 44-72).
Dolutegravir: 50 mg once daily orally
|
Arm 1
n=7 Participants
* Dolutegravir - 50 mg once daily, orally administered for the first 28 days of the study.
* No treatment for the last 44 days of the study.
Dolutegravir: 50 mg once daily orally
|
|---|---|---|
|
Effect of Dolutegravir on Adipocytokines.
Leptin Baseline
|
12.58571 ug/L
Standard Deviation 11.13826
|
8.687143 ug/L
Standard Deviation 5.559331
|
|
Effect of Dolutegravir on Adipocytokines.
Leptin Day 28
|
10.57286 ug/L
Standard Deviation 8.23104
|
12.16571 ug/L
Standard Deviation 10.39278
|
|
Effect of Dolutegravir on Adipocytokines.
Leptin Day 72
|
12.22 ug/L
Standard Deviation 9.240835
|
13.768 ug/L
Standard Deviation 8.141939
|
SECONDARY outcome
Timeframe: Baseline, day 28 & 72 for both groups.Population: Dolutegravir versus No Treatment Two sample Wilcoxon rank sum (Mann Whitney) test
Fasting Ghrelin levels in blood.
Outcome measures
| Measure |
Arm 2
n=8 Participants
* No treatment for the first 28 days of the study.
* Dolutegravir - 50 mg once daily, orally administered for the last 28 days of the study (day 44-72).
Dolutegravir: 50 mg once daily orally
|
Arm 1
n=7 Participants
* Dolutegravir - 50 mg once daily, orally administered for the first 28 days of the study.
* No treatment for the last 44 days of the study.
Dolutegravir: 50 mg once daily orally
|
|---|---|---|
|
Effect of Dolutegravir on Adipocytokines.
Ghrelin Day 72
|
2826.041 ng/L
Standard Deviation 2823.855
|
4557.219 ng/L
Standard Deviation 4493.846
|
|
Effect of Dolutegravir on Adipocytokines.
Ghrelin Baseline
|
3873.6 ng/L
Standard Deviation 2962.185
|
3555.059 ng/L
Standard Deviation 2749.332
|
|
Effect of Dolutegravir on Adipocytokines.
Ghrelin Day 28
|
4171.744 ng/L
Standard Deviation 1671.54
|
1873.901 ng/L
Standard Deviation 1817.324
|
SECONDARY outcome
Timeframe: Baseline, day 28 and 72 for both groups.Prolactin
Outcome measures
| Measure |
Arm 2
n=8 Participants
* No treatment for the first 28 days of the study.
* Dolutegravir - 50 mg once daily, orally administered for the last 28 days of the study (day 44-72).
Dolutegravir: 50 mg once daily orally
|
Arm 1
n=7 Participants
* Dolutegravir - 50 mg once daily, orally administered for the first 28 days of the study.
* No treatment for the last 44 days of the study.
Dolutegravir: 50 mg once daily orally
|
|---|---|---|
|
Effect of Dolutegravir on Pituitary Hormones
Day 28
|
231.5 mIU /L
Standard Deviation 138.0497
|
173.7143 mIU /L
Standard Deviation 110.7019
|
|
Effect of Dolutegravir on Pituitary Hormones
Day 72
|
227.1111 mIU /L
Standard Deviation 86.96327
|
238.5 mIU /L
Standard Deviation 112.5052
|
|
Effect of Dolutegravir on Pituitary Hormones
Baseline
|
196.625 mIU /L
Standard Deviation 54.52113
|
261 mIU /L
Standard Deviation 117.5131
|
SECONDARY outcome
Timeframe: Baseline, day 28 and 72 for both groups.Luteinsing Hormone Level
Outcome measures
| Measure |
Arm 2
n=8 Participants
* No treatment for the first 28 days of the study.
* Dolutegravir - 50 mg once daily, orally administered for the last 28 days of the study (day 44-72).
Dolutegravir: 50 mg once daily orally
|
Arm 1
n=7 Participants
* Dolutegravir - 50 mg once daily, orally administered for the first 28 days of the study.
* No treatment for the last 44 days of the study.
Dolutegravir: 50 mg once daily orally
|
|---|---|---|
|
Effect of Dolutegravir on Pituitary Hormones
Baseline
|
2.1625 mIU /L
Standard Deviation 0.8667468
|
4.585714 mIU /L
Standard Deviation 5.440107
|
|
Effect of Dolutegravir on Pituitary Hormones
Day 28
|
2.825 mIU /L
Standard Deviation 0.9852483
|
3.171429 mIU /L
Standard Deviation 1.900626
|
|
Effect of Dolutegravir on Pituitary Hormones
Day 72
|
2.355556 mIU /L
Standard Deviation 1.35904
|
2.4 mIU /L
Standard Deviation 1.656157
|
SECONDARY outcome
Timeframe: Baseline, day 28 and 72 for both groups.Growth Hormone
Outcome measures
| Measure |
Arm 2
n=8 Participants
* No treatment for the first 28 days of the study.
* Dolutegravir - 50 mg once daily, orally administered for the last 28 days of the study (day 44-72).
Dolutegravir: 50 mg once daily orally
|
Arm 1
n=7 Participants
* Dolutegravir - 50 mg once daily, orally administered for the first 28 days of the study.
* No treatment for the last 44 days of the study.
Dolutegravir: 50 mg once daily orally
|
|---|---|---|
|
Effect of Dolutegravir on Pituitary Hormones
Baseline
|
0.15875 μg /L
Standard Deviation 0.1211183
|
0.1642857 μg /L
Standard Deviation 0.1137039
|
|
Effect of Dolutegravir on Pituitary Hormones
Day 28
|
0.85 μg /L
Standard Deviation 1.859416
|
1.144286 μg /L
Standard Deviation 2.545361
|
|
Effect of Dolutegravir on Pituitary Hormones
Day 72
|
0.3322222 μg /L
Standard Deviation 0.6257551
|
0.58375 μg /L
Standard Deviation 1.241818
|
SECONDARY outcome
Timeframe: Baseline, day 28 and 72 for both groups.Total Cholesterol
Outcome measures
| Measure |
Arm 2
n=8 Participants
* No treatment for the first 28 days of the study.
* Dolutegravir - 50 mg once daily, orally administered for the last 28 days of the study (day 44-72).
Dolutegravir: 50 mg once daily orally
|
Arm 1
n=7 Participants
* Dolutegravir - 50 mg once daily, orally administered for the first 28 days of the study.
* No treatment for the last 44 days of the study.
Dolutegravir: 50 mg once daily orally
|
|---|---|---|
|
Effect of Dolutegravir on Lipid Profile Including Lipid Fractions
Baseline
|
4.25 mmol /L
Standard Deviation 0.8244305
|
4.071429 mmol /L
Standard Deviation 0.3638419
|
|
Effect of Dolutegravir on Lipid Profile Including Lipid Fractions
Day 28
|
4.165 mmol /L
Standard Deviation 0.5593619
|
3.681429 mmol /L
Standard Deviation 1.076358
|
|
Effect of Dolutegravir on Lipid Profile Including Lipid Fractions
Day 72
|
3.867778 mmol /L
Standard Deviation 1.775414
|
2.965 mmol /L
Standard Deviation 1.397252
|
SECONDARY outcome
Timeframe: Baseline, day 28 and 72 for both groups.Triglycerides
Outcome measures
| Measure |
Arm 2
n=8 Participants
* No treatment for the first 28 days of the study.
* Dolutegravir - 50 mg once daily, orally administered for the last 28 days of the study (day 44-72).
Dolutegravir: 50 mg once daily orally
|
Arm 1
n=7 Participants
* Dolutegravir - 50 mg once daily, orally administered for the first 28 days of the study.
* No treatment for the last 44 days of the study.
Dolutegravir: 50 mg once daily orally
|
|---|---|---|
|
Effect of Dolutegravir on Lipid Profile Including Lipid Fractions
Baseline
|
0.87 mmol /L
Standard Deviation 2186974
|
0.7214286 mmol /L
Standard Deviation 0.310023
|
|
Effect of Dolutegravir on Lipid Profile Including Lipid Fractions
Day 28
|
0.76 mmol /L
Standard Deviation 0.1962506
|
0.8342857 mmol /L
Standard Deviation 0.3867754
|
|
Effect of Dolutegravir on Lipid Profile Including Lipid Fractions
Day 72
|
0.6355556 mmol /L
Standard Deviation 0.3005458
|
0.62375 mmol /L
Standard Deviation 0.4254388
|
SECONDARY outcome
Timeframe: Baseline, day 28 and 72 for both groups.Changes in food intake Food preference questionnaire for adolescents and adults (FPQ) 1- Scoring of Individual Items Each food item is rated on a 5-point Likert scale: 1. = Dislike a lot 2. = Dislike a little 3. = Neither like nor dislike 4. = Like a little 5. = Like a lot Responses marked as "Not applicable" are treated as missing and not included in scoring. Food Category Scores Items are grouped into six categories, each scored by averaging across the foods in that group: Vegetables (18 items) Fruits (7 items) Meat/Fish (12 items) Dairy (10 items) Snacks (9 items) Starches (6 items) The category score is the mean of item scores in that category (sum ÷ number of items). For both individual items and category scores: Minimum possible score = 1 ("Dislike a lot") Maximum possible score = 5 ("Like a lot") Direction of Scoring On the FPQ, higher scores reflect greater liking of the foods, Lower scores indicate less liking. 'scores on a scale'
Outcome measures
| Measure |
Arm 2
n=8 Participants
* No treatment for the first 28 days of the study.
* Dolutegravir - 50 mg once daily, orally administered for the last 28 days of the study (day 44-72).
Dolutegravir: 50 mg once daily orally
|
Arm 1
n=7 Participants
* Dolutegravir - 50 mg once daily, orally administered for the first 28 days of the study.
* No treatment for the last 44 days of the study.
Dolutegravir: 50 mg once daily orally
|
|---|---|---|
|
Changes in Food Intake by Food Preference Questionnaire
Baseline
|
4.0375 scores on a scale
Standard Deviation 0.458087055
|
3.719047619 scores on a scale
Standard Deviation 0.464914105
|
|
Changes in Food Intake by Food Preference Questionnaire
Day 28
|
4.066666667 scores on a scale
Standard Deviation 0.339461379
|
3.654285714 scores on a scale
Standard Deviation 0.434338447
|
|
Changes in Food Intake by Food Preference Questionnaire
Day 72
|
3.983958333 scores on a scale
Standard Deviation 0.561874305
|
3.726428571 scores on a scale
Standard Deviation 0.44250229
|
SECONDARY outcome
Timeframe: Baseline, day 28 and 72 for both groups.changes in sleep parameters by Pittsbrough Sleep Quality Index (PSQI) 1. Scoring Components The PSQI has 19 self-rated items, grouped into 7 component scores: Subjective sleep quality Sleep latency Sleep duration Habitual sleep efficiency Sleep disturbances Use of sleeping medication Daytime dysfunction Each component is scored from 0 to 3, where higher values indicate worse sleep in that domain. 2. Global Score The 7 component scores are summed to yield a global PSQI score ranging from 0 to 21. 0 = no difficulty / very good sleep quality 21 = severe difficulties / very poor sleep quality 3- Interpretation A global score \> 5 is commonly used as a cut-off to distinguish between "good sleepers" (≤5) and "poor sleepers" (\>5). 4- Direction of Scoring On the PSQI, higher scores indicate worse outcomes (poorer sleep quality). Lower scores indicate better sleep quality. Unit of Measue = Score on a scale
Outcome measures
| Measure |
Arm 2
n=8 Participants
* No treatment for the first 28 days of the study.
* Dolutegravir - 50 mg once daily, orally administered for the last 28 days of the study (day 44-72).
Dolutegravir: 50 mg once daily orally
|
Arm 1
n=7 Participants
* Dolutegravir - 50 mg once daily, orally administered for the first 28 days of the study.
* No treatment for the last 44 days of the study.
Dolutegravir: 50 mg once daily orally
|
|---|---|---|
|
Change in Sleep Parameters by Sleep Questionnaires
Baseline
|
2.5 Global PSQI score
Standard Deviation 1.414214
|
4.714286 Global PSQI score
Standard Deviation 1.799371
|
|
Change in Sleep Parameters by Sleep Questionnaires
Day 28
|
2.5 Global PSQI score
Standard Deviation 1.85164
|
4.571429 Global PSQI score
Standard Deviation 4.117327
|
|
Change in Sleep Parameters by Sleep Questionnaires
Day 72
|
1.88889 Global PSQI score
Standard Deviation 1.536591
|
4.125 Global PSQI score
Standard Deviation 2.10017
|
Adverse Events
Arm 1 Dolutegravir
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Arm 1 No treatment
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Arm 2 No treatment
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm 2 Dolutegravir
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1 Dolutegravir
n=7 participants at risk
Dolutegravir first - 50 mg once daily, day 0 to 44 (including a 2 week wash out period)
|
Arm 1 No treatment
n=7 participants at risk
No treatment 28 days of the study, day 44 to 100
|
Arm 2 No treatment
n=8 participants at risk
No treatment for the first 28 days of the study day 0 to 44
|
Arm 2 Dolutegravir
n=8 participants at risk
Dolutegravir - 50 mg once daily, orally administered, day 44 to 100 (including a 2 week wash out period)
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Transverse tibial metaphyseal
|
0.00%
0/7 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/7 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
12.5%
1/8 • Number of events 1 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
Other adverse events
| Measure |
Arm 1 Dolutegravir
n=7 participants at risk
Dolutegravir first - 50 mg once daily, day 0 to 44 (including a 2 week wash out period)
|
Arm 1 No treatment
n=7 participants at risk
No treatment 28 days of the study, day 44 to 100
|
Arm 2 No treatment
n=8 participants at risk
No treatment for the first 28 days of the study day 0 to 44
|
Arm 2 Dolutegravir
n=8 participants at risk
Dolutegravir - 50 mg once daily, orally administered, day 44 to 100 (including a 2 week wash out period)
|
|---|---|---|---|---|
|
Investigations
low monocyte
|
0.00%
0/7 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
14.3%
1/7 • Number of events 1 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
|
Investigations
low lymphocyte count
|
0.00%
0/7 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
14.3%
1/7 • Number of events 1 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Number of events 1 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/7 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
12.5%
1/8 • Number of events 1 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
|
Metabolism and nutrition disorders
Hay fever
|
0.00%
0/7 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/7 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
12.5%
1/8 • Number of events 1 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
|
Infections and infestations
Cold
|
0.00%
0/7 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
14.3%
1/7 • Number of events 1 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
25.0%
2/8 • Number of events 2 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
|
Skin and subcutaneous tissue disorders
Contact dermatitis on left ring finger (redness)
|
0.00%
0/7 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
14.3%
1/7 • Number of events 1 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
14.3%
1/7 • Number of events 1 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
1/7 • Number of events 1 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/7 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
|
General disorders
Hit right cheek by cricket ball, swelling only
|
0.00%
0/7 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
14.3%
1/7 • Number of events 1 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
42.9%
3/7 • Number of events 3 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
71.4%
5/7 • Number of events 5 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
71.4%
5/7 • Number of events 5 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
71.4%
5/7 • Number of events 7 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
62.5%
5/8 • Number of events 6 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
62.5%
5/8 • Number of events 7 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
|
Investigations
low white blood cell count
|
0.00%
0/7 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
14.3%
1/7 • Number of events 1 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
|
Investigations
low neutrophil count
|
0.00%
0/7 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
14.3%
1/7 • Number of events 1 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
|
Surgical and medical procedures
left wisdom tooth extraction because of decay and pain
|
14.3%
1/7 • Number of events 1 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/7 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
|
Psychiatric disorders
Vivid Dreams
|
28.6%
2/7 • Number of events 2 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/7 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
|
Musculoskeletal and connective tissue disorders
Lower back pain
|
14.3%
1/7 • Number of events 1 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/7 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/7 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/7 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
12.5%
1/8 • Number of events 1 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
|
Nervous system disorders
Sleep deprivation
|
14.3%
1/7 • Number of events 1 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/7 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
|
Nervous system disorders
Possible vasovagal
|
0.00%
0/7 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/7 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
12.5%
1/8 • Number of events 1 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
|
Metabolism and nutrition disorders
hyperglycemia
|
0.00%
0/7 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/7 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
12.5%
1/8 • Number of events 1 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/7 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/7 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
0.00%
0/8 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
12.5%
1/8 • Number of events 1 • total 100 days for both interventions
All adverse events, however minor, were documented in the CRF whether or not the Investigator concludes the event to be related to drug treatment. from baseline to end of trial visit.
|
Additional Information
Dr Ruth Byrne
Chelsea and Westminster Hospital NHS Foundation Trust
Phone: 02033152560
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place