Trial Outcomes & Findings for A Study of GSK256073 in Subjects With Type 2 Diabetes Mellitus Who Are Being Treated With Metformin (NCT NCT01376323)

NCT ID: NCT01376323

Last Updated: 2017-10-11

Results Overview

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 92 participants
• Primary outcome timeframe: Up to Week 12
• Results posted on: 2017-10-11

Participant Flow

This was a study in participants with Type 2 diabetes mellitus which was conducted across 14 centers in 4 countries (France [4], Spain [3], United Kingdom [4], Unites States [3]) from 13 July 2011 to 17 September 2012. Total of 89 participants were included in the pharmacokinetic population.

Participant milestones

Measure	Placebo (Pooled) Eligible participants in this arm received GSK256073 matching placebo capsules twice a day (BID) and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.	GSK256073 5 mg BID Eligible participants in this arm received GSK256073 5 milligrams (mg) capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 10 mg Once Daily Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.	GSK256073 25 mg BID Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 50 mg Once Daily Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
Overall Study STARTED	20	18	19	19	18
Overall Study COMPLETED	18	17	16	14	17
Overall Study NOT COMPLETED	2	1	3	5	1

Reasons for withdrawal

Measure	Placebo (Pooled) Eligible participants in this arm received GSK256073 matching placebo capsules twice a day (BID) and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.	GSK256073 5 mg BID Eligible participants in this arm received GSK256073 5 milligrams (mg) capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 10 mg Once Daily Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.	GSK256073 25 mg BID Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 50 mg Once Daily Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
Overall Study Adverse Event	1	0	0	2	0
Overall Study Lost to Follow-up	0	0	0	2	0
Overall Study Physician Decision	1	0	2	1	1
Overall Study Withdrawal by Subject	0	1	1	0	0

Baseline Characteristics

A Study of GSK256073 in Subjects With Type 2 Diabetes Mellitus Who Are Being Treated With Metformin

Baseline characteristics by cohort

Measure	Placebo (Pooled) n=20 Participants Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.	GSK256073 5 mg BID n=18 Participants Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 10 mg Once Daily n=19 Participants Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.	GSK256073 25 mg BID n=19 Participants Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 50 mg Once Daily n=18 Participants Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.	Total n=94 Participants Total of all reporting groups
Age, Continuous	57.0 Years STANDARD_DEVIATION 7.01 • n=5 Participants	60.0 Years STANDARD_DEVIATION 6.24 • n=7 Participants	59.6 Years STANDARD_DEVIATION 8.07 • n=5 Participants	60.2 Years STANDARD_DEVIATION 6.21 • n=4 Participants	57.1 Years STANDARD_DEVIATION 7.30 • n=21 Participants	58.8 Years STANDARD_DEVIATION 7.01 • n=8 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	5 Participants n=4 Participants	1 Participants n=21 Participants	27 Participants n=8 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	11 Participants n=7 Participants	9 Participants n=5 Participants	14 Participants n=4 Participants	17 Participants n=21 Participants	67 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	5 Participants n=8 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	18 Participants n=7 Participants	19 Participants n=5 Participants	16 Participants n=4 Participants	18 Participants n=21 Participants	87 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants

PRIMARY outcome

Timeframe: Up to Week 12

Population: Safety population was used which was defined as all participants who received at least one dose of study drug.

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.

Outcome measures

Measure	Placebo (Pooled) n=20 Participants Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.	GSK256073 5 mg BID n=18 Participants Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 10 mg Once Daily n=19 Participants Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.	GSK256073 25 mg BID n=19 Participants Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 50 mg Once Daily n=18 Participants Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) Any AE	11 Participants	12 Participants	12 Participants	11 Participants	10 Participants
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) Any SAE	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline (pre-dose Day 1) and up to Week 12

Population: Safety population. Only those participants available at the specified time points were analyzed.

Mean of triplicate measurements at each time point was considered for the summary. Baseline was defined as pre-dose of Day 1 visit. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. It was assessed on Baseline, Day 1 (12 hours), Day 2 (pre-dose and 12 hours), Week 3, 6 (pre-dose and 12 hours), 9 and 12.

Outcome measures

Measure	Placebo (Pooled) n=20 Participants Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.	GSK256073 5 mg BID n=18 Participants Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 10 mg Once Daily n=19 Participants Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.	GSK256073 25 mg BID n=19 Participants Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 50 mg Once Daily n=18 Participants Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Day 1,12 hours	3.4 Millimeters of mercury Standard Deviation 10.48	0.9 Millimeters of mercury Standard Deviation 10.73	4.9 Millimeters of mercury Standard Deviation 19.88	3.0 Millimeters of mercury Standard Deviation 12.90	1.9 Millimeters of mercury Standard Deviation 11.04
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Day 2, 12 hours	0.7 Millimeters of mercury Standard Deviation 11.84	-3.8 Millimeters of mercury Standard Deviation 8.34	1.1 Millimeters of mercury Standard Deviation 11.76	1.7 Millimeters of mercury Standard Deviation 7.86	-1.8 Millimeters of mercury Standard Deviation 11.16
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Week 3	3.7 Millimeters of mercury Standard Deviation 13.68	-3.9 Millimeters of mercury Standard Deviation 11.83	0.5 Millimeters of mercury Standard Deviation 12.41	-1.7 Millimeters of mercury Standard Deviation 10.71	-1.1 Millimeters of mercury Standard Deviation 8.78
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Day 6, pre-dose	-0.1 Millimeters of mercury Standard Deviation 11.26	-7.7 Millimeters of mercury Standard Deviation 12.96	-3.4 Millimeters of mercury Standard Deviation 9.07	-5.3 Millimeters of mercury Standard Deviation 16.93	-5.8 Millimeters of mercury Standard Deviation 8.19
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Day 6, 12 hours	6.6 Millimeters of mercury Standard Deviation 15.32	-2.5 Millimeters of mercury Standard Deviation 14.05	1.0 Millimeters of mercury Standard Deviation 10.83	2.7 Millimeters of mercury Standard Deviation 12.76	1.6 Millimeters of mercury Standard Deviation 7.51
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Week 9	4.0 Millimeters of mercury Standard Deviation 11.93	-9.1 Millimeters of mercury Standard Deviation 14.02	-1.6 Millimeters of mercury Standard Deviation 10.27	-2.0 Millimeters of mercury Standard Deviation 11.73	-3.8 Millimeters of mercury Standard Deviation 10.57
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Week 12	2.3 Millimeters of mercury Standard Deviation 9.85	-6.4 Millimeters of mercury Standard Deviation 8.08	-0.3 Millimeters of mercury Standard Deviation 7.95	2.8 Millimeters of mercury Standard Deviation 13.13	0.4 Millimeters of mercury Standard Deviation 10.59
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Day 1,12 hours	1.4 Millimeters of mercury Standard Deviation 6.66	0.6 Millimeters of mercury Standard Deviation 7.42	2.0 Millimeters of mercury Standard Deviation 6.00	-0.5 Millimeters of mercury Standard Deviation 7.69	3.2 Millimeters of mercury Standard Deviation 8.55
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Day 2, pre-dose	-1.2 Millimeters of mercury Standard Deviation 6.89	-2.1 Millimeters of mercury Standard Deviation 7.46	-2.1 Millimeters of mercury Standard Deviation 5.27	-1.7 Millimeters of mercury Standard Deviation 5.15	-0.2 Millimeters of mercury Standard Deviation 6.37
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Day 2, 12 hours	0.8 Millimeters of mercury Standard Deviation 6.17	-0.6 Millimeters of mercury Standard Deviation 6.57	1.4 Millimeters of mercury Standard Deviation 4.89	0.8 Millimeters of mercury Standard Deviation 5.65	2.0 Millimeters of mercury Standard Deviation 6.62
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Day 6, pre-dose	1.3 Millimeters of mercury Standard Deviation 6.74	-4.7 Millimeters of mercury Standard Deviation 8.96	-0.4 Millimeters of mercury Standard Deviation 6.82	-2.0 Millimeters of mercury Standard Deviation 9.56	-1.4 Millimeters of mercury Standard Deviation 4.73
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Week 9	3.3 Millimeters of mercury Standard Deviation 7.63	-2.8 Millimeters of mercury Standard Deviation 8.79	0.1 Millimeters of mercury Standard Deviation 7.66	-0.9 Millimeters of mercury Standard Deviation 8.23	-1.2 Millimeters of mercury Standard Deviation 7.65
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Week 12	0.1 Millimeters of mercury Standard Deviation 5.95	-3.4 Millimeters of mercury Standard Deviation 8.69	0.7 Millimeters of mercury Standard Deviation 6.51	0.9 Millimeters of mercury Standard Deviation 7.03	0.3 Millimeters of mercury Standard Deviation 6.30
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Day 2, pre-dose	-0.8 Millimeters of mercury Standard Deviation 10.66	-6.5 Millimeters of mercury Standard Deviation 11.30	-7.7 Millimeters of mercury Standard Deviation 10.97	-1.7 Millimeters of mercury Standard Deviation 7.73	-4.7 Millimeters of mercury Standard Deviation 9.25
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Week 3	2.2 Millimeters of mercury Standard Deviation 6.59	0.3 Millimeters of mercury Standard Deviation 5.32	-0.1 Millimeters of mercury Standard Deviation 8.42	-0.5 Millimeters of mercury Standard Deviation 6.75	1.0 Millimeters of mercury Standard Deviation 6.43
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Day 6, 12 hours	2.9 Millimeters of mercury Standard Deviation 7.94	-1.7 Millimeters of mercury Standard Deviation 8.01	1.0 Millimeters of mercury Standard Deviation 5.55	0.6 Millimeters of mercury Standard Deviation 5.80	1.5 Millimeters of mercury Standard Deviation 7.37

PRIMARY outcome

Timeframe: Baseline (pre-dose Day 1) and up to Week 12

Population: Safety population. Only those participants available at the specified time points were analyzed.

Mean of triplicate measurements at each time point was considered for the summary. Baseline was defined as pre-dose of Day 1 visit. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. It was assessed on Baseline (pre-dose Day 1), Day 1 (12 hours), Day 2, Week 3, 6, 9 and 12.

Outcome measures

Measure	Placebo (Pooled) n=20 Participants Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.	GSK256073 5 mg BID n=18 Participants Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 10 mg Once Daily n=19 Participants Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.	GSK256073 25 mg BID n=19 Participants Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 50 mg Once Daily n=18 Participants Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
Change From Baseline in Heart Rate Day 1,12 hours	2.5 Beats per minute Standard Deviation 5.39	-1.0 Beats per minute Standard Deviation 4.64	1.1 Beats per minute Standard Deviation 7.77	1.3 Beats per minute Standard Deviation 7.07	0.7 Beats per minute Standard Deviation 7.93
Change From Baseline in Heart Rate Day 2, pre-dose	1.2 Beats per minute Standard Deviation 4.79	1.2 Beats per minute Standard Deviation 6.93	2.6 Beats per minute Standard Deviation 5.01	0.9 Beats per minute Standard Deviation 6.99	1.3 Beats per minute Standard Deviation 7.74
Change From Baseline in Heart Rate Day 2, 12 hours	3.3 Beats per minute Standard Deviation 6.80	1.9 Beats per minute Standard Deviation 6.81	4.6 Beats per minute Standard Deviation 7.02	3.8 Beats per minute Standard Deviation 7.62	1.5 Beats per minute Standard Deviation 7.71
Change From Baseline in Heart Rate Week 3	3.2 Beats per minute Standard Deviation 5.44	1.2 Beats per minute Standard Deviation 8.41	3.1 Beats per minute Standard Deviation 7.47	0.1 Beats per minute Standard Deviation 4.81	1.2 Beats per minute Standard Deviation 7.95
Change From Baseline in Heart Rate Week 9	1.7 Beats per minute Standard Deviation 6.44	3.6 Beats per minute Standard Deviation 8.71	4.9 Beats per minute Standard Deviation 11.40	4.4 Beats per minute Standard Deviation 9.26	3.2 Beats per minute Standard Deviation 9.10
Change From Baseline in Heart Rate Day 6, pre-dose	-0.9 Beats per minute Standard Deviation 6.53	-1.6 Beats per minute Standard Deviation 7.62	0.5 Beats per minute Standard Deviation 6.89	3.1 Beats per minute Standard Deviation 14.29	-1.2 Beats per minute Standard Deviation 9.88
Change From Baseline in Heart Rate Day 6, 12 hours	2.9 Beats per minute Standard Deviation 6.56	2.2 Beats per minute Standard Deviation 9.13	3.3 Beats per minute Standard Deviation 7.48	6.6 Beats per minute Standard Deviation 11.16	-3.8 Beats per minute Standard Deviation 9.14
Change From Baseline in Heart Rate Week 12	2.8 Beats per minute Standard Deviation 6.95	1.1 Beats per minute Standard Deviation 10.59	4.1 Beats per minute Standard Deviation 10.12	3.9 Beats per minute Standard Deviation 9.98	-0.5 Beats per minute Standard Deviation 8.46

PRIMARY outcome

Timeframe: Up to Week 20

Population: Safety population. Only those participants available at the specified time points were analyzed.

Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QTc intervals. It was assessed at Baseline (pre-dose Day 1), Day 2, Week 3, Week 6 and 12. Participants with normal, abnormal not clinically significant and abnormal clinically significant ECG were presented.

Outcome measures

Measure	Placebo (Pooled) n=20 Participants Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.	GSK256073 5 mg BID n=18 Participants Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 10 mg Once Daily n=19 Participants Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.	GSK256073 25 mg BID n=19 Participants Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 50 mg Once Daily n=18 Participants Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
Number of Participants With Abnormal Electrocardiograms (ECGs) Findings Day 1 · abnormal not clinically significant	8 Participants	4 Participants	6 Participants	1 Participants	6 Participants
Number of Participants With Abnormal Electrocardiograms (ECGs) Findings Day 1 · abnormal clinically significant	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Electrocardiograms (ECGs) Findings Day 2 · abnormal not clinically significant	6 Participants	3 Participants	5 Participants	1 Participants	6 Participants
Number of Participants With Abnormal Electrocardiograms (ECGs) Findings Day 2 · abnormal clinically significant	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Electrocardiograms (ECGs) Findings Week 3 · abnormal clinically significant	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Electrocardiograms (ECGs) Findings Week 6 · normal	16 Participants	14 Participants	14 Participants	12 Participants	12 Participants
Number of Participants With Abnormal Electrocardiograms (ECGs) Findings Week 6 · abnormal not clinically significant	3 Participants	3 Participants	3 Participants	4 Participants	6 Participants
Number of Participants With Abnormal Electrocardiograms (ECGs) Findings Week 6 · abnormal clinically significant	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Electrocardiograms (ECGs) Findings Week 12 · abnormal clinically significant	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Electrocardiograms (ECGs) Findings Day 1 · normal	12 Participants	14 Participants	13 Participants	18 Participants	12 Participants
Number of Participants With Abnormal Electrocardiograms (ECGs) Findings Day 2 · normal	14 Participants	14 Participants	13 Participants	16 Participants	12 Participants
Number of Participants With Abnormal Electrocardiograms (ECGs) Findings Week 3 · normal	17 Participants	14 Participants	13 Participants	16 Participants	13 Participants
Number of Participants With Abnormal Electrocardiograms (ECGs) Findings Week 3 · abnormal not clinically significant	3 Participants	3 Participants	3 Participants	2 Participants	4 Participants
Number of Participants With Abnormal Electrocardiograms (ECGs) Findings Week 12 · normal	10 Participants	14 Participants	13 Participants	12 Participants	14 Participants
Number of Participants With Abnormal Electrocardiograms (ECGs) Findings Week 12 · abnormal not clinically significant	8 Participants	3 Participants	3 Participants	3 Participants	3 Participants

PRIMARY outcome

Timeframe: Up to Week 12

Population: Safety population

Clinical chemistry parameters included blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST), total bilirubin, direct bilirubin, creatinine, chloride, alanine aminotransferase (ALT), uric acid, fasting glucose, total carbon dioxide, gamma glutamyltransferase (GGT), albumin, sodium, calcium, alkaline phosphatase (ALP), total protein, creatine phosphokinase (CPK) and fasting lipid panel including total cholesterol, triglycerides, high density lipoprotein (HDL) cholesterol and low density lipoprotein (LDL) cholesterol. It was assessed on Baseline (pre-dose Day 1), Week 3 and 12. Data for parameters with high and low of PCI is provided.

Outcome measures

Measure	Placebo (Pooled) n=20 Participants Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.	GSK256073 5 mg BID n=18 Participants Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 10 mg Once Daily n=19 Participants Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.	GSK256073 25 mg BID n=19 Participants Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 50 mg Once Daily n=18 Participants Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) Potassium, high	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) Potassium, low	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) Albumin, low	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) Creatine kinase, high	2 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) Total bilirubin, high	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI) Creatinine, high	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Week 12

Population: Safety population

Hematology parameters included platelet, red blood cell (RBC) count, mean corpuscular volume (MCV), neutrophils, white blood cell (WBC) count (absolute), mean corpuscular hemoglobin (MCH), lymphocytes, reticulocyte count, mean corpuscular hemoglobin concentration (MCHC), monocytes, hemoglobin, eosinophils, hematocrit and basophils. It was assessed on Baseline (pre-dose Day 1) and 12. Data for parameters with high and low of PCI is provided.

Outcome measures

Measure	Placebo (Pooled) n=20 Participants Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.	GSK256073 5 mg BID n=18 Participants Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 10 mg Once Daily n=19 Participants Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.	GSK256073 25 mg BID n=19 Participants Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 50 mg Once Daily n=18 Participants Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) Total neutrophils, low	3 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) Lymphocytes, low	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) Platelet count, low	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) WBC, low	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Week 12

Population: Safety population. Only those participants available at the specified time points were analyzed.

Urinalysis parameters included glucose, protein, blood and ketones by dipstick. It was assessed on Baseline (Day -1) and 12. Urine glucose was measured as grams per deciliter (G/dL).

Outcome measures

Measure	Placebo (Pooled) n=20 Participants Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.	GSK256073 5 mg BID n=18 Participants Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 10 mg Once Daily n=19 Participants Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.	GSK256073 25 mg BID n=19 Participants Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 50 mg Once Daily n=18 Participants Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine glucose, Week 12, Negative	13 Participants	13 Participants	13 Participants	8 Participants	15 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine glucose, Week 12, 3+ or 1 g/dL	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine ketones, Day -1, Negative	18 Participants	17 Participants	19 Participants	18 Participants	17 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine ketones, Day -1, Trace	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine ketones, Day 41, Trace	1 Participants	1 Participants	2 Participants	2 Participants	3 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine ketones, Day 41, 1+ or 1/4	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine occult blood, Day -1, Trace	1 Participants	0 Participants	3 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine protein, Day -1, 3+	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine glucose, Day -1, Negative	13 Participants	11 Participants	14 Participants	10 Participants	14 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine glucose, Day -1, Trace	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine glucose, Day -1, Trace or 1/10 g/dL	1 Participants	4 Participants	2 Participants	3 Participants	1 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine glucose, Day -1, 1+ or 1/4 g/dL	2 Participants	1 Participants	2 Participants	3 Participants	2 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine glucose, Day -1, 2+ or 1/2 g/dL	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine glucose, Day -1, 3+ or 1 g/dL	3 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine ketones, Day -1, 1+	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine glucose, Day 41, Negative	13 Participants	12 Participants	13 Participants	12 Participants	13 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine glucose, Day 41, Trace	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine glucose, Day 41, Trace or 1/10 g/dL	1 Participants	3 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine ketones, Day 41, Negative	18 Participants	15 Participants	13 Participants	14 Participants	14 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine glucose, Day 41, 1+ or 1/4 g/dL	1 Participants	0 Participants	2 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine glucose, Day 41, 2+ or 1/2 g/dL	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine glucose, Day 41, 3+ or 1 g/dL	3 Participants	2 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine glucose, Week 12, Trace	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine glucose, Week 12, Trace or 1/10 g/dL	1 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine ketones, Day 41, 2+	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine ketones, Week 12, Negative	17 Participants	14 Participants	15 Participants	12 Participants	12 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine ketones, Week 12, Trace	1 Participants	3 Participants	0 Participants	1 Participants	3 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine ketones, Week 12, 1+ or 1/4	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine occult blood, Day -1, Negative	18 Participants	17 Participants	16 Participants	17 Participants	18 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine occult blood, Day -1, 1+	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine occult blood, Day 41, Negative	19 Participants	15 Participants	15 Participants	15 Participants	17 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine occult blood, Day 41, Trace	0 Participants	2 Participants	1 Participants	2 Participants	0 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine occult blood, Week 12, Negative	17 Participants	15 Participants	15 Participants	12 Participants	16 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine occult blood, Week 12, Trace	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine occult blood, Week 12, 1+	1 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine protein, Day -1, Negative	18 Participants	13 Participants	12 Participants	14 Participants	14 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine protein, Day -1, Trace	0 Participants	2 Participants	4 Participants	2 Participants	4 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine glucose, Week 12, 1+ or 1/4 g/dL	2 Participants	1 Participants	0 Participants	3 Participants	0 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine protein, Day -1, 1+	0 Participants	2 Participants	2 Participants	2 Participants	0 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine glucose, Week 12, 2+ or 1/2 g/dL	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine protein, Day -1, 2+	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine protein, Day 41, Negative	17 Participants	12 Participants	13 Participants	15 Participants	14 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine protein, Day 41, Trace	1 Participants	3 Participants	1 Participants	0 Participants	3 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine protein, Day 41, 1+	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine protein, Day 41, 2+	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine protein, Week 12, Negative	15 Participants	12 Participants	14 Participants	9 Participants	14 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine protein, Week 12, Trace	2 Participants	2 Participants	0 Participants	3 Participants	2 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine protein, Week 12, 1+	1 Participants	2 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine protein, Week 12, 2+	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick Urine protein, Week 12, 3+	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline (Day -1) and up to Week 12

Population: Pharmacodynamic (PD) population comprised of all participants who provide pharmacodynamic data. Only those participants available at the specified time points were analyzed.

Blood samples for analysis of HbA1c were collected at Baseline (Day -1), Day 41, Week 9 and Week 12. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as Day -1 visit. Statistics is provided for least square mean at Week 12.

Outcome measures

Measure	Placebo (Pooled) n=20 Participants Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.	GSK256073 5 mg BID n=18 Participants Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 10 mg Once Daily n=19 Participants Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.	GSK256073 25 mg BID n=19 Participants Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 50 mg Once Daily n=18 Participants Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 Week 9	-0.44 Percentage of Glycosylated Hemoglobin Standard Deviation 0.808	-0.24 Percentage of Glycosylated Hemoglobin Standard Deviation 0.608	-0.48 Percentage of Glycosylated Hemoglobin Standard Deviation 0.503	-0.56 Percentage of Glycosylated Hemoglobin Standard Deviation 0.512	-0.59 Percentage of Glycosylated Hemoglobin Standard Deviation 0.464
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 Week 12	-0.36 Percentage of Glycosylated Hemoglobin Standard Deviation 0.698	-0.14 Percentage of Glycosylated Hemoglobin Standard Deviation 0.778	-0.46 Percentage of Glycosylated Hemoglobin Standard Deviation 0.507	-0.56 Percentage of Glycosylated Hemoglobin Standard Deviation 0.562	-0.64 Percentage of Glycosylated Hemoglobin Standard Deviation 0.630
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 Day 41	-0.34 Percentage of Glycosylated Hemoglobin Standard Deviation 0.709	-0.18 Percentage of Glycosylated Hemoglobin Standard Deviation 0.555	-0.37 Percentage of Glycosylated Hemoglobin Standard Deviation 0.443	-0.42 Percentage of Glycosylated Hemoglobin Standard Deviation 0.423	-0.44 Percentage of Glycosylated Hemoglobin Standard Deviation 0.370

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to Week 6

Population: PD population. Only those participants available at the specified time points were analyzed.

Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as weighted mean value at Day 1 visit. Statistics is provided for least square mean at Week 6. It was assessed on Baseline (Day 1), Day 2 and Week 6.

Outcome measures

Measure	Placebo (Pooled) n=20 Participants Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.	GSK256073 5 mg BID n=18 Participants Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 10 mg Once Daily n=19 Participants Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.	GSK256073 25 mg BID n=19 Participants Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 50 mg Once Daily n=18 Participants Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6 Glucose, Day 2	0.462 Millimoles per liter Standard Deviation 1.0525	-0.502 Millimoles per liter Standard Deviation 2.0948	0.036 Millimoles per liter Standard Deviation 1.0464	-0.517 Millimoles per liter Standard Deviation 0.8577	-0.076 Millimoles per liter Standard Deviation 0.9745
Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6 Glucose, Week 6	0.009 Millimoles per liter Standard Deviation 1.8099	-0.786 Millimoles per liter Standard Deviation 3.1101	-0.502 Millimoles per liter Standard Deviation 1.2995	-0.647 Millimoles per liter Standard Deviation 1.0043	-0.544 Millimoles per liter Standard Deviation 1.3403
Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6 NEFA, Day 2	-0.0152 Millimoles per liter Standard Deviation 0.08082	-0.1307 Millimoles per liter Standard Deviation 0.09016	-0.1326 Millimoles per liter Standard Deviation 0.12437	-0.1926 Millimoles per liter Standard Deviation 0.13820	-0.1503 Millimoles per liter Standard Deviation 0.09720
Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6 NEFA, Week 6	-0.0457 Millimoles per liter Standard Deviation 0.07154	-0.0342 Millimoles per liter Standard Deviation 0.17352	-0.0423 Millimoles per liter Standard Deviation 0.08431	-0.0293 Millimoles per liter Standard Deviation 0.22736	-0.1032 Millimoles per liter Standard Deviation 0.11673

SECONDARY outcome

Timeframe: Up to Week 12

Population: PD population. The data for this outcome measure was not collected.

The relationships between drug exposure and HbA1c and relative PD endpoints of interest was planned to be plotted graphically. The data for this outcome measure was not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to Week 12

Population: PD population. Only those participants available at the specified time points were analyzed.

Mean of triplicate measurements at pre-dose time point were considered for the summary. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day 1 pre-dose visit. Statistics is provided for least square mean at Week 12. It was assessed on Day 1 (pre-dose), 2 (pre-dose), Week 6 (pre-dose) and Week 12.

Outcome measures

Measure	Placebo (Pooled) n=20 Participants Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.	GSK256073 5 mg BID n=18 Participants Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 10 mg Once Daily n=19 Participants Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.	GSK256073 25 mg BID n=19 Participants Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 50 mg Once Daily n=18 Participants Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
Change From Baseline in Fasting Plasma Glucose at Week 12 Week 6	-0.25 Millimoles per liter Standard Deviation 1.933	-0.82 Millimoles per liter Standard Deviation 2.910	-1.06 Millimoles per liter Standard Deviation 1.472	-0.62 Millimoles per liter Standard Deviation 1.289	-0.91 Millimoles per liter Standard Deviation 1.030
Change From Baseline in Fasting Plasma Glucose at Week 12 Day 2	0.09 Millimoles per liter Standard Deviation 0.723	-0.05 Millimoles per liter Standard Deviation 1.186	0.04 Millimoles per liter Standard Deviation 1.019	0.04 Millimoles per liter Standard Deviation 1.611	-0.34 Millimoles per liter Standard Deviation 0.590
Change From Baseline in Fasting Plasma Glucose at Week 12 Week 12	-0.64 Millimoles per liter Standard Deviation 1.439	-0.85 Millimoles per liter Standard Deviation 2.547	-0.71 Millimoles per liter Standard Deviation 1.290	-0.44 Millimoles per liter Standard Deviation 0.913	-0.83 Millimoles per liter Standard Deviation 1.497

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to Week 12

Population: PD population. Only those participants available at the specified time points were analyzed.

Mean of triplicate measurements at pre-dose time point were considered for the summary. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day 1 pre-dose visit. Statistics is provided for least square mean at Week 12. It was assessed on Day 1 (pre-dose), 2 (pre-dose), Week 6 (pre-dose) and Week 12.

Outcome measures

Measure	Placebo (Pooled) n=20 Participants Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.	GSK256073 5 mg BID n=18 Participants Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 10 mg Once Daily n=19 Participants Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.	GSK256073 25 mg BID n=19 Participants Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 50 mg Once Daily n=18 Participants Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
Change From Baseline in Fasting Insulin at Week 12 Week 12	27.3 Picomoles per liter Standard Deviation 139.30	14.7 Picomoles per liter Standard Deviation 38.66	-2.0 Picomoles per liter Standard Deviation 25.80	33.4 Picomoles per liter Standard Deviation 80.94	4.7 Picomoles per liter Standard Deviation 43.42
Change From Baseline in Fasting Insulin at Week 12 Day 2	-1.1 Picomoles per liter Standard Deviation 73.81	19.1 Picomoles per liter Standard Deviation 52.10	6.6 Picomoles per liter Standard Deviation 34.90	-2.8 Picomoles per liter Standard Deviation 26.41	0.2 Picomoles per liter Standard Deviation 22.75
Change From Baseline in Fasting Insulin at Week 12 Week 6	-3.9 Picomoles per liter Standard Deviation 25.74	-9.1 Picomoles per liter Standard Deviation 38.84	2.9 Picomoles per liter Standard Deviation 20.77	-6.0 Picomoles per liter Standard Deviation 50.97	2.6 Picomoles per liter Standard Deviation 78.83

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to Week 12

Population: PD population. Only those participants available at the specified time points were analyzed.

Mean of triplicate measurements at pre-dose time point was considered for the summary. HOMA was calculated by multiplying insulin concentration with glucose concentration divided by 22.5. Change from Baseline for insulin and glucose was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day 1 pre-dose visit. Statistics is provided for least square mean. It was assessed on Day 1 (pre-dose), 2 (pre-dose), Week 6 (pre-dose) and Week 12.

Outcome measures

Measure	Placebo (Pooled) n=20 Participants Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.	GSK256073 5 mg BID n=18 Participants Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 10 mg Once Daily n=19 Participants Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.	GSK256073 25 mg BID n=19 Participants Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 50 mg Once Daily n=18 Participants Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
Summary of Homeostatic Model Assessment (HOMA) Index Calculated From Change From Baseline in Fasting Insulin and Fasting Glucose at Week 12 Week 6	-0.6 Index Standard Deviation 3.13	-1.4 Index Standard Deviation 4.11	-0.3 Index Standard Deviation 1.75	-0.4 Index Standard Deviation 3.46	-0.7 Index Standard Deviation 3.76
Summary of Homeostatic Model Assessment (HOMA) Index Calculated From Change From Baseline in Fasting Insulin and Fasting Glucose at Week 12 Week 12	-0.0 Index Standard Deviation 3.57	0.0 Index Standard Deviation 2.47	-0.3 Index Standard Deviation 2.08	1.5 Index Standard Deviation 4.17	-0.1 Index Standard Deviation 3.44
Summary of Homeostatic Model Assessment (HOMA) Index Calculated From Change From Baseline in Fasting Insulin and Fasting Glucose at Week 12 Day 2	0.2 Index Standard Deviation 4.24	1.1 Index Standard Deviation 3.83	0.3 Index Standard Deviation 1.98	-0.2 Index Standard Deviation 1.73	-0.2 Index Standard Deviation 1.33

SECONDARY outcome

Timeframe: Baseline (Day -1) and Week 12

Population: PD population. Only those participants available at the specified time points were analyzed.

Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day -1 visit. Statistics is provided for least square mean. It was assessed on Baseline (Day -1), Day 41 and Week 12.

Outcome measures

Measure	Placebo (Pooled) n=20 Participants Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.	GSK256073 5 mg BID n=18 Participants Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 10 mg Once Daily n=19 Participants Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.	GSK256073 25 mg BID n=19 Participants Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 50 mg Once Daily n=18 Participants Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
Change From Baseline in Fructosamine at Week 6 and Week 12 Day 41	-14.9 Micromoles per liter Standard Deviation 33.59	-18.8 Micromoles per liter Standard Deviation 34.49	-21.2 Micromoles per liter Standard Deviation 24.51	-26.3 Micromoles per liter Standard Deviation 25.73	-21.1 Micromoles per liter Standard Deviation 26.39
Change From Baseline in Fructosamine at Week 6 and Week 12 Week 12	-22.3 Micromoles per liter Standard Deviation 27.92	-16.4 Micromoles per liter Standard Deviation 37.43	-30.7 Micromoles per liter Standard Deviation 21.71	-25.4 Micromoles per liter Standard Deviation 33.74	-36.1 Micromoles per liter Standard Deviation 37.23

SECONDARY outcome

Timeframe: Up to Week 12

Population: PD population. Only those participants available at the specified time points were analyzed.

Data has been presented for number of participants with their corresponding percentages with HbA1c <7.0% and <6.5%.

Outcome measures

Measure	Placebo (Pooled) n=18 Participants Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.	GSK256073 5 mg BID n=17 Participants Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 10 mg Once Daily n=16 Participants Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.	GSK256073 25 mg BID n=15 Participants Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 50 mg Once Daily n=17 Participants Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
Number of Participants With HbA1c < 7.0% and < 6.5% <7%	4 Participants	3 Participants	2 Participants	3 Participants	11 Participants
Number of Participants With HbA1c < 7.0% and < 6.5% <6.5%	2 Participants	0 Participants	0 Participants	1 Participants	4 Participants

Adverse Events

Placebo (Pooled)

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

GSK256073 5 mg BID

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

GSK256073 10 mg Once Daily

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

GSK256073 25 mg BID

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

GSK256073 50 mg Once Daily

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo (Pooled) n=20 participants at risk Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.	GSK256073 5 mg BID n=18 participants at risk Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 10 mg Once Daily n=19 participants at risk Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.	GSK256073 25 mg BID n=19 participants at risk Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 50 mg Once Daily n=18 participants at risk Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
Cardiac disorders Atrial fibrillation	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Renal and urinary disorders Nephrotic syndrome	5.0% 1/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.

Other adverse events

Measure	Placebo (Pooled) n=20 participants at risk Eligible participants in this arm received GSK256073 matching placebo capsules BID and once daily orally as directed with water for 12 weeks in a fed state. According to the randomized dose regimen, participants either took 2 capsules in the morning (once daily arm) or 1 capsule each in the morning and evening (BID arms). The data for placebos-GSK256073 matched placebo BID and GSK256073 matched placebo once daily was pooled into one placebo group.	GSK256073 5 mg BID n=18 participants at risk Eligible participants in this arm received GSK256073 5 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 10 mg Once Daily n=19 participants at risk Eligible participants in this arm received GSK256073 10 mg capsules once daily orally as directed with water for 12 weeks in a fed state.	GSK256073 25 mg BID n=19 participants at risk Eligible participants in this arm received GSK256073 25 mg capsules BID orally as directed with water for 12 weeks in a fed state.	GSK256073 50 mg Once Daily n=18 participants at risk Eligible participants in this arm received GSK256073 50 mg capsules once daily orally as directed with water for 12 weeks in a fed state.
Gastrointestinal disorders Enterocolitis	10.0% 2/20 • Number of events 2 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.
Nervous system disorders Presyncope	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Infections and infestations Prostate infection	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.
Infections and infestations Nasopharyngitis	15.0% 3/20 • Number of events 3 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	10.5% 2/19 • Number of events 2 • Up to Week 12. Safety population used for assessment of safety results.	16.7% 3/18 • Number of events 3 • Up to Week 12. Safety population used for assessment of safety results.
Nervous system disorders Headache	5.0% 1/20 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	10.5% 2/19 • Number of events 2 • Up to Week 12. Safety population used for assessment of safety results.	11.1% 2/18 • Number of events 11 • Up to Week 12. Safety population used for assessment of safety results.
Musculoskeletal and connective tissue disorders Arthralgia	5.0% 1/20 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	11.1% 2/18 • Number of events 2 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.
Musculoskeletal and connective tissue disorders Pain in extremity	5.0% 1/20 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	11.1% 2/18 • Number of events 2 • Up to Week 12. Safety population used for assessment of safety results.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	11.1% 2/18 • Number of events 3 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.
Investigations Blood uric acid decreased	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.
Nervous system disorders Dizziness	5.0% 1/20 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	11.1% 2/18 • Number of events 3 • Up to Week 12. Safety population used for assessment of safety results.
Infections and infestations Gastroenteritis	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	16.7% 3/18 • Number of events 3 • Up to Week 12. Safety population used for assessment of safety results.
General disorders Asthenia	10.0% 2/20 • Number of events 2 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Gastrointestinal disorders Diarrhoea	5.0% 1/20 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.
Gastrointestinal disorders Nausea	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	10.5% 2/19 • Number of events 2 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	10.5% 2/19 • Number of events 2 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Investigations Haemoglobin decreased	5.0% 1/20 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Infections and infestations Influenza	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
General disorders Oedema peripheral	5.0% 1/20 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Infections and infestations Pharyngitis	5.0% 1/20 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Investigations Reticulocyte count increased	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.
Infections and infestations Rhinitis	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.
Nervous system disorders Sciatica	5.0% 1/20 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Gastrointestinal disorders Vomiting	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	10.5% 2/19 • Number of events 2 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.
Cardiac disorders Angina pectoris	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Psychiatric disorders Anxiety	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	5.0% 1/20 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Cardiac disorders Atrial flutter	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Investigations Blood creatine phosphokinase increased	5.0% 1/20 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Investigations Blood creatinine increased	5.0% 1/20 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Investigations Blood pressure increased	5.0% 1/20 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Infections and infestations Bronchitis	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Gastrointestinal disorders Cheilitis	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.
Skin and subcutaneous tissue disorders Cold sweat	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Injury, poisoning and procedural complications Contrast media reaction	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 2 • Up to Week 12. Safety population used for assessment of safety results.
Nervous system disorders Dysaesthesia	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Gastrointestinal disorders Dyspepsia	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Renal and urinary disorders Dysuria	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.
Investigations Eosinophil count increased	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.
General disorders Fatigue	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 3 • Up to Week 12. Safety population used for assessment of safety results.
General disorders Feeling abnormal	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.
Infections and infestations Folliculitis	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Investigations Haematocrit decreased	5.0% 1/20 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Hepatobiliary disorders Hepatitis	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.
Vascular disorders Hot flush	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.
Vascular disorders Hypertension	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Metabolism and nutrition disorders Hyperuricaemia	5.0% 1/20 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
General disorders Influenza like illness	5.0% 1/20 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Psychiatric disorders Libido decreased	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Infections and infestations Lower respiratory tract infection	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
General disorders Malaise	5.0% 1/20 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Renal and urinary disorders Nocturia	5.0% 1/20 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Infections and infestations Oral candidiasis	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Infections and infestations Oral herpes	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
General disorders Pain	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.
Nervous system disorders Paraesthesia	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Eye disorders Retinal haemorrhage	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.
Musculoskeletal and connective tissue disorders Sensation of heaviness	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.
Nervous system disorders Somnolence	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Musculoskeletal and connective tissue disorders Torticollis	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Nervous system disorders Tremor	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.6% 1/18 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.
Infections and infestations Upper respiratory tract infection	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.
Vascular disorders Varicose vein	0.00% 0/20 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/19 • Up to Week 12. Safety population used for assessment of safety results.	5.3% 1/19 • Number of events 1 • Up to Week 12. Safety population used for assessment of safety results.	0.00% 0/18 • Up to Week 12. Safety population used for assessment of safety results.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER