Trial Outcomes & Findings for A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes Patients (NCT NCT01298518)

Last Updated: 2012-11-06

Results Overview

Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

48 participants

Primary outcome timeframe

Baseline (Day -1); 2 to 6 hours post-dose on Day 28

Results posted on

2012-11-06

Participant Flow

Participant milestones

Participant milestones
Measure	PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.	PF-04620110 5 mg QD PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.	Placebo Matching placebo orally twice daily (BID) for 4 weeks.
Overall Study STARTED	16	16	16
Overall Study COMPLETED	16	16	15
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.	PF-04620110 5 mg QD PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.	Placebo Matching placebo orally twice daily (BID) for 4 weeks.
Overall Study Withdrawal by Subject	0	0	1

Baseline Characteristics

A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID n=16 Participants PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.	PF-04620110 5 mg QD n=16 Participants PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.	Placebo n=16 Participants Matching placebo orally twice daily (BID) for 4 weeks.	Total n=48 Participants Total of all reporting groups
Age Continuous	51.1 years STANDARD_DEVIATION 5.8 • n=93 Participants	53.4 years STANDARD_DEVIATION 4.2 • n=4 Participants	52.6 years STANDARD_DEVIATION 6.3 • n=27 Participants	52.4 years STANDARD_DEVIATION 5.5 • n=483 Participants
Sex: Female, Male Female	5 Participants n=93 Participants	4 Participants n=4 Participants	4 Participants n=27 Participants	13 Participants n=483 Participants
Sex: Female, Male Male	11 Participants n=93 Participants	12 Participants n=4 Participants	12 Participants n=27 Participants	35 Participants n=483 Participants
Body Mass Index	31.9 kg/m^2 STANDARD_DEVIATION 3.8 • n=93 Participants	30.3 kg/m^2 STANDARD_DEVIATION 3.3 • n=4 Participants	32.6 kg/m^2 STANDARD_DEVIATION 3.7 • n=27 Participants	31.6 kg/m^2 STANDARD_DEVIATION 3.7 • n=483 Participants

PRIMARY outcome

Timeframe: Baseline (Day -1); 2 to 6 hours post-dose on Day 28

Population: Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-MMTT glucose area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.

Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.

Outcome measures

Outcome measures
Measure	PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID n=16 Participants PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.	PF-04620110 5 mg QD n=16 Participants PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.	Placebo n=16 Participants Matching placebo orally twice daily (BID) for 4 weeks.
Change From Baseline in Post-Prandial Glucose Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 Baseline (n=16, 16, 16)	1052.7 mg*hr/dL Standard Deviation 258.2	954.7 mg*hr/dL Standard Deviation 249.2	1005.4 mg*hr/dL Standard Deviation 190.0
Change From Baseline in Post-Prandial Glucose Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 Change at Day 28 (n=15, 16, 15)	-118.3 mg*hr/dL Standard Deviation 269.0	-143.0 mg*hr/dL Standard Deviation 235.8	-117.7 mg*hr/dL Standard Deviation 157.4

SECONDARY outcome

Timeframe: Baseline (Day -1); 24 hours post-dose on Day 28

Population: Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 APG value. Here, 'n' is participants evaluable at specified time points for each group.

APG= AUC (0-24)/24. AUC (0-24) was computed using Linear trapezoidal method.

Outcome measures

Outcome measures
Measure	PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID n=16 Participants PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.	PF-04620110 5 mg QD n=16 Participants PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.	Placebo n=16 Participants Matching placebo orally twice daily (BID) for 4 weeks.
Change From Baseline in 24-Hour Average Plasma Glucose (APG) Post-Dose at Day 28 Baseline (n=16, 16, 16)	204.9 mg/dL Standard Deviation 52.2	188.0 mg/dL Standard Deviation 53.2	187.2 mg/dL Standard Deviation 36.5
Change From Baseline in 24-Hour Average Plasma Glucose (APG) Post-Dose at Day 28 Change at Day 28 (n=15, 16, 15)	-25.4 mg/dL Standard Deviation 60.9	-23.4 mg/dL Standard Deviation 42.5	-18.3 mg/dL Standard Deviation 29.6

SECONDARY outcome

Timeframe: Baseline (Day -1); 2 to 6 hours post-dose on Day 28

Population: Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-MMTT insulin area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.

Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.

Outcome measures

Outcome measures
Measure	PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID n=16 Participants PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.	PF-04620110 5 mg QD n=16 Participants PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.	Placebo n=16 Participants Matching placebo orally twice daily (BID) for 4 weeks.
Change From Baseline in Post-Prandial Insulin Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 Baseline (n=16, 16, 16)	122.9 micro-IU*hr/mL Standard Deviation 82.9	220.2 micro-IU*hr/mL Standard Deviation 282.9	156.7 micro-IU*hr/mL Standard Deviation 63.3
Change From Baseline in Post-Prandial Insulin Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 Change at Day 28 (n=15, 16, 15)	12.4 micro-IU*hr/mL Standard Deviation 63.9	0.6 micro-IU*hr/mL Standard Deviation 159.3	41.0 micro-IU*hr/mL Standard Deviation 46.0

SECONDARY outcome

Timeframe: Baseline (Day -1); 2 to 6 hours post-dose on Day 28

Population: Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-MMTT C-peptide area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.

Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.

Outcome measures

Outcome measures
Measure	PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID n=16 Participants PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.	PF-04620110 5 mg QD n=16 Participants PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.	Placebo n=16 Participants Matching placebo orally twice daily (BID) for 4 weeks.
Change From Baseline in Post-Prandial C-Peptide Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 Baseline (n=16, 16, 16)	17.8 ng*hr/mL Standard Deviation 6.2	21.6 ng*hr/mL Standard Deviation 10.1	20.3 ng*hr/mL Standard Deviation 5.4
Change From Baseline in Post-Prandial C-Peptide Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 Change at Day 28 (15, 16, 15)	-0.2 ng*hr/mL Standard Deviation 6.0	-4.0 ng*hr/mL Standard Deviation 6.2	-0.2 ng*hr/mL Standard Deviation 5.2

SECONDARY outcome

Timeframe: Baseline (Day -1); 2 to 6 hours post-dose on Day 28

Population: Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-MMTT net triglyceride area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.

Change from baseline in post-prandial area under the plasma net triglyceride concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.

Outcome measures

Outcome measures
Measure	PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID n=16 Participants PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.	PF-04620110 5 mg QD n=16 Participants PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.	Placebo n=16 Participants Matching placebo orally twice daily (BID) for 4 weeks.
Change From Baseline in Post-Prandial Net Triglyceride Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 Baseline (n=16, 16, 16)	860.6 mg*hr/dL Standard Deviation 456.9	1014.4 mg*hr/dL Standard Deviation 403.5	961.2 mg*hr/dL Standard Deviation 380.7
Change From Baseline in Post-Prandial Net Triglyceride Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 Change at Day 28 (n=13, 16, 15)	-185.0 mg*hr/dL Standard Deviation 436.7	-100.5 mg*hr/dL Standard Deviation 268.4	-110.3 mg*hr/dL Standard Deviation 245.3

SECONDARY outcome

Timeframe: Baseline (Day -1); 2 to 6 hours post-dose on Day 28

Population: Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 total amide GLP-1 and active GLP-1 area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.

Change from baseline in total amide GLP-1 and active GLP-1 area under the plasma concentration time curve was computed by Linear trapezoidal method.

Outcome measures

Outcome measures
Measure	PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID n=16 Participants PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.	PF-04620110 5 mg QD n=16 Participants PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.	Placebo n=15 Participants Matching placebo orally twice daily (BID) for 4 weeks.
Change From Baseline in Total Amide Glucagon Like Peptide-1 (GLP-1) and Active Glucagon Like Peptide-1 (GLP-1) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28 Total amide GLP-1: Baseline (n=16, 15, 15)	54.4 pmol*hr/L Standard Deviation 26.8	63.2 pmol*hr/L Standard Deviation 36.4	70.2 pmol*hr/L Standard Deviation 88.1
Change From Baseline in Total Amide Glucagon Like Peptide-1 (GLP-1) and Active Glucagon Like Peptide-1 (GLP-1) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28 Total amide GLP-1: Change at Day 28 (n=15, 15, 14)	25.3 pmol*hr/L Standard Deviation 27.9	4.7 pmol*hr/L Standard Deviation 29.5	-17.5 pmol*hr/L Standard Deviation 88.9
Change From Baseline in Total Amide Glucagon Like Peptide-1 (GLP-1) and Active Glucagon Like Peptide-1 (GLP-1) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28 Active GLP-1: Baseline (n=15, 16, 15)	16.3 pmol*hr/L Standard Deviation 11.5	21.0 pmol*hr/L Standard Deviation 21.5	13.9 pmol*hr/L Standard Deviation 11.4
Change From Baseline in Total Amide Glucagon Like Peptide-1 (GLP-1) and Active Glucagon Like Peptide-1 (GLP-1) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28 Active GLP-1: Change at Day 28 (n=14, 14, 14)	12.5 pmol*hr/L Standard Deviation 15.0	-0.5 pmol*hr/L Standard Deviation 23.6	2.1 pmol*hr/L Standard Deviation 11.1

SECONDARY outcome

Timeframe: Baseline (Day -1); 2 to 6 hours post-dose on Day 28

Population: Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 GIP area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.

Change from baseline in GIP area under the plasma concentration time curve was computed by Linear trapezoidal method.

Outcome measures

Outcome measures
Measure	PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID n=15 Participants PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.	PF-04620110 5 mg QD n=16 Participants PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.	Placebo n=16 Participants Matching placebo orally twice daily (BID) for 4 weeks.
Change From Baseline in Gastric Inhibitory Peptide (GIP) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28 Baseline (n=15, 16, 16)	1372.8 pg*hr/mL Standard Deviation 617.2	1181.0 pg*hr/mL Standard Deviation 614.6	1619.2 pg*hr/mL Standard Deviation 627.7
Change From Baseline in Gastric Inhibitory Peptide (GIP) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28 Change at Day 28 (n=14, 16, 15)	-141.6 pg*hr/mL Standard Deviation 726.1	-277.1 pg*hr/mL Standard Deviation 541.4	46.8 pg*hr/mL Standard Deviation 473.1

SECONDARY outcome

Timeframe: Baseline (Day -1); 2 to 6 hours post-dose on Day 28

Population: Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PYY area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.

Change from baseline in PYY area under the plasma concentration time curve was computed by Linear trapezoidal method.

Outcome measures

Outcome measures
Measure	PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID n=15 Participants PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.	PF-04620110 5 mg QD n=16 Participants PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.	Placebo n=16 Participants Matching placebo orally twice daily (BID) for 4 weeks.
Change From Baseline in Peptide YY (PYY) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28 Baseline (n=15, 16, 16)	409.0 pg*hr/mL Standard Deviation 192.4	540.7 pg*hr/mL Standard Deviation 273.8	395.0 pg*hr/mL Standard Deviation 114.6
Change From Baseline in Peptide YY (PYY) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28 Change at Day 28 (n=14, 16, 14)	196.6 pg*hr/mL Standard Deviation 242.8	96.7 pg*hr/mL Standard Deviation 194.2	24.4 pg*hr/mL Standard Deviation 126.9

SECONDARY outcome

Timeframe: 0 hour (pre-dose) on Day -1, Day 28

Population: Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 fasting glucose value. Here, 'n' is participants evaluable at specified time points for each group.

Outcome measures

Outcome measures
Measure	PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID n=16 Participants PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.	PF-04620110 5 mg QD n=16 Participants PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.	Placebo n=16 Participants Matching placebo orally twice daily (BID) for 4 weeks.
Change From Baseline in Fasting Glucose at Day 28 Baseline (n=16, 16, 16)	197.2 mg/dL Standard Deviation 54.6	180.9 mg/dL Standard Deviation 54.7	194.4 mg/dL Standard Deviation 37.4
Change From Baseline in Fasting Glucose at Day 28 Change at Day 28 (16, 16, 15)	-46.9 mg/dL Standard Deviation 49.5	-27.1 mg/dL Standard Deviation 34.9	-25.2 mg/dL Standard Deviation 32.1

SECONDARY outcome

Timeframe: 0 hour (pre-dose) on Day -1, Day 28

Population: Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 fasting insulin value. Here, 'n' is participants evaluable at specified time points for each group.

Outcome measures

Outcome measures
Measure	PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID n=9 Participants PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.	PF-04620110 5 mg QD n=10 Participants PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.	Placebo n=8 Participants Matching placebo orally twice daily (BID) for 4 weeks.
Change From Baseline in Fasting Insulin at Day 28 Baseline (n=9, 10, 8)	10.2 micro-IU/mL Standard Deviation 6.9	19.8 micro-IU/mL Standard Deviation 27.2	9.2 micro-IU/mL Standard Deviation 4.2
Change From Baseline in Fasting Insulin at Day 28 Change at Day 28 (n=8, 9, 8)	-0.8 micro-IU/mL Standard Deviation 4.0	-8.0 micro-IU/mL Standard Deviation 12.8	0.2 micro-IU/mL Standard Deviation 2.7

SECONDARY outcome

Timeframe: 0 hour (pre-dose) on Day -1, Day 28

Population: Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 fasting net triglycerides value. Here, 'n' is participants evaluable at specified time points for each group.

Outcome measures

Outcome measures
Measure	PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID n=16 Participants PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.	PF-04620110 5 mg QD n=16 Participants PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.	Placebo n=16 Participants Matching placebo orally twice daily (BID) for 4 weeks.
Change From Baseline in Fasting Net Triglycerides at Day 28 Baseline (n=16, 16, 16)	189.1 mg/dL Standard Deviation 111.7	234.8 mg/dL Standard Deviation 116.7	187.4 mg/dL Standard Deviation 81.6
Change From Baseline in Fasting Net Triglycerides at Day 28 Change at Day 28 (16, 16, 15)	-31.2 mg/dL Standard Deviation 103.6	-18.4 mg/dL Standard Deviation 52.1	-19.2 mg/dL Standard Deviation 56.7

SECONDARY outcome

Timeframe: Baseline (Day -1); 6 to 10 hours post-dose on Day 28

Population: Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-lunch glucose excursion area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.

Change from baseline in post-lunch glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.

Outcome measures

Outcome measures
Measure	PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID n=16 Participants PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.	PF-04620110 5 mg QD n=16 Participants PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.	Placebo n=16 Participants Matching placebo orally twice daily (BID) for 4 weeks.
Change From Baseline in Post-Lunch Glucose Excursions Area Under the Concentration-Time Curve From Time 6 to 10 Hours (AUC 6-10) Post-dose at Day 28 Baseline (n=16, 16, 16)	853.4 mg*hr/dL Standard Deviation 293.4	772.3 mg*hr/dL Standard Deviation 259.3	730.2 mg*hr/dL Standard Deviation 174.9
Change From Baseline in Post-Lunch Glucose Excursions Area Under the Concentration-Time Curve From Time 6 to 10 Hours (AUC 6-10) Post-dose at Day 28 Change at Day 28 (n=15, 16, 15)	-34.9 mg*hr/dL Standard Deviation 377.2	-41.4 mg*hr/dL Standard Deviation 202.9	-90.4 mg*hr/dL Standard Deviation 157.3

SECONDARY outcome

Timeframe: Baseline (Day -1); 12 to 16 hours post-dose on Day 28

Population: Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-dinner glucose excursion area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.

Change from baseline in post-dinner glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.

Outcome measures

Outcome measures
Measure	PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID n=16 Participants PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.	PF-04620110 5 mg QD n=16 Participants PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.	Placebo n=16 Participants Matching placebo orally twice daily (BID) for 4 weeks.
Change From Baseline in Post-Dinner Glucose Excursions Area Under the Concentration-Time Curve From Time 12 to 16 Hours (AUC 12-16) Post-dose at Day 28 Change at Day 28 (n=15, 16, 15)	-132.8 mg*hr/dL Standard Deviation 267.5	-104.8 mg*hr/dL Standard Deviation 210.8	-41.4 mg*hr/dL Standard Deviation 124.0
Change From Baseline in Post-Dinner Glucose Excursions Area Under the Concentration-Time Curve From Time 12 to 16 Hours (AUC 12-16) Post-dose at Day 28 Baseline (n=16, 16, 16)	851.2 mg*hr/dL Standard Deviation 217.2	763.9 mg*hr/dL Standard Deviation 215.8	759.4 mg*hr/dL Standard Deviation 180.0

SECONDARY outcome

Timeframe: 24 hours post-morning dose on Day 28

Population: Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 Cmax value.

Outcome measures

Outcome measures
Measure	PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID n=15 Participants PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.	PF-04620110 5 mg QD n=16 Participants PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.	Placebo Matching placebo orally twice daily (BID) for 4 weeks.
Maximum Observed Plasma Concentration (Cmax) of PF-04620110	91.0 ng/mL Standard Deviation 39.3	112.0 ng/mL Standard Deviation 43.7	—

SECONDARY outcome

Timeframe: 24 hours post-morning dose on Day 28

Population: Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 Cmin value.

Outcome measures

Outcome measures
Measure	PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID n=15 Participants PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.	PF-04620110 5 mg QD n=16 Participants PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.	Placebo Matching placebo orally twice daily (BID) for 4 weeks.
Minimum Observed Plasma Trough Concentration (Cmin) of PF-04620110	16.2 ng/mL Standard Deviation 12.4	5.2 ng/mL Standard Deviation 9.2	—

SECONDARY outcome

Timeframe: 24 hours post-morning dose on Day 28

Population: Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 Tmax value.

Outcome measures

Outcome measures
Measure	PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID n=15 Participants PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.	PF-04620110 5 mg QD n=16 Participants PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.	Placebo Matching placebo orally twice daily (BID) for 4 weeks.
Time to Cmax (Tmax) of PF-04620110	3.0 hr Interval 1.7 to 12.0	3.0 hr Interval 1.7 to 12.0	—

SECONDARY outcome

Timeframe: 24 hours post-morning dose on Day 28

Population: Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 AUC(0-24) value.

Area under the plasma concentration-time curve from time 0 (pre-dose) to 24 hours. AUC (0-24) was computed using the linear trapezoidal method.

Outcome measures

Outcome measures
Measure	PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID n=15 Participants PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.	PF-04620110 5 mg QD n=16 Participants PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.	Placebo Matching placebo orally twice daily (BID) for 4 weeks.
Area Under the Concentration-Time Curve AUC (0-24) of PF-04620110	1055 ng*hr/mL Standard Deviation 397.7	1027 ng*hr/mL Standard Deviation 441.6	—

Adverse Events

PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

PF-04620110 5 mg QD

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Other adverse events
Measure	PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID n=16 participants at risk PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.	PF-04620110 5 mg QD n=16 participants at risk PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.	Placebo n=16 participants at risk Matching placebo orally twice daily (BID) for 4 weeks.
Ear and labyrinth disorders Ear pain	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Dry eye	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Eye pruritus	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Eye swelling	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Lacrimation increased	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Photophobia	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal discomfort	18.8% 3/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	12.5% 2/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal distension	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	12.5% 2/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	12.5% 2/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain upper	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Constipation	18.8% 3/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	31.2% 5/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	25.0% 4/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	12.5% 2/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dyspepsia	31.2% 5/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	12.5% 2/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dysphagia	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Flatulence	12.5% 2/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	43.8% 7/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	43.8% 7/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Proctalgia	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	18.8% 3/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	37.5% 6/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Asthenia	12.5% 2/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chest discomfort	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chills	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pain	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Thirst	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperglycaemia	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypoglycaemia	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dysgeusia	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	25.0% 4/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	37.5% 6/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	12.5% 2/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Somnolence	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Tremor	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Dysuria	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	12.5% 2/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	6.2% 1/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/16 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.