Trial Outcomes & Findings for Efficacy and Safety of Exenatide in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s) (NCT NCT00577824)

NCT ID: NCT00577824

Last Updated: 2015-04-09

Results Overview

Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 181 participants
• Primary outcome timeframe: baseline, 24 weeks
• Results posted on: 2015-04-09

Participant Flow

Participant milestones

Measure	5mcg Exenatide BID exenatide SC 5mcg, twice daily	10mcg Exenatide BID exenatide SC 10mcg, twice daily	Placebo BID placebo SC, twice daily
Overall Study STARTED	72	73	36
Overall Study Full Analysis Set	72	72	35
Overall Study COMPLETED	65	53	34
Overall Study NOT COMPLETED	7	20	2

Reasons for withdrawal

Measure	5mcg Exenatide BID exenatide SC 5mcg, twice daily	10mcg Exenatide BID exenatide SC 10mcg, twice daily	Placebo BID placebo SC, twice daily
Overall Study Adverse Event	6	18	1
Overall Study Patient decision	0	1	1
Overall Study Protocol Violation	1	1	0

Baseline Characteristics

Efficacy and Safety of Exenatide in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s)

Baseline characteristics by cohort

Measure	5mcg Exenatide BID n=72 Participants exenatide SC 5mcg, twice daily	10mcg Exenatide BID n=72 Participants exenatide SC 10mcg, twice daily	Placebo BID n=35 Participants placebo SC, twice daily	Total n=179 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	53 Participants n=5 Participants	46 Participants n=7 Participants	27 Participants n=5 Participants	126 Participants n=4 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants	26 Participants n=7 Participants	8 Participants n=5 Participants	53 Participants n=4 Participants
Age, Continuous	58.5 years STANDARD_DEVIATION 9.33 • n=5 Participants	59.4 years STANDARD_DEVIATION 9.75 • n=7 Participants	56.3 years STANDARD_DEVIATION 11.41 • n=5 Participants	58.4 years STANDARD_DEVIATION 9.94 • n=4 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	23 Participants n=7 Participants	11 Participants n=5 Participants	57 Participants n=4 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	49 Participants n=7 Participants	24 Participants n=5 Participants	122 Participants n=4 Participants

PRIMARY outcome

Timeframe: baseline, 24 weeks

Population: Full analysis set; Last observation carried forward.

Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)

Outcome measures

Measure	5mcg Exenatide BID n=71 Participants exenatide SC 5mcg, twice daily	10mcg Exenatide BID n=72 Participants exenatide SC 10mcg, twice daily	Placebo BID n=35 Participants placebo SC, twice daily
Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24	-1.34 Percentage of hemoglobin Standard Error 0.11	-1.62 Percentage of hemoglobin Standard Error 0.11	-0.28 Percentage of hemoglobin Standard Error 0.15

SECONDARY outcome

Timeframe: 24 weeks

Population: Full analysis set; Last observation carried forward. Only those patients with HbA1c \>=7% at baseline included.

Percentage of subjects whose HbA1c was >=7.0% at baseline who achieved an HbA1c < 7.0% at endpoint (i.e., number of eligible subjects who achieved HbA1c < 7.0% divided by total number of eligible subjects times 100)

Outcome measures

Measure	5mcg Exenatide BID n=70 Participants exenatide SC 5mcg, twice daily	10mcg Exenatide BID n=69 Participants exenatide SC 10mcg, twice daily	Placebo BID n=33 Participants placebo SC, twice daily
Percentage of Patients Achieving HbA1c < 7.0%	67.1 percentage of participants	71.0 percentage of participants	15.2 percentage of participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Full analysis set; Last observation carried forward. Only subjects whose HbA1c was \>=6.5% at baseline were included.

Percentage of subjects whose HbA1c was >=6.5% at baseline who achieved an HbA1c < 6.5% at endpoint (i.e., number of eligible subjects who achieved HbA1c < 6.5% divided by total number of eligible subjects times 100)

Outcome measures

Measure	5mcg Exenatide BID n=71 Participants exenatide SC 5mcg, twice daily	10mcg Exenatide BID n=72 Participants exenatide SC 10mcg, twice daily	Placebo BID n=35 Participants placebo SC, twice daily
Percentage of Patients Achieving HbA1c < 6.5%	36.6 percentage of participants	47.2 percentage of participants	8.6 percentage of participants

SECONDARY outcome

Timeframe: baseline, week 24

Population: Full analysis set; Last observation carried forward

Change in fasting blood glucose from baseline to endpoint (i.e., fasting blood glucose at week 24 minus fasting blood glucose at week 0)

Outcome measures

Measure	5mcg Exenatide BID n=71 Participants exenatide SC 5mcg, twice daily	10mcg Exenatide BID n=72 Participants exenatide SC 10mcg, twice daily	Placebo BID n=35 Participants placebo SC, twice daily
Change in Fasting Blood Glucose	-25.1 mg/dL Standard Error 3.83	-29.0 mg/dL Standard Error 3.81	-7.6 mg/dL Standard Error 5.46

SECONDARY outcome

Timeframe: baseline, week 24

Population: Full analysis set; Last observation carried forward

Change in body weight form baseline to endpoint (i.e., body weight at week 24 minus body weight at week 0)

Outcome measures

Measure	5mcg Exenatide BID n=71 Participants exenatide SC 5mcg, twice daily	10mcg Exenatide BID n=72 Participants exenatide SC 10mcg, twice daily	Placebo BID n=35 Participants placebo SC, twice daily
Change in Body Weight	-0.39 kg Standard Error 0.28	-1.54 kg Standard Error 0.27	-0.47 kg Standard Error 0.39

SECONDARY outcome

Timeframe: baseline, week 24

Population: Full analysis set; Last observation carried forward

Change in total cholesterol from baseline to endpoint (i.e., total cholesterol at week 24 minus total cholesterol at week 0)

Outcome measures

Measure	5mcg Exenatide BID n=71 Participants exenatide SC 5mcg, twice daily	10mcg Exenatide BID n=72 Participants exenatide SC 10mcg, twice daily	Placebo BID n=35 Participants placebo SC, twice daily
Change in Total Cholesterol	-14.45 mg/dL Standard Error 3.36	-7.01 mg/dL Standard Error 3.13	-4.80 mg/dL Standard Error 3.76

SECONDARY outcome

Timeframe: baseline, week 24

Population: Full analysis set; Last observation carried forward.

Change in LDL-C from baseline to endpoint (i.e., LDL-C at week 24 minus LDL-C at week 0)

Outcome measures

Measure	5mcg Exenatide BID n=71 Participants exenatide SC 5mcg, twice daily	10mcg Exenatide BID n=72 Participants exenatide SC 10mcg, twice daily	Placebo BID n=35 Participants placebo SC, twice daily
Change in Low Density Lipoprotein Cholesterol (LDL-C)	-8.89 mg/dL Standard Error 3.01	-5.03 mg/dL Standard Error 2.45	-2.66 mg/dL Standard Error 3.50

SECONDARY outcome

Timeframe: baseline, week 24

Population: Full analysis set; Last observation carried forward.

Change in HDL-C from baseline to endpoint (i.e., HDL-C at week 24 minus HDL-C at week 0)

Outcome measures

Measure	5mcg Exenatide BID n=71 Participants exenatide SC 5mcg, twice daily	10mcg Exenatide BID n=72 Participants exenatide SC 10mcg, twice daily	Placebo BID n=35 Participants placebo SC, twice daily
Change in High Density Lipoprotein Cholesterol (HDL-C)	-4.63 mg/dL Standard Error 0.91	-4.22 mg/dL Standard Error 0.70	-0.97 mg/dL Standard Error 1.20

SECONDARY outcome

Timeframe: baseline, week 24

Population: Full analysis set; Last observation carried forward

Change in triglycerides from baseline to endpoint (i.e., triglycerides at week 24 minus triglycerides at week 0)

Outcome measures

Measure	5mcg Exenatide BID n=71 Participants exenatide SC 5mcg, twice daily	10mcg Exenatide BID n=72 Participants exenatide SC 10mcg, twice daily	Placebo BID n=35 Participants placebo SC, twice daily
Change in Triglycerides	4.00 mg/dL Standard Error 15.59	4.13 mg/dL Standard Error 8.03	-4.60 mg/dL Standard Error 7.25

SECONDARY outcome

Timeframe: baseline, week 24

Population: Full Analysis Set; Last Observation Carried Forward

Change in waist size from baseline to endpoint (i.e., waist size at week 24 minus waist size at week 0)

Outcome measures

Measure	5mcg Exenatide BID n=70 Participants exenatide SC 5mcg, twice daily	10mcg Exenatide BID n=71 Participants exenatide SC 10mcg, twice daily	Placebo BID n=35 Participants placebo SC, twice daily
Change in Waist Size	-0.17 cm Standard Error 0.36	-1.81 cm Standard Error 0.46	0.41 cm Standard Error 0.45

SECONDARY outcome

Timeframe: baseline, week 24

Population: Full Analysis Set; Last Observation Carried Forward

Change in waist-to-hip ratio from baseline to endpoint (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0). Waist-to-hip ratio is waist circumference divided by hip circumference.

Outcome measures

Measure	5mcg Exenatide BID n=70 Participants exenatide SC 5mcg, twice daily	10mcg Exenatide BID n=71 Participants exenatide SC 10mcg, twice daily	Placebo BID n=35 Participants placebo SC, twice daily
Change in Waist-to-hip Ratio	0.0016 ratio (cm/cm) Standard Error 0.0047	-0.0108 ratio (cm/cm) Standard Error 0.0047	-0.0007 ratio (cm/cm) Standard Error 0.0061

SECONDARY outcome

Timeframe: baseline, week 24

Population: Full Analysis Set; Last Observation Carried Forward

Self-monitored blood glucose at 7 different time points during the day (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime).

Outcome measures

Measure	5mcg Exenatide BID n=72 Participants exenatide SC 5mcg, twice daily	10mcg Exenatide BID n=71 Participants exenatide SC 10mcg, twice daily	Placebo BID n=35 Participants placebo SC, twice daily
7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 30 minutes prior to breakfast SMBG at week 0	169 mg/dL Standard Deviation 36.3	175 mg/dL Standard Deviation 40.9	170 mg/dL Standard Deviation 38.6
7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 30 minutes prior to breakfast SMBG at week 24	150 mg/dL Standard Deviation 36.4	140 mg/dL Standard Deviation 32.2	167 mg/dL Standard Deviation 37.9
7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 2hr post-breakfast SMBG at week 0	261 mg/dL Standard Deviation 50.5	263 mg/dL Standard Deviation 55.1	254 mg/dL Standard Deviation 65.1
7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 2hr post-breakfast SMBG at week 24	178 mg/dL Standard Deviation 61.1	149 mg/dL Standard Deviation 54.4	257 mg/dL Standard Deviation 74.5
7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 30 minutes prior to lunch SMBG at week 0	179 mg/dL Standard Deviation 48.4	189 mg/dL Standard Deviation 68.4	179 mg/dL Standard Deviation 49.2
7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 30 minutes prior to lunch SMBG at week 24	155 mg/dL Standard Deviation 43.9	152 mg/dL Standard Deviation 41.3	182 mg/dL Standard Deviation 57.0
7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 2hr post-lunch SMBG at week 0	263 mg/dL Standard Deviation 62.7	268 mg/dL Standard Deviation 62.4	264 mg/dL Standard Deviation 51.7
7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 2hr post-lunch SMBG at week 24	213 mg/dL Standard Deviation 63.2	195 mg/dL Standard Deviation 60.7	254 mg/dL Standard Deviation 73.5
7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 30 minutes prior to dinner SMBG at week 0	166 mg/dL Standard Deviation 53.7	176 mg/dL Standard Deviation 51.4	173 mg/dL Standard Deviation 42.5
7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 30 minutes prior to dinner SMBG at week 24	149 mg/dL Standard Deviation 45.1	140 mg/dL Standard Deviation 35.5	181 mg/dL Standard Deviation 57.0
7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 2hr post-dinner SMBG at week 0	246 mg/dL Standard Deviation 53.4	247 mg/dL Standard Deviation 63.6	239 mg/dL Standard Deviation 49.1
7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 2hr post-dinner SMBG at week 24	160 mg/dL Standard Deviation 62.8	141 mg/dL Standard Deviation 57.7	247 mg/dL Standard Deviation 78.6
7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 bedtime SMBG at week 0	216 mg/dL Standard Deviation 53.7	225 mg/dL Standard Deviation 66.2	206 mg/dL Standard Deviation 46.8
7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 bedtime SMBG at week 24	170 mg/dL Standard Deviation 48.9	151 mg/dL Standard Deviation 44.3	212 mg/dL Standard Deviation 63.5

SECONDARY outcome

Timeframe: baseline, week 24

Population: Full Analysis Set; Last Observation Carried Forward

Change in HOMA-B from baseline to endpoint (i.e., HOMA-B at week 24 minus HOMA-B at week 0). HOMA-B is a measurement of beta cell function.

Outcome measures

Measure	5mcg Exenatide BID n=70 Participants exenatide SC 5mcg, twice daily	10mcg Exenatide BID n=72 Participants exenatide SC 10mcg, twice daily	Placebo BID n=35 Participants placebo SC, twice daily
Change in Homeostasis Model Assessment - Beta Cell Function (HOMA-B)	2.475 ratio Standard Error 10.566	6.836 ratio Standard Error 13.858	-0.707 ratio Standard Error 3.436

SECONDARY outcome

Timeframe: baseline, week 24

Population: Full Analysis Set; Last Observation Carried Forward

Change in HOMA-R from baseline to endpoint (i.e., HOMA-R at week 24 minus HOMA-R at week 0). HOMA-R is a measurement of insulin resistance.

Outcome measures

Measure	5mcg Exenatide BID n=70 Participants exenatide SC 5mcg, twice daily	10mcg Exenatide BID n=72 Participants exenatide SC 10mcg, twice daily	Placebo BID n=35 Participants placebo SC, twice daily
Change in Homeostasis Model Assessment - Insulin Resistance (HOMA-R)	-0.541 ratio Standard Error 0.402	-0.366 ratio Standard Error 0.188	-0.375 ratio Standard Error 0.164

SECONDARY outcome

Timeframe: baseline, week 24

Population: Full Analysis Set; Last Observation Carried Forward

Change in serum insulin from baseline to endpoint (i.e., serum insulin at week 24 minus serum insulin at week 0)

Outcome measures

Measure	5mcg Exenatide BID n=72 Participants exenatide SC 5mcg, twice daily	10mcg Exenatide BID n=72 Participants exenatide SC 10mcg, twice daily	Placebo BID n=35 Participants placebo SC, twice daily
Change in Serum Insulin	-0.2 mcU/mL Standard Deviation 5.03	0.2 mcU/mL Standard Deviation 3.42	-0.7 mcU/mL Standard Deviation 2.42

SECONDARY outcome

Timeframe: baseline, week 24

Population: Full Analysis Set; Last Observation Carried Forward

Change in C-peptide from baseline to endpoint (i.e., C-peptide at week 24 minus C-peptide at week 0)

Outcome measures

Measure	5mcg Exenatide BID n=70 Participants exenatide SC 5mcg, twice daily	10mcg Exenatide BID n=72 Participants exenatide SC 10mcg, twice daily	Placebo BID n=35 Participants placebo SC, twice daily
Change in C-peptide	0.05 ng/mL Standard Error 0.11	0.07 ng/mL Standard Error 0.07	-0.08 ng/mL Standard Error 0.06

SECONDARY outcome

Timeframe: baseline, week 24

Population: Full Analysis Set; Last Observation Carried Forward

Change in 1,5-anhydroglucitol from baseline to endpoint (i.e., 1,5-anhydroglucitol at week 24 minus 1,5-anhydroglucitol at week 0)

Outcome measures

Measure	5mcg Exenatide BID n=64 Participants exenatide SC 5mcg, twice daily	10mcg Exenatide BID n=66 Participants exenatide SC 10mcg, twice daily	Placebo BID n=32 Participants placebo SC, twice daily
Change in 1,5-anhydroglucitol	5.29 mcg/mL Standard Error 0.55	4.52 mcg/mL Standard Error 0.54	0.66 mcg/mL Standard Error 0.30

Adverse Events

5mcg Exenatide BID

Serious events: 2 serious events

Other events: 63 other events

Deaths: 0 deaths

10mcg Exenatide BID

Serious events: 0 serious events

Other events: 63 other events

Deaths: 0 deaths

Placebo BID

Serious events: 4 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Measure	5mcg Exenatide BID n=72 participants at risk exenatide SC 5mcg, twice daily	10mcg Exenatide BID n=72 participants at risk exenatide SC 10mcg, twice daily	Placebo BID n=35 participants at risk placebo SC, twice daily
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	0.00% 0/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	2.9% 1/35 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).
Gastrointestinal disorders Gastric mucosal lesion	0.00% 0/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	0.00% 0/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	2.9% 1/35 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).
Gastrointestinal disorders Duodenitis	0.00% 0/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	0.00% 0/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	2.9% 1/35 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).
Cardiac disorders Coronary artery stenosis	0.00% 0/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	0.00% 0/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	2.9% 1/35 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	1.4% 1/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	0.00% 0/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	0.00% 0/35 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).
Psychiatric disorders Major depression	1.4% 1/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	0.00% 0/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	0.00% 0/35 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).
Metabolism and nutrition disorders Diabetic ketoacidosis	1.4% 1/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	0.00% 0/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	0.00% 0/35 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).
Respiratory, thoracic and mediastinal disorders Sleep apnea syndrome	0.00% 0/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	0.00% 0/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	2.9% 1/35 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).

Other adverse events

Measure	5mcg Exenatide BID n=72 participants at risk exenatide SC 5mcg, twice daily	10mcg Exenatide BID n=72 participants at risk exenatide SC 10mcg, twice daily	Placebo BID n=35 participants at risk placebo SC, twice daily
Metabolism and nutrition disorders Hypoglycemia	51.4% 37/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	58.3% 42/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	22.9% 8/35 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).
Gastrointestinal disorders Nausea	25.0% 18/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	36.1% 26/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	8.6% 3/35 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).
Investigations Blood glucose decreased	13.9% 10/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	25.0% 18/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	11.4% 4/35 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).
Gastrointestinal disorders Vomiting	4.2% 3/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	16.7% 12/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	2.9% 1/35 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).
Gastrointestinal disorders Constipation	13.9% 10/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	15.3% 11/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	2.9% 1/35 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).
Infections and infestations Nasopharyngitis	11.1% 8/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	12.5% 9/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	22.9% 8/35 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).
Gastrointestinal disorders Stomach discomfort	9.7% 7/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	12.5% 9/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	2.9% 1/35 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).
Metabolism and nutrition disorders Decreased appetite	9.7% 7/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	12.5% 9/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	2.9% 1/35 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).
Metabolism and nutrition disorders Anorexia	2.8% 2/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	11.1% 8/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	2.9% 1/35 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).
Gastrointestinal disorders Dyspepsia	4.2% 3/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	6.9% 5/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	0.00% 0/35 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).
Gastrointestinal disorders Diarrhoea	11.1% 8/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	5.6% 4/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	5.7% 2/35 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).
General disorders Feeling abnormal	0.00% 0/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	5.6% 4/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	0.00% 0/35 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).
General disorders Malaise	2.8% 2/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	5.6% 4/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	5.7% 2/35 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).
Investigations Blood creatinine phosphokinase increased	0.00% 0/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	4.2% 3/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	5.7% 2/35 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).
Gastrointestinal disorders Abdominal pain upper	4.2% 3/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	2.8% 2/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	5.7% 2/35 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).
Infections and infestations Bronchitis	1.4% 1/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	2.8% 2/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	5.7% 2/35 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).
Skin and subcutaneous tissue disorders Eczema	5.6% 4/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	2.8% 2/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	0.00% 0/35 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).
Nervous system disorders Headache	5.6% 4/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	2.8% 2/72 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).	2.9% 1/35 • Up to 30 weeks (Up to a 6 week screening period, and then 24 weeks on treatment).

Additional Information

Peter Ohman, Medical Science Director

AstraZeneca

Email: ClinicalTrialTransparency@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60