Trial Outcomes & Findings for Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus (NCT NCT00765817)

NCT ID: NCT00765817

Last Updated: 2016-10-24

Results Overview

Change in HbA1c from baseline following 30 weeks of therapy (i.e., HbA1c at week 30 minus HbA1c at baseline). Unit of measure is percent of hemoglobin that is glycosylated.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 261 participants
• Primary outcome timeframe: baseline and 30 weeks
• Results posted on: 2016-10-24

Participant Flow

Two subjects who started the study, subsequently withdrew prior to receiving study medication and are not part of the full analysis set

Participant milestones

Measure	Exenatide Arm Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)	Placebo Arm Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Overall Study STARTED	138	123
Overall Study COMPLETED	112	101
Overall Study NOT COMPLETED	26	22

Reasons for withdrawal

Measure	Exenatide Arm Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)	Placebo Arm Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Overall Study Adverse Event	13	1
Overall Study Death	0	1
Overall Study Entry criteria not met	2	2
Overall Study Loss of glucose control	0	2
Overall Study Lost to Follow-up	1	3
Overall Study Physician Decision	2	1
Overall Study Protocol Violation	1	1
Overall Study Subject decision	7	11

Baseline Characteristics

Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus

Baseline characteristics by cohort

Measure	Exenatide Arm n=137 Participants Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)	Placebo Arm n=122 Participants Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)	Total n=259 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
Age, Categorical Between 18 and 65 years	100 Participants n=5 Participants	84 Participants n=7 Participants	184 Participants n=5 Participants
Age, Categorical >=65 years	37 Participants n=5 Participants	38 Participants n=7 Participants	75 Participants n=5 Participants
Age, Continuous	58.67 years STANDARD_DEVIATION 8.91 • n=5 Participants	59.40 years STANDARD_DEVIATION 9.96 • n=7 Participants	59.01 years STANDARD_DEVIATION 9.41 • n=5 Participants
Sex: Female, Male Female	67 Participants n=5 Participants	44 Participants n=7 Participants	111 Participants n=5 Participants
Sex: Female, Male Male	70 Participants n=5 Participants	78 Participants n=7 Participants	148 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 30 weeks

Population: Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis

Change in HbA1c from baseline following 30 weeks of therapy (i.e., HbA1c at week 30 minus HbA1c at baseline). Unit of measure is percent of hemoglobin that is glycosylated.

Outcome measures

Measure	Exenatide Arm n=112 Participants Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)	Placebo Arm n=100 Participants Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Change in Glycosylated Hemoglobin (HbA1c)	-1.71 percentage of hemoglobin Standard Error 0.09	-1.00 percentage of hemoglobin Standard Error 0.09

SECONDARY outcome

Timeframe: baseline and 30 weeks

Population: Full analysis set. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Only patients with baseline HbA1c \> target were included in calculation.

Percentage of patients in each arm who had HbA1c >7% at baseline and had HbA1c <=7% at week 30 (percentage = [number of subjects with HbA1c <=7% at week 30 divided by number of subjects with HbA1c >7% at baseline] * 100%).

Outcome measures

Measure	Exenatide Arm n=127 Participants Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)	Placebo Arm n=106 Participants Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Percentage of Patients Achieving HbA1c <=7%	58.3 percentage	31.1 percentage

SECONDARY outcome

Timeframe: baseline and 30 weeks

Population: Full analysis set. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Only patients with baseline HbA1c \> target were included in calculation.

Percentage of patients in each arm who had HbA1c >6.5% at baseline and had HbA1c <=6.5% at week 30 (percentage = [number of subjects with HbA1c <=6.5% at week 30 divided by number of subjects with HbA1c >6.5% at baseline] * 100%).

Outcome measures

Measure	Exenatide Arm n=131 Participants Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)	Placebo Arm n=113 Participants Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Percentage of Patients Achieving HbA1c <=6.5%	42.0 percentage	13.3 percentage

SECONDARY outcome

Timeframe: baseline and 30 weeks

Population: Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis

Change in fasting serum glucose following 30 weeks of therapy (i.e., fasting serum glucose at week 30 minus fasting serum glucose at baseline)

Outcome measures

Measure	Exenatide Arm n=111 Participants Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)	Placebo Arm n=98 Participants Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Change in Fasting Serum Glucose	-1.28 mmol/L Standard Error 0.2	-0.87 mmol/L Standard Error 0.2

SECONDARY outcome

Timeframe: baseline and 30 weeks

Population: Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis

Change in 7-point (pre-breakfast, 2 hour post-breakfast, pre-lunch, 2 hour post-lunch, pre-dinner, 2 hour post-dinner, 0300 hours) SMBG profile from baseline to week 30 (change = blood glucose value at week 30 minus blood glucose value at baseline)

Outcome measures

Measure	Exenatide Arm n=108 Participants Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)	Placebo Arm n=89 Participants Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile Pre-breakfast: baseline	7.89 mmol/L Standard Error 0.2	8.27 mmol/L Standard Error 0.2
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile Pre-breakfast: change at week 30	-1.58 mmol/L Standard Error 0.1	-1.48 mmol/L Standard Error 0.1
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile 2 hour post-breakfast: baseline	10.89 mmol/L Standard Error 0.2	11.82 mmol/L Standard Error 0.2
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile 2 hour post-breakfast: change at week 30	-3.56 mmol/L Standard Error 0.2	-1.72 mmol/L Standard Error 0.2
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile Pre-lunch: baseline	8.95 mmol/L Standard Error 0.2	9.77 mmol/L Standard Error 0.2
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile Pre-lunch: change at week 30	-2.23 mmol/L Standard Error 0.2	-1.15 mmol/L Standard Error 0.2
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile 2 hour post-lunch: baseline	11.35 mmol/L Standard Error 0.2	11.70 mmol/L Standard Error 0.2
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile 2 hour post-lunch: change at week 30	-2.74 mmol/L Standard Error 0.2	-1.38 mmol/L Standard Error 0.2
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile Pre-dinner: baseline	9.85 mmol/L Standard Error 0.2	9.99 mmol/L Standard Error 0.2
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile Pre-dinner: change at week 30	-2.25 mmol/L Standard Error 0.2	-1.33 mmol/L Standard Error 0.2
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile 2 hour post-dinner: baseline	12.03 mmol/L Standard Error 0.3	11.86 mmol/L Standard Error 0.3
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile 2 hour post-dinner: change at week 30	-3.87 mmol/L Standard Error 0.2	-1.34 mmol/L Standard Error 0.3
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile 0300: baseline	8.95 mmol/L Standard Error 0.2	9.20 mmol/L Standard Error 0.2
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile 0300: change at week 30	-2.27 mmol/L Standard Error 0.2	-1.48 mmol/L Standard Error 0.2

SECONDARY outcome

Timeframe: baseline and 30 weeks

Population: Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis

Change in total cholesterol following 30 weeks of therapy (i.e., total cholesterol at week 30 minus total cholesterol at baseline)

Outcome measures

Measure	Exenatide Arm n=110 Participants Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)	Placebo Arm n=98 Participants Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Change in Total Cholesterol	-0.16 mmol/L Standard Error 0.08	-0.02 mmol/L Standard Error 0.09

SECONDARY outcome

Timeframe: baseline and 30 weeks

Population: Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis

Change in LDL cholesterol following 30 weeks of therapy (i.e., LDL cholesterol at week 30 minus LDL cholesterol at baseline)

Outcome measures

Measure	Exenatide Arm n=102 Participants Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)	Placebo Arm n=97 Participants Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Change in Low Density Lipoprotein (LDL) Cholesterol	-0.19 mmol/L Standard Error 0.07	-0.00 mmol/L Standard Error 0.07

SECONDARY outcome

Timeframe: baseline and 30 weeks

Population: Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.

Change in HDL cholesterol following 30 weeks of therapy (i.e., HDL cholesterol at week 30 minus HDL cholesterol at baseline)

Outcome measures

Measure	Exenatide Arm n=110 Participants Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)	Placebo Arm n=98 Participants Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Change in High Density Lipoprotein (HDL) Cholesterol	0.01 mmol/L Standard Error 0.02	0.00 mmol/L Standard Error 0.02

SECONDARY outcome

Timeframe: baseline and 30 weeks

Population: Full analysis set. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis

Change in triglycerides following 30 weeks of therapy (i.e., triglycerides at week 30 minus triglycerides at baseline)

Outcome measures

Measure	Exenatide Arm n=110 Participants Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)	Placebo Arm n=98 Participants Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Change in Triglycerides	-0.02 mmol/L Standard Error 0.09	-0.03 mmol/L Standard Error 0.09

SECONDARY outcome

Timeframe: baseline and 30 weeks

Population: Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis

Change in body weight following 30 weeks of therapy (i.e., body weight at week 30 minus body weight at baseline)

Outcome measures

Measure	Exenatide Arm n=112 Participants Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)	Placebo Arm n=101 Participants Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Change in Body Weight	-1.78 kg Standard Error 0.3	0.96 kg Standard Error 0.3

SECONDARY outcome

Timeframe: baseline and 30 weeks

Population: Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis

Change in waist circumference following 30 weeks of therapy (i.e., waist circumference at week 30 minus waist circumference at baseline)

Outcome measures

Measure	Exenatide Arm n=137 Participants Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)	Placebo Arm n=120 Participants Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Change in Waist Circumference	-1.08 cm Standard Error 0.52	-0.25 cm Standard Error 0.55

SECONDARY outcome

Timeframe: baseline and 30 weeks

Population: Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis

Change in daily insulin dose following 30 weeks of therapy (i.e., daily insulin dose at week 30 minus daily insulin dose at baseline)

Outcome measures

Measure	Exenatide Arm n=110 Participants Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)	Placebo Arm n=100 Participants Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Change in Daily Insulin Dose	13.19 insulin units (U) Standard Error 2.02	19.71 insulin units (U) Standard Error 2.11

SECONDARY outcome

Timeframe: baseline and 30 weeks

Population: Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis

Change in daily insulin dose per kilogram (kg) following 30 weeks of therapy (i.e., daily insulin dose per kg at week 30 minus daily insulin dose per kg at baseline)

Outcome measures

Measure	Exenatide Arm n=110 Participants Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)	Placebo Arm n=100 Participants Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Change in Daily Insulin Dose (on a Per Body Weight Basis)	0.15 insulin units per kg (U/kg) Standard Error 0.02	0.20 insulin units per kg (U/kg) Standard Error 0.02

SECONDARY outcome

Timeframe: baseline and 30 weeks

Population: Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis

Change in SBP following 30 weeks of therapy (i.e., SBP at week 30 minus SBP at baseline)

Outcome measures

Measure	Exenatide Arm n=112 Participants Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)	Placebo Arm n=101 Participants Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Change in Systolic Blood Pressure (SBP)	-2.74 mmHg Standard Error 1.2	1.71 mmHg Standard Error 1.3

SECONDARY outcome

Timeframe: baseline and 30 weeks

Population: Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis

Change in DBP following 30 weeks of therapy (i.e., DBP at week 30 minus DBP at baseline)

Outcome measures

Measure	Exenatide Arm n=112 Participants Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)	Placebo Arm n=101 Participants Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Change in Diastolic Blood Pressure (DBP)	-1.73 mmHg Standard Error 0.6	1.69 mmHg Standard Error 0.7

SECONDARY outcome

Timeframe: baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30

Population: Full analysis set

Number of minor hypoglycemia events experienced per subject per year. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).

Outcome measures

Measure	Exenatide Arm n=137 Participants Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)	Placebo Arm n=122 Participants Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Minor Hypoglycemia Rate Per Year	1.61 events per subject per year Standard Deviation 5.94	1.55 events per subject per year Standard Deviation 4.79

SECONDARY outcome

Timeframe: baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30

Population: Full analysis set

Percentage of subjects in each arm experiencing at least one episode of minor hypoglycemia at any point during the study. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).

Outcome measures

Measure	Exenatide Arm n=137 Participants Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)	Placebo Arm n=122 Participants Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Percentage of Subjects Experiencing Minor Hypoglycemia	24.8 percentage	28.7 percentage

Adverse Events

Exenatide Arm

Serious events: 8 serious events

Other events: 109 other events

Deaths: 0 deaths

Placebo Arm

Serious events: 11 serious events

Other events: 66 other events

Deaths: 0 deaths

Serious adverse events

Measure	Exenatide Arm n=138 participants at risk；n=137 participants at risk Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)	Placebo Arm n=123 participants at risk；n=122 participants at risk Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
General disorders Chest pain	0.73% 1/137	0.82% 1/122
Musculoskeletal and connective tissue disorders Osteoarthritis	1.5% 2/137	0.00% 0/122
Injury, poisoning and procedural complications Accidental overdose	0.73% 1/137	0.00% 0/122
Cardiac disorders Angina unstable	0.00% 0/137	0.82% 1/122
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/137	0.82% 1/122
Cardiac disorders Coronary artery occlusion	0.73% 1/137	0.00% 0/122
Renal and urinary disorders Cystitis	0.00% 0/137	0.82% 1/122
Respiratory, thoracic and mediastinal disorders Dyspnea	0.73% 1/137	0.00% 0/122
Injury, poisoning and procedural complications Eye penetration	0.73% 1/137	0.00% 0/122
Injury, poisoning and procedural complications Fall	0.73% 1/137	0.00% 0/122
Infections and infestations Herpes zoster	0.73% 1/137	0.00% 0/122
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/137	0.82% 1/122
Cardiac disorders Myocardial infarction	0.00% 0/137	0.82% 1/122
Cardiac disorders Palpitations	0.00% 0/137	0.82% 1/122
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/137	0.82% 1/122
Infections and infestations Sepsis	0.00% 0/137	0.82% 1/122
Gastrointestinal disorders Small intestine obstruction	0.00% 0/137	0.82% 1/122
Infections and infestations Staphylococcal infection	0.73% 1/137	0.00% 0/122
Psychiatric disorders Suicide attempt	0.00% 0/137	0.82% 1/122
Cardiac disorders Transient ischemic attack	0.00% 0/137	0.82% 1/122
Skin and subcutaneous tissue disorders Uticaria	0.00% 0/137	0.82% 1/122

Other adverse events

Measure	Exenatide Arm n=138 participants at risk；n=137 participants at risk Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)	Placebo Arm n=123 participants at risk；n=122 participants at risk Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Gastrointestinal disorders Nausea	40.6% 56/138	8.1% 10/123
Gastrointestinal disorders Diarrhea	18.1% 25/138	8.1% 10/123
Gastrointestinal disorders Vomiting	18.1% 25/138	4.1% 5/123
Nervous system disorders Headache	13.8% 19/138	4.1% 5/123
Respiratory, thoracic and mediastinal disorders Upper Respiratory Tract Infection	8.0% 11/138	7.3% 9/123
Gastrointestinal disorders Constipation	10.1% 14/138	1.6% 2/123
Respiratory, thoracic and mediastinal disorders Cough	5.1% 7/138	5.7% 7/123
Infections and infestations Nasopharyngitis	5.8% 8/138	4.9% 6/123
Nervous system disorders Dizziness	4.3% 6/138	5.7% 7/123
Musculoskeletal and connective tissue disorders Back Pain	6.5% 9/138	1.6% 2/123
Gastrointestinal disorders Dyspepsia	6.5% 9/138	1.6% 2/123
General disorders Asthenia	5.1% 7/138	0.81% 1/123

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