Phase 3 28-Week study with 24-Week and 52-week extension phases to evaluate efficacy and safety of Exenatide once weekly and Dapagliflozin versus Exenatide and Dapagliflozin matching placebo

Study identifier:D5553C00003

ClinicalTrials.gov identifier:NCT02229396

EudraCT identifier:2014-003503-29

CTIS identifier:N/A

Study Complete

Official Title

A 28-week, Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Study with a 24-week Extension Phase Followed by a 52-week Extension Phase to Evaluate the Efficacy and Safety of Simultaneous Administration of Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg Compared to Exenatide Once Weekly 2 mg Alone and Dapagliflozin Once Daily 10 mg Alone in Patients with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin

Medical condition

Diabetes Mellitus

Phase

Phase 3

Healthy volunteers

Study drug

Exantide with Dapagliflozin, Exentide, Dapagliflozin

Sex

All

Actual Enrollment

695

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 04 Sept 2014

Primary Completion Date: 26 Apr 2016

Study Completion Date: 28 Dec 2017

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2018 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Chicago, IL, United States, 60607

Location

Research Site

North Miami Beach, FL, United States, 33162

Location

Research Site

Clinton, UT, United States, 84015

Location

Research Site

Houston, TX, United States, 77074

Location

Research Site

Miami, FL, United States, 33175

Location

Research Site

Orlando, FL, United States, 32801

Location

Research Site

Richmond, VA, United States, 23294

Location

Research Site

Tampa, FL, United States, 33603

Arms	Assigned Interventions
Experimental: Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg	Drug: Exantide with Dapagliflozin 2 mg weekly suspension injection and 10 mg Dapagliflozin
Experimental: Exenatide Once Weekly 2 mg Alone	Drug: Exentide 2 mg
Active Comparator: Dapagliflozin Once Daily 10 mg Alone	Drug: Dapagliflozin 10 mg once daily Dapagliflozin

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study conducted between 04 September 2014 and 28 December 2017. 118 centers in 6 countries randomized patients in the study. A Primary Analysis was performed following completion of the 28-week Treatment Period with a data cut-off date of 26 April 2016. All Primary and Secondary Outcome measures were reported at the time of the Primary Analysis.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study had a Screening Visit, a 1-week placebo Lead-in Period, a Randomization Visit, and 9 further visits at 1- to 4-week intervals during a 28-week Treatment Period. Patients then entered a 24-week Extension Period 1 and subsequent 52-week Extension Period 2. A follow-up visit occurred 10 weeks after last dose of study medication.

Reporting Groups

	Description
Dapagliflozin + Placebo	Dapagliflozin 10 milligram (mg) tablet administered orally once daily + matching placebo for exenatide administered as subcutaneous (SC) injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
Exenatide + Dapagliflozin	Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
Exenatide + Placebo	Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.

Participant Flow: Overall Study

	Dapagliflozin + Placebo	Exenatide + Dapagliflozin	Exenatide + Placebo
STARTED	233	231	231
Randomization Code Allocated	233	231	231
Safety Analysis Set	233	231	230
Intent-to-Treat (ITT) Analysis Set	230	228	227
Completed 28-Week Study Period	208	202	193
Completed 52-Week Study Period	194	193	177
COMPLETED	155	154	136
NOT COMPLETED	78	77	95
Adverse Event	6	12	12
Death	2	3	1
Lost to Follow-up	14	14	21
Protocol Violation	2	1	0
Patient Incorrectly Randomized	0	0	1
Unspecified	10	18	15
Withdrawal by Subject	42	28	41
Study-Specific Withdrawal Criteria	0	1	3
Withdrew; No Record on Termination Page	2	0	1

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

The overall number of baseline participants is comprised of the ITT analysis set, defined as all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline hemoglobin A1c (HbA1c) assessment.

Reporting Groups

	Description
Dapagliflozin + Placebo	Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
Exenatide + Dapagliflozin	Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
Exenatide + Placebo	Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.

Baseline Measures

	Dapagliflozin + Placebo	Exenatide + Dapagliflozin	Exenatide + Placebo	Total
Number of Participants [units: Participants]	230	228	227	685
Age Continuous [units: Years] Mean ± Standard Deviation	54.5 ± 9.16	53.8 ± 9.82	54.2 ± 9.62	54.2 ± 9.53
Gender, Male/Female [units: ]
Female	120	126	111	357
Male	110	102	116	328
Race, Customized [units: Participants]
American Indian Or Alaska Native	0	0	2	2
Asian	1	3	1	5
Black Or African American	33	34	27	94
Other	7	1	3	11
White	189	190	194	573

Outcome Measures

1. Primary Outcome Measure: Change in HbA1c from baseline to Week 28 [ Time Frame: Baseline to Week 28 ]

Measure Type	Primary
Measure Name	Change in HbA1c from baseline to Week 28
Measure Description	To compare the change from baseline to Week 28 in HbA1c between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Time Frame	Baseline to Week 28
Safety Issue?	No

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

2. Secondary Outcome Measure: Change in body weight from baseline to Week 28 [ Time Frame: Baseline to Week 28 ]

Measure Type	Secondary
Measure Name	Change in body weight from baseline to Week 28
Measure Description	To compare the change from baseline to Week 28 in body weight between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Time Frame	Baseline to Week 28
Safety Issue?	No

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

3. Secondary Outcome Measure: Change in fasting plasma glucose from baseline to Week 28 [ Time Frame: Baseline to Week 28 ]

Measure Type	Secondary
Measure Name	Change in fasting plasma glucose from baseline to Week 28
Measure Description	To compare the change from baseline to Week 28 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Time Frame	Baseline to Week 28
Safety Issue?	No

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

4. Secondary Outcome Measure: Change from baseline to Week 28 in 2-hour postprandial glucose after a standard Meal Tolerance Test [ Time Frame: Baseline to Week 28 ]

Measure Type	Secondary
Measure Name	Change from baseline to Week 28 in 2-hour postprandial glucose after a standard Meal Tolerance Test
Measure Description	To compare the change from baseline to Week 28 in 2-hour postprandial glucose after a standard Meal Tolerance Test between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Time Frame	Baseline to Week 28
Safety Issue?	No

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

5. Secondary Outcome Measure: Percentage of patients achieving weight loss ≥5.0% at Week 28 [ Time Frame: Baseline to Week 28 ]

Measure Type	Secondary
Measure Name	Percentage of patients achieving weight loss ≥5.0% at Week 28
Measure Description	To compare the percentage of patients achieving weight loss ≥5.0% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Time Frame	Baseline to Week 28
Safety Issue?	No

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

6. Secondary Outcome Measure: Change in fasting plasma glucose from baseline to Week 2 [ Time Frame: Baseline to Week 2 ]

Measure Type	Secondary
Measure Name	Change in fasting plasma glucose from baseline to Week 2
Measure Description	To compare the change from baseline to Week 2 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Time Frame	Baseline to Week 2
Safety Issue?	No

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

7. Secondary Outcome Measure: Percentage of patients achieving HbA1c <7% at Week 28 [ Time Frame: Baseline to Week 28 ]

Measure Type	Secondary
Measure Name	Percentage of patients achieving HbA1c <7% at Week 28
Measure Description	To compare the percentage of patients achieving HbA1c <7% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Time Frame	Baseline to Week 28
Safety Issue?	No

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

8. Secondary Outcome Measure: Change in systolic blood pressure from baseline to Week 28 [ Time Frame: Baseline to Week 28 ]

Measure Type	Secondary
Measure Name	Change in systolic blood pressure from baseline to Week 28
Measure Description	To compare the change from baseline to Week 28 in systolic blood pressure between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Time Frame	Baseline to Week 28
Safety Issue?	No

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

Time Frame	From baseline (Day 1) up to Week 104 (28-week Treatment Period + 24-week Extension Period 1 + 52-week Extension Period 2).
Additional Description	Treatment-emergent adverse event data is reported for the Safety Analysis set defined as all randomized patients receiving at least 1 dose of study medication. One patient who was randomized did not receive study medication (the patient was randomized in error); this patient was not counted as completing or discontinuing treatment.

Reporting Groups

	Description
Dapagliflozin + Placebo	Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
Exenatide + Dapagliflozin	Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
Exenatide + Placebo	Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.

Serious Adverse Events

Dapagliflozin + Placebo

Exenatide + Dapagliflozin

Exenatide + Placebo

Total, serious adverse events

# participants affected / at risk

18/233 (7.73%)

17/231 (7.36%)

18/230 (7.83%)

Gastrointestinal disorders

Abdominal pain lower¹,^†

# participants affected / at risk

0/233 (0.00%)

1/231 (0.43%)

0/230 (0.00%)

# events

Injury, poisoning and procedural complications

Rib fracture¹,^†

# participants affected / at risk

0/233 (0.00%)

0/231 (0.00%)

1/230 (0.43%)

# events

Injury, poisoning and procedural complications

Splenic rupture¹,^†

# participants affected / at risk

0/233 (0.00%)

0/231 (0.00%)

1/230 (0.43%)

# events

Cardiac disorders

Acute myocardial infarction¹,^†

# participants affected / at risk

2/233 (0.86%)

0/231 (0.00%)

1/230 (0.43%)

# events

Cardiac disorders

Angina pectoris¹,^†

# participants affected / at risk

0/233 (0.00%)

0/231 (0.00%)

1/230 (0.43%)

# events

Cardiac disorders

Arteriosclerosis coronary artery¹,^†

# participants affected / at risk

0/233 (0.00%)

1/231 (0.43%)

0/230 (0.00%)

# events

Cardiac disorders

Atrial fibrillation¹,^†

# participants affected / at risk

1/233 (0.43%)

0/231 (0.00%)

2/230 (0.87%)

# events

Cardiac disorders

Bradycardia¹,^†

# participants affected / at risk

1/233 (0.43%)

0/231 (0.00%)

0/230 (0.00%)

# events

Cardiac disorders

Coronary artery occlusion¹,^†

# participants affected / at risk

1/233 (0.43%)

0/231 (0.00%)

0/230 (0.00%)

# events

Cardiac disorders

Myocardial infarction¹,^†

# participants affected / at risk

0/233 (0.00%)

0/231 (0.00%)

2/230 (0.87%)

# events

Cardiac disorders

Palpitations¹,^†

# participants affected / at risk

1/233 (0.43%)

0/231 (0.00%)

0/230 (0.00%)

# events

Cardiac disorders

Tachycardia¹,^†

# participants affected / at risk

1/233 (0.43%)

0/231 (0.00%)

0/230 (0.00%)

# events

Ear and labyrinth disorders

Tinnitus¹,^†

# participants affected / at risk

1/233 (0.43%)

0/231 (0.00%)

0/230 (0.00%)

# events

Endocrine disorders

Pituitary-dependent Cushing's syndrome¹,^†

# participants affected / at risk

0/233 (0.00%)

1/231 (0.43%)

0/230 (0.00%)

# events

Gastrointestinal disorders

Anal haemorrhage¹,^†

# participants affected / at risk

0/233 (0.00%)

1/231 (0.43%)

0/230 (0.00%)

# events

Gastrointestinal disorders

Colitis¹,^†

# participants affected / at risk

0/233 (0.00%)

1/231 (0.43%)

0/230 (0.00%)

# events

Gastrointestinal disorders

Gastritis¹,^†

# participants affected / at risk

1/233 (0.43%)

0/231 (0.00%)

0/230 (0.00%)

# events

Gastrointestinal disorders

Gastrooesophageal reflux disease¹,^†

# participants affected / at risk

0/233 (0.00%)

1/231 (0.43%)

0/230 (0.00%)

# events

Gastrointestinal disorders

Pancreatic necrosis¹,^†

# participants affected / at risk

0/233 (0.00%)

1/231 (0.43%)

0/230 (0.00%)

# events

Gastrointestinal disorders

Umbilical hernia¹,^†

# participants affected / at risk

0/233 (0.00%)

1/231 (0.43%)

0/230 (0.00%)

# events

General disorders and administration site conditions

Chest pain¹,^†

# participants affected / at risk

1/233 (0.43%)

0/231 (0.00%)

1/230 (0.43%)

# events

General disorders and administration site conditions

Non-cardiac chest pain¹,^†

# participants affected / at risk

1/233 (0.43%)

0/231 (0.00%)

0/230 (0.00%)

# events

Hepatobiliary disorders

Biliary dyskinesia¹,^†

# participants affected / at risk

0/233 (0.00%)

1/231 (0.43%)

0/230 (0.00%)

# events

Hepatobiliary disorders

Cholecystitis¹,^†

# participants affected / at risk

0/233 (0.00%)

1/231 (0.43%)

0/230 (0.00%)

# events

Hepatobiliary disorders

Cholelithiasis¹,^†

# participants affected / at risk

0/233 (0.00%)

2/231 (0.87%)

1/230 (0.43%)

# events

Immune system disorders

Anaphylactic reaction¹,^†

# participants affected / at risk

1/233 (0.43%)

0/231 (0.00%)

1/230 (0.43%)

# events

Infections and infestations

Cellulitis¹,^†

# participants affected / at risk

0/233 (0.00%)

0/231 (0.00%)

1/230 (0.43%)

# events

Infections and infestations

Diverticulitis¹,^†

# participants affected / at risk

0/233 (0.00%)

0/231 (0.00%)

1/230 (0.43%)

# events

Infections and infestations

Meningitis viral¹,^†

# participants affected / at risk

0/233 (0.00%)

0/231 (0.00%)

1/230 (0.43%)

# events

Infections and infestations

Osteomyelitis¹,^†

# participants affected / at risk

1/233 (0.43%)

0/231 (0.00%)

0/230 (0.00%)

# events

Infections and infestations

Pneumonia¹,^†

# participants affected / at risk

0/233 (0.00%)

1/231 (0.43%)

1/230 (0.43%)

# events

Injury, poisoning and procedural complications

Multiple injuries¹,^†

# participants affected / at risk

0/233 (0.00%)

1/231 (0.43%)

0/230 (0.00%)

# events

Injury, poisoning and procedural complications

Spinal compression fracture¹,^†

# participants affected / at risk

1/233 (0.43%)

0/231 (0.00%)

0/230 (0.00%)

# events

Injury, poisoning and procedural complications

Toxicity to various agents¹,^†

# participants affected / at risk

0/233 (0.00%)

1/231 (0.43%)

0/230 (0.00%)

# events

Investigations

Hepatic enzyme increased¹,^†

# participants affected / at risk

0/233 (0.00%)

0/231 (0.00%)

2/230 (0.87%)

# events

Metabolism and nutrition disorders

Hyperglycaemia¹,^†

# participants affected / at risk

1/233 (0.43%)

0/231 (0.00%)

0/230 (0.00%)

# events

Metabolism and nutrition disorders

Hypoglycaemia¹,^†

# participants affected / at risk

1/233 (0.43%)

0/231 (0.00%)

0/230 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Exostosis¹,^†

# participants affected / at risk

0/233 (0.00%)

1/231 (0.43%)

0/230 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Intervertebral disc protrusion¹,^†

# participants affected / at risk

0/233 (0.00%)

1/231 (0.43%)

0/230 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Osteoarthritis¹,^†

# participants affected / at risk

0/233 (0.00%)

1/231 (0.43%)

0/230 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Periarthritis¹,^†

# participants affected / at risk

1/233 (0.43%)

0/231 (0.00%)

0/230 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Adenocarcinoma of colon¹,^†

# participants affected / at risk

1/233 (0.43%)

0/231 (0.00%)

0/230 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lipoma¹,^†

# participants affected / at risk

1/233 (0.43%)

0/231 (0.00%)

0/230 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pancreatic carcinoma¹,^†

# participants affected / at risk

0/233 (0.00%)

1/231 (0.43%)

0/230 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Renal neoplasm¹,^†

# participants affected / at risk

0/233 (0.00%)

0/231 (0.00%)

1/230 (0.43%)

# events

Nervous system disorders

Diabetic neuropathy¹,^†

# participants affected / at risk

1/233 (0.43%)

0/231 (0.00%)

0/230 (0.00%)

# events

Nervous system disorders

Haemorrhagic stroke¹,^†

# participants affected / at risk

0/233 (0.00%)

1/231 (0.43%)

0/230 (0.00%)

# events

Nervous system disorders

Ischaemic stroke¹,^†

# participants affected / at risk

1/233 (0.43%)

0/231 (0.00%)

1/230 (0.43%)

# events

Nervous system disorders

Optic neuritis¹,^†

# participants affected / at risk

0/233 (0.00%)

1/231 (0.43%)

0/230 (0.00%)

# events

Nervous system disorders

Presyncope¹,^†

# participants affected / at risk

1/233 (0.43%)

0/231 (0.00%)

0/230 (0.00%)

# events

Nervous system disorders

Transient ischaemic attack¹,^†

# participants affected / at risk

1/233 (0.43%)

0/231 (0.00%)

0/230 (0.00%)

# events

Psychiatric disorders

Anxiety¹,^†

# participants affected / at risk

0/233 (0.00%)

1/231 (0.43%)

0/230 (0.00%)

# events

Psychiatric disorders

Suicidal ideation¹,^†

# participants affected / at risk

1/233 (0.43%)

0/231 (0.00%)

0/230 (0.00%)

# events

Renal and urinary disorders

Hydronephrosis¹,^†

# participants affected / at risk

1/233 (0.43%)

0/231 (0.00%)

0/230 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Asthma¹,^†

# participants affected / at risk

1/233 (0.43%)

0/231 (0.00%)

0/230 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Interstitial lung disease¹,^†

# participants affected / at risk

0/233 (0.00%)

0/231 (0.00%)

1/230 (0.43%)

# events

Skin and subcutaneous tissue disorders

Hyperhidrosis¹,^†

# participants affected / at risk

1/233 (0.43%)

0/231 (0.00%)

0/230 (0.00%)

# events

Vascular disorders

Hypertension¹,^†

# participants affected / at risk

1/233 (0.43%)

0/231 (0.00%)

0/230 (0.00%)

# events

Vascular disorders

Hypotension¹,^†

# participants affected / at risk

0/233 (0.00%)

1/231 (0.43%)

0/230 (0.00%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 20.1

Other Adverse Events

Time Frame	From baseline (Day 1) up to Week 104 (28-week Treatment Period + 24-week Extension Period 1 + 52-week Extension Period 2).
Additional Description	Treatment-emergent adverse event data is reported for the Safety Analysis set defined as all randomized patients receiving at least 1 dose of study medication. One patient who was randomized did not receive study medication (the patient was randomized in error); this patient was not counted as completing or discontinuing treatment.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Dapagliflozin + Placebo	Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
Exenatide + Dapagliflozin	Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
Exenatide + Placebo	Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.

Other Adverse Events

Dapagliflozin + Placebo

Exenatide + Dapagliflozin

Exenatide + Placebo

Total, other (not including serious) adverse events

# participants affected / at risk

73/233 (31.33%)

87/231 (37.66%)

78/230 (33.91%)

Gastrointestinal disorders

Diarrhoea¹,^†

# participants affected / at risk

11/233 (4.72%)

13/231 (5.63%)

17/230 (7.39%)

# events

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

10/233 (4.29%)

13/231 (5.63%)

26/230 (11.30%)

# events

Gastrointestinal disorders

Vomiting¹,^†

# participants affected / at risk

7/233 (3.00%)

8/231 (3.46%)

12/230 (5.22%)

# events

General disorders and administration site conditions

Injection site nodule¹,^†

# participants affected / at risk

13/233 (5.58%)

20/231 (8.66%)

14/230 (6.09%)

# events

Infections and infestations

Nasopharyngitis¹,^†

# participants affected / at risk

12/233 (5.15%)

15/231 (6.49%)

8/230 (3.48%)

# events

Infections and infestations

Upper respiratory tract infection¹,^†

# participants affected / at risk

22/233 (9.44%)

15/231 (6.49%)

17/230 (7.39%)

# events

Infections and infestations

Urinary tract infection¹,^†

# participants affected / at risk

16/233 (6.87%)

19/231 (8.23%)

15/230 (6.52%)

# events

Nervous system disorders

Headache¹,^†

# participants affected / at risk

12/233 (5.15%)

16/231 (6.93%)

12/230 (5.22%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 20.1

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: At least 30 days prior to submission for publication or presentation, Authors shall provide Sponsor with such material for its review. Sponsor shall have 30 days to comment. If requested by Sponsor, Authors shall withhold material for an additional 90 days to allow for the taking of measures to establish its proprietary rights. No publication or presentation shall be made unless and until any information determined at Sponsor’s sole discretion to be Confidential has been removed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact

Name/Title:	Global Clinical Leader
Organization:	AstraZeneca
Phone	+1 302 885 1180
E-mail:	[email protected]

Documents available

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Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

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Trial Results Summaries