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A Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control and Safety in Asian Subjects

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ClinicalTrials.gov Identifier: NCT00917267
Recruitment Status : Completed
First Posted : June 10, 2009
Results First Posted : December 31, 2012
Last Update Posted : April 9, 2015
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: exenatide once weekly
Drug: exenatide twice daily
Enrollment 691
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Exenatide Once Weekly Exenatide Twice Daily
Hide Arm/Group Description Subcutaneous injection of 2 mg exenatide, once a week Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
Period Title: Overall Study
Started 346 345
Intent to Treat (ITT) 340 338
Completed 307 266
Not Completed 39 79
Reason Not Completed
Adverse Event             15             36
Physician Decision             2             4
Protocol Violation             9             18
Withdrawal by Subject             5             12
Lost to follow up             0             2
Entry Criteria Not Met             1             0
Sponsor Decision             5             5
Lack of Efficacy-Loss of Glucose Control             2             2
Arm/Group Title Exenatide Once Weekly Exenatide Twice Daily Total
Hide Arm/Group Description Subcutaneous injection of 2 mg exenatide, once a week Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks) Total of all reporting groups
Overall Number of Baseline Participants 340 338 678
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 340 participants 338 participants 678 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
275
  80.9%
274
  81.1%
549
  81.0%
>=65 years
65
  19.1%
64
  18.9%
129
  19.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 340 participants 338 participants 678 participants
55.4  (10.59) 56.2  (9.99) 55.8  (10.30)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 340 participants 338 participants 678 participants
Female
157
  46.2%
154
  45.6%
311
  45.9%
Male
183
  53.8%
184
  54.4%
367
  54.1%
Glycosylated hemoglobin (HbA1c)  
Mean (Standard Deviation)
Unit of measure:  Percentage of total hemoglobin
Number Analyzed 340 participants 338 participants 678 participants
8.7  (1.04) 8.7  (1.03) 8.7  (1.03)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 340 participants 338 participants 678 participants
69.6  (12.44) 70.4  (12.09) 70.0  (12.26)
Background Oral Antidiabetic Agent (OAD)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 340 participants 338 participants 678 participants
Metformin (MET) 62 60 122
MET+Sulfonylurea (SU) 210 216 426
MET+SU+Thiazolidinedione (TZD) 6 10 16
MET+TZD 12 9 21
SU 30 29 59
SU+TZD 18 12 30
TZD 2 2 4
1.Primary Outcome
Title Change in HbA1c From Baseline to Week 26.
Hide Description Change in HbA1c from baseline to Week 26.
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: Randomized patients received at least one dose of study drug. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.
Arm/Group Title Exenatide Once Weekly Exenatide Twice Daily
Hide Arm/Group Description:
Subcutaneous injection of 2 mg exenatide, once a week
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
Overall Number of Participants Analyzed 307 263
Least Squares Mean (Standard Error)
Unit of Measure: percentage of total hemoglobin
-1.43  (0.07) -1.12  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide Once Weekly, Exenatide Twice Daily
Comments MMRM analysis of covariance (ANCOVA) model includes treatment, baseline HbA1c, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects. Power: 306 patients per treatment group provides approximately 98% power to detect a true difference between treatments of 0.4% in change in HbA1c from baseline with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Superiority of exenatide once weekly to exenatide twice daily concluded if upper limit of the 2-sided 95% confidence interval for treatment difference is <0; noninferiority concluded if upper limit is <0.4%.
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.31
Confidence Interval (2-Sided) 95%
-0.49 to -0.14
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.09
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Patients Achieving HbA1c Targets <=7% at Week 26
Hide Description Percentage of patients achieving HbA1c <=7% at Week 26 (for patients with HbA1c >7% at baseline).
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only patients with baseline HbA1c > target were included in calculation. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was imputed using last observation carried forward (LOCF) approach.
Arm/Group Title Exenatide Once Weekly Exenatide Twice Daily
Hide Arm/Group Description:
Subcutaneous injection of 2 mg exenatide, once a week
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
Overall Number of Participants Analyzed 332 333
Measure Type: Number
Unit of Measure: percentage of patients
46.7 35.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide Once Weekly, Exenatide Twice Daily
Comments Percentage of patients achieving HbA1c target <=7% at Week 26 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which country and background OAD served as the stratification factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Patients Achieving HbA1c Targets <=6.5% at Week 26
Hide Description Percentage of patients achieving HbA1c <=6.5% at Week 26 (for patients with HbA1c >6.5% at baseline).
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only patients with baseline HbA1c > target were included in calculation. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was imputed using LOCF approach.
Arm/Group Title Exenatide Once Weekly Exenatide Twice Daily
Hide Arm/Group Description:
Subcutaneous injection of 2 mg exenatide, once a week
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
Overall Number of Participants Analyzed 338 335
Measure Type: Number
Unit of Measure: percentage of patients
26.0 15.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide Once Weekly, Exenatide Twice Daily
Comments Percentage of patients achieving HbA1c target <=6.5% at Week 26 were compared between treatments using a CMH test, in which country and background OAD served as the stratification factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Change in Fasting Serum Glucose (FSG) From Baseline to Week 26
Hide Description Change in FSG from baseline to Week 26.
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT 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.
Arm/Group Title Exenatide Once Weekly Exenatide Twice Daily
Hide Arm/Group Description:
Subcutaneous injection of 2 mg exenatide, once a week
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
Overall Number of Participants Analyzed 307 274
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-40.57  (2.36) -23.90  (2.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide Once Weekly, Exenatide Twice Daily
Comments MMRM ANCOVA model includes treatment, baseline FSG, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -16.67
Confidence Interval (2-Sided) 95%
-22.50 to -10.83
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.97
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Body Weight (BW) From Baseline to Week 26
Hide Description Change in BW from baseline to Week 26.
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT 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.
Arm/Group Title Exenatide Once Weekly Exenatide Twice Daily
Hide Arm/Group Description:
Subcutaneous injection of 2 mg exenatide, once a week
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
Overall Number of Participants Analyzed 309 265
Least Squares Mean (Standard Error)
Unit of Measure: kg
-1.63  (0.16) -2.45  (0.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide Once Weekly, Exenatide Twice Daily
Comments MMRM ANCOVA model includes treatment, baseline BW, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.39 to 1.25
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.22
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change in Total Cholesterol (TC) From Baseline to Week 26
Hide Description Change in TC from baseline to Week 26.
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT 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.
Arm/Group Title Exenatide Once Weekly Exenatide Twice Daily
Hide Arm/Group Description:
Subcutaneous injection of 2 mg exenatide, once a week
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
Overall Number of Participants Analyzed 309 277
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-9.41  (1.96) -8.10  (2.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide Once Weekly, Exenatide Twice Daily
Comments MMRM ANCOVA model includes treatment, baseline TC, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.609
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.31
Confidence Interval (2-Sided) 95%
-6.33 to 3.71
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.56
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change in High-Density Lipoprotein (HDL) From Baseline to Week 26
Hide Description Change in HDL from baseline to Week 26.
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT 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.
Arm/Group Title Exenatide Once Weekly Exenatide Twice Daily
Hide Arm/Group Description:
Subcutaneous injection of 2 mg exenatide, once a week
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
Overall Number of Participants Analyzed 309 277
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-0.11  (0.41) -0.48  (0.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide Once Weekly, Exenatide Twice Daily
Comments MMRM ANCOVA model includes treatment, baseline HDL, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.476
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.37
Confidence Interval (2-Sided) 95%
-0.65 to 1.38
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.52
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Ratio of Triglycerides (TG) at Week 26 to Baseline
Hide Description Ratio of TG (measured in mg/dL) at Week 26 to baseline. Log(Post-baseline TG) - log(Baseline TG); change from baseline to Week 26 is presented as ratio of Week 26 to baseline.
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT 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.
Arm/Group Title Exenatide Once Weekly Exenatide Twice Daily
Hide Arm/Group Description:
Subcutaneous injection of 2 mg exenatide, once a week
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
Overall Number of Participants Analyzed 309 277
Least Squares Mean (Standard Error)
Unit of Measure: ratio
0.97  (0.02) 0.97  (0.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide Once Weekly, Exenatide Twice Daily
Comments TG data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using a MMRM ANCOVA model with treatment, baseline TG, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.807
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometic Least Squares Mean Ratio
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.93 to 1.06
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.03
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change in Blood Pressure From Baseline to Week 26
Hide Description Change in systolic blood pressure and diastolic blood pressure from baseline to Week 26.
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT 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. Missing data at endpoint was not imputed.
Arm/Group Title Exenatide Once Weekly Exenatide Twice Daily
Hide Arm/Group Description:
Subcutaneous injection of 2 mg exenatide, once a week
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
Overall Number of Participants Analyzed 337 335
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic Blood Pressure -5.33  (15.99) -5.22  (16.23)
Diastolic Blood Pressure -1.47  (9.52) -2.24  (9.56)
10.Secondary Outcome
Title Assessment of Event Rate of Treatment-emergent Hypoglycemic Events
Hide Description Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last post-baseline visit date - baseline visit date. Mean and Standard Error were then derived from ITT.
Time Frame Baseline to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Exenatide Once Weekly With SU Use at Screening Exenatide Twice Daily With SU Use at Screening Exenatide Once Weekly Without SU Use at Screening Exenatide Twice Daily Without SU Use at Screening
Hide Arm/Group Description:
Subcutaneous injection of 2 mg exenatide, once a week and with SU use at Screening
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks) and with SU use at Screening
Subcutaneous injection of 2 mg exenatide, once a week and without SU use at Screening
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks) and without SU use at Screening
Overall Number of Participants Analyzed 264 267 76 71
Mean (Standard Error)
Unit of Measure: events per subject-year
Major Hypoglycemia 0.00  (0.000) 0.01  (0.007) 0.00  (0.000) 0.00  (0.000)
Minor Hypoglycemia 0.24  (0.069) 0.59  (0.180) 0.03  (0.027) 0.11  (0.113)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Exenatide Once Weekly Exenatide Twice Daily
Hide Arm/Group Description Subcutaneous injection of 2 mg exenatide, once a week Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
All-Cause Mortality
Exenatide Once Weekly Exenatide Twice Daily
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Exenatide Once Weekly Exenatide Twice Daily
Affected / at Risk (%) Affected / at Risk (%)
Total   13/340 (3.82%)   8/338 (2.37%) 
Cardiac disorders     
Atrial tachycardia * 1  1/340 (0.29%)  0/338 (0.00%) 
Coronary artery disease * 1  1/340 (0.29%)  0/338 (0.00%) 
Acute myocardial infarction * 1  0/340 (0.00%)  1/338 (0.30%) 
Eye disorders     
Vitreous haemorrhage * 1  0/340 (0.00%)  1/338 (0.30%) 
Gastrointestinal disorders     
Gastritis * 1  1/340 (0.29%)  0/338 (0.00%) 
Pancreatitis acute * 1  1/340 (0.29%)  0/338 (0.00%) 
Small intestinal haemorrhage * 1  1/340 (0.29%)  0/338 (0.00%) 
Ileus * 1  0/340 (0.00%)  1/338 (0.30%) 
Infections and infestations     
Bronchopneumonia * 1  1/340 (0.29%)  0/338 (0.00%) 
Chronic sinusitis * 1  1/340 (0.29%)  0/338 (0.00%) 
Pneumonia haemophilus * 1  1/340 (0.29%)  0/338 (0.00%) 
Pneumonia * 1  0/340 (0.00%)  1/338 (0.30%) 
Pyelonephritis acute * 1  0/340 (0.00%)  1/338 (0.30%) 
Injury, poisoning and procedural complications     
Fall * 1  1/340 (0.29%)  0/338 (0.00%) 
Lower limb fracture * 1  1/340 (0.29%)  0/338 (0.00%) 
Ankle fracture * 1  0/340 (0.00%)  1/338 (0.30%) 
Tendon rupture * 1  0/340 (0.00%)  1/338 (0.30%) 
Investigations     
Blood calcitonin increased * 1  1/340 (0.29%)  0/338 (0.00%) 
Metabolism and nutrition disorders     
Diabetic ketoacidosis * 1  1/340 (0.29%)  0/338 (0.00%) 
Nervous system disorders     
Cerebral infarction * 1  2/340 (0.59%)  0/338 (0.00%) 
Cerebral artery occlusion * 1  1/340 (0.29%)  0/338 (0.00%) 
Diplegia * 1  1/340 (0.29%)  0/338 (0.00%) 
Transient global amnesia * 1  0/340 (0.00%)  1/338 (0.30%) 
Reproductive system and breast disorders     
Vaginal haemorrhage * 1  1/340 (0.29%)  0/338 (0.00%) 
Vascular disorders     
Aortic aneurysm * 1  0/340 (0.00%)  1/338 (0.30%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Exenatide Once Weekly Exenatide Twice Daily
Affected / at Risk (%) Affected / at Risk (%)
Total   131/340 (38.53%)   150/338 (44.38%) 
Gastrointestinal disorders     
Diarrhoea * 1  32/340 (9.41%)  27/338 (7.99%) 
Nausea * 1  32/340 (9.41%)  73/338 (21.60%) 
Vomiting * 1  27/340 (7.94%)  39/338 (11.54%) 
Constipation * 1  20/340 (5.88%)  24/338 (7.10%) 
General disorders     
Injection site induration * 1  33/340 (9.71%)  2/338 (0.59%) 
Injection site nodule * 1  18/340 (5.29%)  0/338 (0.00%) 
Injection site pruritus * 1  18/340 (5.29%)  9/338 (2.66%) 
Metabolism and nutrition disorders     
Dyslipidaemia * 1  21/340 (6.18%)  23/338 (6.80%) 
Decreased appetite * 1  15/340 (4.41%)  28/338 (8.28%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Peter Ohman, Medical Science Director
Organization: AstraZeneca
EMail: ClinicalTrialTransparency@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00917267     History of Changes
Other Study ID Numbers: H8O-MC-GWCK
First Submitted: June 8, 2009
First Posted: June 10, 2009
Results First Submitted: February 14, 2012
Results First Posted: December 31, 2012
Last Update Posted: April 9, 2015