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Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin

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ClinicalTrials.gov Identifier: NCT00701935
Recruitment Status : Terminated (Enrollment was much slower than anticipated, leading to a decision to terminate the study early for enrollment futility.)
First Posted : June 19, 2008
Results First Posted : February 13, 2013
Last Update Posted : April 10, 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: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Diabetes Mellitus
Interventions Drug: placebo
Drug: exenatide
Enrollment 80

Recruitment Details

Initial planned enrolment was 12 months, starting August 2008. Eventual enrolment time was 3+ years – decision made to close end of 2011.

Number of patients initially planned: 94 randomized and 74 completers Final number of patients: 80 randomized and 53 completers

Pre-assignment Details  
Arm/Group Title Exenatide BID Placebo
Hide Arm/Group Description Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months) Subcutaneous injection of placebo twice a day for 6 months
Period Title: Overall Study
Started 43 37
Completed 27 26
Not Completed 16 11
Arm/Group Title Exenatide BID Placebo Total
Hide Arm/Group Description Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months) Subcutaneous injection of placebo twice a day for 6 months Total of all reporting groups
Overall Number of Baseline Participants 43 37 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 37 participants 80 participants
58.2  (12.2) 57.9  (11.0) 58.1  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 37 participants 80 participants
Female
20
  46.5%
18
  48.6%
38
  47.5%
Male
23
  53.5%
19
  51.4%
42
  52.5%
1.Primary Outcome
Title Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months
Hide Description Percentage change in abdominal visceral fat
Time Frame baseline, 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis done on the Intent To Treat (ITT) Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received
Arm/Group Title Exenatide BID Placebo
Hide Arm/Group Description:
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
Subcutaneous injection of placebo twice a day for 6 months
Overall Number of Participants Analyzed 29 27
Least Squares Mean (Standard Error)
Unit of Measure: % change
-5.28  (3.23) -4.30  (3.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide BID, Placebo
Comments

The power calculation is based on a two-sided t-test and significance level of 0.05.

Hypotheses for sample size:

Power: 80% Drop-out rate: 20% Difference in the percentage change in abdominal visceral fat from baseline to 6 months between exenatide and placebo: 10% Common standard deviation: 15%

94 patients are needed to attain the 37 patients randomized and analyzed in each group.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8252
Comments p-values were not adjusted for multiple comparisons.
Method ANCOVA
Comments The ANCOVA model includes terms of treatment, gender, investigator and baseline abdominal visceral fat.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.98
Confidence Interval (2-Sided) 95%
-9.92 to 7.95
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.432
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage Change in Total Abdominal Fat From Baseline to 6 Months
Hide Description Percentage change in total abdominal fat
Time Frame baseline, 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received
Arm/Group Title Exenatide BID Placebo
Hide Arm/Group Description:
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
Subcutaneous injection of placebo twice a day for 6 months
Overall Number of Participants Analyzed 26 25
Least Squares Mean (Standard Error)
Unit of Measure: % change
-5.81  (2.28) -3.74  (2.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5207
Comments p-values were not adjusted for multiple comparisons.
Method ANCOVA
Comments The ANCOVA model includes terms of treatment, gender, investigator and baseline total abdominal fat.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.07
Confidence Interval (2-Sided) 95%
-8.53 to 4.39
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.193
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage Change in Subcutaneous Abdominal Fat From Baseline to 6 Months
Hide Description Percentage change in subcutaneous abdominal fat
Time Frame baseline, 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received
Arm/Group Title Exenatide BID Placebo
Hide Arm/Group Description:
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
Subcutaneous injection of placebo twice a day for 6 months
Overall Number of Participants Analyzed 25 25
Least Squares Mean (Standard Error)
Unit of Measure: % change
-7.27  (1.93) -3.56  (1.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1755
Comments p-values were not adjusted for multiple comparisons.
Method ANCOVA
Comments The ANCOVA model includes terms of treatment, gender, investigator and baseline subcutaneous abdominal fat.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.71
Confidence Interval (2-Sided) 95%
-9.15 to 1.73
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.687
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in HbA1c From Baseline to 6 Months
Hide Description Change in HbA1c from baseline to 6 months. HbA1c is a measurement of the amount of hemogobin that is glycosylated.
Time Frame baseline, 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received. Last observation (month 6 or early discontinuation) was analysed.
Arm/Group Title Exenatide BID Placebo
Hide Arm/Group Description:
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
Subcutaneous injection of placebo twice a day for 6 months
Overall Number of Participants Analyzed 42 33
Least Squares Mean (Standard Error)
Unit of Measure: % change
-0.69  (0.12) 0.19  (0.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p-values were not adjusted for multiple comparisons.
Method ANCOVA
Comments ANCOVA analysis included the following factors: treatment, gender, investigator and baseline HbA1c
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.88
Confidence Interval (2-Sided) 95%
-1.19 to -0.57
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.155
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Patients With HbA1c <=7.0% at 6 Months
Hide Description Percentage of patients with HbA1c values <= 7.0% measured at 6 months. HbA1c is a measurement of the amount of hemogobin that is glycosylated.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received.Analysis done only for patients with measurement at Month 6.
Arm/Group Title Exenatide BID Placebo
Hide Arm/Group Description:
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
Subcutaneous injection of placebo twice a day for 6 months
Overall Number of Participants Analyzed 28 28
Measure Type: Number
Unit of Measure: Percentage of patients
60.7 21.4
6.Secondary Outcome
Title Change in Fasting Plasma Glucose From Baseline to 6 Months
Hide Description Change in Fasting plasma glucose
Time Frame baseline, 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received. Analysis done only for patients with measurement at Month 6.
Arm/Group Title Exenatide BID Placebo
Hide Arm/Group Description:
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
Subcutaneous injection of placebo twice a day for 6 months
Overall Number of Participants Analyzed 26 26
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-1.47  (0.36) -0.08  (0.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0073
Comments p-values were not adjusted for multiple comparisons.
Method ANCOVA
Comments The ANCOVA model includes terms of treatment, gender, investigator and baseline fasting plasma glucose.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.39
Confidence Interval (2-Sided) 95%
-2.38 to -0.40
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.491
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change in Weight From Baseline to 6 Months
Hide Description Change in weight
Time Frame baseline, 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received. Last observation (month 6 or early discontinuation) was analyzed.
Arm/Group Title Exenatide BID Placebo
Hide Arm/Group Description:
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
Subcutaneous injection of placebo twice a day for 6 months
Overall Number of Participants Analyzed 42 33
Least Squares Mean (Standard Error)
Unit of Measure: kg
-2.54  (0.57) -0.33  (0.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0035
Comments p-values were not adjusted for multiple comparisons.
Method ANCOVA
Comments The ANCOVA model includes terms of treatment, gender, investigator and baseline body weight.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.21
Confidence Interval (2-Sided) 95%
-3.66 to -0.76
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.725
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change in Systolic Blood Pressure From Baseline to 6 Months
Hide Description Change in Systolic blood pressure
Time Frame baseline, 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug.
Arm/Group Title Exenatide BID Placebo
Hide Arm/Group Description:
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
Subcutaneous injection of placebo twice a day for 6 months
Overall Number of Participants Analyzed 29 28
Mean (Standard Deviation)
Unit of Measure: mmHg
-7.48  (12.57) 1.79  (12.41)
9.Secondary Outcome
Title Change in Diastolic Blood Pressure From Baseline to 6 Months
Hide Description Change in Diastolic blood pressure
Time Frame baseline, 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug.
Arm/Group Title Exenatide BID Placebo
Hide Arm/Group Description:
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
Subcutaneous injection of placebo twice a day for 6 months
Overall Number of Participants Analyzed 29 28
Mean (Standard Deviation)
Unit of Measure: mmHg
-2.86  (6.99) -0.18  (8.97)
10.Secondary Outcome
Title Change in Total Cholesterol From Baseline to 6 Months
Hide Description Change in total cholesterol
Time Frame baseline, 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received
Arm/Group Title Exenatide BID Placebo
Hide Arm/Group Description:
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
Subcutaneous injection of placebo twice a day for 6 months
Overall Number of Participants Analyzed 29 27
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.06  (0.18) 0.14  (0.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4145
Comments p-values were not adjusted for multiple comparisons.
Method ANCOVA
Comments The ANCOVA model includes terms of treatment, gender, investigator and baseline total cholesterol
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-0.71 to 0.30
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.248
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change in Triglycerides From Baseline to 6 Months
Hide Description Change in triglycerides
Time Frame baseline, 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received
Arm/Group Title Exenatide BID Placebo
Hide Arm/Group Description:
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
Subcutaneous injection of placebo twice a day for 6 months
Overall Number of Participants Analyzed 29 27
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.17  (0.21) 0.06  (0.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4007
Comments p-values were not adjusted for multiple comparisons.
Method ANCOVA
Comments The ANCOVA model includes terms of treatment, gender, investigator and baseline triglycerides
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-0.80 to 0.33
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.279
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change in High-Density Lipoprotein (HDL) Cholesterol From Baseline to 6 Months
Hide Description Change in HDL cholesterol
Time Frame baseline, 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received
Arm/Group Title Exenatide BID Placebo
Hide Arm/Group Description:
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
Subcutaneous injection of placebo twice a day for 6 months
Overall Number of Participants Analyzed 29 27
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
0.06  (0.04) 0.04  (0.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7915
Comments p-values were not adjusted for multiple comparisons.
Method ANCOVA
Comments The ANCOVA model includes terms of treatment, gender, investigator and baseline HDL cholesterol
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.08 to 0.11
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.048
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Assessment of Event Rate of Treatment- Emergent Hypoglycemic Event
Hide Description All hypoglycemia episodes defined as major (results in loss of consciousness, seizure or coma resolving after administration of glucagon or glucose OR needing third-party assistance to resolve due to severe impairment in consciousness and associated with glucose concentration < 2.8 mol/L.) or minor (non-major event with symptoms consistent with hypoglycemia and glucose value < 2.8 mmol/L prior to treating) or symptoms of hypoglycemia (does not meet the criteria for a major or minor event).
Time Frame baseline, 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug.
Arm/Group Title Exenatide BID Placebo
Hide Arm/Group Description:
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
Subcutaneous injection of placebo twice a day for 6 months
Overall Number of Participants Analyzed 43 37
Mean (Standard Error)
Unit of Measure: hypoglycemia rate/year
0.41  (0.15) 0.12  (0.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide BID, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1388
Comments p-values were not adjusted for multiple comparisons.
Method Regression, Linear
Comments Generalized linear model was used with the assumption of an underlying Poisson distribution and the logarithm of exposure (years) as offset variable.
Method of Estimation Estimation Parameter Ratio
Estimated Value 3.28
Confidence Interval (2-Sided) 95%
0.68 to 15.77
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.63
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Exenatide BID Placebo
Hide Arm/Group Description Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months) Subcutaneous injection of placebo twice a day for 6 months
All-Cause Mortality
Exenatide BID Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Exenatide BID Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   3/43 (6.98%)   1/37 (2.70%) 
Cardiac disorders     
Atrial fibrillation * 1  0/43 (0.00%)  1/37 (2.70%) 
Cardiac failure congestive * 1  0/43 (0.00%)  1/37 (2.70%) 
Myocardial infarction * 1  0/43 (0.00%)  1/37 (2.70%) 
Gastrointestinal disorders     
Intestinal obstruction * 1  1/43 (2.33%)  0/37 (0.00%) 
Mesenteritis * 1  1/43 (2.33%)  0/37 (0.00%) 
General disorders     
Malaise * 1  0/43 (0.00%)  1/37 (2.70%) 
Infections and infestations     
Diverticulitis * 1  1/43 (2.33%)  0/37 (0.00%) 
Renal and urinary disorders     
Nephrolithiasis * 1  1/43 (2.33%)  0/37 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (15.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Exenatide BID Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   38/43 (88.37%)   25/37 (67.57%) 
Ear and labyrinth disorders     
vertigo * 1  3/43 (6.98%)  0/37 (0.00%) 
Gastrointestinal disorders     
Nausea * 1  15/43 (34.88%)  11/37 (29.73%) 
Diarrhoea * 1  7/43 (16.28%)  1/37 (2.70%) 
Vomiting * 1  7/43 (16.28%)  3/37 (8.11%) 
Abdominal pain upper * 1  4/43 (9.30%)  1/37 (2.70%) 
Dyspepsia * 1  2/43 (4.65%)  6/37 (16.22%) 
Abdominal discomfort * 1  1/43 (2.33%)  2/37 (5.41%) 
General disorders     
Fatigue * 1  5/43 (11.63%)  1/37 (2.70%) 
Injection site reaction * 1  2/43 (4.65%)  2/37 (5.41%) 
Infections and infestations     
Nasopharyngitis * 1  8/43 (18.60%)  7/37 (18.92%) 
Influenza * 1  3/43 (6.98%)  2/37 (5.41%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  8/43 (18.60%)  4/37 (10.81%) 
Hyperglycaemia * 1  0/43 (0.00%)  2/37 (5.41%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  3/43 (6.98%)  2/37 (5.41%) 
Myalgia * 1  3/43 (6.98%)  0/37 (0.00%) 
Arthralgia * 1  1/43 (2.33%)  3/37 (8.11%) 
Nervous system disorders     
Headache * 1  6/43 (13.95%)  5/37 (13.51%) 
Dizziness * 1  2/43 (4.65%)  3/37 (8.11%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  1/43 (2.33%)  2/37 (5.41%) 
Oropharyngeal pain * 1  1/43 (2.33%)  2/37 (5.41%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (15.0)
The dropout rate in the study was higher than anticipated (of 80 patients randomized, only 53 completed Study Period II), and enrollment was much slower than anticipated, leading to a decision to terminate the study early for enrollment futility.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Name/Title: Peter Ohman, Medical Science Director
Organization: AstraZeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00701935     History of Changes
Other Study ID Numbers: H8O-CA-GWCE
First Submitted: June 17, 2008
First Posted: June 19, 2008
Results First Submitted: January 11, 2013
Results First Posted: February 13, 2013
Last Update Posted: April 10, 2015