Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00658021
Collaborator
Quintiles, Inc. (Industry)
122
53
3
142.1
2.3
0

Study Details

Study Description

Brief Summary

The primary objective of this study is to test the hypothesis that glycemic control, as measured by change in hemoglobin A1c (HbA1c) from baseline to endpoint, with exenatide is superior to that of placebo after 28 weeks of treatment in adolescent patients with type 2 diabetes who are naïve to antidiabetes agents, or patients who are being treated with metformin, an SU, or a combination of metformin and an SU

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
122 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes.
Actual Study Start Date :
May 30, 2008
Actual Primary Completion Date :
Apr 18, 2019
Actual Study Completion Date :
Apr 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Subcutaneous injection, twice a day

Drug: Placebo
Subcutaneous injection, twice a day

Experimental: Exenatide 5 µg

Subcutaneous injection, twice a day

Drug: Exenatide
Subcutaneous injection, 5 µg, twice a day

Experimental: Exenatide 10 µg

Subcutaneous injection, twice a day

Drug: Exenatide
Subcutaneous injection,10 µg, twice a day

Outcome Measures

Primary Outcome Measures

  1. Adjusted Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 28 [Baseline (Day 1) and Week 28]

    Change from baseline in HbA1c is reported as adjusted least square (LS) mean values at Week 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. A mixed model with repeated measures (MMRM) analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.

  2. Number of Participants With Post-Treatment Adverse Events of Special Interest (AESI) During Safety Follow-up Period [From 1 day after the Week 28/ED visit to 3 years after Week 28/ED visit.]

    Post-treatment adverse events (AEs) were defined as AEs that started or worsened during the off-treatment period (Safety Follow-up Period), which was defined as the day after the Week 28/early discontinuation (ED) visit to the date of completion of the Safety Follow-up Period. The AESIs recorded were as follows: hematological malignancies, thyroid neoplasms, pancreas neoplasms, aplastic anemia, pancreatitis, pregnancy and pregnancy outcomes (including congenital anomalies).

Secondary Outcome Measures

  1. Percentage of Participants Achieving HbA1c Goals of < 7%, <= 6.5%, and < 6.5% Through Week 28 [Weeks 0, 4, 12, 20 and 28]

    The percentage of participants achieving HbA1c goals of < 7%, <= 6.5%, and < 6.5% through Week 28 were compared between treatments using the Cochran-Mantel-Haenszel (CMH) procedure, in which screening HbA1c strata and background diabetes therapy strata served as the stratification factors. The CMH analysis excluded measurements after initiation of rescue medication and study drug discontinuation with missing data treated as non-responder.

  2. Adjusted Change From Baseline in Body Weight Through Week 28 [Baseline (Day 1) up to Week 28]

    Change from baseline in body weight is reported as adjusted LS mean values at Weeks 4, 12, 20 and 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. A MMRM analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.

  3. Adjusted Change From Baseline in Fasting Serum Glucose (FSG) at Week 28 [Baseline (Day 1) and Week 28]

    Change from baseline in FSG is reported as adjusted LS mean values at Week 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. An analysis of covariance (ANCOVA) analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.

  4. Adjusted Change From Baseline in Self-Monitored Blood Glucose (SMBG) at Week 28 [Pre-meal and 2 hours post-meal on Baseline (Day 1) and Week 28]

    Change from baseline in SMBG measurements are reported as adjusted LS mean values at Week 28. SMBG measurements were taken before (pre-prandial) and 2 hours after (post-prandial) the 2 main meals of the day on 3 separate days during the week before baseline (Day 1) and Week 28. Post-prandial excursions were calculated as the difference between the pre-prandial and post-prandial blood glucose concentrations (post-prandial - pre-prandial) and averaged (mean) over the 2 main meals over the 3 separate days in each period. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. An ANCOVA analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.

  5. Adjusted Change From Baseline in Fasting Serum Insulin at Week 28 [Baseline (Day 1) and Week 28]

    Change from baseline in fasting serum insulin is reported as adjusted LS mean values at Week 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. An ANCOVA analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.

  6. Adjusted Change From Baseline in Homeostasis Model Assessments - Beta-Cell Function (HOMA-B) and Insulin Sensitivity (HOMA-S) at Week 28 [Baseline (Day 1) and Week 28]

    Change from baseline in HOMA-B and HOMA-S are reported as adjusted LS mean values at Week 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. An ANCOVA analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.

  7. Percentage of Participants Discontinuing the Study Due to Failure to Maintain Glycemic Control Through Week 28 [Weeks 2, 4, 8, 12, 16, 20, 24 and 28]

    Participants were discontinued from the study due to failure to maintain glycemic control if either discontinuation reason on summary case report form was "Loss of glucose control" or AE with lower level Medical Dictionary for Regulatory Activities (MedDRA) term "Loss of control of blood sugar" or "Hyperglycaemia" leading to study drug discontinuation, using MedDRA Version 23.0.

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Inclusion Criteria-patients are eligible to be included in the study only if they meet all of the following criteria:

  • are a male or a female between ages 10 to 17 years, inclusive. The number of patients ≥17 years of age will be limited to no more than 10% of patients in each treatment arm

  • have a history of type 2 diabetes with the original diagnosis based on at least one American Diabetes Association (ADA) diagnostic criteria

  • have been treated with metformin, an SU, or both metformin and an SU (with or without diet and exercise), for at least 3 months or are naïve to anti-diabetes agents and being treated with diet and exercise alone. The dose of oral agent(s) should be stable for the 30 days prior to the screening visit

  • have fasting C-peptide >0.6 ng/mL

  • have HbA1c between 6.5% and 10.5%, inclusive.

Disease Diagnostic Criteria-for the purposes of this study, patients with type 2 diabetes are defined by:

  • diagnosis of type 2 diabetes, as determined by ADA diagnostic criteria and antibody testing, documented and confirmed in the patient's medical record, which includes laboratory determinations consistent with one or more of the following in the patient's medical history

  • fasting blood glucose 126 mg/dL (7.0 mmol/L)

  • random blood glucose 200 mg/dL (11.1 mmol/L)

  • two-hour OGTT (Oral Glucose Tolerance Test) ≥ 200 mg/dL (11.1 mmol/L) AND one or more of the following: no antibodies to GAD65 OR no antibodies to islet cell antigen (ICA512).

Exclusion Criteria-patients will be excluded from the study if they meet any of the following criteria:

  • have previously been exposed to exenatide or, completed or withdrawn from this study or any other study investigating exenatide

  • are unwilling or unable to inject the study medication

  • currently use inhaled steroids at a dose equal to or above 1000g Flovent (fluticasone propionate) daily

  • have used oral steroids within the last 60 days or more than 20 days use within the past year

  • have used any weight loss medication(s) within 30 days of screening

  • have used insulin for more than 10 weeks during the 3 months prior to screening

  • have history of renal disease, or serum creatinine >1.6 mg/dL (141.4 µmol/L) (males) or >1.4 mg/dL (123.8 µmol/L) (females)

  • have hepatic dysfunction, defined by aspartate (AST) or alanine (ALT) transaminase

3.0 times the upper limit of normal (ULN).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Site Birmingham Alabama United States 35233
2 Research Site Tucson Arizona United States 85724
3 Research Site Los Angeles California United States 90048
4 Research Site Montclair California United States 91763
5 Research Site Sacramento California United States 95819
6 Research Site San Diego California United States 92123
7 Research Site Santa Ana California United States 92707
8 Research Site Aurora Colorado United States 80045
9 Research Site Melbourne Florida United States 32901
10 Research Site Miami Lakes Florida United States 33014
11 Research Site Miami Florida United States 33144
12 Research Site Orlando Florida United States 32806
13 Research Site Pensacola Florida United States 32504
14 Research Site Tallahassee Florida United States 32308
15 Research Site Dalton Georgia United States 30721
16 Research Site Chicago Illinois United States 60612
17 Research Site Chicago Illinois United States 60637
18 Research Site Indianapolis Indiana United States 46202
19 Research Site Wichita Kansas United States 67226
20 Research Site Dearborn Michigan United States 48124
21 Research Site Kansas City Missouri United States 64108
22 Research Site Saint Louis Missouri United States 63104
23 Research Site Reno Nevada United States 89502
24 Research Site Jamaica New York United States 11432
25 Research Site Greenville North Carolina United States 27834
26 Research Site Raleigh North Carolina United States 27610
27 Research Site Oklahoma City Oklahoma United States 73104-5008
28 Research Site Memphis Tennessee United States 38401
29 Research Site Dallas Texas United States 75235
30 Research Site San Antonio Texas United States 78207
31 Research Site Spokane Washington United States 99202
32 Research Site Fortaleza Brazil 60430-370
33 Research Site Juiz de Fora Brazil 36025-330
34 Research Site Santo André Brazil 09030-010
35 Research Site Ahmedabad India 380006
36 Research Site Bangalore India
37 Research Site Pune India
38 Research Site Seoul Korea, Republic of
39 Research Site Aguascalientes Mexico 20127
40 Research Site Culiacán Mexico 80200
41 Research Site Guadalajara Mexico 44650
42 Research Site Monterrey Mexico 64710
43 Research Site San Juan del Rio Mexico 76800
44 Research Site Tamaupilas Mexico 87070
45 Research Site Tampico Mexico 89170
46 Research Site Quezon City Philippines 1100
47 Research Site Moscow Russian Federation 125373
48 Research Site Tomsk Russian Federation 634050
49 Research Site Ufa Russian Federation 450077
50 Research Site Moloto South Africa 1022
51 Research Site Paarl South Africa 7626
52 Research Site Pretoria South Africa 0087
53 Research Site Verulam South Africa 4345

Sponsors and Collaborators

  • AstraZeneca
  • Quintiles, Inc.

Investigators

None specified.

Study Documents (Full-Text)

More Information

Additional Information:

Publications

None provided.
Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00658021
Other Study ID Numbers:
  • D5550C00002
  • H8O-MC-GWBQ
First Posted:
Apr 14, 2008
Last Update Posted:
Dec 1, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by AstraZeneca
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details This study was conducted in adolescents (aged 10 to 17 years inclusive) with type 2 diabetes who were naïve to antidiabetics, or were receiving metformin, an sulfonylurea (SU) or a combination of metformin and an SU in 7 countries (Brazil, India, South Korea, Mexico, Russia, the United States and South Africa) between 30 May 2008 and 01 April 2020.
Pre-assignment Detail The study commenced with a 1-week, single-blind, injectable placebo lead-in period before participants were randomized to 1 of 3 treatment groups: exenatide 5 microgram (mcg) twice daily, exenatide 10 mcg twice daily, or placebo twice daily. A total of 122 participants were randomized in this study.
Arm/Group Title Exenatide 5 mcg Exenatide 10 mcg Placebo
Arm/Group Description Adolescent participants received exenatide 5 mcg subcutaneous (SC) injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 millimeter (mm) between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period. Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period. Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period.
Period Title: 28-Week Treatment Period
STARTED 42 38 42
Received Treatment 40 38 42
COMPLETED 31 25 25
NOT COMPLETED 11 13 17
Period Title: 28-Week Treatment Period
STARTED 7 5 7
COMPLETED 7 2 7
NOT COMPLETED 0 3 0

Baseline Characteristics

Arm/Group Title Exenatide 5 mcg Exenatide 10 mcg Placebo Total
Arm/Group Description Adolescent participants received exenatide 5 mcg SC injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period. Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period. Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period. Total of all reporting groups
Overall Participants 42 38 42 122
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
13.7
(1.94)
14.0
(1.95)
14.4
(1.82)
14.0
(1.91)
Sex: Female, Male (Count of Participants)
Female
31
73.8%
22
57.9%
29
69%
82
67.2%
Male
11
26.2%
16
42.1%
13
31%
40
32.8%
Race/Ethnicity, Customized (Count of Participants)
White
7
16.7%
5
13.2%
13
31%
25
20.5%
Black or African American
14
33.3%
8
21.1%
7
16.7%
29
23.8%
Asian
3
7.1%
2
5.3%
5
11.9%
10
8.2%
American Indian or Alaska Native
0
0%
1
2.6%
0
0%
1
0.8%
Hispanic
18
42.9%
22
57.9%
17
40.5%
57
46.7%

Outcome Measures

1. Primary Outcome
Title Adjusted Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 28
Description Change from baseline in HbA1c is reported as adjusted least square (LS) mean values at Week 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. A mixed model with repeated measures (MMRM) analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.
Time Frame Baseline (Day 1) and Week 28

Outcome Measure Data

Analysis Population Description
The Evaluable Analysis Set included all randomized participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline HbA1c assessment. For analysis of efficacy, a decision was made with agreement by the European Medicines Agency and the Food and Drug Administration to pool participants from both exenatide groups (Total EBID) and compare this pooled group with placebo.
Arm/Group Title Total Exenatide Twice Daily (EBID) Placebo
Arm/Group Description Efficacy data from participants from both exenatide groups (Total EBID) was pooled for comparison with placebo. Adolescent participants received exenatide 5 mcg SC injection twice daily for 28 weeks; or Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks. Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period.
Measure Participants 78 42
Least Squares Mean (Standard Error) [percentage (%HbA1c)]
0.11
(0.215)
0.38
(0.293)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Exenatide Twice Daily (EBID), Placebo
Comments Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline HbA1c, background diabetes therapy strata, week of visit, baseline HbA1c-by-visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.444
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-1.01 to 0.45
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.363
Estimation Comments
2. Primary Outcome
Title Number of Participants With Post-Treatment Adverse Events of Special Interest (AESI) During Safety Follow-up Period
Description Post-treatment adverse events (AEs) were defined as AEs that started or worsened during the off-treatment period (Safety Follow-up Period), which was defined as the day after the Week 28/early discontinuation (ED) visit to the date of completion of the Safety Follow-up Period. The AESIs recorded were as follows: hematological malignancies, thyroid neoplasms, pancreas neoplasms, aplastic anemia, pancreatitis, pregnancy and pregnancy outcomes (including congenital anomalies).
Time Frame From 1 day after the Week 28/ED visit to 3 years after Week 28/ED visit.

Outcome Measure Data

Analysis Population Description
The Safety Follow-up Analysis Set included all participants who had at least 1 safety follow-up period assessment visit.
Arm/Group Title Exenatide 5 mcg Exenatide 10 mcg Placebo
Arm/Group Description Adolescent participants received exenatide 5 mcg SC injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period. Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period. Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period.
Measure Participants 7 5 7
Count of Participants [Participants]
0
0%
0
0%
0
0%
3. Secondary Outcome
Title Percentage of Participants Achieving HbA1c Goals of < 7%, <= 6.5%, and < 6.5% Through Week 28
Description The percentage of participants achieving HbA1c goals of < 7%, <= 6.5%, and < 6.5% through Week 28 were compared between treatments using the Cochran-Mantel-Haenszel (CMH) procedure, in which screening HbA1c strata and background diabetes therapy strata served as the stratification factors. The CMH analysis excluded measurements after initiation of rescue medication and study drug discontinuation with missing data treated as non-responder.
Time Frame Weeks 0, 4, 12, 20 and 28

Outcome Measure Data

Analysis Population Description
The Evaluable Analysis Set included all randomized participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline HbA1c assessment. For analysis of efficacy, a decision was made with agreement by the European Medicines Agency and the Food and Drug Administration to pool participants from both exenatide groups (Total EBID) and compare this pooled group with placebo.
Arm/Group Title Total Exenatide Twice Daily (EBID) Placebo
Arm/Group Description Efficacy data from participants from both exenatide groups (Total EBID) was pooled for comparison with placebo. Adolescent participants received exenatide 5 mcg SC injection twice daily for 28 weeks; or Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks. Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period.
Measure Participants 78 42
HbA1c < 7%: Week 0
37.2
88.6%
38.1
100.3%
HbA1c < 7%: Week 4
44.9
106.9%
42.9
112.9%
HbA1c < 7%: Week 12
43.6
103.8%
33.3
87.6%
HbA1c < 7%: Week 20
35.9
85.5%
35.7
93.9%
HbA1c < 7%: Week 28
33.3
79.3%
28.6
75.3%
HbA1c <=6.5%: Week 0
17.9
42.6%
16.7
43.9%
HbA1c <=6.5%: Week 4
29.5
70.2%
23.8
62.6%
HbA1c <=6.5%: Week 12
33.3
79.3%
23.8
62.6%
HbA1c <=6.5%: Week 20
24.4
58.1%
19.0
50%
HbA1c <=6.5%: Week 28
23.1
55%
19.0
50%
HbA1c <6.5%: Week 0
15.4
36.7%
7.1
18.7%
HbA1c <6.5%: Week 4
26.9
64%
21.4
56.3%
HbA1c <6.5%: Week 12
30.8
73.3%
19.0
50%
HbA1c <6.5%: Week 20
21.8
51.9%
19.0
50%
HbA1c <6.5%: Week 28
23.1
55%
14.3
37.6%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Exenatide Twice Daily (EBID), Placebo
Comments Treatment difference in HbA1c < 7% at Week 28: Treatment group comparison is based on CMH test stratified by screening HbA1c and background diabetes therapy strata. P-value is from the general association statistics.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.562
Comments
Method Cochran-Mantel-Haenszel
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Total Exenatide Twice Daily (EBID), Placebo
Comments Treatment difference in HbA1c <= 6.5% at Week 28: Treatment group comparison is based on CMH test stratified by screening HbA1c and background diabetes therapy strata. P-value is from the general association statistics.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.621
Comments
Method Cochran-Mantel-Haenszel
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Total Exenatide Twice Daily (EBID), Placebo
Comments Treatment difference in HbA1c < 6.5% at Week 28: Treatment group comparison is based on CMH test stratified by screening HbA1c and background diabetes therapy strata. P-value is from the general association statistics.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.229
Comments
Method Cochran-Mantel-Haenszel
Comments
4. Secondary Outcome
Title Adjusted Change From Baseline in Body Weight Through Week 28
Description Change from baseline in body weight is reported as adjusted LS mean values at Weeks 4, 12, 20 and 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. A MMRM analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.
Time Frame Baseline (Day 1) up to Week 28

Outcome Measure Data

Analysis Population Description
The Full Analysis Set included all randomized participants who received at least 1 dose of randomized study medication. For analysis of efficacy, a decision was made with agreement by the European Medicines Agency and the Food and Drug Administration to pool participants from both exenatide groups (Total EBID) and compare this pooled group with placebo.
Arm/Group Title Total Exenatide Twice Daily (EBID) Placebo
Arm/Group Description Efficacy data from participants from both exenatide groups (Total EBID) was pooled for comparison with placebo. Adolescent participants received exenatide 5 mcg SC injection twice daily for 28 weeks; or Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks. Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period.
Measure Participants 78 42
Week 4
-0.89
(0.196)
0.04
(0.260)
Week 12
-1.09
(0.401)
-0.42
(0.534)
Week 20
-0.71
(0.559)
-0.33
(0.755)
Week 28
-0.81
(0.632)
-0.36
(0.857)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Exenatide Twice Daily (EBID), Placebo
Comments Treatment difference in body weight at Week 4: Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.005
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.93
Confidence Interval (2-Sided) 95%
-1.58 to -0.28
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.327
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Total Exenatide Twice Daily (EBID), Placebo
Comments Treatment difference in body weight at Week 12: Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.314
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.68
Confidence Interval (2-Sided) 95%
-2.00 to 0.65
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.669
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Total Exenatide Twice Daily (EBID), Placebo
Comments Treatment difference in body weight at Week 20: Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.692
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.37
Confidence Interval (2-Sided) 95%
-2.24 to 1.50
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.940
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Total Exenatide Twice Daily (EBID), Placebo
Comments Treatment difference in body weight at Week 28: Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.679
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.44
Confidence Interval (2-Sided) 95%
-2.56 to 1.68
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.065
Estimation Comments
5. Secondary Outcome
Title Adjusted Change From Baseline in Fasting Serum Glucose (FSG) at Week 28
Description Change from baseline in FSG is reported as adjusted LS mean values at Week 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. An analysis of covariance (ANCOVA) analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.
Time Frame Baseline (Day 1) and Week 28

Outcome Measure Data

Analysis Population Description
The Full Analysis Set included all randomized participants who received at least 1 dose of randomized study medication. For analysis of efficacy, a decision was made with agreement by the European Medicines Agency and the Food and Drug Administration to pool participants from both exenatide groups (Total EBID) and compare this pooled group with placebo.
Arm/Group Title Total Exenatide Twice Daily (EBID) Placebo
Arm/Group Description Efficacy data from participants from both exenatide groups (Total EBID) was pooled for comparison with placebo. Adolescent participants received exenatide 5 mcg SC injection twice daily for 28 weeks; or Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks. Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period.
Measure Participants 78 42
Least Squares Mean (Standard Error) [millimoles per liter (mmol/L)]
0.791
(0.4010)
1.072
(0.5466)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Exenatide Twice Daily (EBID), Placebo
Comments Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline fasting serum glucose, screening HbA1c strata and background diabetes therapy strata as fixed effects.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.679
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.281
Confidence Interval (2-Sided) 95%
-1.614 to 1.052
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.6800
Estimation Comments
6. Secondary Outcome
Title Adjusted Change From Baseline in Self-Monitored Blood Glucose (SMBG) at Week 28
Description Change from baseline in SMBG measurements are reported as adjusted LS mean values at Week 28. SMBG measurements were taken before (pre-prandial) and 2 hours after (post-prandial) the 2 main meals of the day on 3 separate days during the week before baseline (Day 1) and Week 28. Post-prandial excursions were calculated as the difference between the pre-prandial and post-prandial blood glucose concentrations (post-prandial - pre-prandial) and averaged (mean) over the 2 main meals over the 3 separate days in each period. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. An ANCOVA analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.
Time Frame Pre-meal and 2 hours post-meal on Baseline (Day 1) and Week 28

Outcome Measure Data

Analysis Population Description
The Full Analysis Set included all randomized participants who received at least 1 dose of randomized study medication. For analysis of efficacy, a decision was made with agreement by the European Medicines Agency and the Food and Drug Administration to pool participants from both exenatide groups (Total EBID) and compare this pooled group with placebo.
Arm/Group Title Total Exenatide Twice Daily (EBID) Placebo
Arm/Group Description Efficacy data from participants from both exenatide groups (Total EBID) was pooled for comparison with placebo. Adolescent participants received exenatide 5 mcg SC injection twice daily for 28 weeks; or Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks. Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period.
Measure Participants 78 42
Pre-meal SMBG
-0.699
(0.2709)
-0.888
(0.4511)
Post-meal SMBG
-1.029
(0.2722)
-1.542
(0.4503)
Post-prandial excursion SMBG
-0.181
(0.2107)
-0.391
(0.3418)
Overall SMBG
-0.877
(0.2468)
-1.193
(0.4117)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Exenatide Twice Daily (EBID), Placebo
Comments Treatment difference for pre-meal SMBG: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.714
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.189
Confidence Interval (2-Sided) 95%
-0.821 to 1.199
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.5151
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Total Exenatide Twice Daily (EBID), Placebo
Comments Treatment difference for post-meal SMBG: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.329
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.513
Confidence Interval (2-Sided) 95%
-0.516 to 1.541
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.5245
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Total Exenatide Twice Daily (EBID), Placebo
Comments Treatment difference for post-prandial excursion SMBG: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.601
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.210
Confidence Interval (2-Sided) 95%
-0.577 to 0.997
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.4015
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Total Exenatide Twice Daily (EBID), Placebo
Comments Treatment difference for overall SMBG: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.505
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.316
Confidence Interval (2-Sided) 95%
-0.615 to 1.248
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.4749
Estimation Comments
7. Secondary Outcome
Title Adjusted Change From Baseline in Fasting Serum Insulin at Week 28
Description Change from baseline in fasting serum insulin is reported as adjusted LS mean values at Week 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. An ANCOVA analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.
Time Frame Baseline (Day 1) and Week 28

Outcome Measure Data

Analysis Population Description
The Full Analysis Set included all randomized participants who received at least 1 dose of randomized study medication. For analysis of efficacy, a decision was made with agreement by the European Medicines Agency and the Food and Drug Administration to pool participants from both exenatide groups (Total EBID) and compare this pooled group with placebo.
Arm/Group Title Total Exenatide Twice Daily (EBID) Placebo
Arm/Group Description Efficacy data from participants from both exenatide groups (Total EBID) was pooled for comparison with placebo. Adolescent participants received exenatide 5 mcg SC injection twice daily for 28 weeks; or Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks. Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period.
Measure Participants 78 42
Least Squares Mean (Standard Error) [picomoles per liter]
1.67
(25.323)
12.49
(34.825)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Exenatide Twice Daily (EBID), Placebo
Comments Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline fasting serum insulin, screening HbA1c strata and background diabetes therapy strata as fixed effects.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.802
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -10.82
Confidence Interval (2-Sided) 95%
-95.48 to 73.84
Parameter Dispersion Type: Standard Error of the Mean
Value: 43.187
Estimation Comments
8. Secondary Outcome
Title Adjusted Change From Baseline in Homeostasis Model Assessments - Beta-Cell Function (HOMA-B) and Insulin Sensitivity (HOMA-S) at Week 28
Description Change from baseline in HOMA-B and HOMA-S are reported as adjusted LS mean values at Week 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. An ANCOVA analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.
Time Frame Baseline (Day 1) and Week 28

Outcome Measure Data

Analysis Population Description
The Full Analysis Set included all randomized participants who received at least 1 dose of randomized study medication. For analysis of efficacy, a decision was made with agreement by the European Medicines Agency and the Food and Drug Administration to pool participants from both exenatide groups (Total EBID) and compare this pooled group with placebo.
Arm/Group Title Total Exenatide Twice Daily (EBID) Placebo
Arm/Group Description Efficacy data from participants from both exenatide groups (Total EBID) was pooled for comparison with placebo. Adolescent participants received exenatide 5 mcg SC injection twice daily for 28 weeks; or Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks. Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period.
Measure Participants 78 42
HOMA-B
-25.93
(10.404)
-22.10
(14.885)
HOMA-S
-3.18
(2.172)
-2.90
(3.117)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Exenatide Twice Daily (EBID), Placebo
Comments Treatment difference for HOMA-B: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline %HOMA-B, screening HbA1c strata and background diabetes therapy strata as fixed effects.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.836
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.84
Confidence Interval (2-Sided) 95%
-40.19 to 32.51
Parameter Dispersion Type: Standard Error of the Mean
Value: 18.542
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Total Exenatide Twice Daily (EBID), Placebo
Comments Treatment difference for HOMA-S: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline %HOMA-S, screening HbA1c strata and background diabetes therapy strata as fixed effects.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.941
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-7.82 to 7.26
Parameter Dispersion Type: Standard Error of the Mean
Value: 3.846
Estimation Comments
9. Secondary Outcome
Title Percentage of Participants Discontinuing the Study Due to Failure to Maintain Glycemic Control Through Week 28
Description Participants were discontinued from the study due to failure to maintain glycemic control if either discontinuation reason on summary case report form was "Loss of glucose control" or AE with lower level Medical Dictionary for Regulatory Activities (MedDRA) term "Loss of control of blood sugar" or "Hyperglycaemia" leading to study drug discontinuation, using MedDRA Version 23.0.
Time Frame Weeks 2, 4, 8, 12, 16, 20, 24 and 28

Outcome Measure Data

Analysis Population Description
The Full Analysis Set included all randomized participants who received at least 1 dose of randomized study medication. For analysis of efficacy, a decision was made with agreement by the European Medicines Agency and the Food and Drug Administration to pool participants from both exenatide groups (Total EBID) and compare this pooled group with placebo.
Arm/Group Title Total Exenatide Twice Daily (EBID) Placebo
Arm/Group Description Efficacy data from participants from both exenatide groups (Total EBID) was pooled for comparison with placebo. Adolescent participants received exenatide 5 mcg SC injection twice daily for 28 weeks; or Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks. Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks. In the Safety Follow-up Period, participants with a height difference of at least 5 mm between Day 1 and Week 28 visits returned for study visits every 6 months for up to 3 years after completion of the treatment period.
Measure Participants 78 42
Week 2
0
0%
0
0%
Week 4
0
0%
2.4
6.3%
Week 8
0
0%
0
0%
Week 12
1.4
3.3%
5.0
13.2%
Week 16
1.4
3.3%
0
0%
Week 20
0
0%
14.7
38.7%
Week 24
0
0%
6.9
18.2%
Week 28
1.6
3.8%
0
0%

Adverse Events

Time Frame Serious AEs: From first dose of study drug (Day 1) up to 30 days after last dose of study drug, approximately 32 weeks. Non-serious AEs: From first dose of study drug (Day 1) up to 1 day after last dose of study drug, approximately 28 weeks.
Adverse Event Reporting Description The Safety Analysis Set included all participants who received at least 1 dose of randomized study medication. Treatment-emergent AEs (TEAEs) are reported. A TEAE was defined as an AE starting (or worsening) after the first dose of randomized study medication through the end of treatment + 1 day for non-serious AEs or + 30 days for serious AEs.
Arm/Group Title Exenatide 5 mcg Exenatide 10 mcg Placebo
Arm/Group Description Adolescent participants received exenatide 5 mcg SC injection twice daily for 28 weeks. Adolescent participants received exenatide 5 mcg SC injection twice daily for 4 weeks after randomization. At the end of 4 weeks post-randomization, participants received exenatide 10 mcg SC injection twice daily for next 24 weeks. Adolescent participants received placebo matching with exenatide 5 mcg or 10 mcg SC injection twice daily for 28 weeks.
All Cause Mortality
Exenatide 5 mcg Exenatide 10 mcg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/41 (0%) 0/37 (0%) 0/42 (0%)
Serious Adverse Events
Exenatide 5 mcg Exenatide 10 mcg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 3/41 (7.3%) 1/37 (2.7%) 1/42 (2.4%)
Infections and infestations
Cellulitis 1/41 (2.4%) 1 0/37 (0%) 0 0/42 (0%) 0
Gastroenteritis 1/41 (2.4%) 1 0/37 (0%) 0 1/42 (2.4%) 1
Gastroenteritis viral 0/41 (0%) 0 0/37 (0%) 0 1/42 (2.4%) 1
Staphylococcal abscess 1/41 (2.4%) 1 0/37 (0%) 0 0/42 (0%) 0
Pregnancy, puerperium and perinatal conditions
Pregnancy 0/41 (0%) 0 1/37 (2.7%) 1 0/42 (0%) 0
Psychiatric disorders
Intentional self-injury 1/41 (2.4%) 1 0/37 (0%) 0 0/42 (0%) 0
Other (Not Including Serious) Adverse Events
Exenatide 5 mcg Exenatide 10 mcg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 26/41 (63.4%) 24/37 (64.9%) 23/42 (54.8%)
Ear and labyrinth disorders
Ear pain 2/41 (4.9%) 2 2/37 (5.4%) 2 3/42 (7.1%) 3
Gastrointestinal disorders
Abdominal pain upper 1/41 (2.4%) 1 2/37 (5.4%) 5 2/42 (4.8%) 4
Diarrhoea 2/41 (4.9%) 3 3/37 (8.1%) 3 5/42 (11.9%) 9
Nausea 4/41 (9.8%) 4 11/37 (29.7%) 15 7/42 (16.7%) 10
Vomiting 2/41 (4.9%) 2 8/37 (21.6%) 10 3/42 (7.1%) 3
General disorders
Pyrexia 2/41 (4.9%) 2 1/37 (2.7%) 1 3/42 (7.1%) 3
Infections and infestations
Furuncle 0/41 (0%) 0 2/37 (5.4%) 2 0/42 (0%) 0
Influenza 3/41 (7.3%) 3 0/37 (0%) 0 0/42 (0%) 0
Nasopharyngitis 8/41 (19.5%) 10 2/37 (5.4%) 4 3/42 (7.1%) 3
Pharyngitis 4/41 (9.8%) 6 2/37 (5.4%) 5 1/42 (2.4%) 1
Pharyngitis streptococcal 0/41 (0%) 0 2/37 (5.4%) 2 0/42 (0%) 0
Sinusitis 4/41 (9.8%) 4 1/37 (2.7%) 1 2/42 (4.8%) 2
Upper respiratory tract infection 5/41 (12.2%) 8 3/37 (8.1%) 3 5/42 (11.9%) 9
Musculoskeletal and connective tissue disorders
Back pain 1/41 (2.4%) 1 2/37 (5.4%) 4 2/42 (4.8%) 2
Nervous system disorders
Dizziness 2/41 (4.9%) 2 2/37 (5.4%) 3 2/42 (4.8%) 2
Headache 9/41 (22%) 14 9/37 (24.3%) 15 11/42 (26.2%) 27
Reproductive system and breast disorders
Dysmenorrhoea 2/41 (4.9%) 3 3/37 (8.1%) 4 4/42 (9.5%) 6
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain 3/41 (7.3%) 3 0/37 (0%) 0 3/42 (7.1%) 3

Limitations/Caveats

[Not Specified]

More Information

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 Global Clinical Lead
Organization AstraZeneca
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00658021
Other Study ID Numbers:
  • D5550C00002
  • H8O-MC-GWBQ
First Posted:
Apr 14, 2008
Last Update Posted:
Dec 1, 2020
Last Verified:
Oct 1, 2020