Effects of Exenatide Long-Acting Release on Glucose Contr... | NCT00308139 | Trialant
NCT00308139
Sponsor
AstraZeneca
Status
Completed
Last Update Posted
Aug 26, 2015Estimated
Enrollment
303Actual
Phase
Phase 3
Conditions
Type 2 Diabetes Mellitus
Interventions
exenatide, long acting release
exenatide
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
NCT00308139
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
2993LAR-105 (DURATION - 1)
Secondary IDs
ID
Type
Description
Link
MB001-010
Other Identifier
Bristol Myers Squibb
Brief Title
Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1)
Official Title
A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of Exenatide Long-Acting Release on Glucose Control (HbA1c) and Safety in Subjects With Type 2 Diabetes Mellitus Managed With Diet Modification and Exercise and/or Oral Antidiabetic Medications
Acronym
Not provided
Organization
AstraZenecaINDUSTRY
Status Module
Record Verification Date
Jul 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 2006
Primary Completion Date
Jul 2008Actual
Completion Date
Aug 2014Actual
First Submitted Date
Mar 27, 2006
First Submission Date that Met QC Criteria
Mar 27, 2006
First Posted Date
Mar 29, 2006Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 14, 2012
Results First Submitted that Met QC Criteria
Jul 12, 2012
Results First Posted Date
Aug 17, 2012Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 17, 2011
Certification/Extension First Submitted that Passed QC Review
Jun 17, 2011
Certification/Extension First Posted Date
Jun 27, 2011Estimated
Last Update Submitted Date
Jul 29, 2015
Last Update Posted Date
Aug 26, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AstraZenecaINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of Exenatide Long-Acting Release (LAR) on Glucose Control (HbA1c) and Safety in Subjects with Type 2 Diabetes Mellitus Managed with Diet Modification and Exercise and/or Oral Antidiabetic Medications.
Detailed Description
This trial is designed to examine the effect of exenatide once weekly compared to exenatide twice daily on glucose control and safety in subjects for at least 30 weeks. The study is also designed to examine glucose control during the transition from exenatide twice daily for 30 weeks to exenatide once weekly. Long-term safety and efficacy will be monitored during the open-ended assessment periods. This study will be conducted in approximately 300 subjects with type 2 diabetes treated with diet modification and exercise alone or in combination with a stable regimen of metformin, SU, thiazolidinedione (TZD), a combination of metformin and SU, a combination of metformin and TZD, or a combination of SU and TZD.
Conditions Module
Conditions
Type 2 Diabetes Mellitus
Keywords
diabetes
exenatide
long acting release
LAR
Amylin
Lilly
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
303Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Exenatide Once Weekly
Experimental
Subcutaneous injection (SC), once a week of long acting release (LAR) exenatide.
Drug: exenatide, long acting release
Exenatide Twice Daily
Active Comparator
subcutaneous injection (SC), twice a day for the first 30 weeks, followed by exenatide LAR SC injection weekly for the remainder of the study.
Sub-study: Exenatide 2 mg subcutaneous injection, Administered Using the Exenatide Once Weekly Single-Dose Tray , once a week for 11 visits, switch to Exenatide 2 mg subcutaneous injection, Administered Using the Dual chamber pen device. Exenatide 2mg SC injection administered using the Dual chamber pen device.
Drug: exenatide
Interventions
Name
Type
Description
Arm Group Labels
Other Names
exenatide, long acting release
Drug
Exenatide Once Weekly
BYDUREON
exenatide
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change in HbA1c From Baseline to Week 30
Absolute change in HbA1c from Baseline (Day -3) to Week 30 [Week 30 - Baseline]
Day -3, Week 30
Sub-study Relative Bioavailability of Exenatide When Administered Using the Exenatide Once Weekly Dual Chambered Pen and the Exenatide Once Weekly Single Dose Tray (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose)
Measure by Geometric mean ratio (GMR) of plasma exenatide average steady state concentration Css,avg at Visit 11-14 to Visit 24-27 with 90% confidence interval
Week 22
Secondary Outcomes
Measure
Description
Time Frame
Change in HbA1c From Baseline to Week 364
Absolute change in HbA1c from Baseline (Day -3) to Week 364
Day -3, Week 364
Percentage of Subjects Achieving HbA1c Target of <7%
Percentage of subjects achieving HbA1c target value of <7% at Week 30.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Has type 2 diabetes mellitus treated with diet modification and exercise alone or in combination with a stable regimen of a combination of metformin, sulphonylureas, and thiazolidinediones for a minimum of 2 months at screening.
Hemoglobin A1c (HbA1c) of 7.1% to 11.0%, inclusive, at screening.
Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.
(For sub-study) Currently participating in open ended assessment period of main study 2993 LAR105
Exclusion Criteria:
Has been previously exposed to exenatide (Byetta®), exenatide LAR, or any glucagon-like peptide-1 (GLP-1) analog.
Received any investigational drug or has participated in any type of clinical trial within 30 days prior to screening.
Has been treated, is currently treated, or is expected to require or undergo treatment with any of the following excluded medications:
Alpha glucosidase inhibitor or meglitinide within 30 days of screening;
Insulin within 2 weeks prior to screening or insulin for longer than 1 week within 3 months of screening;
Regular use (> 14 days) of drugs that directly affect gastrointestinal motility;
Regular use (> 14 days) of systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary steroids known to have a high rate of systemic absorption;
Regular use (> 14 days) of medications with addictive potential such as opiates and opioids;
Prescription or over-the-counter weight loss medications within 6 months of screening.
(For sub-study) Subjects will be terminated from study who do not participate in the dual chamber pen substudy
Philis-Tsimikas A, Wysham CH, Hardy E, Han J, Iqbal N. Efficacy and tolerability of exenatide once weekly over 7 years in patients with type 2 diabetes: An open-label extension of the DURATION-1 study. J Diabetes Complications. 2019 Mar;33(3):223-230. doi: 10.1016/j.jdiacomp.2018.11.012. Epub 2018 Dec 5.
Subcutaneous injection of 2 mg exenatide, once a week.
FG001
Exenatide Twice Daily -> Exenatide Once Weekly
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug
Exenatide Twice Daily
Byetta
Week 30
Percentage of Subjects Achieving HbA1c Target of <7%
Percentages of subjects achieving HbA1c target value of <7% at Week 364
Week 364
Percentage of Subjects Achieving HbA1c Target of <=6.5%
Percentages of subjects achieving HbA1c target values of <=6.5% at Week 30.
Week 30
Percentage of Subjects Achieving HbA1c Target of <=6.5%
Percentages of subjects achieving HbA1c target values of <=6.5% at Week 364
Week 364
Percentage of Subjects Achieving HbA1c Target of <=6.0%
Percentage of subjects achieving HbA1c target values of <=6.0% at Week 30.
Week 30
Exenatide LAR Steady State Concentration From Week 29 to Week 30
Steady-state plasma exenatide concentration over the dosing interval of Week 29 to Week 30 (0-168 hours) was evaluated. Geometric mean for the average steady-state concentration and its 10th and 90th percentiles were reported.
Week 29 to Week 30
Change in 2 Hours (2h) Postprandial Glucose From Baseline to Week 14
Change in 2h Postprandial Glucose from baseline (Day -3) to Week 14
Day -3, Week 14
Sub-study Safety and Tolerability of Exenatide When Administered Using the Once Weekly Single Dose Tray and the Once Weekly Dual (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose)
Measure by geometric mean ratio of the maximum steady state plasma exenatide concentration Css, max at Visit 11-14 to Visit 24-27 with 90% confidence interval and incidence of treatment-emergent injection site adverse events.
Week 22
Change in Body Weight From Baseline to Week 30
Change in body weight from baseline (Day -3) to Week 30
Day -3, Week 30
Change in Body Weight From Baseline to Week 364
Change in body weight from baseline (Day -3) to Week 364
Day -3, Week 364
Change in Fasting Plasma Glucose From Baseline to Week 30
Change in fasting plasma glucose from baseline (Day -3) to Week 30.
Day -3, Week 30
Change in Fasting Plasma Glucose From Baseline to Week 364
Change in fasting plasma glucose from baseline (Day -3) to Week 364.
Day -3, Week 364
Change in Blood Pressure From Baseline to Week 30
Change in Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure from baseline to Week 30
Day -3, Week 30
Change in Blood Pressure From Baseline to Week 364
Change in Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure from baseline to Week 364
Day -3, Week 364
Change in Total Cholesterol From Baseline to Week 30
Change in total cholesterol from baseline (Day -3) to Week 30.
Day -3, Week 30
Change in Total Cholesterol From Baseline to Week 364
Change in total cholesterol from baseline (Day -3) to Week 364.
Day -3, Week 364
Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 30
Change in high-density lipoprotein cholesterol (HDL-C) from baseline (Day -3) to Week 30.
Day -3, Week 30
Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 364
Change in high-density lipoprotein cholesterol (HDL-C) from baseline (Day -3) to Week 364.
Day -3, Week 364
Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 364
Change in low-density lipoprotein cholesterol (LDL-C) from baseline (Day -3) to Week 364.
Day -3, Week 364
Ratio of Triglycerides at Week 30 to Baseline
Ratio of triglycerides (measured in mg/dL) at Week 30 to baseline (Day -3). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.
Day -3, Week 30
Ratio of Triglycerides at Week 364 to Baseline
Ratio of triglycerides (measured in mg/dL) at Week 364 to baseline (Day -3). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.
Day -3, Week 364
Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With SU Use at Screening
The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject. The minor hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.
Day 1 to Week 364
Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With Non-SU Use at Screening
The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject. The minor hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.
Day 1 to Week 364
La Jolla
California
92037
United States
Research Site 518
San Diego
California
92161
United States
Research Site 024
Walnut Creek
California
94598
United States
Research Site
Colorado Springs
Colorado
United States
Research Site 057
Miami
Florida
33156
United States
Research Site
Chicago
Illinois
United States
Research Site 149
Indianapolis
Indiana
46254
United States
Research Site 099
Lexington
Kentucky
40503
United States
Research Site 017
Detroit
Michigan
48202
United States
Research Site 224
Minneapolis
Minnesota
55416
United States
Research Site 312
St Louis
Missouri
63141
United States
Research Site 023
Butte
Montana
59701
United States
Research Site 053
Rochester
New York
14609
United States
Research Site 002
Durham
North Carolina
27713
United States
Research Site 123
Winston-Salem
North Carolina
27103
United States
Research Site 405
Cincinnati
Ohio
45219
United States
Research Site 557
Marion
Ohio
43302
United States
Research Site 231
Portland
Oregon
97239
United States
Research Site 152
Philadelphia
Pennsylvania
19146
United States
Research Site 587
Greer
South Carolina
29651
United States
Research Site 015
Dallas
Texas
75230
United States
Research Site 009
San Antonio
Texas
78229
United States
Research Site 108
Olympia
Washington
98502
United States
Research Site
Toronto
Ontario
Canada
Henry RR, Klein EJ, Han J, Iqbal N. Efficacy and Tolerability of Exenatide Once Weekly Over 6 Years in Patients with Type 2 Diabetes: An Uncontrolled Open-Label Extension of the DURATION-1 Study. Diabetes Technol Ther. 2016 Nov;18(11):677-686. doi: 10.1089/dia.2016.0107. Epub 2016 Aug 15.
Wysham CH, MacConell LA, Maggs DG, Zhou M, Griffin PS, Trautmann ME. Five-year efficacy and safety data of exenatide once weekly: long-term results from the DURATION-1 randomized clinical trial. Mayo Clin Proc. 2015 Mar;90(3):356-65. doi: 10.1016/j.mayocp.2015.01.008.
Grimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47-57. doi: 10.3810/pgm.2013.05.2660.
Macconell L, Pencek R, Li Y, Maggs D, Porter L. Exenatide once weekly: sustained improvement in glycemic control and cardiometabolic measures through 3 years. Diabetes Metab Syndr Obes. 2013;6:31-41. doi: 10.2147/DMSO.S35801. Epub 2013 Jan 21.
Chiquette E, Toth PP, Ramirez G, Cobble M, Chilton R. Treatment with exenatide once weekly or twice daily for 30 weeks is associated with changes in several cardiovascular risk markers. Vasc Health Risk Manag. 2012;8:621-9. doi: 10.2147/VHRM.S37969. Epub 2012 Nov 12.
Taylor K, Gurney K, Han J, Pencek R, Walsh B, Trautmann M. Exenatide once weekly treatment maintained improvements in glycemic control and weight loss over 2 years. BMC Endocr Disord. 2011 Apr 29;11:9. doi: 10.1186/1472-6823-11-9.
Buse JB, Drucker DJ, Taylor KL, Kim T, Walsh B, Hu H, Wilhelm K, Trautmann M, Shen LZ, Porter LE; DURATION-1 Study Group. DURATION-1: exenatide once weekly produces sustained glycemic control and weight loss over 52 weeks. Diabetes Care. 2010 Jun;33(6):1255-61. doi: 10.2337/dc09-1914. Epub 2010 Mar 9.
Drucker DJ, Buse JB, Taylor K, Kendall DM, Trautmann M, Zhuang D, Porter L; DURATION-1 Study Group. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study. Lancet. 2008 Oct 4;372(9645):1240-50. doi: 10.1016/S0140-6736(08)61206-4. Epub 2008 Sep 7.
FG000152 subjects
FG001151 subjects
Intent to Treat (ITT)
FG000148 subjectsSubjects who received at least one injection of lead-in exenatide 5 mcg.
FG001147 subjectsSubjects who received at least one injection of lead-in exenatide 5 mcg.
ITT in the 30-Week Assessment
FG000148 subjectsITT Subjects who received at least one injection of randomized dose.
FG001145 subjectsITT Subjects who received at least one injection of randomized dose.
Pharmacokinetics Population
FG000129 subjects
FG0010 subjects
Evaluable Meal Tolerance Cohort
FG00027 subjects
FG00124 subjects
30-Week Completed
FG000128 subjectsSubjects who completed 30 weeks of assessment
FG001130 subjectsSubjects who completed 30 weeks of assessment
COMPLETED
FG00058 subjectsSubjects who completed 364 weeks of assessment
FG00164 subjectsSubjects who completed 364 weeks of assessment
NOT COMPLETED
FG00094 subjects
FG00187 subjects
Type
Comment
Reasons
Adverse Event
FG00020 subjects
FG00114 subjects
Lost to Follow-up
FG00013 subjects
FG0018 subjects
Protocol Violation
FG0003 subjects
FG0012 subjects
Withdrawal of Consent
FG00040 subjects
FG00142 subjects
Investigator Decision
FG00011 subjects
FG00110 subjects
Loss of Glucose Control
FG0005 subjects
FG0017 subjects
Administrative
FG0001 subjects
FG0014 subjects
Other
FG0001 subjects
FG0010 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Exenatide Once Weekly -> Exenatide Once Weekly
Subcutaneous injection of 2 mg exenatide, once a week.
BG001
Exenatide Twice Daily -> Exenatide Once Weekly
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000148
BG001147
BG002295
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
Between 18 and 65 years
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00055.2± 9.72
BG00154.9± 9.63
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00066
BG00172
BG002
Glycosylated hemoglobin (HbA1c)
Mean
Standard Deviation
percentage of total hemoglobin
Title
Denominators
Categories
Title
Measurements
BG0008.3± 0.99
BG0018.3± 1.00
BG002
Weight
Mean
Standard Deviation
kg
Title
Denominators
Categories
Title
Measurements
BG000101.7± 18.76
BG001101.9± 21.05
BG002
Background Oral Antidiabetic Agent
Number
participants
Title
Denominators
Categories
Diet and Exercise
Title
Measurements
BG00021
BG00122
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change in HbA1c From Baseline to Week 30
Absolute change in HbA1c from Baseline (Day -3) to Week 30 [Week 30 - Baseline]
The ITT Population consisted of all randomized subjects who received at least one injection of study medication. Missing data up to Week 30 were imputed using the last observation carried forward (LOCF) approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Posted
Least Squares Mean
Standard Error
percentage of total hemoglobin
Day -3, Week 30
ID
Title
Description
OG000
Exenatide Once Weekly
Subcutaneous injection of 2 mg exenatide, once a week.
OG001
Exenatide Twice Daily
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
Units
Counts
Participants
OG000148
OG001147
Title
Denominators
Categories
Title
Measurements
OG000-1.87± 0.082(-2.03 to -1.71)
OG001-1.54± 0.082(-1.70 to -1.38)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Superiority of exenatide long-acting release (LAR) once weekly to BYETTA if the upper limit of the 2-sided 95% confidence interval (CI) for treatment difference (LAR minus BYETTA) is less than 0; non-inferiority if this upper limit is less than 0.4%. Power:Assuming 20% dropout rate with 246 subjects will complete the study. This sample size would provide 90% power for non-inferiority test with assumption of greater reduction (0.1%) in LAR and a common standard deviation of 1.2%.
ANOVA
Analysis of variance (ANOVA) model includes treatment, baseline HbA1c stratum (<9% or >=9%), and concomitant SU use at screening as factors.
0.0023
Least Squares Mean Difference
-0.33
Standard Error of the Mean
0.107
2-Sided
95
-0.54
-0.12
Secondary
Change in HbA1c From Baseline to Week 364
Absolute change in HbA1c from Baseline (Day -3) to Week 364
7-Year Completer Population. Missing data up to Week 364 were imputed using the last observation carried forward (LOCF) approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Posted
Least Squares Mean
95% Confidence Interval
percentage of total hemoglobin
Day -3, Week 364
ID
Title
Description
OG000
Exenatide Once Weekly -> Exenatide Once Weekly
Subcutaneous injection of 2 mg exenatide, once a week.
OG001
Exenatide Twice Daily -> Exenatide Once Weekly
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
OG002
All Treatment
Units
Counts
Participants
Primary
Sub-study Relative Bioavailability of Exenatide When Administered Using the Exenatide Once Weekly Dual Chambered Pen and the Exenatide Once Weekly Single Dose Tray (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose)
Measure by Geometric mean ratio (GMR) of plasma exenatide average steady state concentration Css,avg at Visit 11-14 to Visit 24-27 with 90% confidence interval
Not Posted
Week 22
Secondary
Percentage of Subjects Achieving HbA1c Target of <7%
Percentage of subjects achieving HbA1c target value of <7% at Week 30.
ITT Population. Missing data up to Week 30 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.
Posted
Number
percentage of subjects
Week 30
ID
Title
Description
OG000
Exenatide Once Weekly
Subcutaneous injection of 2 mg exenatide, once a week.
OG001
Exenatide Twice Daily
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
Units
Counts
Participants
OG000
Secondary
Percentage of Subjects Achieving HbA1c Target of <7%
Percentages of subjects achieving HbA1c target value of <7% at Week 364
7-Year Completer Population. Missing data up to Week 364 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.
Posted
Number
percentage of subjects
Week 364
ID
Title
Description
OG000
Exenatide Once Weekly -> Exenatide Once Weekly
Subcutaneous injection of 2 mg exenatide, once a week.
OG001
Exenatide Twice Daily -> Exenatide Once Weekly
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
OG002
All Treatment
Units
Counts
Participants
Secondary
Percentage of Subjects Achieving HbA1c Target of <=6.5%
Percentages of subjects achieving HbA1c target values of <=6.5% at Week 30.
ITT Population. Missing data up to Week 30 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.
Posted
Number
percentage of subjects
Week 30
ID
Title
Description
OG000
Exenatide Once Weekly
Subcutaneous injection of 2 mg exenatide, once a week.
OG001
Exenatide Twice Daily
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
Units
Counts
Participants
OG000
Secondary
Percentage of Subjects Achieving HbA1c Target of <=6.5%
Percentages of subjects achieving HbA1c target values of <=6.5% at Week 364
7-Year Completer Population. Missing data up to Week 364 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.
Posted
Number
percentage of subjects
Week 364
ID
Title
Description
OG000
Exenatide Once Weekly -> Exenatide Once Weekly
Subcutaneous injection of 2 mg exenatide, once a week.
OG001
Exenatide Twice Daily -> Exenatide Once Weekly
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
OG002
All Treatmeat
Units
Counts
Participants
Secondary
Percentage of Subjects Achieving HbA1c Target of <=6.0%
Percentage of subjects achieving HbA1c target values of <=6.0% at Week 30.
ITT Population. Missing data up to Week 30 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.
Posted
Number
percentage of subjects
Week 30
ID
Title
Description
OG000
Exenatide Once Weekly
Subcutaneous injection of 2 mg exenatide, once a week.
OG001
Exenatide Twice Daily
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
Units
Counts
Participants
OG000
Secondary
Exenatide LAR Steady State Concentration From Week 29 to Week 30
Steady-state plasma exenatide concentration over the dosing interval of Week 29 to Week 30 (0-168 hours) was evaluated. Geometric mean for the average steady-state concentration and its 10th and 90th percentiles were reported.
The Pharmacokinetics Population consisted of subjects who received exenatide LAR treatment, and had adequate plasma exenatide concentration-time data to allow for reliable evaluation of exenatide LAR pharmacokinetics.
Posted
Geometric Mean
Inter-Quartile Range
pg/mL
Week 29 to Week 30
ID
Title
Description
OG000
Exenatide Once Weekly
Subcutaneous injection of 2 mg exenatide, once a week.
Units
Counts
Participants
OG000
Secondary
Change in 2 Hours (2h) Postprandial Glucose From Baseline to Week 14
Change in 2h Postprandial Glucose from baseline (Day -3) to Week 14
Evaluable Meal Tolerance Cohort consisted of ITT subjects who participated in the meal tolerance test and had adequate data to allow the reliable assessment of pharmacodynamics. Only subjects with non-missing baseline and Week 14 values were included in analysis.
Posted
Least Squares Mean
Standard Error
mg/dL
Day -3, Week 14
ID
Title
Description
OG000
Exenatide Once Weekly
Subcutaneous injection of 2 mg exenatide, once a week.
OG001
Exenatide Twice Daily
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
Units
Counts
Participants
OG000
Secondary
Sub-study Safety and Tolerability of Exenatide When Administered Using the Once Weekly Single Dose Tray and the Once Weekly Dual (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose)
Measure by geometric mean ratio of the maximum steady state plasma exenatide concentration Css, max at Visit 11-14 to Visit 24-27 with 90% confidence interval and incidence of treatment-emergent injection site adverse events.
Not Posted
Week 22
Secondary
Change in Body Weight From Baseline to Week 30
Change in body weight from baseline (Day -3) to Week 30
ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Posted
Least Squares Mean
Standard Error
kg
Day -3, Week 30
ID
Title
Description
OG000
Exenatide Once Weekly
Subcutaneous injection of 2 mg exenatide, once a week.
OG001
Exenatide Twice Daily
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 week).
Units
Counts
Participants
OG000
Secondary
Change in Body Weight From Baseline to Week 364
Change in body weight from baseline (Day -3) to Week 364
7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Posted
Least Squares Mean
95% Confidence Interval
kg
Day -3, Week 364
ID
Title
Description
OG000
Exenatide Once Weekly -> Exenatide Once Weekly
Subcutaneous injection of 2 mg exenatide, once a week.
OG001
Exenatide Twice Daily -> Exenatide Once Weekly
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
OG002
All Treatment
Units
Counts
Participants
Secondary
Change in Fasting Plasma Glucose From Baseline to Week 30
Change in fasting plasma glucose from baseline (Day -3) to Week 30.
ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Posted
Least Squares Mean
Standard Error
mg/dL
Day -3, Week 30
ID
Title
Description
OG000
Exenatide Once Weekly
Subcutaneous injection of 2 mg exenatide, once a week.
OG001
Exenatide Twice Daily
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
Units
Counts
Participants
OG000
Secondary
Change in Fasting Plasma Glucose From Baseline to Week 364
Change in fasting plasma glucose from baseline (Day -3) to Week 364.
7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Posted
Least Squares Mean
95% Confidence Interval
mg/dL
Day -3, Week 364
ID
Title
Description
OG000
Exenatide Once Weekly -> Exenatide Once Weekly
Subcutaneous injection of 2 mg exenatide, once a week.
OG001
Exenatide Twice Daily -> Exenatide Once Weekly
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
OG002
All Treatment
Units
Counts
Participants
Secondary
Change in Blood Pressure From Baseline to Week 30
Change in Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure from baseline to Week 30
ITT Population using observed data.
Posted
Mean
Standard Error
mmHg
Day -3, Week 30
ID
Title
Description
OG000
Exenatide Once Weekly
Subcutaneous injection of 2 mg exenatide, once a week.
OG001
Exenatide Twice Daily
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
Units
Counts
Participants
OG000
Secondary
Change in Blood Pressure From Baseline to Week 364
Change in Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure from baseline to Week 364
7-Year Completer Population using observed data.
Posted
Mean
Standard Deviation
mmHg
Day -3, Week 364
ID
Title
Description
OG000
Exenatide Once Weekly -> Exenatide Once Weekly
Subcutaneous injection of 2 mg exenatide, once a week.
OG001
Exenatide Twice Daily -> Exenatide Once WeeklyEdit
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
OG002
All Treatment
Units
Counts
Participants
OG000
Secondary
Change in Total Cholesterol From Baseline to Week 30
Change in total cholesterol from baseline (Day -3) to Week 30.
ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Posted
Least Squares Mean
Standard Error
mg/dL
Day -3, Week 30
ID
Title
Description
OG000
Exenatide Once Weekly
Subcutaneous injection of 2 mg exenatide, once a week.
OG001
Exenatide Twice Daily
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
Units
Counts
Participants
OG000
Secondary
Change in Total Cholesterol From Baseline to Week 364
Change in total cholesterol from baseline (Day -3) to Week 364.
7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Posted
Least Squares Mean
95% Confidence Interval
mg/dL
Day -3, Week 364
ID
Title
Description
OG000
Exenatide Once Weekly -> Exenatide Once Weekly
Subcutaneous injection of 2 mg exenatide, once a week.
OG001
Exenatide Twice Daily -> Exenatide Once Weekly
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
OG002
All Treatment
Units
Counts
Participants
Secondary
Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 30
Change in high-density lipoprotein cholesterol (HDL-C) from baseline (Day -3) to Week 30.
ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Posted
Least Squares Mean
Standard Error
mg/dL
Day -3, Week 30
ID
Title
Description
OG000
Exenatide Once Weekly
Subcutaneous injection of 2 mg exenatide, once a week.
OG001
Exenatide Twice Daily
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
Units
Counts
Participants
OG000
Secondary
Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 364
Change in high-density lipoprotein cholesterol (HDL-C) from baseline (Day -3) to Week 364.
7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Posted
Least Squares Mean
95% Confidence Interval
mg/dL
Day -3, Week 364
ID
Title
Description
OG000
Exenatide Once Weekly -> Exenatide Once Weekly
Subcutaneous injection of 2 mg exenatide, once a week.
OG001
Exenatide Twice Daily -> Exenatide Once Weekly
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
OG002
All Treatment
Units
Counts
Participants
Secondary
Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 364
Change in low-density lipoprotein cholesterol (LDL-C) from baseline (Day -3) to Week 364.
7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Posted
Least Squares Mean
95% Confidence Interval
mg/dL
Day -3, Week 364
ID
Title
Description
OG000
Exenatide Once Weekly -> Exenatide Once Weekly
Subcutaneous injection of 2 mg exenatide, once a week.
OG001
Exenatide Twice Daily -> Exenatide Once Weekly
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
OG002
All Treatment
Units
Counts
Participants
Secondary
Ratio of Triglycerides at Week 30 to Baseline
Ratio of triglycerides (measured in mg/dL) at Week 30 to baseline (Day -3). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.
ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Posted
Least Squares Mean
Standard Error
ratio
Day -3, Week 30
ID
Title
Description
OG000
Exenatide Once Weekly
Subcutaneous injection of 2 mg exenatide, once a week.
OG001
Exenatide Twice Daily
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
Units
Counts
Participants
OG000
Secondary
Ratio of Triglycerides at Week 364 to Baseline
Ratio of triglycerides (measured in mg/dL) at Week 364 to baseline (Day -3). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.
7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Posted
Least Squares Mean
95% Confidence Interval
ratio
Day -3, Week 364
ID
Title
Description
OG000
Exenatide Once Weekly -> Exenatide Once Weekly
Subcutaneous injection of 2 mg exenatide, once a week.
OG001
Exenatide Twice Daily -> Exenatide Once Weekly
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
OG002
All Treatment
Units
Counts
Secondary
Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With SU Use at Screening
The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject. The minor hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.
ITT Population who participated in the 30-week assessment period and using SU at screening.
Posted
Mean
Standard Error
events per subject-year
Day 1 to Week 364
ID
Title
Description
OG000
Exenatide Once Weekly With SU
Subjects subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Week 0 to week 30.
OG001
Exenatide Twice Daily With SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) using concomitant SU at screening. Week 0 to week 30.
OG002
Secondary
Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With Non-SU Use at Screening
The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject. The minor hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.
ITT Population who participated in the 30-week assessment period and not using SU at screening.
Posted
Mean
Standard Error
events per subject-year
Day 1 to Week 364
ID
Title
Description
OG000
Exenatide Once Weekly With Non-SU
Subjects subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening. Week 0 to week 30.
OG001
Exenatide Twice Daily With Non-SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) not using concomitant SU at screening. Week 0 to week 30.
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Exenatide Once Weekly (WK 0-30)
Subcutaneous injection of 2 mg exenatide, once a week.
8
148
124
148
EG001
Exenatide Twice Daily (WK 0-30)
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
5
145
106
145
EG002
Exenatide Once Weekly -> Exenatide Once Weekly (WK 31-364)
Subcutaneous injection of 2 mg exenatide, once a week.
36
128
121
128
EG003
Exenatide Twice Daily -> Exenatide Once Weekly (WK 31-364)
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
29
130
122
130
EG004
Exenatide Once Weekly
Subcutaneous injection of 2 mg exenatide, once a week. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -> exenatide once weekly (WK 31-364), and exenatide twice daily -> exenatide once weekly (WK 31-364).
71
278
265
278
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Bacteraemia
Infections and infestations
MedDRA 17.0
EG0001 affected148 at risk
EG0010 affected145 at risk
EG0020 affected128 at risk
EG0030 affected130 at risk
EG0041 affected278 at risk
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
EG0001 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Cerebral artery occlusion
Nervous system disorders
MedDRA 17.0
EG0001 affected148 at risk
EG0010 affected145 at risk
EG0020 affected128 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 17.0
EG0001 affected148 at risk
EG0010 affected145 at risk
EG0020 affected128 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 17.0
EG0001 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
EG0001 affected148 at risk
EG0010 affected145 at risk
EG0020 affected128 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
EG0001 affected148 at risk
EG0010 affected145 at risk
EG0020 affected128 at risk
EG003
Tooth impacted
Gastrointestinal disorders
MedDRA 17.0
EG0001 affected148 at risk
EG0010 affected145 at risk
EG0020 affected128 at risk
EG003
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0011 affected145 at risk
EG0020 affected128 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0011 affected145 at risk
EG0021 affected128 at risk
EG003
Convulsion
Nervous system disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0011 affected145 at risk
EG0020 affected128 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0011 affected145 at risk
EG0021 affected128 at risk
EG003
Multiple fractures
Injury, poisoning and procedural complications
MedDRA 17.0
EG0000 affected148 at risk
EG0011 affected145 at risk
EG0020 affected128 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0011 affected145 at risk
EG0020 affected128 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0011 affected145 at risk
EG0024 affected128 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0011 affected145 at risk
EG0021 affected128 at risk
EG003
Subdural haemorrhage
Injury, poisoning and procedural complications
MedDRA 17.0
EG0000 affected148 at risk
EG0011 affected145 at risk
EG0020 affected128 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0023 affected128 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0022 affected128 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0022 affected128 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0022 affected128 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0024 affected128 at risk
EG003
Coronary artery occlusion
Cardiac disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Macular oedema
Eye disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0022 affected128 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0020 affected128 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Chest discomfort
General disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0020 affected128 at risk
EG003
Chest pain
General disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0020 affected128 at risk
EG003
Device dislocation
General disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0011 affected145 at risk
EG0020 affected128 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0022 affected128 at risk
EG003
Pyrexia
General disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0020 affected128 at risk
EG003
Bile duct stenosis
Hepatobiliary disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0023 affected128 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0020 affected128 at risk
EG003
Hepatitis cholestatic
Hepatobiliary disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0020 affected128 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0020 affected128 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Herpes zoster oticus
Infections and infestations
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0020 affected128 at risk
EG003
Infected bites
Infections and infestations
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0020 affected128 at risk
EG003
Perirectal abscess
Infections and infestations
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0020 affected128 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Craniocerebral injury
Injury, poisoning and procedural complications
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Limb crushing injury
Injury, poisoning and procedural complications
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0020 affected128 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0020 affected128 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Hyperlactacidaemia
Metabolism and nutrition disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0020 affected128 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0020 affected128 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0022 affected128 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0022 affected128 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0020 affected128 at risk
EG003
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Breast cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Endometrial adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0020 affected128 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0020 affected128 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0020 affected128 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0020 affected128 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0020 affected128 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Syncope
Nervous system disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0020 affected128 at risk
EG003
Female genital tract fistula
Reproductive system and breast disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0020 affected128 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0020 affected128 at risk
EG003
Hypertension
Vascular disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Hypotension
Vascular disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0021 affected128 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRA 17.0
EG00040 affected148 at risk
EG00149 affected145 at risk
EG00226 affected128 at risk
EG00325 affected130 at risk
EG00482 affected278 at risk
Injection site pruritus
General disorders
MedDRA 17.0
EG00027 affected148 at risk
EG0012 affected145 at risk
EG0025 affected128 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 17.0
EG00024 affected148 at risk
EG00118 affected145 at risk
EG00235 affected128 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 17.0
EG00015 affected148 at risk
EG0019 affected145 at risk
EG00211 affected128 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 17.0
EG00016 affected148 at risk
EG00127 affected145 at risk
EG00221 affected128 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 17.0
EG00015 affected148 at risk
EG00111 affected145 at risk
EG00223 affected128 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 17.0
EG00012 affected148 at risk
EG0018 affected145 at risk
EG00218 affected128 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 17.0
EG00012 affected148 at risk
EG00125 affected145 at risk
EG00254 affected128 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 17.0
EG00011 affected148 at risk
EG0013 affected145 at risk
EG0027 affected128 at risk
EG003
Injection site erythema
General disorders
MedDRA 17.0
EG00011 affected148 at risk
EG0010 affected145 at risk
EG0027 affected128 at risk
EG003
Fatigue
General disorders
MedDRA 17.0
EG0009 affected148 at risk
EG0015 affected145 at risk
EG00211 affected128 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 17.0
EG00011 affected148 at risk
EG0016 affected145 at risk
EG00215 affected128 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 17.0
EG00010 affected148 at risk
EG0018 affected145 at risk
EG00234 affected128 at risk
EG003
Headache
Nervous system disorders
MedDRA 17.0
EG0009 affected148 at risk
EG0017 affected145 at risk
EG00215 affected128 at risk
EG003
Injection site bruising
General disorders
MedDRA 17.0
EG0007 affected148 at risk
EG00114 affected145 at risk
EG0027 affected128 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 17.0
EG0007 affected148 at risk
EG00110 affected145 at risk
EG00226 affected128 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 17.0
EG0005 affected148 at risk
EG0019 affected145 at risk
EG00210 affected128 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 17.0
EG0002 affected148 at risk
EG0012 affected145 at risk
EG0028 affected128 at risk
EG003
Cataract
Eye disorders
MedDRA 17.0
EG0002 affected148 at risk
EG0010 affected145 at risk
EG00215 affected128 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 17.0
EG0005 affected148 at risk
EG0012 affected145 at risk
EG0028 affected128 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 17.0
EG0005 affected148 at risk
EG0013 affected145 at risk
EG0028 affected128 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 17.0
EG0002 affected148 at risk
EG0012 affected145 at risk
EG0027 affected128 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 17.0
EG0001 affected148 at risk
EG0010 affected145 at risk
EG00211 affected128 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 17.0
EG0001 affected148 at risk
EG0013 affected145 at risk
EG0026 affected128 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 17.0
EG0002 affected148 at risk
EG0012 affected145 at risk
EG00213 affected128 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 17.0
EG0004 affected148 at risk
EG0016 affected145 at risk
EG00218 affected128 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 17.0
EG0001 affected148 at risk
EG0012 affected145 at risk
EG0026 affected128 at risk
EG003
Ear infection
Infections and infestations
MedDRA 17.0
EG0000 affected148 at risk
EG0011 affected145 at risk
EG0026 affected128 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0029 affected128 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 17.0
EG0001 affected148 at risk
EG0011 affected145 at risk
EG0027 affected128 at risk
EG003
Influenza
Infections and infestations
MedDRA 17.0
EG0002 affected148 at risk
EG0013 affected145 at risk
EG00211 affected128 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0026 affected128 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 17.0
EG0003 affected148 at risk
EG0011 affected145 at risk
EG0027 affected128 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 17.0
EG0004 affected148 at risk
EG0011 affected145 at risk
EG00210 affected128 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 17.0
EG0003 affected148 at risk
EG0011 affected145 at risk
EG00212 affected128 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 17.0
EG0002 affected148 at risk
EG0012 affected145 at risk
EG00212 affected128 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA 17.0
EG0001 affected148 at risk
EG0011 affected145 at risk
EG0026 affected128 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 17.0
EG0001 affected148 at risk
EG0013 affected145 at risk
EG0026 affected128 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG00213 affected128 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0011 affected145 at risk
EG0027 affected128 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 17.0
EG0007 affected148 at risk
EG0016 affected145 at risk
EG00225 affected128 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
EG0002 affected148 at risk
EG0013 affected145 at risk
EG0027 affected128 at risk
EG003
Oedema peripheral
General disorders
MedDRA 17.0
EG0001 affected148 at risk
EG0010 affected145 at risk
EG0026 affected128 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
EG0007 affected148 at risk
EG0016 affected145 at risk
EG00227 affected128 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
EG0002 affected148 at risk
EG0010 affected145 at risk
EG0025 affected128 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 17.0
EG0003 affected148 at risk
EG0013 affected145 at risk
EG00212 affected128 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
EG0002 affected148 at risk
EG0010 affected145 at risk
EG00223 affected128 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 17.0
EG0005 affected148 at risk
EG0012 affected145 at risk
EG0024 affected128 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
EG0001 affected148 at risk
EG0012 affected145 at risk
EG00215 affected128 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 17.0
EG0001 affected148 at risk
EG0012 affected145 at risk
EG00221 affected128 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
EG0001 affected148 at risk
EG0010 affected145 at risk
EG0025 affected128 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 17.0
EG0002 affected148 at risk
EG0013 affected145 at risk
EG00210 affected128 at risk
EG003
Depression
Psychiatric disorders
MedDRA 17.0
EG0002 affected148 at risk
EG0014 affected145 at risk
EG00210 affected128 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 17.0
EG0004 affected148 at risk
EG0014 affected145 at risk
EG0029 affected128 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 17.0
EG0002 affected148 at risk
EG0011 affected145 at risk
EG00213 affected128 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 17.0
EG0001 affected148 at risk
EG0011 affected145 at risk
EG0027 affected128 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
EG0005 affected148 at risk
EG0012 affected145 at risk
EG00214 affected128 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG0025 affected128 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
EG0002 affected148 at risk
EG0012 affected145 at risk
EG0028 affected128 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0012 affected145 at risk
EG0027 affected128 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 17.0
EG0000 affected148 at risk
EG0010 affected145 at risk
EG00214 affected128 at risk
EG003
Hypertension
Vascular disorders
MedDRA 17.0
EG0005 affected148 at risk
EG0014 affected145 at risk
EG00222 affected128 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
LTE60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
ClinicalTrialTransparency@astrazeneca.com
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com
ID
Term
D003924
Diabetes Mellitus, Type 2
D003920
Diabetes Mellitus
Ancestor Terms
ID
Term
D044882
Glucose Metabolism Disorders
D008659
Metabolic Diseases
D009750
Nutritional and Metabolic Diseases
D004700
Endocrine System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000077270
Exenatide
Ancestor Terms
ID
Term
D010455
Peptides
D000602
Amino Acids, Peptides, and Proteins
D014688
Venoms
D045424
Complex Mixtures
D014118
Toxins, Biological
D001685
Biological Factors
Browse Leaves
Not provided
Browse Branches
Not provided
BG000122
BG001123
BG002245
>=65 years
BG00026
BG00124
BG00250
55.0
± 9.66
138
Male
BG00082
BG00175
BG002157
8.3
± 0.99
101.8
± 19.90
43
Metformin (MET)
Title
Measurements
BG00056
BG00150
BG002106
Sulfonylurea (SU)
Title
Measurements
BG0006
BG00110
BG00216
Thiazolidinediones (TZD)
Title
Measurements
BG0002
BG0017
BG0029
MET+SU
Title
Measurements
BG00043
BG00139
BG00282
MET+TZD
Title
Measurements
BG00014
BG00114
BG00228
SU+TZD
Title
Measurements
BG0005
BG0015
BG00210
SU+MET+TZD
Title
Measurements
BG0001
BG0010
BG0021
Yes
Non-Inferiority or Equivalence
The choice of a 0.4% noninferiority margin was resulted from the considerations of expected clinical benefit of BYETTA in this study based on clinical data evaluating exenatide LAR and BYETTA, regulatory guidance, published literature, and statistical considerations.
OG00058
OG00164
OG002122
Title
Denominators
Categories
Title
Measurements
OG000-1.49± 0.155(-1.80 to -1.19)
OG001-1.57± 0.144(-1.85 to -1.28)
OG002-1.53± 0.115(-1.76 to -1.31)
148
OG001147
Title
Denominators
Categories
Title
Measurements
OG00070.9
OG00151.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis: Percentages of subjects achieving HbA1c target value of <7% at Week 30 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which baseline HbA1c stratum (<9% or >=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.
Cochran-Mantel-Haenszel
0.0003
2-Sided
No
Superiority or Other
OG00058
OG00164
OG002122
Title
Denominators
Categories
Title
Measurements
OG00041.4
OG00150.0
OG00245.9
148
OG001147
Title
Denominators
Categories
Title
Measurements
OG0003.0
OG00116.3
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis: Percentage of subjects achieving HbA1c target value of <=6.5% at Week 30 were compared between treatments using CMH test, in which baseline HbA1c stratum (<9% or >=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.
Cochran-Mantel-Haenszel
0.2042
2-Sided
No
Superiority or Other
OG00058
OG00164
OG002122
Title
Denominators
Categories
Title
Measurements
OG00022.4
OG00137.5
OG00230.3
148
OG001147
Title
Denominators
Categories
Title
Measurements
OG00023.0
OG00116.3
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis: Percentages of subjects achieving HbA1c target values of <=6.0% at Week 30 were compared between treatments using CMH test, in which baseline HbA1c stratum (<9% or >=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.
Cochran-Mantel-Haenszel
0.1513
2-Sided
No
Superiority or Other
114
Title
Denominators
Categories
Title
Measurements
OG000300.23(145.13 to 702.21)
22
OG00121
Title
Denominators
Categories
Title
Measurements
OG000-95.88± 8.420(-112.92 to -78.83)
OG001-125.96± 8.292(-142.74 to -109.17)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis: Change in 2h postprandial glucose from baseline (Day -3) to Week 14 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (<9% or >=9%), and concomitant SU use at screening as factors, and baseline value of the 2h postprandial glucose as a covariate. Null hypothesis: no difference between treatments in change from baseline 2h postprandial glucose.
ANCOVA
0.0124
Least Squares Mean Difference
30.08
Standard Error of the Mean
11.458
2-Sided
95
6.88
53.28
No
Superiority or Other
148
OG001147
Title
Denominators
Categories
Title
Measurements
OG000-3.67± 0.468(-4.59 to -2.75)
OG001-3.59± 0.468(-4.51 to -2.67)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis: Change in body weight from baseline (Day -3) to Week 30 was analyzed using an analysis of covariance (ANCOVA) model including treatment, baseline HbA1c stratum (<9% or >=9%), and concomitant SU use at screening as factors, and baseline value of the body weight as a covariate. Null hypothesis: no difference between treatments in change from baseline body weight. Power: based on the primary measurement.
ANCOVA
0.8916
Least Squares Mean Difference
-0.08
Standard Error of the Mean
0.612
2-Sided
95
-1.29
1.12
No
Superiority or Other
OG00058
OG00164
OG002122
Title
Denominators
Categories
Title
Measurements
OG000-5.25± 0.468(-7.23 to -3.27)
OG001-2.71± 0.468(-4.55 to -0.87)
OG002-3.87(-5.36 to -2.37)
148
OG001147
Title
Denominators
Categories
Title
Measurements
OG000-41.5± 2.97(-47.4 to -35.7)
OG001-24.6± 2.90(-30.3 to -18.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis: Change in fasting plasma glucose from baseline (Day -3) to Week 30 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (<9% or >=9%), and concomitant SU use at screening as factors, and baseline value of the fasting plasma glucose as a covariate. Null hypothesis: no difference between treatments in change from baseline fasting plasma glucose. Power: based on the primary measurement.
ANCOVA
<.0001
Least Squares Mean Difference
-16.9
Standard Error of the Mean
3.80
2-Sided
95
-24.4
-9.4
No
Superiority or Other
OG00058
OG00164
OG002122
Title
Denominators
Categories
Title
Measurements
OG000-18.3± 2.97(-30.8 to -5.7)
OG001-27.7± 2.90(-39.0 to -16.4)
OG002-23.6(-33.0 to -14.2)
126
OG001130
Title
Denominators
Categories
Sitting Systolic Blood Pressure
Title
Measurements
OG000-4.4± 1.04
OG001-3.8± 1.28
Sitting Diastolic Blood Pressure
Title
Measurements
OG000-1.1± 0.76
OG001-2.3± 0.83
58
OG00164
OG002122
Title
Denominators
Categories
Sitting Systolic Blood Pressure
Title
Measurements
OG0001.3± 16.21
OG0011.0± 17.32
OG0021.2± 16.73
Sitting Diastolic Blood Pressure
Title
Measurements
OG000-1.7± 8.87
OG001-3.6± 9.59
OG002-2.7± 9.26
139
OG001137
Title
Denominators
Categories
Title
Measurements
OG000-11.9± 2.29(-16.4 to -7.4)
OG001-3.8± 2.35(-8.4 to 0.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis: Change in total cholesterol from baseline (Day -3) to Week 30 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (<9% or >=9%), and concomitant SU use at screening as factors, and baseline value of the total cholesterol as a covariate. Null hypothesis: no difference between treatments in change from baseline total cholesterol. Power: based on the primary measurement.
ANCOVA
0.0077
Least Squares Mean Difference
-8.2
Standard Error of the Mean
3.04
2-Sided
95
-14.1
-2.2
No
Superiority or Other
OG00058
OG00164
OG002122
Title
Denominators
Categories
Title
Measurements
OG000-15.0± 2.29(-23.6 to -6.4)
OG001-4.8± 2.35(-13.0 to 3.3)
OG002-9.6(-16.2 to -3.0)
139
OG001137
Title
Denominators
Categories
Title
Measurements
OG000-0.9± 0.56(-2.0 to 0.2)
OG001-1.3± 0.57(-2.5 to -0.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis: Change in HDL-C from baseline (Day -3) to Week 30 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (<9% or >=9%), and concomitant SU use at screening as factors, and baseline value of the HDL as a covariate. Null hypothesis: no difference between treatments in change from baseline HDL. Power: based on the primary measurement.
ANCOVA
0.5613
Least Squares Mean Difference
0.4
Standard Error of the Mean
0.74
2-Sided
95
-1.0
1.9
No
Superiority or Other
OG00058
OG00164
OG002122
Title
Denominators
Categories
Title
Measurements
OG0002.2± 0.56(-0.2 to 4.7)
OG0013.4± 0.57(1.0 to 5.7)
OG0022.8(1.0 to 4.7)
OG00058
OG00164
OG002122
Title
Denominators
Categories
Title
Measurements
OG000-13.6± 0.56(-21.3 to -6.0)
OG001-7.5± 0.57(-14.7 to -0.3)
OG002-10.4(-16.2 to -4.6)
139
OG001137
Title
Denominators
Categories
Title
Measurements
OG0000.85± 0.029(0.80 to 0.91)
OG0010.89± 0.031(0.84 to 0.96)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis: Triglycerides data were logarithm-transformed and the change at Week 30 to baseline (Day -3), expressed as the ratio, was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (<9% or >=9%), and concomitant SU use at screening as factors, and baseline value of the triglycerides as a covariate. Null hypothesis: no difference between treatments in change from baseline triglycerides. Power: based on the primary measurement.
ANCOVA
0.2915
Geometic Least Squares Mean Ratio
0.95
Standard Error of the Mean
0.042
2-Sided
95
0.87
1.04
No
Superiority or Other
Participants
OG00058
OG00164
OG002122
Title
Denominators
Categories
Title
Measurements
OG0000.91± 0.029(0.80 to 1.02)
OG0010.94± 0.031(0.84 to 1.06)
OG0020.93(0.85 to 1.01)
Exenatide Once Weekly -> Exenatide Once Weekly With SU
Subjects subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364
OG003
Exenatide Twice Daily -> Exenatide Once Weekly With SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
OG004
Exenatide Once Weekly With SU
Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -> exenatide once weekly (WK 31-364), and exenatide twice daily -> exenatide once weekly (WK 31-364).
Units
Counts
Participants
OG00055
OG00152
OG00249
OG00350
OG004105
Title
Denominators
Categories
Major hypoglycemic events
Title
Measurements
OG0000.00± 0.000
OG0010.00± 0.000
OG0020.00± 0.000
OG0030.00± 0.000
OG0040.00± 0.000
Minor hypoglycemic events
Title
Measurements
OG0000.57± 0.139
OG0010.38± 0.113
OG0020.49± 0.046
OG003
OG002
Exenatide Once Weekly -> Exenatide Once Weekly With Non-SU
Subjects subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening. Week 31 to week 364
OG003
Exenatide Twice Daily -> Exenatide Once Weekly With Non-SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week not using concomitant SU at screening. Week 31 to week 364.
OG004
Exenatide Once Weekly With Non-SU
Subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -> exenatide once weekly (WK 31-364), and exenatide twice daily -> exenatide once weekly (WK 31-364).