Trial Outcomes & Findings for Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus (NCT NCT02229383)
NCT ID: NCT02229383
Last Updated: 2019-01-08
Results Overview
To compare the change from baseline in HbA1c achieved with exenatide once weekly (EQW) added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment. SU= sulfonylurea.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
464 participants
Primary outcome timeframe
Baseline to Week 28
Results posted on
2019-01-08
Participant Flow
This study was conducted in 107 centers globally between 06 September 2014 and 29 August 2016.
The study had a Screening Visit, an 8-week insulin dose optimization phase, followed by a 28-week randomized, double-blind treatment phase. A total of 464 participants were randomized and entered the double-blind Treatment Period. Of which, 3 participants from 1 center in the United States have been excluded from analyses.
Participant milestones
| Measure |
Exenatide
Exenatide 2 milligram (mg) 1 time per week + titrated basal insulin glargine with or without metformin.
|
Placebo
Placebo (matching with exenatide) 1 time per week + titrated basal insulin glargine with or without metformin.
|
|---|---|---|
|
Overall Study
STARTED
|
232
|
229
|
|
Overall Study
Received Treatment
|
231
|
229
|
|
Overall Study
Safety Analysis Set
|
231
|
229
|
|
Overall Study
Intent-to-treat (ITT) Analysis Set
|
230
|
228
|
|
Overall Study
COMPLETED
|
212
|
207
|
|
Overall Study
NOT COMPLETED
|
20
|
22
|
Reasons for withdrawal
| Measure |
Exenatide
Exenatide 2 milligram (mg) 1 time per week + titrated basal insulin glargine with or without metformin.
|
Placebo
Placebo (matching with exenatide) 1 time per week + titrated basal insulin glargine with or without metformin.
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
4
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
6
|
|
Overall Study
Did not receive treatment
|
1
|
0
|
|
Overall Study
Other
|
3
|
8
|
Baseline Characteristics
Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Exenatide
n=230 Participants
Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin.
|
Placebo
n=228 Participants
Placebo (matching with exenatide) 1 time per week + titrated basal insulin glargine with or without metformin.
|
Total
n=458 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.8 Years
STANDARD_DEVIATION 9.04 • n=5 Participants
|
57.5 Years
STANDARD_DEVIATION 10.28 • n=7 Participants
|
57.7 Years
STANDARD_DEVIATION 9.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
239 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
219 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian Or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black Or African American
|
19 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian Or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
204 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
398 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 28Population: The ITT analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment. Only participants with data available for analysis are presented.
To compare the change from baseline in HbA1c achieved with exenatide once weekly (EQW) added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment. SU= sulfonylurea.
Outcome measures
| Measure |
Exenatide
n=230 Participants
Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin.
|
Placebo
n=228 Participants
Placebo (matching with exenatide) 1 time per week + titrated basal insulin glargine with or without metformin.
|
|---|---|---|
|
Change in HbA1c From Baseline to Week 28
|
-0.96 Percentage of HbA1c
Interval -1.12 to -0.81
|
-0.22 Percentage of HbA1c
Interval -0.38 to -0.07
|
SECONDARY outcome
Timeframe: Baseline to Week 28Population: The ITT analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment. Only participants with data available for analysis are presented.
To compare the change from baseline in body weight achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.
Outcome measures
| Measure |
Exenatide
n=230 Participants
Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin.
|
Placebo
n=228 Participants
Placebo (matching with exenatide) 1 time per week + titrated basal insulin glargine with or without metformin.
|
|---|---|---|
|
Change in Body Weight From Baseline to Week 28
|
-1.04 kilogram
Interval -1.54 to -0.53
|
0.48 kilogram
Interval -0.02 to 0.98
|
SECONDARY outcome
Timeframe: Baseline to Week 28Population: The ITT analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment. Only participants with data available for analysis are presented.
To compare the change from baseline in 2-hour postprandial glucose after a standard MTT achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.
Outcome measures
| Measure |
Exenatide
n=230 Participants
Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin.
|
Placebo
n=228 Participants
Placebo (matching with exenatide) 1 time per week + titrated basal insulin glargine with or without metformin.
|
|---|---|---|
|
Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test (MTT)
|
-28.73 milligram per deciliter
Interval -40.0 to -17.45
|
-0.96 milligram per deciliter
Interval -12.41 to 10.48
|
SECONDARY outcome
Timeframe: Baseline to Week 28Population: The ITT analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.
To compare the percentage of participants achieving HbA1c \<7.0% between EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.
Outcome measures
| Measure |
Exenatide
n=230 Participants
Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin.
|
Placebo
n=228 Participants
Placebo (matching with exenatide) 1 time per week + titrated basal insulin glargine with or without metformin.
|
|---|---|---|
|
Percentage of Participants Achieving HbA1c <7.0% at Week 28
|
32.6 Percentage of participants
Interval 26.6 to 38.7
|
7.0 Percentage of participants
Interval 3.7 to 10.3
|
SECONDARY outcome
Timeframe: Baseline to Week 28Population: The ITT analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment. Only participants with data available for analysis are presented.
To compare the change from baseline in daily insulin dose achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.
Outcome measures
| Measure |
Exenatide
n=230 Participants
Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin.
|
Placebo
n=228 Participants
Placebo (matching with exenatide) 1 time per week + titrated basal insulin glargine with or without metformin.
|
|---|---|---|
|
Change From Baseline to Week 28 in Daily Insulin Dose
|
1.6 Units
Interval 0.1 to 3.1
|
3.5 Units
Interval 2.0 to 5.1
|
SECONDARY outcome
Timeframe: Baseline to Week 28Population: The ITT analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.
To compare the percentage of participants achieving HbA1c \<7.0% at Week 28, no weight gain at Week 28, and no major hypoglycemia over 28 weeks between EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin.
Outcome measures
| Measure |
Exenatide
n=230 Participants
Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin.
|
Placebo
n=228 Participants
Placebo (matching with exenatide) 1 time per week + titrated basal insulin glargine with or without metformin.
|
|---|---|---|
|
Percentage of Participants Achieving HbA1c <7.0% at Week 28, No Weight Gain at Week 28, and No Major Hypoglycemia Over 28 Weeks
|
22.2 Percentage of participants
Interval 16.8 to 27.5
|
2.2 Percentage of participants
Interval 0.3 to 4.1
|
SECONDARY outcome
Timeframe: Baseline to Week 28Population: The ITT analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment. Only participants with data available for analysis are presented.
To compare the change from baseline in seated systolic blood pressure achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.
Outcome measures
| Measure |
Exenatide
n=230 Participants
Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin.
|
Placebo
n=228 Participants
Placebo (matching with exenatide) 1 time per week + titrated basal insulin glargine with or without metformin.
|
|---|---|---|
|
Change in Seated Systolic Blood Pressure From Baseline to Week 28
|
-2.5 millimeter of mercury
Interval -4.4 to -0.7
|
-0.7 millimeter of mercury
Interval -2.6 to 1.1
|
Adverse Events
Exenatide
Serious events: 11 serious events
Other events: 40 other events
Deaths: 0 deaths
Placebo
Serious events: 11 serious events
Other events: 36 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Exenatide
n=231 participants at risk
Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin.
|
Placebo
n=229 participants at risk
Placebo (matching with exenatide) 1 time per week + titrated basal insulin glargine with or without metformin.
|
|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.00%
0/231 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
0.44%
1/229 • Number of events 1 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/231 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
0.87%
2/229 • Number of events 2 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
|
Cardiac disorders
Coronary artery disease
|
0.43%
1/231 • Number of events 1 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
0.44%
1/229 • Number of events 1 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.43%
1/231 • Number of events 1 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
0.00%
0/229 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/231 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
0.44%
1/229 • Number of events 1 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
|
Gastrointestinal disorders
Abdominal mass
|
0.43%
1/231 • Number of events 1 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
0.00%
0/229 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.43%
1/231 • Number of events 1 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
0.00%
0/229 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.43%
1/231 • Number of events 1 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
0.00%
0/229 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
|
General disorders
Chest pain
|
0.43%
1/231 • Number of events 1 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
0.00%
0/229 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/231 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
0.44%
1/229 • Number of events 1 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
|
Infections and infestations
Cellulitis
|
0.43%
1/231 • Number of events 1 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
0.44%
1/229 • Number of events 1 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/231 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
0.44%
1/229 • Number of events 1 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
|
Infections and infestations
Osteomyelitis
|
0.43%
1/231 • Number of events 1 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
0.00%
0/229 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/231 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
0.44%
1/229 • Number of events 1 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.43%
1/231 • Number of events 1 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
0.00%
0/229 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.43%
1/231 • Number of events 1 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
0.00%
0/229 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/231 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
0.87%
2/229 • Number of events 2 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.43%
1/231 • Number of events 1 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
0.00%
0/229 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/231 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
0.44%
1/229 • Number of events 1 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
|
Nervous system disorders
Headache
|
0.00%
0/231 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
0.44%
1/229 • Number of events 1 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/231 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
0.44%
1/229 • Number of events 1 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
|
Psychiatric disorders
Acute stress disorder
|
0.43%
1/231 • Number of events 1 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
0.00%
0/229 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.43%
1/231 • Number of events 1 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
0.00%
0/229 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
|
Psychiatric disorders
Depression
|
0.43%
1/231 • Number of events 1 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
0.00%
0/229 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.43%
1/231 • Number of events 1 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
0.00%
0/229 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
|
Renal and urinary disorders
Bladder neck obstruction
|
0.00%
0/231 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
0.44%
1/229 • Number of events 1 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.43%
1/231 • Number of events 1 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
0.00%
0/229 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
Other adverse events
| Measure |
Exenatide
n=231 participants at risk
Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin.
|
Placebo
n=229 participants at risk
Placebo (matching with exenatide) 1 time per week + titrated basal insulin glargine with or without metformin.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
5.2%
12/231 • Number of events 13 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
3.9%
9/229 • Number of events 10 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
|
General disorders
Injection site nodule
|
5.2%
12/231 • Number of events 14 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
0.44%
1/229 • Number of events 1 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
|
Infections and infestations
Urinary tract infection
|
7.8%
18/231 • Number of events 25 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
6.6%
15/229 • Number of events 21 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.2%
5/231 • Number of events 6 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
5.7%
13/229 • Number of events 15 • From Baseline (Day 1) up to Week 28
Safety analysis set included all participants who received at least 1 dose of randomized study medication. All-Cause Mortality is reported for the overall study period, including the off-treatment period; Serious and Other adverse event data is reported for the on-treatment period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At least 30 days prior to submission for publication or presentation, Authors shall provide Sponsor with such material for its review. Sponsor shall have 30 days to comment. If requested by Sponsor, Authors shall withhold material for an additional 90 days to allow for the taking of measures to establish its proprietary rights. No publication or presentation shall be made unless and until any information determined at Sponsor's sole discretion to be Confidential has been removed.
- Publication restrictions are in place
Restriction type: OTHER