Trial Outcomes & Findings for An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes (NCT NCT00516048)
NCT ID: NCT00516048
Last Updated: 2015-04-07
Results Overview
Patients who experienced specified treatment-emergent antibody status at any point during the study (grouped by maximum titer level experienced)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
58 participants
Primary outcome timeframe
24 weeks
Results posted on
2015-04-07
Participant Flow
Following a period of treatment interruption of at least 2 months, patients for this study were recruited from among patients who were previously exposed to exenatide for at least 3 months in Amylin/Lilly studies GWAO, GWAP, GWAT, and GWBA.
Participant milestones
| Measure |
Exenatide:Treatment-Emergent Antibody Negative
5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
|
Exenatide: Treatment-Emergent Antibody Positive
5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
|
Enrolled But Withdrew Before Receiving Treatment
No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
42
|
1
|
|
Overall Study
COMPLETED
|
15
|
40
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
Exenatide:Treatment-Emergent Antibody Negative
5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
|
Exenatide: Treatment-Emergent Antibody Positive
5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
|
Enrolled But Withdrew Before Receiving Treatment
No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
1
|
|
Overall Study
Subject Decision
|
0
|
2
|
0
|
Baseline Characteristics
An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Negative Baseline (Week 0) Antibody Status
n=50 Participants
Patients assessed as negative for antibodies to exenatide at baseline (Week 0).
|
Positive Baseline (Week 0) Antibody Status
n=8 Participants
Patients assessed as positive for antibodies to exenatide at baseline (Week 0).
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Age, Continuous
|
60.65 years
STANDARD_DEVIATION 8.95 • n=93 Participants
|
49.88 years
STANDARD_DEVIATION 9.84 • n=4 Participants
|
59.17 years
STANDARD_DEVIATION 9.74 • n=27 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Intent to Treat
Patients who experienced specified treatment-emergent antibody status at any point during the study (grouped by maximum titer level experienced)
Outcome measures
| Measure |
Exenatide:Treatment-Emergent Antibody Negative
n=15 Participants
5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
|
Exenatide: Treatment-Emergent Antibody Positive
n=42 Participants
5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
|
Enrolled But Withdrew Before Receiving Treatment
n=1 Participants
No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
|
|---|---|---|---|
|
Treatment-emergent Antibody Status (Maximum Titer Level Experienced)
Antibody negative
|
15 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-emergent Antibody Status (Maximum Titer Level Experienced)
Low titer antibodies
|
0 Participants
|
25 Participants
|
0 Participants
|
|
Treatment-emergent Antibody Status (Maximum Titer Level Experienced)
Higher titer antibodies
|
0 Participants
|
17 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Intent to Treat
Number of patients experiencing a potentially immune-related treatment-emergent adverse event at any point during the study
Outcome measures
| Measure |
Exenatide:Treatment-Emergent Antibody Negative
n=15 Participants
5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
|
Exenatide: Treatment-Emergent Antibody Positive
n=42 Participants
5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
|
Enrolled But Withdrew Before Receiving Treatment
n=1 Participants
No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
|
|---|---|---|---|
|
Incidence of Potentially Immune-related Treatment-emergent Adverse Events
Arthralgia
|
1 participants
|
0 participants
|
0 participants
|
|
Incidence of Potentially Immune-related Treatment-emergent Adverse Events
Spinal osteoarthritis
|
1 participants
|
0 participants
|
0 participants
|
|
Incidence of Potentially Immune-related Treatment-emergent Adverse Events
Injection site pruritis
|
0 participants
|
2 participants
|
0 participants
|
|
Incidence of Potentially Immune-related Treatment-emergent Adverse Events
Injection site rash
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Potentially Immune-related Treatment-emergent Adverse Events
Rash
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Potentially Immune-related Treatment-emergent Adverse Events
Eye allergy
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Intent to Treat; Last Observation Carried Forward
Change in HbA1c from baseline (Week 0) to endpoint (Week 24) by treatment-emergent antibody status
Outcome measures
| Measure |
Exenatide:Treatment-Emergent Antibody Negative
n=15 Participants
5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
|
Exenatide: Treatment-Emergent Antibody Positive
n=42 Participants
5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
|
Enrolled But Withdrew Before Receiving Treatment
n=1 Participants
No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
|
|---|---|---|---|
|
Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint
Baseline HbA1c (Week 0)
|
8.13 percent
Standard Deviation 0.66
|
8.05 percent
Standard Deviation 1.00
|
0 percent
Standard Deviation 0
|
|
Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint
Change in HbA1c at endpoint (Week 24)
|
-1.03 percent
Standard Deviation 0.74
|
-0.30 percent
Standard Deviation 0.94
|
0 percent
Standard Deviation 0
|
Adverse Events
Exenatide:Treatment-Emergent Antibody Negative
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Exenatide: Treatment-Emergent Antibody Positive
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Enrolled But Withdrew Before Receiving Treatment
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exenatide:Treatment-Emergent Antibody Negative
5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
|
Exenatide: Treatment-Emergent Antibody Positive
5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
|
Enrolled But Withdrew Before Receiving Treatment
No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/15
|
2.4%
1/42
|
0.00%
0/1
|
|
General disorders
Sudden death
|
0.00%
0/15
|
0.00%
0/42
|
100.0%
1/1
|
Other adverse events
| Measure |
Exenatide:Treatment-Emergent Antibody Negative
5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
|
Exenatide: Treatment-Emergent Antibody Positive
5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
|
Enrolled But Withdrew Before Receiving Treatment
No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.7%
1/15
|
4.8%
2/42
|
0.00%
0/1
|
|
Infections and infestations
Influenza
|
0.00%
0/15
|
4.8%
2/42
|
0.00%
0/1
|
|
General disorders
Injection site pruritis
|
0.00%
0/15
|
4.8%
2/42
|
0.00%
0/1
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/15
|
4.8%
2/42
|
0.00%
0/1
|
|
Infections and infestations
Viral infection
|
0.00%
0/15
|
4.8%
2/42
|
0.00%
0/1
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15
|
2.4%
1/42
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15
|
0.00%
0/42
|
0.00%
0/1
|
|
Gastrointestinal disorders
Gastrooesphageal reflux disease
|
6.7%
1/15
|
0.00%
0/42
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.7%
1/15
|
0.00%
0/42
|
0.00%
0/1
|
|
Infections and infestations
Otitis externa
|
6.7%
1/15
|
0.00%
0/42
|
0.00%
0/1
|
|
Infections and infestations
Otitis media
|
6.7%
1/15
|
0.00%
0/42
|
0.00%
0/1
|
|
Gastrointestinal disorders
Periodontitis
|
6.7%
1/15
|
0.00%
0/42
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
6.7%
1/15
|
0.00%
0/42
|
0.00%
0/1
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15
|
0.00%
0/42
|
0.00%
0/1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60