Trial Outcomes & Findings for Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes (NCT NCT00097500)
NCT ID: NCT00097500
Last Updated: 2015-04-07
Results Overview
Treatment effect on beta-cell function as measured by the ratio of Week 52 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period \[i.e., clamp time 290 min to 300 min\]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 52 divided by arginine-stimulated insulin secretion at baseline \[week -2\]).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
69 participants
Primary outcome timeframe
Baseline (week -2) and 52 weeks
Results posted on
2015-04-07
Participant Flow
Participant milestones
| Measure |
Exenatide Arm
5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
|
Insulin Glargine Arm
Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
|
|---|---|---|
|
On-drug Period (Week 0 to Week 52)
STARTED
|
36
|
33
|
|
On-drug Period (Week 0 to Week 52)
COMPLETED
|
30
|
30
|
|
On-drug Period (Week 0 to Week 52)
NOT COMPLETED
|
6
|
3
|
|
Off-drug Period (Week 52 to Week 64)
STARTED
|
30
|
30
|
|
Off-drug Period (Week 52 to Week 64)
COMPLETED
|
25
|
26
|
|
Off-drug Period (Week 52 to Week 64)
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Exenatide Arm
5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
|
Insulin Glargine Arm
Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
|
|---|---|---|
|
On-drug Period (Week 0 to Week 52)
Withdrawal of consent
|
1
|
1
|
|
On-drug Period (Week 0 to Week 52)
Adverse Event
|
5
|
0
|
|
On-drug Period (Week 0 to Week 52)
Physician Decision
|
0
|
1
|
|
On-drug Period (Week 0 to Week 52)
Lost to Follow-up
|
0
|
1
|
|
Off-drug Period (Week 52 to Week 64)
Withdrawal of consent
|
2
|
1
|
|
Off-drug Period (Week 52 to Week 64)
Physician Decision
|
0
|
1
|
|
Off-drug Period (Week 52 to Week 64)
Loss of glucose control
|
3
|
2
|
Baseline Characteristics
Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Exenatide Arm
n=36 Participants
5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
|
Insulin Glargine Arm
n=33 Participants
Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
58.3 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
58.4 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
30.87 kg/m^2
STANDARD_DEVIATION 4.15 • n=5 Participants
|
30.13 kg/m^2
STANDARD_DEVIATION 3.49 • n=7 Participants
|
30.52 kg/m^2
STANDARD_DEVIATION 3.84 • n=5 Participants
|
|
Body weight
|
90.56 kg
STANDARD_DEVIATION 12.66 • n=5 Participants
|
92.39 kg
STANDARD_DEVIATION 13.56 • n=7 Participants
|
91.44 kg
STANDARD_DEVIATION 13.03 • n=5 Participants
|
|
Glycosylated hemoglobin (HbA1c)
|
7.58 percentage
STANDARD_DEVIATION 0.89 • n=5 Participants
|
7.41 percentage
STANDARD_DEVIATION 0.81 • n=7 Participants
|
7.50 percentage
STANDARD_DEVIATION 0.85 • n=5 Participants
|
|
Duration of diabetes
|
5.72 years
STANDARD_DEVIATION 4.70 • n=5 Participants
|
3.97 years
STANDARD_DEVIATION 3.62 • n=7 Participants
|
4.88 years
STANDARD_DEVIATION 4.28 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (week -2) and 52 weeksPopulation: Evaluable population
Treatment effect on beta-cell function as measured by the ratio of Week 52 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period \[i.e., clamp time 290 min to 300 min\]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 52 divided by arginine-stimulated insulin secretion at baseline \[week -2\]).
Outcome measures
| Measure |
Exenatide Arm
n=30 Participants
5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
|
Insulin Glargine Arm
n=30 Participants
Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
|
|---|---|---|
|
Beta-cell Function After 52 Weeks of Therapy
|
2.89 ratio
Standard Error 0.27
|
1.15 ratio
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline (week -2) and 56 weeksPopulation: Evaluable population
Treatment effect on beta-cell function as measured by the ratio of Week 56 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period \[i.e., clamp time 290 min to 300 min\]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 56 divided by arginine-stimulated insulin secretion at baseline \[week -2\]).
Outcome measures
| Measure |
Exenatide Arm
n=30 Participants
5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
|
Insulin Glargine Arm
n=30 Participants
Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
|
|---|---|---|
|
Beta-cell Function 4 Weeks After Cessation of Therapy
|
1.02 ratio
Standard Error 0.06
|
1.08 ratio
Standard Error 0.07
|
SECONDARY outcome
Timeframe: baseline (week -2), 52 weeks, and 56 weeksPopulation: Evaluable population. Last observation carried forward.
Ratio of first phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to first phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline \[week -2\]). C-peptide is measured as a surrogate marker of insulin secretion. First phase C-peptide/insulin release is measured during the first ten minutes of glucose infusion during a hyperglycemic clamp procedure.
Outcome measures
| Measure |
Exenatide Arm
n=29 Participants
5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
|
Insulin Glargine Arm
n=30 Participants
Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
|
|---|---|---|
|
Change in First Phase C-peptide Release
52 weeks
|
1.72 ratio
Standard Error 0.11
|
1.13 ratio
Standard Error 0.07
|
|
Change in First Phase C-peptide Release
56 weeks
|
0.95 ratio
Standard Error 0.05
|
1.06 ratio
Standard Error 0.06
|
SECONDARY outcome
Timeframe: baseline (-2 weeks), 52 weeks, and 56 weeksPopulation: Evaluable population. Last observation carried forward.
Ratio of second phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to second phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline \[week -2\]). C-peptide is measured as a surrogate marker of insulin secretion. Second phase C-peptide/insulin release is measured from time=10 minutes to time=80 minutes of glucose infusion during a hyperglycemic clamp procedure.
Outcome measures
| Measure |
Exenatide Arm
n=30 Participants
5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
|
Insulin Glargine Arm
n=30 Participants
Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
|
|---|---|---|
|
Change in Second Phase C-peptide Release
52 weeks
|
2.88 ratio
Standard Error 0.18
|
1.01 ratio
Standard Error 0.07
|
|
Change in Second Phase C-peptide Release
56 weeks
|
1.00 ratio
Standard Error 0.05
|
1.08 ratio
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Week 0 and week 52Population: Intent to treat population. Last observation carried forward.
Change in HbA1c from week 0 to week 52 (i.e., HbA1c at week 52 minus HbA1c at week 0).
Outcome measures
| Measure |
Exenatide Arm
n=36 Participants
5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
|
Insulin Glargine Arm
n=33 Participants
Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
|
|---|---|---|
|
Change in Glycosylated Hemoglobin (HbA1c)
|
-0.97 percent
Standard Error 0.14
|
-0.87 percent
Standard Error 0.15
|
SECONDARY outcome
Timeframe: 0 weeks and 52 weeksPopulation: Intent to treat population. Last observation carried forward.
Change in fasting plasma glucose from week 0 to week 52 (i.e., fasting plasma glucose at week 52 minus fasting plasma glucose at week 0).
Outcome measures
| Measure |
Exenatide Arm
n=36 Participants
5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
|
Insulin Glargine Arm
n=33 Participants
Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
|
|---|---|---|
|
Change in Fasting Plasma Glucose
|
-1.53 mmol/L
Standard Error 0.25
|
-3.10 mmol/L
Standard Error 0.27
|
SECONDARY outcome
Timeframe: 0 weeks and 52 weeksPopulation: Intent to treat population.
SMBG measured at 7 time points (before and after breakfast, before and after lunch, before and after dinner, at bedtime).
Outcome measures
| Measure |
Exenatide Arm
n=36 Participants
5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
|
Insulin Glargine Arm
n=33 Participants
Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
|
|---|---|---|
|
Seven Point Self Monitored Blood Glucose (SMBG) Measurements
Pre-breakfast measurement (week 0)
|
8.92 mmol/L
Standard Deviation 1.80
|
8.38 mmol/L
Standard Deviation 1.91
|
|
Seven Point Self Monitored Blood Glucose (SMBG) Measurements
Pre-breakfast measurement (week 52)
|
7.27 mmol/L
Standard Deviation 1.63
|
5.63 mmol/L
Standard Deviation 0.85
|
|
Seven Point Self Monitored Blood Glucose (SMBG) Measurements
2-hour post-breakfast measurement (week 0)
|
11.00 mmol/L
Standard Deviation 2.58
|
11.17 mmol/L
Standard Deviation 3.30
|
|
Seven Point Self Monitored Blood Glucose (SMBG) Measurements
2-hour post-breakfast measurement (week 52)
|
6.98 mmol/L
Standard Deviation 2.42
|
7.53 mmol/L
Standard Deviation 2.16
|
|
Seven Point Self Monitored Blood Glucose (SMBG) Measurements
Pre-lunch measurement (week 0)
|
8.14 mmol/L
Standard Deviation 2.25
|
8.54 mmol/L
Standard Deviation 2.51
|
|
Seven Point Self Monitored Blood Glucose (SMBG) Measurements
Pre-lunch measurement (week 52)
|
6.52 mmol/L
Standard Deviation 1.52
|
6.24 mmol/L
Standard Deviation 1.66
|
|
Seven Point Self Monitored Blood Glucose (SMBG) Measurements
2-hour post-lunch measurement (week 0)
|
9.90 mmol/L
Standard Deviation 2.54
|
10.52 mmol/L
Standard Deviation 2.96
|
|
Seven Point Self Monitored Blood Glucose (SMBG) Measurements
2-hour post-lunch measurement (week 52)
|
7.97 mmol/L
Standard Deviation 2.01
|
8.15 mmol/L
Standard Deviation 1.77
|
|
Seven Point Self Monitored Blood Glucose (SMBG) Measurements
Pre-dinner measurement (week 0)
|
8.38 mmol/L
Standard Deviation 2.40
|
8.07 mmol/L
Standard Deviation 2.48
|
|
Seven Point Self Monitored Blood Glucose (SMBG) Measurements
Pre-dinner measurement (week 52)
|
7.53 mmol/L
Standard Deviation 2.63
|
6.98 mmol/L
Standard Deviation 2.04
|
|
Seven Point Self Monitored Blood Glucose (SMBG) Measurements
2-hour post-dinner measurement (week 0)
|
10.42 mmol/L
Standard Deviation 2.42
|
10.26 mmol/L
Standard Deviation 2.82
|
|
Seven Point Self Monitored Blood Glucose (SMBG) Measurements
2-hour post-dinner measurement (week 52)
|
6.98 mmol/L
Standard Deviation 2.25
|
8.81 mmol/L
Standard Deviation 2.03
|
|
Seven Point Self Monitored Blood Glucose (SMBG) Measurements
Bedtime measurement (week 0)
|
9.76 mmol/L
Standard Deviation 2.44
|
9.85 mmol/L
Standard Deviation 3.09
|
|
Seven Point Self Monitored Blood Glucose (SMBG) Measurements
Bedtime measurement (week 52)
|
7.61 mmol/L
Standard Deviation 2.11
|
8.03 mmol/L
Standard Deviation 2.82
|
SECONDARY outcome
Timeframe: 0 weeks and 52 weeksPopulation: Intent to treat population. Last observation carried forward.
Change in body weight from week 0 to week 52 (i.e., body weight at week 52 minus body weight at week 0).
Outcome measures
| Measure |
Exenatide Arm
n=36 Participants
5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
|
Insulin Glargine Arm
n=33 Participants
Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
|
|---|---|---|
|
Change in Body Weight
|
-3.80 kg
Standard Error 0.87
|
0.75 kg
Standard Error 0.95
|
SECONDARY outcome
Timeframe: baseline (week -2), 52 weeks, and 56 weeksPopulation: Evaluable population.
M-value at baseline (week -2), week 52 (end of on-drug period), and week 56 (during off-drug period). Insulin sensitivity was assessed during the euglycemic/hyperglycemic clamp test at baseline (week -2), week 52, and week 56. Insulin-mediated glucose uptake (M-value) was calculated as the mean glucose requirement during the 90-120 minute interval of the clamp.
Outcome measures
| Measure |
Exenatide Arm
n=30 Participants
5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
|
Insulin Glargine Arm
n=30 Participants
Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
|
|---|---|---|
|
M-value at Baseline, Week 52 and Week 56
baseline (week -2)
|
2.24 mg/min/kg
Standard Error 0.39
|
2.79 mg/min/kg
Standard Error 0.26
|
|
M-value at Baseline, Week 52 and Week 56
week 52
|
3.18 mg/min/kg
Standard Error 0.42
|
3.85 mg/min/kg
Standard Error 0.32
|
|
M-value at Baseline, Week 52 and Week 56
week 56
|
3.19 mg/min/kg
Standard Error 0.44
|
2.81 mg/min/kg
Standard Error 0.29
|
Adverse Events
Exenatide Arm
Serious events: 3 serious events
Other events: 32 other events
Deaths: 0 deaths
Insulin Glargine Arm
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exenatide Arm
n=36 participants at risk
5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
|
Insulin Glargine Arm
n=33 participants at risk
Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
|
|---|---|---|
|
Cardiac disorders
Coronary Artery Stenosis
|
2.8%
1/36 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
0.00%
0/33 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
|
Gastrointestinal disorders
Pancreatitis
|
2.8%
1/36 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
0.00%
0/33 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
|
Infections and infestations
Diverticulitis
|
2.8%
1/36 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
0.00%
0/33 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
|
Vascular disorders
Thrombophlebitis Superficial
|
0.00%
0/36 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
3.0%
1/33 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
Other adverse events
| Measure |
Exenatide Arm
n=36 participants at risk
5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
|
Insulin Glargine Arm
n=33 participants at risk
Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.8%
1/36 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
12.1%
4/33 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
|
Gastrointestinal disorders
Abdominal Distension
|
11.1%
4/36 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
0.00%
0/33 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
3/36 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
3.0%
1/33 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
|
Gastrointestinal disorders
Dyspepsia
|
13.9%
5/36 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
6.1%
2/33 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
|
Gastrointestinal disorders
Flatulence
|
8.3%
3/36 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
0.00%
0/33 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
18/36 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
0.00%
0/33 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
4/36 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
0.00%
0/33 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
|
General disorders
Injection Site Rash
|
8.3%
3/36 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
0.00%
0/33 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
|
General disorders
Edema Peripheral
|
0.00%
0/36 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
6.1%
2/33 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
|
Infections and infestations
Gastroenteritis
|
2.8%
1/36 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
12.1%
4/33 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
|
Infections and infestations
Influenza
|
13.9%
5/36 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
27.3%
9/33 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
|
Infections and infestations
Laryngitis
|
5.6%
2/36 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
3.0%
1/33 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/36 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
6.1%
2/33 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
|
Infections and infestations
Urinary Tract Infection
|
8.3%
3/36 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
6.1%
2/33 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
8.3%
3/36 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
0.00%
0/33 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.00%
0/36 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
9.1%
3/33 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
16.7%
6/36 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
30.3%
10/33 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
2/36 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
12.1%
4/33 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
|
Nervous system disorders
Headache
|
2.8%
1/36 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
6.1%
2/33 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
|
Renal and urinary disorders
Proteinuria
|
5.6%
2/36 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
0.00%
0/33 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
|
Vascular disorders
Hypertension
|
0.00%
0/36 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
6.1%
2/33 • Total reporting period for adverse events is 64 weeks: a 52-week on-drug period followed by a 12-week off-drug period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60