Trial Outcomes & Findings for Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes (NCT NCT00434954)
NCT ID: NCT00434954
Last Updated: 2015-04-07
Results Overview
Change in HbA1c from baseline after 26 weeks of treatment (i.e., HbA1c at week 26 minus HbA1c at week 0)
COMPLETED
PHASE3
494 participants
Baseline and 26 weeks
2015-04-07
Participant Flow
Patients treated with metformin (MET only;confirmatory population used for primary analysis) and additional patients treated with metformin plus either sulfonylurea or meglitinide (MET+SU; exploratory population) were enrolled at a 3:1 ratio; metformin was continued.Within each population, patients were then randomly assigned 1:1 to study treatment
Participant milestones
| Measure |
Exenatide Twice Daily
Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
|
Premixed Insulin Aspart Twice Daily
Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
248
|
246
|
|
Overall Study
Started - Previous Treatment MET Only
|
182
|
181
|
|
Overall Study
Started - Previous Treatment MET + SU
|
66
|
65
|
|
Overall Study
Full Analysis Set (FAS) Overall
|
247
|
233
|
|
Overall Study
FAS - Previous Treatment MET Only
|
181
|
173
|
|
Overall Study
FAS - Previous Treatment MET + SU
|
66
|
60
|
|
Overall Study
Completed - Previous Treatment MET Only
|
135
|
137
|
|
Overall Study
Completed - Previous Treatment MET + SU
|
31
|
38
|
|
Overall Study
COMPLETED
|
166
|
175
|
|
Overall Study
NOT COMPLETED
|
82
|
71
|
Reasons for withdrawal
| Measure |
Exenatide Twice Daily
Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
|
Premixed Insulin Aspart Twice Daily
Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
17
|
2
|
|
Overall Study
Entry criteria not met
|
14
|
16
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
6
|
3
|
|
Overall Study
Protocol Violation
|
36
|
27
|
|
Overall Study
Sponsor decision
|
1
|
0
|
|
Overall Study
Subject decision
|
8
|
22
|
Baseline Characteristics
Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Exenatide Twice Daily
n=181 Participants
Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
|
Premixed Insulin Aspart Twice Daily
n=173 Participants
Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
|
Total
n=354 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
138 Participants
n=99 Participants
|
133 Participants
n=107 Participants
|
271 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
43 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Age, Continuous
|
57.2 years
STANDARD_DEVIATION 10.03 • n=99 Participants
|
56.9 years
STANDARD_DEVIATION 9.94 • n=107 Participants
|
57.1 years
STANDARD_DEVIATION 9.97 • n=206 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
150 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=99 Participants
|
96 Participants
n=107 Participants
|
204 Participants
n=206 Participants
|
|
Body Mass Index (BMI)
|
33.4 kg / m^2
STANDARD_DEVIATION 4.23 • n=99 Participants
|
32.9 kg / m^2
STANDARD_DEVIATION 4.37 • n=107 Participants
|
33.2 kg / m^2
STANDARD_DEVIATION 4.30 • n=206 Participants
|
|
Body Weight
|
99.4 kg
STANDARD_DEVIATION 16.22 • n=99 Participants
|
96.6 kg
STANDARD_DEVIATION 17.40 • n=107 Participants
|
98.0 kg
STANDARD_DEVIATION 16.85 • n=206 Participants
|
|
Duration of Diabetes
|
4.8 years
STANDARD_DEVIATION 4.39 • n=99 Participants
|
5.2 years
STANDARD_DEVIATION 4.67 • n=107 Participants
|
5.0 years
STANDARD_DEVIATION 4.53 • n=206 Participants
|
|
Glycosylated hemoglobin (HbA1c)
|
7.89 percentage
STANDARD_DEVIATION 0.822 • n=99 Participants
|
7.88 percentage
STANDARD_DEVIATION 0.918 • n=107 Participants
|
7.88 percentage
STANDARD_DEVIATION 0.869 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 26 weeksPopulation: All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS) and had baseline and at least one post-baseline value available
Change in HbA1c from baseline after 26 weeks of treatment (i.e., HbA1c at week 26 minus HbA1c at week 0)
Outcome measures
| Measure |
Exenatide Twice Daily
n=181 Participants
Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
|
Premixed Insulin Aspart Twice Daily
n=173 Participants
Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
|
|---|---|---|
|
Change in Glycosylated Hemoglobin (HbA1c)
|
-1.00 Percentage of glycosylated hemoglobin
Standard Error 0.05
|
-1.14 Percentage of glycosylated hemoglobin
Standard Error 0.05
|
PRIMARY outcome
Timeframe: 26 weeksPopulation: All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS)
Risk for first hypoglycemic episode (blood glucose \<=3.9 mmol/L or severe episode) to occur up to week 26
Outcome measures
| Measure |
Exenatide Twice Daily
n=181 Participants
Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
|
Premixed Insulin Aspart Twice Daily
n=173 Participants
Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
|
|---|---|---|
|
Incidence of Hypoglycemia (Percentage of Participants With at Least One Hypoglycemic Episode)
|
8.0 Percentage of participants
|
20.5 Percentage of participants
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward
Percentage of subjects achieving HbA1c target of \< 6.5% at the end of study (week 26) \[i.e., number of subjects who achieved HbA1c \< 6.5% divided by total number of subjects times 100%\].
Outcome measures
| Measure |
Exenatide Twice Daily
n=181 Participants
Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
|
Premixed Insulin Aspart Twice Daily
n=173 Participants
Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
|
|---|---|---|
|
Percentage of Subjects Achieving HbA1c Target of < 6.5%
|
27.6 Percentage of participants
|
24.9 Percentage of participants
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward
Percentage of subjects achieving HbA1c target of \< 7.0% at the end of study (week 26) \[i.e., number of subjects who achieved HbA1c \< 7.0% divided by total number of subjects times 100%\].
Outcome measures
| Measure |
Exenatide Twice Daily
n=181 Participants
Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
|
Premixed Insulin Aspart Twice Daily
n=173 Participants
Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
|
|---|---|---|
|
Percentage of Subjects Achieving HbA1c Target of < 7.0%
|
49.2 Percentage of participants
|
56.6 Percentage of participants
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS)
Risk for the first hypoglycemic episode to occur up to Week 26 (percentage of subjects who experienced at least one treatment-emergent hypoglycemic episode during the 26-week treatment period)\[ i.e., number of subjects experiencing at least one hypoglycemic episode divided by total number of subjects times 100%\]
Outcome measures
| Measure |
Exenatide Twice Daily
n=181 Participants
Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
|
Premixed Insulin Aspart Twice Daily
n=173 Participants
Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
|
|---|---|---|
|
Incidence of Hypoglycemic Episodes [Blood Glucose <= 3.0 mmol/L or Severe] (Percentage of Subjects Who Experienced at Least One Treatment-emergent Hypoglycemic Episode During the 26-week Treatment Period)
|
1.8 Percentage of participants
|
6.3 Percentage of participants
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS)
Risk for first nocturnal (night-time) hypoglycemic episode to occur up to week 26 (percentage of subjects who experienced at least one episode of nocturnal hypoglycemia during the 26 week treatment period) \[i.e., number of subjects who experienced nocturnal hypoglycemia divided by total number of subjects times 100%\].
Outcome measures
| Measure |
Exenatide Twice Daily
n=181 Participants
Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
|
Premixed Insulin Aspart Twice Daily
n=173 Participants
Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
|
|---|---|---|
|
Incidence of Nocturnal Hypoglycemia (Percentage of Subjects Who Experienced at Least One Episode of Nocturnal Hypoglycemia During the 26 Week Treatment Period)
|
3.9 Percentage of participants
|
7.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward
7-point self-monitored blood glucose profiles at baseline and the end of the study, measured at 7 times during the day (pre-breakfast, 2 hours post-breakfast, pre-lunch, 2 hours post-lunch, pre-dinner, 2 hours post-dinner, and 3:00am).
Outcome measures
| Measure |
Exenatide Twice Daily
n=181 Participants
Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
|
Premixed Insulin Aspart Twice Daily
n=173 Participants
Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
|
|---|---|---|
|
7 Point Self-monitored Blood Glucose (SMBG) Profiles
2 hrs post-breakfast at baseline (week 0)
|
10.821 mg/dL
Standard Deviation 2.5306
|
10.902 mg/dL
Standard Deviation 2.8499
|
|
7 Point Self-monitored Blood Glucose (SMBG) Profiles
2 hrs post-breakfast at endpoint (week 26)
|
8.014 mg/dL
Standard Deviation 2.0557
|
8.304 mg/dL
Standard Deviation 2.1212
|
|
7 Point Self-monitored Blood Glucose (SMBG) Profiles
Pre-lunch at baseline (week 0)
|
8.443 mg/dL
Standard Deviation 2.1814
|
8.357 mg/dL
Standard Deviation 2.3221
|
|
7 Point Self-monitored Blood Glucose (SMBG) Profiles
Pre-lunch at endpoint (week 26)
|
7.506 mg/dL
Standard Deviation 1.8800
|
6.656 mg/dL
Standard Deviation 1.7011
|
|
7 Point Self-monitored Blood Glucose (SMBG) Profiles
2 hrs post-lunch at baseline (week 0)
|
9.698 mg/dL
Standard Deviation 2.2370
|
9.899 mg/dL
Standard Deviation 2.6433
|
|
7 Point Self-monitored Blood Glucose (SMBG) Profiles
2 hrs post-lunch at endpoint (week 26)
|
8.513 mg/dL
Standard Deviation 5.8997
|
8.216 mg/dL
Standard Deviation 1.6108
|
|
7 Point Self-monitored Blood Glucose (SMBG) Profiles
Pre-dinner at baseline (week 0)
|
8.684 mg/dL
Standard Deviation 2.0059
|
8.759 mg/dL
Standard Deviation 2.2174
|
|
7 Point Self-monitored Blood Glucose (SMBG) Profiles
Pre-dinner at endpoint (week 26)
|
7.616 mg/dL
Standard Deviation 2.1727
|
7.194 mg/dL
Standard Deviation 1.5572
|
|
7 Point Self-monitored Blood Glucose (SMBG) Profiles
2 hrs post-dinner at baseline (week 0)
|
10.241 mg/dL
Standard Deviation 2.2880
|
10.259 mg/dL
Standard Deviation 2.4868
|
|
7 Point Self-monitored Blood Glucose (SMBG) Profiles
3:00 am at baseline (week 0)
|
8.323 mg/dL
Standard Deviation 1.8692
|
8.475 mg/dL
Standard Deviation 2.2643
|
|
7 Point Self-monitored Blood Glucose (SMBG) Profiles
3:00 am at endpoint (week 26)
|
7.518 mg/dL
Standard Deviation 1.5861
|
6.999 mg/dL
Standard Deviation 1.5596
|
|
7 Point Self-monitored Blood Glucose (SMBG) Profiles
Pre-breakfast at baseline (week 0)
|
8.933 mg/dL
Standard Deviation 1.7138
|
9.005 mg/dL
Standard Deviation 2.0432
|
|
7 Point Self-monitored Blood Glucose (SMBG) Profiles
Pre-breakfast at endpoint (week 26)
|
7.774 mg/dL
Standard Deviation 1.7730
|
7.293 mg/dL
Standard Deviation 1.3349
|
|
7 Point Self-monitored Blood Glucose (SMBG) Profiles
2 hrs post-dinner at endpoint (week 26)
|
7.727 mg/dL
Standard Deviation 1.8820
|
8.143 mg/dL
Standard Deviation 1.5614
|
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward
Total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol (calculated), and triglyceride levels at baseline (week 0) and the end of the study (week 26)
Outcome measures
| Measure |
Exenatide Twice Daily
n=181 Participants
Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
|
Premixed Insulin Aspart Twice Daily
n=173 Participants
Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
|
|---|---|---|
|
Blood Lipid Levels
Total cholesterol at baseline (week 0)
|
5.147 mmol/L
Standard Deviation 1.0008
|
5.084 mmol/L
Standard Deviation 1.0079
|
|
Blood Lipid Levels
Total cholesterol at endpoint (week 26)
|
4.971 mmol/L
Standard Deviation 0.9653
|
5.050 mmol/L
Standard Deviation 0.8933
|
|
Blood Lipid Levels
HDL cholesterol at endpoint (week 26)
|
1.244 mmol/L
Standard Deviation 0.2805
|
1.319 mmol/L
Standard Deviation 0.3394
|
|
Blood Lipid Levels
LDL cholesterol (calculated) at baseline (week 0)
|
2.845 mmol/L
Standard Deviation 0.8308
|
2.768 mmol/L
Standard Deviation 0.8103
|
|
Blood Lipid Levels
LDL cholesterol (calculated) at endpoint (week 26)
|
2.738 mmol/L
Standard Deviation 0.8472
|
2.852 mmol/L
Standard Deviation 0.8134
|
|
Blood Lipid Levels
Triglycerides at baseline (week 0)
|
2.391 mmol/L
Standard Deviation 1.5497
|
2.410 mmol/L
Standard Deviation 1.4398
|
|
Blood Lipid Levels
Triglycerides at endpoint (week 26)
|
2.234 mmol/L
Standard Deviation 1.1886
|
2.006 mmol/L
Standard Deviation 1.2040
|
|
Blood Lipid Levels
HDL cholesterol at baseline (week 0)
|
1.234 mmol/L
Standard Deviation 0.3065
|
1.255 mmol/L
Standard Deviation 0.3324
|
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS) and had baseline and at least one post-baseline value available; last observation carried forward
Change in body weight from baseline after 26 weeks of treatment (i.e., body weight at week 26 minus body weight at week 0)
Outcome measures
| Measure |
Exenatide Twice Daily
n=181 Participants
Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
|
Premixed Insulin Aspart Twice Daily
n=173 Participants
Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
|
|---|---|---|
|
Change in Body Weight
|
-4.10 kg
Standard Error 0.22
|
1.02 kg
Standard Error 0.22
|
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS) and had baseline and at least one post-baseline value available; last observation carried forward
Change in BMI from baseline after 26 weeks of treatment (i.e., BMI at week 26 minus BMI at week 0)
Outcome measures
| Measure |
Exenatide Twice Daily
n=181 Participants
Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
|
Premixed Insulin Aspart Twice Daily
n=173 Participants
Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
|
|---|---|---|
|
Change in Body Mass Index (BMI)
|
-1.39 kg/m^2
Standard Error 0.07
|
0.32 kg/m^2
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward
Total DTSQ treatment satisfaction score at baseline (week 0) and after 26 weeks of treatment (LOCF). Total DTSQ treatment satisfaction score is derived as sum score of the individual components 1 and 4-8 of the DTSQ questionnaire. Each component is scored on a scale of 0 (worst case) to 6 (best case). Higher values represent higher treatment satisfaction.
Outcome measures
| Measure |
Exenatide Twice Daily
n=181 Participants
Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
|
Premixed Insulin Aspart Twice Daily
n=173 Participants
Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
|
|---|---|---|
|
Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ)
DTSQ score at baseline (week 0)
|
29.5 scores on DTSQ scale
Standard Deviation 6.13
|
29.7 scores on DTSQ scale
Standard Deviation 6.25
|
|
Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ)
DTSQ score at endpoint (week 26)
|
30.6 scores on DTSQ scale
Standard Deviation 6.05
|
29.3 scores on DTSQ scale
Standard Deviation 6.59
|
SECONDARY outcome
Timeframe: Baseline and 26 weeksPopulation: All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward
SF-12 Physical and Mental Component Summary Scores at baseline (week 0) and after 26 weeks of treatment (LOCF). SF-12 Physical and Mental Component Summary Scores are normalized scores ranging from 0 (worst case) to 100 (best case), and are derived from responses to 12 questions. Scores \> 50 indicate an above-average health status.
Outcome measures
| Measure |
Exenatide Twice Daily
n=181 Participants
Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
|
Premixed Insulin Aspart Twice Daily
n=173 Participants
Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
|
|---|---|---|
|
Patient Reported Outcomes: Quality of Life (SF-12)
Mental Component at baseline (week 0)
|
31.3 scores on SF-12 scale
Standard Deviation 18.33
|
28.3 scores on SF-12 scale
Standard Deviation 19.43
|
|
Patient Reported Outcomes: Quality of Life (SF-12)
Mental Component at endpoint (week 26)
|
31.1 scores on SF-12 scale
Standard Deviation 19.38
|
29.6 scores on SF-12 scale
Standard Deviation 18.36
|
|
Patient Reported Outcomes: Quality of Life (SF-12)
Physical Component at baseline (week 0)
|
35.5 scores on SF-12 scale
Standard Deviation 13.99
|
36.3 scores on SF-12 scale
Standard Deviation 14.45
|
|
Patient Reported Outcomes: Quality of Life (SF-12)
Physical Component at endpoint (week 26)
|
39.1 scores on SF-12 scale
Standard Deviation 14.30
|
37.7 scores on SF-12 scale
Standard Deviation 14.28
|
Adverse Events
Exenatide Twice Daily
Premixed Insulin Aspart Twice Daily
Serious adverse events
| Measure |
Exenatide Twice Daily
n=247 participants at risk
Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
|
Premixed Insulin Aspart Twice Daily
n=233 participants at risk
Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.40%
1/247 • 26 weeks
|
0.00%
0/233 • 26 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.40%
1/247 • 26 weeks
|
0.00%
0/233 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/247 • 26 weeks
|
0.43%
1/233 • 26 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.40%
1/247 • 26 weeks
|
0.00%
0/233 • 26 weeks
|
|
Infections and infestations
Breast abscess
|
0.40%
1/247 • 26 weeks
|
0.00%
0/233 • 26 weeks
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/247 • 26 weeks
|
0.43%
1/233 • 26 weeks
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.40%
1/247 • 26 weeks
|
0.00%
0/233 • 26 weeks
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/247 • 26 weeks
|
0.43%
1/233 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/247 • 26 weeks
|
0.43%
1/233 • 26 weeks
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.40%
1/247 • 26 weeks
|
0.00%
0/233 • 26 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.40%
1/247 • 26 weeks
|
0.43%
1/233 • 26 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.40%
1/247 • 26 weeks
|
0.43%
1/233 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.40%
1/247 • 26 weeks
|
0.00%
0/233 • 26 weeks
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.40%
1/247 • 26 weeks
|
0.00%
0/233 • 26 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.81%
2/247 • 26 weeks
|
0.00%
0/233 • 26 weeks
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.40%
1/247 • 26 weeks
|
0.00%
0/233 • 26 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.40%
1/247 • 26 weeks
|
0.00%
0/233 • 26 weeks
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/247 • 26 weeks
|
0.43%
1/233 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/247 • 26 weeks
|
0.43%
1/233 • 26 weeks
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.40%
1/247 • 26 weeks
|
0.00%
0/233 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/247 • 26 weeks
|
0.43%
1/233 • 26 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/247 • 26 weeks
|
0.43%
1/233 • 26 weeks
|
|
Injury, poisoning and procedural complications
Nerve injury
|
0.00%
0/247 • 26 weeks
|
0.43%
1/233 • 26 weeks
|
|
Nervous system disorders
Parkinson's disease
|
0.40%
1/247 • 26 weeks
|
0.00%
0/233 • 26 weeks
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/247 • 26 weeks
|
0.43%
1/233 • 26 weeks
|
|
Nervous system disorders
Syncope
|
0.40%
1/247 • 26 weeks
|
0.00%
0/233 • 26 weeks
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.40%
1/247 • 26 weeks
|
0.00%
0/233 • 26 weeks
|
Other adverse events
| Measure |
Exenatide Twice Daily
n=247 participants at risk
Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
|
Premixed Insulin Aspart Twice Daily
n=233 participants at risk
Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
10.9%
27/247 • 26 weeks
|
6.9%
16/233 • 26 weeks
|
|
Nervous system disorders
Headache
|
10.5%
26/247 • 26 weeks
|
10.7%
25/233 • 26 weeks
|
|
Infections and infestations
Nasopharyngitis
|
15.0%
37/247 • 26 weeks
|
18.0%
42/233 • 26 weeks
|
|
Gastrointestinal disorders
Nausea
|
18.6%
46/247 • 26 weeks
|
3.4%
8/233 • 26 weeks
|
|
Gastrointestinal disorders
Vomiting
|
8.9%
22/247 • 26 weeks
|
0.86%
2/233 • 26 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
6.1%
15/247 • 26 weeks
|
0.86%
2/233 • 26 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60