Background
Methods
Study Selection
Exenatide† | Placebo or Comparator | ||||||
---|---|---|---|---|---|---|---|
Study/Registry Number | Diabetes Management | Duration* (Weeks) | ITT (N) | Exposure (SY) | ITT (N) | Exposure (SY) | |
DeFronzo et al, 2005
18
|
NCT00039013
| Met | 30 | 223 | 113.8 | 113 | 57.8 |
Buse et al, 2004
20
|
NCT00039026
| SFU | 30 | 254 | 123.2 | 123 | 55.1 |
Kendall et al, 2005
19
|
NCT00035984
| Met + SFU | 30 | 486 | 254.9 | 247 | 122.2 |
Zinman et al, 2007
24
|
NCT00099320
| TZD ± Met | 16 | 121 | 31.7 | 112 | 32.3 |
Kadowaki et al, 2008
27
|
NCT00382239
| SFU ± Met | 12 | 111 | 23.9 | 40 | 9.2 |
Gao, et al, 2009
26
|
NCT00324363
| Met ± SFU | 16 | 234 | 65.5 | 233 | 67.3 |
Moretto et al, 2008
28
|
NCT00381342
| D + E | 24 | 155 | 65.2 | 77 | 33.1 |
Gill et al, 2010
29
|
NCT00516074
| Met and/or TZD | 12 | 28 | 5.8 | 26 | 5.7 |
Heine et al, 2005
22
|
NCT00082381
| Met + SFU | 26 | 282 | 122.5 | 267 | 124.6 |
Nauck et al, 2007
23
|
NCT00082407
| Met + SFU | 52 | 253 | 220.1 | 248 | 228.6 |
Davis et al, 2007
25
|
NCT00099333
| SFU or Meg and/or Met | 16 | 33 | 7.7 | 16 | 5.2 |
Barnett et al, 2007
21
|
NCT00099619
| Met or SFU | 16‡ | 136 | 37.3 | 127 | 38.9 |
Totals
| -- | -- |
2,316
|
1,071.6
|
1,629
|
779.9
|
Analysis population
Outcomes
Primary Outcome
Secondary Outcome
Analysis
Results
Baseline Characteristics | Exenatide (N = 2,316) | Pooled Comparator (N = 1,629) |
---|---|---|
Gender, M/F (%)
| 56/44 | 53/47 |
Race (%)
| ||
Caucasian | 64 | 65 |
Black | 6 | 4 |
Hispanic | 11 | 10 |
Asian | 19 | 20 |
Other | 1 | 1 |
Age (years)
| 56 ± 10 | 56 ± 10 |
≥65 years (%) | 21 | 20 |
Duration of Diabetes (years)
| 8 ± 6 | 8 ± 6 |
≥10 years (%) | 32 | 35 |
Weight (kg)
| 89.1 ± 20.3 | 87.8 ± 19.8 |
Body Mass Index (BMI [kg/m
2
])
| 31.5 ± 5.6 | 31.3 ± 5.4 |
BMI <30 kg/m2 (%) | 44 | 45 |
BMI ≥30 kg/m2 (%) | 56 | 55 |
HbA
1c
(%)
| 8.33 ± 1.06 | 8.38 ± 1.07 |
Systolic Blood Pressure (SBP [mm Hg])
| 131 ± 4 | 132 ± 5 |
Diastolic Blood Pressure (DBP [mm Hg])
| 79 ± 2 | 79 ± 1 |
Heart Rate (beats per minute)
| 75 ± 9 | 75 ± 9 |
Renal Function Impairment* (%)
| ||
None | 86 | 86 |
Mild | 13 | 14 |
Moderate | 1 | 1 |
Primary MACE Endpoint | Secondary MACE Endpoint | |||
---|---|---|---|---|
Exenatide (N = 2,316) | Pooled Comparator (N = 1,629) | Exenatide (N = 2,316) | Pooled Comparator (N = 1,629) | |
Primary Analyses | ||||
Incidence (n)
| 20 | 18 | 46 | 42 |
Incidence (n/N)
| 0.009 | 0.011 | 0.020 | 0.026 |
RR (95% CI) | 0.70 (0.38, 1.31) | 0.69 (0.46, 1.03) | ||
Secondary Analysis
| ||||
EAIR (per 1,000 years)
| 18.73 | 23.17 | 43.37 | 54.37 |
RR (95% CI) | 0.81 (0.43, 1.53) | 0.80 (0.53, 1.21) | ||
Event Rate (per 1,000 years)
| 22.40 | 28.21 | 54.13 | 66.67 |
RR (95% CI) | 0.79 (0.45, 1.42) | 0.81 (0.56, 1.18) |