Both BYDUREON and exenatide twice daily patients achieved a reduction in weight compared to baseline, although the difference between the two treatment arms was not significant.

Further reductions in HbA1c and sustained weight loss were observed for at least 52 weeks in the patients completing both the controlled 30 week study and the uncontrolled study extension. The eva luable patients who switched from exenatide twice daily to BYDUREON (n= 121) achieved the same improvement in HbA1c of -2.0 % , at the end of the 22 week extension compared to the initial baseline, as the patients treated with BYDUREON for 52 weeks.

Table 3: Results of two trials of BYDUREON versus exenatide twice daily in combination with diet and exercise alone, metformin and/or sulphonylurea and metformin and/or thiazolidinedione (intent to treat patients).

24 Week Study
 BYDUREON 2 mg
 Exenatide 10 µg twice daily
 
N
 129
 123
 
Mean HbA1c (%)
 
 
 
Baseline
 8.5
 8.4
 
Change from baseline (± SE)
 -1.6 (±0.1)**
 -0.9 (±0.1)
 
Mean difference change from baseline between treatments (95 % CI)
 -0.67 (-0.94, -0.39) **
 
Patients (%) achieving HbA1c< 7 %
 58
 30
 
Change in fasting plasma glucose (mmol/l) (± SE)
 -1.4 (±0.2)
 -0.3 (±0.2)
 
Mean body weight (kg)
 
 
 
Baseline
 97
 94
 
Change from baseline (± SE)
 -2.3 (±0.4)
 -1.4 (± 0.4)
 
Mean difference change from baseline between treatments (95 % CI)
 -0.95 (-1.91, 0.01)
 
30 Week Study

 
 
 
N
 148
 147
 
Mean HbA1c (%)
 
 
 
Baseline
 8.3
 8.3
 
Change from baseline (± SE)
 1.9 (±0.1)*
 1.5 (±0.1)
 
Mean difference change from baseline between treatments (95 % CI)
 -0.33 (-0.54, -0.12) *
 
Patients (%) achieving HbA1c7 %
 73
 57
 
Change in fasting plasma glucose (mmol/l) (± SE)
 -2.3 (±0.2)
 -1.4(±0.2)
 
Mean body weight (kg)
 
 
 
Baseline
 102
 102
 
Change from baseline (± SE)
 3.7 (±0.5)
 3.6 (±0.5)
 
Mean difference change from baseline between treatments (95 % CI)
 -0.08 (-1.29, 1.12)
 

SE = standard error, CI= confidence interval, * p< 0.05, **p< 0.0001

A study of 26 week duration has been conducted, in which BYDUREON 2 mg is compared to insulin glargine QD. BYDUREON demonstrated a superior change in HbA1c compared to insulin glargine. Compared with insulin glargine treatment, BYDUREON treatment significantly lowered mean body weight and was associated with fewer hypoglycaemic events (Table 4).

Table 4: Results of one 26 week trial of BYDUREON versus insulin glargine in combination with metformin and/or sulphonylurea (intent to treat patients).

 
 BYDUREON 2 mg