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

1 Insulin glargine was dosed to a target glucose concentration of 4.0 to 5.5 mmol/l (72 to 100 mg/dl). The mean dose of insulin glargine at the beginning of treatment was 10.1 IU/day rising to 31.1 IU/day for insulin glargine-treated patients.

In a 26 week double blind study BYDUREON was compared to maximum daily doses of sitagliptin and pioglitazone in subjects also using metformin. All treatment groups had a significant reduction in HbA1c compared to baseline. BYDUREON demonstrated superiority to both sitagliptin and pioglitazone with respect to change in HbA1c from baseline.

BYDUREON demonstrated significantly greater weight reductions compared to sitagliptin. Patients on pioglitazone gained weight (Table 5).

Table 5: Results of one 26 week trial of BYDUREON versus sitagliptin and versus pioglitazone in combination with metformin (intent to treat patients).

 
 BYDUREON 2 mg
 Sitagliptin 100 mg
 Pioglitazone 45 mg
 
N
 160
 166
 165
 
Mean HbA1c (%)
 
 
 
 
Baseline
 8.6
 8.5
 8.5
 
Change from baseline (± SE)
 -1.4 (± 0.1)*
 -0.8 (± 0.1)*
 -1.1 (± 0.1)*
 
Mean difference change from baseline between treatments (95 % CI) versus sitagliptin
 -0.63 (-0.89, -0.37)**
 
Mean difference change from baseline between treatments (95 % CI) versus pioglitazone
 -0.32 (-0.57, -0.06,)*
 
Patients (%) achieving HbA1c7 %
 62
 36
 49
 
Change in fasting serum glucose (mmol/l) (± SE)
 -1.8 (± 0.2)
 -0.9 (± 0.2)
 -1.5 (± 0.2)
 
Mean body weight (kg)
 
 
 
 
Baseline
 89
 87
 88
 
Change from baseline (± SE)
 -2.3 (± 0.3)
 -0.8 (± 0.3)
 +2.8 (± 0.3)
 
Mean difference change from baseline between treatments (95 % CI) versus sitagliptin
 -1.54 (-2.35, -0.72)*
 
Mean difference change from baseline between treatments (95 % CI) versus pioglitazone
 -5.10 (-5.91, -4.28)**
 

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

Body weight

A reduction in body weigh