|
Buse[61]
|
US
|
30
|
377
|
GLP-1
|
1) exenatide 5 μg BID (125);
|
Unchanged from baseline SUb,c
|
At least the maximally effective dose of a SUc as monotherapy for ≥3 months before screening
|
| |
2) exenatide 10 μg BID (129);
| |
| |
3) placebo BID (123)
| |
|
Garber[62]
|
US, Sweden, Finland, Argentina, Lithuania
|
24
|
515
|
DPP-4
|
1) vildagliptin 50 mg QD (170);
|
Glimepiride 4 mg QD, reduced to 2 mg QD if hypoglycaemia occurred
|
≥7.5 mg glyburide or glipizide QD, or ≥2 mg glimepiride or equivalent, treated for >3 months with stable dose for ≥4 weeks before screening, switched to glimepiride 4 mg QD for 4 weeks prior to baseline
|
|
2) vildagliptin 100 mg QD (169);
|
|
3) placebo QD (176)
|
|
Hermansen[63]
|
Multi-country
|
24
|
212d
|
DPP-4
|
1) sitagliptin 100 mg QD (106);
|
Stable dose of glimepiride (4 mg – 8 mg QD)
|
A stable dose of glimepiride 4 – 8 mg QD for ≥10 weeks + 2 week run-in
|
|
2) placebo QD (106)
|
|
Lewin[64]
|
US, Argentina, India, Japan, Hungary, Poland, Russia
|
18
|
245
|
DPP-4
|
1) linagliptin 5 mg QD (161);
|
Unchanged from baseline SUb,c
|
Stable SUc dose of ≥ half the maximum dose for 10 weeks (or documented maximum tolerated dose for ≥12 weeks) + 2 week run-in
|
|
2) placebo QD (84)
|
|
Strojek[31]
|
Czech Republic, Hungary, Poland, Ukraine, Republic of Korea, Philippines, Thailand
|
24
|
597
|
SGLT2
|
1) dapagliflozin 2.5 mg QD (154);
|
Glimepiride 4 mg QD, reduced to 2 mg QD or discontinued if hypoglycaemia occurred
|
Stable SUc dose of ≥ half the maximum dose for 8 weeks. Continued on or switched to glimepiride 4 mg/day during an 8 week run-in
|
|
2) dapagliflozin 5 mg QD (145);
|
|
3) dapagliflozin 10 mg QD (151);
|
|
4) placebo QD (146)
|
