Author | Study setting | Duration, weeks | N, randomised | Class | Study armsa, treatment and dose (n) | SU background during trial | Pre-trial SU use |
---|---|---|---|---|---|---|---|
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 100Â 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 5Â mg QD (145); | |||||||
3) dapagliflozin 10Â mg QD (151); | |||||||
4) placebo QD (146) |