Table 2.
Author | Study setting | Duration, weeks | N, randomised | Class | Study arms a , 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 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) |
aStudy arms in italics were not included in the meta-analysis (not EU licensed dose); bDown-titration allowed in response to hypoglycaemia; cSU not specified in the publication; dStrata 1 (glimepiride only subgroup) n = 212, full trial population n = 441; BID, twice daily; DPP-4, dipeptidyl peptidase-4 inhibitors; GLP-1, glucagon-like peptide-1 analogues; NMA, network meta-analysis; QD, once daily; SGLT2, sodium glucose co-transporter 2 inhibitors; SU, sulfonylurea.