A systematic review and mixed-treatment comparison of dapagliflozin with existing anti-diabetes treatments for those with type 2 diabetes mellitus inadequately controlled by sulfonylurea monotherapy

Michelle Orme; Peter Fenici; Isabelle Duprat Lomon; Gail Wygant; Rebecca Townsend; Marina Roudaut

doi:10.1186/1758-5996-6-73

Table 2 Studies identified by the systematic review and eligible for inclusion in the NMA

From: A systematic review and mixed-treatment comparison of dapagliflozin with existing anti-diabetes treatments for those with type 2 diabetes mellitus inadequately controlled by sulfonylurea monotherapy

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 SU^b,c	At least the maximally effective dose of a SU^c 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	212^d	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
Hermansen[63]	Multi-country	24	212^d	DPP-4	2) placebo QD (106)	Stable dose of glimepiride (4 mg – 8 mg QD)
Lewin[64]	US, Argentina, India, Japan, Hungary, Poland, Russia	18	245	DPP-4	1) linagliptin 5 mg QD (161);	Unchanged from baseline SU^b,c	Stable SU^c dose of ≥ half the maximum dose for 10 weeks (or documented maximum tolerated dose for ≥12 weeks) + 2 week run-in
Lewin[64]	US, Argentina, India, Japan, Hungary, Poland, Russia	18	245	DPP-4	2) placebo QD (84)	Unchanged from baseline SU^b,c
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 SU^c 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.

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