Clinical trials of SGLT2 inhibitors - TrialResults-center.org

pathology

treatment

patient

Demonstrated benefit and harm

diabetes type 2

dapagliflozin

not classified

versus

No demonstrated result for efficacy

meta-analysis

Trial	control	p<0.05	harm	NS
Bailey (MB102014), 2010	dapagliflozin vs placebo (add on MET)
Bolinder, 2012	dapagliflozin vs placebo (add on MET)
Ferrannini (MB102013), 2010	dapagliflozin vs placebo
Wilding (MB102009), 2009	dapagliflozin vs placebo (add on insulin)
Komoroski (MB102007), 2009	dapagliflozin vs placebo
List (MB102008), 2009	dapagliflozin vs placebo
KOhan	dapagliflozin vs placebo
Wilding, 2012	dapagliflozin vs placebo (add on insulin)
Nauck, 2011	dapagliflozin vs dlipizide add on metformin
Kohan	dapagliflozin vs placebo
Kohan	dapagliflozin + merformin vs dapagliflozin
Strojek, 2011	dapagliflozin + Glimepiride vs glimepiride
Rosenstock, 2012	dapagliflozin vs placebo (add on TZD)
MB102034, 2016	dapagliflozin + merformin vs metformin or dapa
Kohan	dapagliflozin vs placebo
MB102035	dapagliflozin vs placebo (on top standard treatment)
MB102061	dapagliflozin vs placebo add on DPP-4
Cefalu, 2015	dapagliflozin vs placebo (on top standard treatment)
Leiter, 2016	dapagliflozin vs placebo (on top standard treatment)
MB102073	dapagliflozin vs placebo (on top standard treatment)
Weber	dapagliflozin vs placebo (on top standard treatment)
Schumm-Draeger , 2015	dapagliflozin vs placebo (add on MET)
	T1 vs T0
	T1 vs T0
	T1 vs T0
	T1 vs T0
	T1 vs T0

Trial	Treatments	Patients	Method
Bailey (MB102014), 2010	dapagliflozin (2¡¤5 mg, n=137; 5 mg, n=137; or 10 mg, n=135) (n=-9) vs. placebo (n=-9)	adults with type 2 diabetes who were receiving daily metformin (¡Ý1500 mg per day) and had inadequate glycaemic control	double-blind Parallel groups Sample size: -9/-9 Primary endpoint: HbA1c FU duration: 24 weeks dose ranging
Bolinder, 2012	dapagliflozin (n=-9) vs. placebo or Sitagliptin (on top MET) (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration:
Ferrannini (MB102013), 2010	a morning dose of 5 or 10 mg/day dapagliflozin (n=-9) vs. placebo (n=-9)	treatment-naive patients with type 2 diabetes	double-blind Sample size: -9/-9 Primary endpoint: change from baseline in A1C FU duration: 24 weeks
Wilding (MB102009), 2009	10 mg dapagliflozin, or 20 mg dapagliflozin, plus OAD(s) and 50% of their daily insulin dose (n=-9) vs. placebo (n=-9)	patients with type 2 diabetes that is poorly controlled with high insulin doses plus oral antidiabetic agents	double-blind Sample size: -9/-9 Primary endpoint: change from baseline in A1C FU duration: 12 weeks
Komoroski (MB102007), 2009	daily oral doses of 5-, 25-, or 100-mg doses of dapagliflozin (n=-9) vs. placebo (n=-9)	patients with type 2 diabetes mellitus	Sample size: -9/-9 Primary endpoint: FU duration: 14 days
List (MB102008), 2009	one of five dapagliflozin doses (n=-9) vs. placebo (n=-9) 7 arms trial: five dapagliflozin doses, metformin XR, or placebo	type 2 diabetic patients	Sample size: -9/-9 Primary endpoint: mean change from baseline in A1C FU duration: 12 weeks
KOhan	Dapagliflozin monotherapy (n=-9) vs. placebo (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration:
Wilding, 2012	Dapagliflozin (n=-9) vs. placebo on top of insulin (n=-9)	Type 2 Diabetes With Inadequate Glycaemic Control on Insulin	Sample size: -9/-9 Primary endpoint: FU duration:
Nauck, 2011	Dapagliflozin in Combination With Metformin (n=-9) vs. Sulphonylurea in Combination With Metformin (n=-9)	Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone	Sample size: -9/-9 Primary endpoint: FU duration:
Kohan	Dapagliflozin (n=-9) vs. placebo (n=-9)	Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Contro	Sample size: -9/-9 Primary endpoint: FU duration:
Kohan	Dapagliflozin in Combination With Metformin (n=-9) vs. Dapagliflozin Monotherapy (n=-9)	Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control	Sample size: -9/-9 Primary endpoint: FU duration:
Strojek, 2011	Dapagliflozin in Comb.With Glimepiride (n=-9) vs. glimepiride alone (n=-9)	Type2 Diab.Who Have Inadeq. Glycaemic Control on Glimepiride Therapy Alone	Sample size: -9/-9 Primary endpoint: FU duration:
Rosenstock, 2012	Dapagliflozin in Combination With Thiazolidinedione (n=-9) vs. Thiazolidinedione (n=-9)	Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Thiazolidinedione Therapy Alone	Sample size: -9/-9 Primary endpoint: FU duration:
MB102034, 2016	Dapagliflozin 10 mg in Combination With Metformin (n=-9) vs. Dapagliflozin 10 mg Monotherapy or Metformin Monotherapy (n=-9)	Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control	Sample size: -9/-9 Primary endpoint: FU duration:
Kohan	Dapagliflozin as Monotherapy (n=-9) vs. placebo (n=-9)	Japanese Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control	Sample size: -9/-9 Primary endpoint: FU duration:
MB102035	Dapagliflozin Tablets, Oral, 10 mg, once daily, 12 weeks (n=-9) vs. placebo (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration:
MB102061	Dapagliflozin 10 mg tablet, oral, once daily, 48 weeks (n=-9) vs. placebo (n=-9)	Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on a DPP-4 Inhibitor Sitagliptin+/-Metformin	Sample size: -9/-9 Primary endpoint: FU duration:
Cefalu, 2015	Dapagliflozin 10 mg tablet, oral, once daily, 24- week (n=-9) vs. placebo (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration:
Leiter, 2016	Dapagliflozin 10 mg tablet, oral, once daily, 24- week treatment (n=-9) vs. placebo (n=-9)	Patients With T2DM and Cardiovascular Disease, Who Exhibit Inadequate Glycaemic Control on Usual Care	Sample size: -9/-9 Primary endpoint: FU duration:
MB102073	Dapagliflozin Tablets, Oral, 10 mg, once daily, up to 12 weeks (n=-9) vs. placebo (n=-9)	patients with type 2 diabetes with uncontrolled hypertension who are on an Angiotensin-converting enzyme (ACE) inhibitor or an Angiotensin Receptor Blocker (ARB).	Sample size: -9/-9 Primary endpoint: FU duration:
Weber	Dapagliflozin Tablets, Oral, 10 mg, once daily, Up to 12 weeks (n=-9) vs. placebo (n=-9)	Subjects With Type 2 Diabetes With Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) and an Additional Antihypertensive Medication	Sample size: -9/-9 Primary endpoint: FU duration:
Schumm-Draeger , 2015	Dapagliflozin 2.5 mg BID, 5 mg BID and 10 mg QD (n=-9) vs. placebo (n=-9)	Patients With Type 2 Diabetes Who Are Inadequately Controlled on Metformin-IR Monotherapy	Sample size: -9/-9 Primary endpoint: FU duration:
Rosenstock, 2015	(n=-9) vs. (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration: 24 w
Yang, 2015	(n=-9) vs. (n=-9)		Sample size: -9/-9 Primary endpoint: Change from baseline in HbA1c FU duration:
Matthaei, 2015	(n=-9) vs. (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration:
Mathieu, 2015	(n=-9) vs. (n=-9)		Sample size: -9/-9 Primary endpoint: , FU duration: 24 w
Kaku, 2014	(n=-9) vs. (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration: 24 w

diabetes type 2

empagliflozin

not classified

versus

No demonstrated result for efficacy

meta-analysis

Trial	control	p<0.05	harm	NS
	T1 vs T0
	T1 vs T0
	T1 vs T0
	T1 vs T0
	T1 vs T0
	T1 vs T0
Lewin, 2015	empagliflozin vs linagliptin (monotherapy)
Ferrannini, 2013	empagliflozin vs placebo
Kadowaki, 2013	empagliflozin vs
EMPA-REG PIO (Kovacs), 2013	empagliflozin vs placebo (add on MET+/-PIO)
EMPA-REG MONO (Roden) vs placebo, 2013	empagliflozin vs placebo
Rosenstock, 2013	empagliflozin vs placebo (add-on MET)
Rosenstock DOUBLON ???, 2013	empagliflozin vs placebo (add-on INS)
Kadowaki, 2015	empagliflozin vs placebo
Ross, 2015	empagliflozin vs placebo (add-on MET)
Kadowaki , 2014	empagliflozin vs
EMPA-REG MET (Haring), 2014	empagliflozin vs placebo (add-on MET)

Trial	Treatments	Patients	Method
EMPA-REG OUTCOME	(n=-9) vs. (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration:
Barnett, 2014	/ BI 10773 low dose (BI 10773 tablets once daily) 2/ BI 10773 high dose (BI 10773 tablets once daily) (n=-9) vs. Placebo (n=-9)	Patients With Mild or Moderate Renal Impairment	Sample size: -9/-9 Primary endpoint: HbA1c Change , , FU duration:
Araki, 2015	BI 10773 low dose (BI 10773 low dose tablet once daily) 2/ BI 10773 high dose (BI 10773 high dose tablet once daily) (n=-9) vs. Metformin (Metformin tablets 500-2250 mg a day (twice or three times per day)) (n=-9)	Japanese patients with type 2 diabetes mellitus	Sample size: -9/-9 Primary endpoint: Drug Related Adverse Events FU duration: 52 w
Rosenstock (1245.49), 2014	once-daily empagliflozin 10 mg (n = 186), empagliflozin 25 mg (n = 189), (n=-9) vs. placebo (n=-9)	Patients inadequately controlled on MDI insulin ± metformin	Sample size: -9/-9 Primary endpoint: FU duration: 18 weeks
Ridderstrale, 2014	BI 10773 dose plus metformin (n=-9) vs. Glimepiride 1-4 mg plus metformin (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration: 104 w
DeFronzo, 2015	(n=-9) vs. add-on to metformin for 52 weeks (n=-9)	subjects with type 2 diabetes inadequately controlled on metformin	Sample size: -9/-9 Primary endpoint: , FU duration:
Lewin, 2015	empagliflozin 25 mg/linagliptin 5 mg (n = 137), empagliflozin 10 mg/linagliptin 5 mg (n = 136), empagliflozin 25 mg (n = 135), empagliflozin 10 mg (n = 134) (n=-9) vs. linagliptin 5 mg (n = 135) for 52 weeks (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration:
Ferrannini, 2013	empagliflozin 5, 10 or 25 mg once daily (n=-9) vs. placebo (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration: phase 2b
Kadowaki, 2013	(n=-9) vs. (n=-9)	Japanese patients with type 2 diabetes	Sample size: -9/-9 Primary endpoint: FU duration:
EMPA-REG PIO (Kovacs), 2013	once daily empagliflozin 10 mg (n = 165), empagliflozin 25 mg (n=-9) vs. add-on to pioglitazone ± metformin (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration:
EMPA-REG MONO (Roden) vs placebo, 2013	(n=-9) vs. (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration:
Rosenstock, 2013	(n=-9) vs. ??? (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration:
Rosenstock DOUBLON ???, 2013	(n=-9) vs. (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration:
Kadowaki, 2015	empagliflozin (5, 10, 25, or 50 mg) (n=-9) vs. placebo (n=-9)	Japanese patients with type 2 diabetes	Sample size: -9/-9 Primary endpoint: FU duration:
Ross, 2015	empagliflozin 12.5 mg twice daily (n = 219), 25 mg once daily (n = 218), 5 mg twice daily (n = 219) or 10 mg once daily (n = 220), (n=-9) vs. placebo (n=-9)	patients with type 2 diabetes inadequately controlled on metformin	Sample size: -9/-9 Primary endpoint: FU duration:
Kadowaki , 2014	(n=-9) vs. (n=-9)		Sample size: -9/-9 Primary endpoint: FU duration:
EMPA-REG MET (Haring), 2014	empagliflozin 10 mg (n = 217), empagliflozin 25 mg (n = 213), (n=-9) vs. placebo (n=-9)	Patients with HbA1c levels of ¡Ý7% to ¡Ü 10% (¡Ý53 to ¡Ü86 mmol/mol) while receiving metformin (¡Ý1,500 mg/day)	Sample size: -9/-9 Primary endpoint: FU duration:

SGLT2 inhibitors Description Results NMA

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SGLT2 inhibitors
Description Results NMA