Table 1 Studies included in the 20-study pool

NCT00950599

Phase 2, randomized, 6-wk (high-dose cohort) or 12-wk (main cohort) dose ranging study in treatment-naïve patients

423

7.5–8.0

SAXA 2.5, 5, 10, 20, 40, or 100 mg/d vs PBO

Rosenstock et al, 2008 [28]

NCT00575588^†

Phase 3, randomized, 52 wk + 52-wk LTE

858

7.7

SAXA 5 mg/d + MET vs glipizide 5–20 mg/d + MET

Göke et al, 2010; 2013 [29, 30]

NCT00666458^†

Phase 3, randomized, 18 wk

801

7.7

SAXA 5 mg/d + MET vs SITA 100 mg/d + MET

Scheen et al, 2010 [31]

NCT00698932

Phase 3, randomized, 24 wk in treatment-naïve Asian patients. Rescue medication: metformin

568

8.1–8.2

SAXA 5 mg/d vs PBO

Pan et al, 2012 [32]

NCT00661362^†

Phase 3, randomized, 24 wk in Asian patients

570

7.9

SAXA 5 mg/d + MET vs PBO + MET

Yang et al, 2011 [33]

NCT00614939

Phase 3, randomized, 12 wk + 40-wk LTE in patients with renal impairment

170

8.1–8.5

SAXA 2.5 mg/d vs PBO (± other OADs or INS)

Nowicki et al, 2011 [34, 35]

NCT00918879

Phase 3, randomized, 24 wk in treatment-naïve Indian patients. Rescue medication: metformin

213

8.3

SAXA 5 mg/d vs PBO

Prasanna Kumar et al, 2014 [36]

NCT00121641

Phase 3, randomized, 24 wk + 42-mo LTE in treatment-naïve patients. Rescue medication: metformin; placebo arm: metformin 500 mg/d during LTE

401^‡

7.8–8.0

SAXA 2.5, 5, or 10 mg/d vs PBO

Rosenstock et al, 2009; 2013 [20, 37]

NCT00295633

Phase 3, randomized, 24 wk + 52-wk LTE. Rescue medication: metformin

565

8.2–8.4

SAXA 2.5 or 5 mg/d + TZD vs PBO + TZD

Hollander et al, 2009; 2011 [23, 38]

NCT00121667^†

Phase 3, randomized, 24 wk + up to 42-mo LTE. Rescue medication: pioglitazone

743

8.0

SAXA 2.5, 5, or 10 mg/d + MET vs PBO + MET

DeFronzo et al, 2009; Rosenstock et al, 2013 [21, 37]

NCT00316082

Phase 3, randomized, 24 wk + 52-wk LTE in treatment-naïve patients. Rescue medication: metformin; placebo arm: metformin 500 mg/d during LTE

365

7.8–8.0

SAXA 2.5 mg QAM ± titration to 5 mg,^§ 5 mg QAM, or 5 mg QPM vs PBO

Frederich et al, 2012 [19]

NCT00327015^†

Phase 3, randomized, 24 wk + 52-wk LTE in treatment-naïve patients. Rescue medication: pioglitazone

1306

9.4–9.6

SAXA 5 or 10 mg/d + MET vs SAXA 10 mg/d + PBO or MET + PBO

Jadzinsky et al, 2009; Pfützner et al, 2011 [39, 40]

NCT00313313

Phase 3, randomized, 24 wk + 52-wk LTE. Rescue medication: metformin

768

8.4–8.5

SAXA 2.5 or 5 mg/d + GLY vs PBO + GLY uptitrated to 15 mg/d^‡

Chacra et al, 2009; 2011 [22, 41]

NCT00374907

Phase 3, randomized, 12 wk + 104-wk LTE in treatment-naïve patients. Rescue medication: metformin; placebo arm: metformin 500 mg/d during LTE

36

6.6–6.9

SAXA 5 mg/d vs PBO

Henry et al, 2011 [42]

NCT00757588^†

Phase 3, randomized, 24 wk + 28-wk LTE. Rescue medication: titrated insulin

455

8.6–8.7

SAXA 5 mg/d + INS ± MET vs PBO + INS ± MET

Barnett et al, 2012 [43]

NCT00683657^†

Phase 3, randomized, 4 wk

93

8.1

SAXA 5 mg/d + MET XR vs PBO + MET XR

Stenlof et al, 2010 [44]

NCT00885378^†

Phase 3, randomized, 12 wk

160

7.9–8.0

SAXA (2.5 mg twice daily) + MET vs PBO MET

White et al, 2014 [45]

NCT00918138^†

Phase 3, randomized, 4 wk

93

8.4–8.6

SAXA 5 mg/d + MET XR 1500 mg vs MET XR uptitration to 2000 mg^¶

Neutel et al, 2013 [46]

NCT01006590^†

Phase 3/4, randomized, 24 wk

286

7.7–7.8

SAXA 5 mg/d + MET 1500 mg vs MET uptitration to 2000 or 2500 mg^§

Hermans et al, 2012 [47]

NCT00960076^†

Phase 3, randomized, 18 wk

282

8.3–8.4

SAXA 5 mg/d + MET XR vs MET XR uptitration to 1000 mg^§

Fonseca et al, 2012 [48]