Table 3. Studies Reporting Changes in Body Composition with SGLT2i Therapy.
| Study (location) | Study design | No. (in group prescribed SGLT2i therapy) | Population | Dose (all once-daily, oral tablet unless otherwise specified) | Duration | Tech. used | Total BW change, kg (% change from baseline) | FM change, kg | LBM change, kg | Skeletal muscle mass change, kg | Total body water change, kg | Proportion of weight loss from FM, % | Proportion of weight loss from LBM, % |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Various | |||||||||||||
| Arase et al. (2019) [64] (Japan) | Case series (retrospective) | 17 (DAPA=10; CANA=7) | Overweight, T2DM and NAFLD | DAPA: 5 mg | 24 wk | BIA | −5.2 (−7.1%) | −2.7 | −2.5a | −0.7 | −1.2 | 51.9 | 48.1 |
| CANA: 100 mg | |||||||||||||
| Kinoshita et al. (2018) [65] (Japan) | Case series (prospective) | 156 (n=108 for body composition) (LUSEO=52%; TOFO=29%; IPRA=15%; DAPA=4%) | T2DM | NR | 12 wk | BIA | −2.8 (−3.6%) | NR | NR | −0.1 | NR | - | - |
| Seko et al. (2017) [66] (Japan) | Case series (retrospective) | 24 (n=17 for body composition) (CANA=18; IPRA=6) | T2DM and biopsy-proven NAFLD/NASH | CANA: 100 mg | 24 wk | BIA | NR | −2.4 | −1.1 | −0.6 | −0.8 | - | - |
| IPRA: 50 mg | |||||||||||||
| Canagliflozin | |||||||||||||
| Blonde et al. (2016) [40] Study 2 (Global; multi-site) | Three-arm RCT (sub-study) | CANA 100=63 | T2DM | 100 mg | 26 wk | DXA | −2.5 (−2.8%) | −1.9 | −0.9 | NR | NR | 76 | 36.0 |
| CANA 300=71 | 300 mg | −3.2 (−3.4%) | −2.4 | −1.2 | NR | NR | 75 | 37.5 | |||||
| Cefalu et al. (2013) [41]b (Global; multi-site) | Three-arm RCT (sub-study) | CANA 100=111 | T2DM | 100 mg | 52 wk | DXA | −4.4 (−5.2%) | −2.9 | −0.9 | NR | NR | 65.9 | 20.5 |
| CANA 300=102 | 300 mg | −4.2 (−4.9%) | −2.5 | −1.1 | NR | NR | 59.5 | 26.2 | |||||
| Koike et al. (2019) [42] (Japan) | Case series (prospective) | 38 | T2DM | 100 mg | 24 wk | DXA | −2.4 (−3.3%) | −1.3 | −1.1 | NR | NR | 54.2 | 45.8 |
| Inoue et al. (2019) [43] (Japan) | Case series (prospective) | 20 | T2DM and NAFLD | 100 mg | 12 mo | BIA | −2.9 (−3.5%) | −2.6 | −0.2 | −0.2 | −0.2 | 89.7 | 6.9 |
| Dapagliflozin | |||||||||||||
| Bolinder et al. (2014) [44] (Europe; multi-site) | Two-arm RCT | 69 | Overweight/obese with T2DM | 10 mg (added to open-label metformin) | 104 wk | DXA | −4.5 (−4.9%) | −2.8 | −1.3 | NR | NR | 62.2 | 28.9 |
| Kosugi et al. (2019) [45] (Japan) | Case series (prospective) | 26 | T2DM | 5 mg | 12 wk | DXA | −2.1 (−2.9%) | −1.7 | −0.5 | NR | NR | 81 | 23.8 |
| Fadini et al. (2017) [46] (Italy) | Two-arm RCT | 16 | T2DM | 10 mg | 12 wk | BIA | −3.1 (baseline NR) | −0.1 | −2.9a | NR | −2.4 | 3.2 | 93.5 |
| Shimizu et al. (2019) [47] (Japan) | Two-arm RCT | 33 | T2DM and NAFLD | 5 mg | 24 wk | BIA | −2.9 (−3.9%) | NR | NR | −0.9 | −1.1 | - | - |
| Sugiyama et al. (2018) [48] (Japan) | Two-arm non-randomised cohort study | 28 | T2DM | 5 mg | 6 mo | BIA | −3.4 (−4.4%) | −3.1 | −0.5 | −0.2 | NR | 91.2 | 14.7 |
| Tobita et al. (2017) [49] (Japan) | Case series (prospective) | 11 | T2DM and NASH | 5 mg | 24 wk | BIA | −3.8 (−4.8%) | −6.1 | 1.2 | 0.1 | 1.2 | 160.5 | LBM increased Fluctuation over 24 wk |
| Empagliflozin | |||||||||||||
| Ridderstrale et al. (2014) [50] (Global; multi-site) | Two-arm RCT (sub-study) | 46 | T2DM | 25 mg | 104 wk | DXA | NR (−2.8 kg [–3.4%] in entire EMPA group; n=765) | −1.6 | −0.9a | NR | NR | 57.1 | 32.1c |
| Javed et al. (2019) [51] (UK) | Two-arm RCT | 19 | PCOS | 25 mg | 12 wk | BIA | −0.8 (−0.8%) | −0.3 | −1.1a | NR | −0.8 | 37.5 | 137.5 |
| Ipragliflozin | |||||||||||||
| Inoue et al. (2019) [52] (Japan) | Two-arm RCT | 24 | T2DM (on insulin therapy) | 50 mg (insulin dose reduced by 20%) | 24 wk | DXA | −2.8 (−4.4%) | −2.1 | −0.6 | NR | NR | 75 | 21.6 |
| Ohta et al. (2017) [53] (Japan) | Case series (prospective) | 20 | T2DM | 50 mg | 24 wk | DXA | −3.5 (−4.3%) | −1.8 | −1.7 | NR | NR | 51.4 | 48.6 |
| Iemitsu et al. (2019) [54] (Japan) | Case series (prospective) | 217 | T2DM | 50 mg | 104 wk | BIA | −2.9 (−3.7%) | −1.9 | −1.0a | −0.9 | −0.7 | 31 | 34.0 |
| Kato et al. (2017) [55] (Japan) | Case series (prospective) | 20 | T2DM | 50 mg | 12 wk | BIA | −1.9 (−2.3%) | −1.3 | −0.6a | −0.6 | −0.7 | 68.4 | 31.6 |
| Miyake et al. (2018) [56] (Japan) | Case series (prospective) | 12 | T2DM+NAFLD | 50 mg | 24 wk | BIA | −1.4 (−2.1%) | −1.6 | +0.2a | −0.5 | NR | 114.3 | FFM increased |
| Osonoi et al. (2018) [57] (Japan) | Case series (prospective) | 98 | T2DM | 50 mg | 24 wk | BIA | −2.1 (−3.2%) | −1.5 | −0.6a | NR | NR | 71.4 | 28.6 |
| Yamamoto et al. (2016) [58] (Japan) | Case series (prospective) | 24 | T2DM | 50 mg | 16 wk | BIA | −2.5 (−3.3%) | −1.7 | −0.6 | NR | −0.6 | 68 | 24.0 |
| Luseogliflozin | |||||||||||||
| Bouchi et al. (2017) [59] (Japan) | Case series (prospective) | 19 | T2DM | 2.5 mg, titrated up to 5 mg where tolerated and safe | 12 wk | DXA | −2.7 (−3.3%) | −1.4 | −1.1a | NR | NR | 51.9 | 40.7 |
| Sasaki et al. (2019) [60] (Japan) | Case series (prospective) | 37 | T2DM | 2.5 mg, titrated up to 5 mg where tolerated and safe | 52 wk | DXA | −3.1 (−3.9%) | −2.0 | −1.0 | NR | NR | 64.5 | 32.3 |
| Tofogliflozin | |||||||||||||
| Iwahashi et al. (2016) [61] (Japan) | Case series (prospective) | 17 | T2DM | 20 mg | 48 wk | BIA | −2.3 (−3.0%) | −2.6 | +0.2a | NR | −0.3 | 113 | FFM increased |
| Kamei et al. (2018) [62] (Japan) | Case series (retrospective) | 37 | T2DM | 20 mg | 12 wk | BIA | −3.3 (−3.7%) | −1.9 | −1.0 | −0.8 | −0.9 | 57.6 | 30.3 |
| Matsuba et al. (2018) [63] (Japan) | Case series (prospective) | 14 | T2DM | 20 mg | 12 wk | BIA | −2.9 (baseline NR) | −1.3 | −1.5 | −1.4 | −1.1 | 44.8 | 51.7 |
SGLT2i, sodium-glucose cotransporter 2 inhibitor; BW, body weight; FM, fat mass; LBM, lean body mass; DAPA, dapagliflozin; CANA, canagliflozin; T2DM, type 2 diabetes mellitus; NAFLD, nonalcoholic fatty liver disease; BIA, bioelectrical impedance analysis; LUSEO, luseogliflozin; TOFO, tofogliflozin; IPRA, ipragliflozin; NR, not reported; NASH, nonalcoholic steatohepatitis; RCT, randomised controlled trial; DXA, dual-energy X-ray absorptiometry; EMPA, empagliflozin; PCOS, polycystic ovarian syndrome; FFM, fat-free mass.
aFFM; bSame as “Study 1” in Blonde et al. (2016) [41]; cCalculated using mean weight loss in entire cohort.