Table 1 List of clinical trials examining migitol’s anti-obesity effect

[4]

Shimabukuro et al., 2012, Japan

Open-label, randomized-control.

12 weeks

111 drug-naive patients. Men and women aged 34–69 years with metabolic syndrome

Lifestyle modification (LSF) (n = 56) vs LSF with miglitol (n = 55)

Before/

After treatment

:72.6 ± 11.7/

68.9 ± 10.4

Parameters improved in LSF + miglitol: BW, systolic and diastolic blood pressure, HOMA-R, blood examination (T-cho, LDL, TG, γGTP, high sensitive CRP, HbA1c, 1,5-AG), insulin and blood glucose during OGTT, SFA , mean % change from baseline in VFA.

Parameters improved in both groups: BMI, waist circumstance, VFA

Mild flatulence, abdominal pain,

and diarrhea

[5]

Narita et al.,

2012, Japan

Open-label, randomized parallel controlled.

12 weeks

50 patients with type 2 DM with diet therapy alone or with oral hypoglycemic agents other than αGI

Miglitol (n = 26) vs voglibose (n = 24)

64.5 ± 14.0

/63.6 ± 14.0

Parameters improved in miglitol group: BW, BMI

Parameters improved in both groups: HbA1c, 2-hour MTT (plasma glucose AUC, insulin AUC)

Both miglitol and voglibose decreased total GIP and increased active GLP1 during the MTT (GIP was lower in the miglitol group than in the voglibose group).

Not documented

[6]

Mikada et al., 2014, Japan

Open-label, randomized parallel, three armed.

24 weeks

41 patients with type 2 DM and overweight (BMI ≥ 25) aged 20–80 years

Miglitol (n = 14) vs sitagliptin (n = 14) vs both drugs (n = 13)

81.4 ± 11.2

/79.9 ± 11.5

(Data are shown for only the miglitol-treated group): BW, BMI, total body fat mass, systolic blood pressure, blood glucose-iAUC, and insulin-iAUC decreased after treatment compared with before treatment. Miglitol decreased total GIP-iAUC and increased total GLP1-iAUC, but did not affect active GIP-iAUC and active GLP1-iAUC.

Not documented

[7]

Sugihara et al., 2014, Japan

Open-label randomized.

12 weeks

81 patients with obesity and type 2 diabetes (BMI ≥ 25) aged ≥40 years

Control (n = 22), miglitol (n = 18), acarbose (n = 22), voglibose (n = 19)

69.0 ± 11.2

/67.8 ± 11.2

In only the miglitol group BW and BMI decreased after treatment compared with before treatment at 4, 8, and 12 weeks.

HbA1c decreased after treatment compared with before treatment in the control (at 12 weeks) and in the miglitol-treated group (at 4, 8, and 12 weeks).

Some digestive symptoms observed in the three αGI-treated groups