Study of impact on body weight change and dehydration in the initial administration of Tofogliflozin

Study of impact on body weight change and dehydration in the initial administration of Tofogliflozin - Study of impact on body weight change and dehydration in the initial administration of Tofogliflozin

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017062

Enrollment

200

Registered

2015-04-07

Start date

2015-04-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus

Interventions

From baseline to Week 24, patients will receive oral tofogliflozin at a dose of 20 mg per administration, once daily, either before or after breakfast.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients diagnosed with diabetes mellitus (2) Patients aged 20 years of age or more (3) Patients who have no prior history of using SGLT2 inhibitors (4) Patients who provide written informed consent to participate in this clinical study

Exclusion criteria

Exclusion criteria: (1) Patients with a prior history of hypersensitivity to any of the ingredients of tofogliflozin (2) Patients with severe ketosis, diabetic coma, or precoma (3) Patients with severe infections or severe injuries or those who are scheduled to receive or have received surgical treatment (4) Patients with severe hepatic function impairment (5) Patients with end-term renal failure who are on hemodialysis or peritoneal dialysis (6) Patients who are determined by principal investigators or sub-investigators to be ineligible for the clinical study

Design outcomes

Primary

Measure	Time frame
Relationship between changes in body weight at Week 2 of treatment and the frequency of deviations from upper limit reference values for hematocrit at Week 24	—

Secondary

Measure	Time frame
(1) Safety: frequency of adverse effects and adverse events (events, severity, incidence rates, etc.) (2) Efficacy: changes over time in the parameters listed below. HbA1c (NGSP value), blood sugar, total cholesterol, LDL-cholesterol (formula), HDL-cholesterol, triglycerides, BUN, serum creatinine, uric acid, body weight, blood pressure, hematocrit. (3) Others changes from baseline in HbA1c, body weight, hematocrit, lipid, uric acid, and frequency of adverse events, etc. in tofogliflozin-treated patients after stratification based on baseline values	—

Measure

Time frame

(1) Safety: frequency of adverse effects and adverse events (events, severity, incidence rates, etc.) (2) Efficacy: changes over time in the parameters listed below. HbA1c (NGSP value), blood sugar, total cholesterol, LDL-cholesterol (formula), HDL-cholesterol, triglycerides, BUN, serum creatinine, uric acid, body weight, blood pressure, hematocrit. (3) Others changes from baseline in HbA1c, body weight, hematocrit, lipid, uric acid, and frequency of adverse events, etc. in tofogliflozin-treated patients after stratification based on baseline values

—

Countries

Japan

Contacts

Public ContactClinical Study Support Center

Satt Co., Ltd. Promotion division of the clinical study

sweat@sa-tt.co.jp03-5312-5026

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026