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A study on multifaceted clinical effects of SGLT2 inhibitors

A study on multifaceted clinical effects of SGLT2 inhibitors - Multifaceted clinical effects of SGLT2 inhibitors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031947
Enrollment
120
Registered
2018-05-01
Start date
2018-05-01
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

Interventions

Patients receive SGLT2 inhibitors for 16 weeks.

Sponsors

Tokushima University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Participants were eligible if they were at least 20 years old, had type 2 diabetes mellitus, poorly controlled diabetes (HbA1c levels >6.9% within 12 weeks before screening), and had been treated with diet therapy and/or a single OHA, such as sulfonylurea (SU), biguanide (BG), thiazolidinedione (TZD) or dipeptidyl peptidase-4 (DPP-4) inhibitor class drugs, for 12 weeks or longer.

Exclusion criteria

Exclusion criteria: Exclusion criteria were: (1) hypersensitivity or a contraindication to sitagliptin or voglibose; (2) history of type 1 diabetes; (3) history of ketoacidosis; (4) having experienced symptoms of hypoglycemia; (5) treatment with sitagliptin or voglibose within 12 weeks before screening; (6) treatment with insulin within 12 weeks before screening; (7) concomitant corticosteroid therapy; (8) poorly controlled or unstable diabetes (the state with ketoacidosis or with an increase in HbA1c >3% in the 12 weeks before screening); (9) alanine aminotransferase and/or aspartate aminotransferase levels more than 2.5-fold the upper limit of normal; (10) poorly controlled hypertension or systolic blood pressure >160 mm/Hg or diastolic blood pressure >100 mm/Hg; (11) presence of a severe health problem not suitable for the study; (12) pregnancy or breastfeeding; or (13) inability to participate in the study due to psychiatric or psychosocial status as assessed by the investigators.

Design outcomes

Primary

MeasureTime frame
HbA1c levels, urinary albumin-to-creatinine ratio, and urinary L-FABP-to-creatinine ratio over 16 weeks

Countries

Japan

Contacts

Public ContactToshiki Otoda

Tokushima University Graduate School of Biomedical Sciences Department of Community Medicine and Medical Science

otoda.toshiki@tokushima-u.ac.jp088-633-7120

Outcome results

None listed

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