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Effects of transglucosidase on diabetes, cardiovascular risk factors, and hepatic biomarkers in patients with type 2 diabetes: a 12-week, randomized, double-blind, placebo-controlled trial

Effects of transglucosidase on diabetes, cardiovascular risk factors, and hepatic biomarkers in patients with type 2 diabetes: a 12-week, randomized, double-blind, placebo-controlled trial - TG Effect on Diabete

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010318
Enrollment
66
Registered
2013-03-26
Start date
2007-09-12
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

Patients

Interventions

Placebo 3 times/day after every meal Transglucosidase 100mg 3 times after every meal Transglucosidase 300mg 3 times after every meal

Sponsors

Nagoya City University Graduate School of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who were diagnosed to type-2 diabetes according to the diagnosis criteria of diabetes mellitus of the Japanese Diabetes Society. 2) Patients whose HbA1c level was between 5.8 and 7.5% at screening. 3) Patiens who had stable dosages of medication for at least 1 month. 4) Patients who were stable diabetes condition for at least 3 months (change in HbA1c less than 1.0%).

Exclusion criteria

Exclusion criteria: Patients who had a history of gut resection.

Design outcomes

Primary

MeasureTime frame
To evaluate the change of HbA1c of diabetes patients after transglucosidase treatment

Secondary

MeasureTime frame
To evaluate the change of fasting blood glucose, HOMA-IR, and intestinal microbiota of diabetes patients after transglucosidase treatment

Countries

Japan

Contacts

Public ContactMakoto Sasaki

Aichi Medical University Gastroenterology

msasaki@aichi-med-u.ac.jp+81-561-62-3311

Outcome results

None listed

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