Skip to content

An Open label multi- facilities cooperation randomized control trial to verify methylglyoxal reductive effects of sitagliptin treatment in the type 2 diabetic patients.

An Open label multi- facilities cooperation randomized control trial to verify methylglyoxal reductive effects of sitagliptin treatment in the type 2 diabetic patients. - Sitagliptin reduces the plasma methylglyoxal levels in poorly controlled type 2 diabetic patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005115
Enrollment
100
Registered
2011-05-01
Start date
2011-05-01
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

Poorly controlled type 2 diabetic patients.

Interventions

This study is a prospective randomized control trial. The entry period of this study is three years. Study subjects are poorly controlled type 2 diabetic patients. These patients are randomly assigned

Sponsors

Graduate School of Medicine, Tohoku University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The subjects enrolled in the present study are poorly glycemic controlled out-patients with type 2 diabetes mellitus, who fulfill the following criteria; 1) poorly glycemic controlled defined as the HbA1c of more than 6.0%. 2) The medicine is not changed within the last three months, and the change of the medicine is not scheduled for the examination period (three months). 3) Serum creatinine is less than 2.5 mg/dl. 4) The participation agreement of this study is obtained.

Exclusion criteria

Exclusion criteria: 1) The participation agreement of this study is not obtained. 2) To have other serious and active diseases such as severe hypertension, liver dysfunction, cardiovascular disease and so on. 3) Corresponding to the serum creatinine level > 2.5 mg/dl, or receiving continuous dialysis). 4) Woman who has pregnancy or possibility of pregnancy and suckling. 5) The patient that corresponds to contraindication of siutagliptin treatment. 6) Severe hyperglycemic subjects (HbA1c>10%). (It is necessary to do the insulin treatment.) 7) Patient from whom physician in charge of treatment judged this study participation to be improper.

Design outcomes

Primary

MeasureTime frame
percent change of plasma methylglyoxal level.

Secondary

MeasureTime frame
Percent changes in blood pressure, HbA1c, the urinary excretions of albumin, MCP-1, 8-OHdG and AGT.

Countries

Japan

Contacts

Public ContactSusumu Ogawa

Tohoku University Hospital Division of Nephrology, Endocrinology and Hypertension

ogawa-s@hosp.tohoku.ac.jp022-717-7166

Outcome results

None listed

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