A prospetctive observational study to elucidate the safty and efficacy of GLP-1 analogue treatment for non-alcoholic steatohepatitis patients with type2 diabetes mellitus

A prospetctive observational study to elucidate the safty and efficacy of GLP-1 analogue treatment for non-alcoholic steatohepatitis patients with type2 diabetes mellitus - NASH DM GLP-1 study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004512

Enrollment

Registered

2010-12-01

Start date

2010-12-01

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

NASH patients with type2 diabetes mellitus who have indication for GLP-1 analogue treatment.

Interventions

GLP-1 analogue treatment.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Age over 20 years. 2.Type2 DM patients who have not effectiveness with exercise therapy or alimentary therapy. 3.Type2 DM patients who have not effectiveness with sulfonylurea agent. 4.Type2 DM patients who are treated with other than sulfonylurea agent and have indication of treatment for combination therapy of sulfonylurea agent and GLP-1 analogue. 5.Type2 DM patients who are considering to quite insulin therpay by using GLP-1 analogue. 6.Abnormal elevation of GPT above normal upper limit over 6 months. 7.Taking alcohol less than 20g/day as 100% ethanol. 8.Patients who are excepted for other liver diseases by blood test. 9.Patients who agreed to this study via sufficient informed concent.

Exclusion criteria

Exclusion criteria: 1.Patinets who have history of HBV or HCV infection, and auto-immune hepatitis. 2.Patients who take alcohol more than 20g/day as 100% ethanol. 3.Patients who have renal dysfunction (Cre over 2.0 mg/dl or eGFR less than 30 mL/min). 4.Patients who have platelet counts less than 50,000/micro-litter or prothrombin activity less than 50%. 5.Patients who have history of pancreatitis. 6.Patients who are treated with other clinical trial medicine. 7.Patients who have malignancy. 8.Patients who are judged no indication by whome resposible for this study.

Design outcomes

Primary

Measure	Time frame
Imprpvment of the value of transaminase and NAFLD activity score.	—

Secondary

Measure	Time frame
Imprpvment of the value of fasting blood sugar, HbA1c, and fasting blood concentration of insulin. Imprpvment of body weight, visveral fat areas, and fatty liver.	—

Countries

Japan

Contacts

Public ContactTakamasa Ohki

Mitsui Memorial Hospital Gastroenterology

anb72547@nifty.com03-3862-9111

Outcome results

None listed

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