Efficacy and safety of metformin plus carnitine complex(Godex) compaired with metformin monotherapy in type 2 DM and impaired glucose tolerance patients with non-alcoholic fatty liver disease.

Efficacy and safety of metformin plus carnitine complex(Godex) compaired with metformin monotherapy in type 2 DM and impaired glucose tolerance patients with non-alcoholic fatty liver disease; A randomized, placebo controlled, double blind, parallel desinged phase 4 clinical trials.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0000193

Enrollment

Registered

2011-10-04

Start date

2010-05-11

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

carnitine orotate complex(brand name

Godex cap.), 412mg/1capsule, 2cap. tid, peroral 2) Antidiabetic

metformin HCl(brand name

Diabex tab., 250mg/1tablet, 1tab. tid, peroral 2. Monotherapy treatment group 1) Placebo

412mg/1capsule, 2cap. tid, peroral 2) Antidiabetic

Diabex tab., 250mg/1tablet, 1tab. tid, peroral

Drug : 1. Combination therapy treatment group 1) Carnitine complex

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age at least 18 years and under 80 years 2) Subjects with non-alcoholic fatty liver disease; 35U/L = ALT = 250u/L 3) 100mg/dL = fasting glucose = 300mg/dL or HbA1c > 6.5% 4) Able and willing to provide informed consent

Exclusion criteria

Exclusion criteria: 1) Subject with current viral hepatitis(HAV, HBV, HCV), alcoholic liver disease, and other liver disease 2) Subject with allergy to study agent(s) or their formulations 3) Current levodopa medication 4) Pregnant or breastfeeding women 5) Subject who participated in any clinical studies within 30 days prior to study entry and during study 6) Subjects who were prescribed hypoglycemic agent including insulin within 30 days of screening or prior to randomization 7) Inability or unwillingness to give informed consent or abide by the study protocol

Design outcomes

Primary

Measure	Time frame
The rate of ALT normalization	—

Secondary

Measure	Time frame
The changes and change rate of glycemic control (fasting glucose, fasting insulin, HbA1c) ;The changes of plasma ALT levels;The changes of urine 8-OHdG;The changes of mitochondria DNA copy number	—

Countries

Korea, Republic of

Contacts

Public Contactsoo lim

Seoul National University Bundang Hospital

Outcome results