The Effect of Adding Metformin to the Treatment of Hepatitis C

Effect and Safety of Adding Metformin to the Standard Treatment of Hepatitis C on Sustained Viral Response

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00560690

Enrollment

140

Registered

2007-11-20

Start date

2007-12-31

Completion date

2010-12-31

Last updated

2015-04-06

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

Conditions

Hepatitis C

Keywords

Hepatitis C, metformin, Insulin Resistance

Brief summary

Insulin resistance is known to adversely effect viral response to treatment in hepatitis C patients We are aiming to study the effect of an insulin sensitizer, metformin, in viral response of hepatitis C to treatment with pegylated interferon and ribavirin in a double blind randomized controlled trial

Detailed description

Subjects with hepatitis C will be randomized to receive standard treatment with or without metformin. The results will be compared.

Interventions

DRUGMetformin

500 mg oral three times a day for 6 months

DRUGpegylated interferon

180 micrograms, or 1.5 micrograms/kg body weight weekly SQ injection for 6 or 12 months depending on genotype

DRUGRibavirin

800-1200 mg PO given in 2 divided doses for 6 to 12 months depending on weight and genotype

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

15 Years to 65 Years

Healthy volunteers

Inclusion criteria

* chronic hepatitis C * Iranian nationality * Treatment naive

Exclusion criteria

* cirrhosis * diabetes mellitus * HBV/HIV coinfection * contraindications of metformin, interferon, ribavirin * severe medical conditions (e.g. CHF, CRF, psychosis, ...) * not consenting

Design outcomes

Primary

Measure	Time frame
Sustained viral response, defined as undetectable virus RNA 6 months after end of treatment	6 months after end of treatment

Secondary

Measure	Time frame
adverse effects leading to discontinuation of treatment	anytime during the study
Rapid viral response, defined as undetectable viral RNA one month after start of treatment	one month after start of treatment
Early viral response, defined as undetectable viral RNA or 2 log drop in viral count three month after start of treatment	three months after start of treatment

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026