Metformin to Prevent Metabolic Complications in Glucocorticoid Excess

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01187849

Enrollment

Registered

2010-08-24

Start date

2010-08-31

Completion date

2015-12-31

Last updated

2016-04-28

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

Conditions

Patients With Glucocorticoid Treatment

Brief summary

The purpose of this study is to evaluate if a treatment with metformin compared to placebo reduces metabolic side-effects in patients with glucocorticoid treatment over three months time.

Interventions

DRUGMetformin

Volunteers will be given Metformin or placebo for 1 month, once daily.

DRUGPlacebo

Volunteers will be given Metformin or placebo for 1 month, once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

* Glucocorticoid treatment for ≥ 3 months with a prednisone dose of ≥ 7.5mg/d or equivalent glucocorticoid

Exclusion criteria

* Refusal of informed consent * Prior therapy with metformin during the last 6 month * Preexisting diabetes * Pregnancy or current malignancy * Renal insufficiency with a creatinine clearance lower than 30ml/min

Design outcomes

Primary

Measure	Time frame
2 hours glucose level after a standardized 75g oral glucose tolerance test (OGTT)	0 months, 3 months

Secondary

Measure	Time frame
homeostasis model assessment (HOMA)-index	0 months, 3 months

Countries

Switzerland

Outcome results

None listed

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