Metformin to Prevent Metabolic Complications in Glucocorticoid Excess

University Hospital Basel

Status and phase: Completed; Phase 4

Conditions: Patients With Glucocorticoid Treatment

Treatments: Drug: Placebo; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT01187849

EKBB 245/09

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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29 participants in 2 patient groups, including a placebo group

Metformin

Active Comparator group

Treatment:

Drug: Metformin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo