Metformin to Prevent Metabolic Complications in Glucocorticoid Excess

Phase 4

Completed

• Conditions: Patients With Glucocorticoid Treatment
• Interventions: Drug: Metformin; Drug: Placebo

• Registration Number: NCT01187849
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-23
• Study First Submitted QC: 2010-08-23
• Study First Posted: 2010-08-24
• Primary Completion: 2015-08
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-27
• Last Update Posted: 2016-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin	-
Placebo	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
homeostasis model assessment (HOMA)-index	0 months, 3 months

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Basel-Stadt, Switzerland