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Clinical Trials/NCT01187849
NCT01187849
Completed
Phase 4

Metformin to Prevent Metabolic Complications in Glucocorticoid Excess

University Hospital, Basel, Switzerland1 site in 1 country29 target enrollmentAugust 2010
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ConditionsPatients With Glucocorticoid Treatment
InterventionsMetforminPlacebo
DrugsMetforminPlacebo

Overview

Phase
Phase 4
Intervention
Metformin
Conditions
Patients With Glucocorticoid Treatment
Sponsor
University Hospital, Basel, Switzerland
Enrollment
29
Locations
1
Primary Endpoint
2 hours glucose level after a standardized 75g oral glucose tolerance test (OGTT)
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
December 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Basel, Switzerland
Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Metformin

Intervention: Metformin

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

2 hours glucose level after a standardized 75g oral glucose tolerance test (OGTT)

Time Frame: 0 months, 3 months

Secondary Outcomes

  • homeostasis model assessment (HOMA)-index(0 months, 3 months)

Study Sites (1)

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