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Metformin to Prevent Metabolic Complications in Glucocorticoid Excess

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland Identifier:
First received: August 23, 2010
Last updated: April 27, 2016
Last verified: April 2016
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.

Condition Intervention Phase
Patients With Glucocorticoid Treatment
Drug: Metformin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Metformin to Prevent Metabolic Complications in Glucocorticoid Excess

Resource links provided by NLM:

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • 2 hours glucose level after a standardized 75g oral glucose tolerance test (OGTT) [ Time Frame: 0 months, 3 months ]

Secondary Outcome Measures:
  • homeostasis model assessment (HOMA)-index [ Time Frame: 0 months, 3 months ]

Enrollment: 29
Study Start Date: August 2010
Study Completion Date: December 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metformin Drug: Metformin
Volunteers will be given Metformin or placebo for 1 month, once daily.
Placebo Comparator: Placebo Drug: Placebo
Volunteers will be given Metformin or placebo for 1 month, once daily


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01187849

University Hospital Basel
Basel, Basel-Stadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Principal Investigator: Mirjam Christ-Crain, MD, Prof. University Hospital, Basel, Switzerland
  More Information

Responsible Party: University Hospital, Basel, Switzerland Identifier: NCT01187849     History of Changes
Other Study ID Numbers: EKBB 245/09
Study First Received: August 23, 2010
Last Updated: April 27, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on May 25, 2017