Metformin to Prevent Metabolic Complications in Glucocorticoid Excess

This study is currently recruiting participants.
Verified January 2013 by University Hospital, Basel, Switzerland
Sponsor:
Information provided by (Responsible Party):
Mirjam Christ-Crain, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01187849
First received: August 23, 2010
Last updated: January 15, 2013
Last verified: January 2013

August 23, 2010
January 15, 2013
August 2010
August 2013   (final data collection date for primary outcome measure)
2 hours glucose level after a standardized 75g OGTT [ Time Frame: 0 months, 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01187849 on ClinicalTrials.gov Archive Site
HOMA-index [ Time Frame: 0 months, 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Metformin to Prevent Metabolic Complications in Glucocorticoid Excess
Metformin to Prevent Metabolic Complications in Glucocorticoid Excess

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Patients With Glucocorticoid Treatment
  • Drug: Metformin
    Volunteers will be given Metformin or placebo for 1 month, once daily.
  • Drug: Placebo
    Volunteers will be given Metformin or placebo for 1 month, once daily
  • Active Comparator: Metformin
    Intervention: Drug: Metformin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
66
December 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Mirjam Christ-Crain, Prof. Dr. med. 61 265 5078 ext 0041 Mirjam.Christ-Crain@unibas.ch
Switzerland
 
NCT01187849
EKBB 245/09
Yes
Mirjam Christ-Crain, University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
Not Provided
Principal Investigator: Mirjam Christ-Crain, Prof. Dr. med. University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP