Metformin to Prevent Metabolic Complications in Glucocorticoid Excess

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 19, 2014
Last verified: May 2014

August 23, 2010
May 19, 2014
August 2010
August 2015   (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 2015
August 2015   (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
May 2014

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