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Metformin to Prevent Metabolic Complications in Glucocorticoid Excess

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01187849
First Posted: August 24, 2010
Last Update Posted: April 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
August 23, 2010
August 24, 2010
April 28, 2016
August 2010
August 2015   (Final data collection date for primary outcome measure)
2 hours glucose level after a standardized 75g oral glucose tolerance test (OGTT) [ Time Frame: 0 months, 3 months ]
2 hours glucose level after a standardized 75g OGTT [ Time Frame: 0 months, 3 months ]
Complete list of historical versions of study NCT01187849 on ClinicalTrials.gov Archive Site
homeostasis model assessment (HOMA)-index [ Time Frame: 0 months, 3 months ]
HOMA-index [ Time Frame: 0 months, 3 months ]
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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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.
 
Completed
29
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
Sexes Eligible for Study: All
18 Years to 100 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT01187849
EKBB 245/09
Yes
Not Provided
Plan to Share IPD: No
University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
Not Provided
Principal Investigator: Mirjam Christ-Crain, MD, Prof. University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
April 2016

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