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Metformin to Prevent Metabolic Complications in Glucocorticoid Excess

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01187849
First received: August 23, 2010
Last updated: April 27, 2016
Last verified: April 2016

August 23, 2010
April 27, 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 ] [ Designated as safety issue: No ]
2 hours glucose level after a standardized 75g OGTT [ Time Frame: 0 months, 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01187849 on ClinicalTrials.gov Archive Site
homeostasis model assessment (HOMA)-index [ Time Frame: 0 months, 3 months ] [ Designated as safety issue: No ]
HOMA-index [ Time Frame: 0 months, 3 months ] [ Designated as safety issue: No ]
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.
 
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
Both
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
No
Not Provided
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