NCT01187849

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2010

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 28, 2016

Status Verified

April 1, 2016

Enrollment Period

5 years

First QC Date

August 23, 2010

Last Update Submit

April 27, 2016

Conditions

Patients With Glucocorticoid Treatment

Outcome Measures

Primary Outcomes (1)

  • 2 hours glucose level after a standardized 75g oral glucose tolerance test (OGTT)

    0 months, 3 months

Secondary Outcomes (1)

  • homeostasis model assessment (HOMA)-index

    0 months, 3 months

Study Arms (2)

Metformin

ACTIVE COMPARATOR
Drug: Metformin

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MetforminDRUG

Volunteers will be given Metformin or placebo for 1 month, once daily.

Metformin
PlaceboDRUG

Volunteers will be given Metformin or placebo for 1 month, once daily

Placebo

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Glucocorticoid treatment for ≥ 3 months with a prednisone dose of ≥ 7.5mg/d or equivalent glucocorticoid

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Mirjam Christ-Crain, MD, Prof.

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2010

First Posted

August 24, 2010

Study Start

August 1, 2010

Primary Completion

August 1, 2015

Study Completion

December 1, 2015

Last Updated

April 28, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)