Biomarkers of Prednisolone Treatment (P05888)

Not Applicable

Completed

• Conditions: Insulin Resistance; Hyperglycemia; Glucose Intolerance
• Interventions: Drug: Placebo; Drug: Prednisolone

• Registration Number: NCT00971724
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Primary objective:

* To identify a biomarker or biomarker-set for the adverse metabolic effects of various doses of prednisolone treatment.

Secondary objectives:

* To describe the PK of prednisolone and PD of a series of biomarkers.

* To identify biomarkers that reflect side effects of prednisolone.

* To elucidate part of the mechanisms by which prednisolone induces metabolic changes.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2006-10
• Study Completion: 2008-03
• Study First Submitted: 2009-09-03
• Study First Submitted QC: 2009-09-03
• Study First Posted: 2009-09-04
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-21
• Last Update Posted: 2015-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 72

Inclusion Criteria

• 22 < BMI < 30
• fasting glucose < 5.6 mmol/L and glucose < 7.8 mmol/L 2hr after OGTT
• able and willing to sign informed consent
• history of good physical and mental health
• subject smokes less than 5 cigarettes per day
• able to keep a normal day and night rhythm

Exclusion Criteria

• allergy to prednisolone
• glucocorticoid use during last 3 months prior to study
• use of any drug or substance
• history of familiar diabetes type 2
• clinically relevant history or presence of any medical disorder
• clinically relevant abnormal lab or ECG
• positive drug or alcohol screen, positive hepatitis B or C surface antigen
• donation of blood (>100 mL) within 90 days prior to the first dose

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Treatment with placebo for 15 days
Prednisolone 15 mg daily	Prednisolone	Treatment with prednisolone 15 mg daily for 15 days
Prednisolone 7.5 mg daily	Prednisolone	Treatment with prednisolone 7.5 mg daily for 15 days
Prednisolone 30 mg daily	Prednisolone	Treatment with prednisolone 30 mg daily for 15 days
Prednisolone 75 mg	Prednisolone	Treatment with prednisolone 75 mg for a single day
Prednisolone 15 mg twice daily	Prednisolone	Treatment with prednisolone 15 mg twice daily for a single day

Primary Outcome Measures

Name	Time	Method
To identify a biomarker or biomarker-set for adverse metabolic effects of various doses of prednisolone	Day 1 and day 15

Secondary Outcome Measures

Name	Time	Method
To describe the PK of prednisolone and PD of a series of biomarkers	Day 1 and day 15