Predictive Markers of Glitazone Efficacy in Diabetic Patients - Pilot Study

NCT00481429 | Withdrawn

• 1 other identifier: cro700
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief Summary

Hypothesis: A cluster of biochemical measurements (biomarkers) predict which diabetic patients will respond to treatment with a therapeutic dose of rosiglitazone over a 12 week treatment period. Brief Summary: The purpose of this study is to assess the predictive value of the biomarkers in diabetic patients treated with a full dose of a thiazolidinedione (eg 4mg bid rosiglitazone) for 12 weeks. Specifically - the questions asked are:

1. 1.Do baseline measurements of a selected panel of biomarkers predict the patients' response to rosiglitazone over 12 weeks?
2. 2.How does the panel of biomarkers change over that 12 week treatment period?

Conditions

Diabetes Mellitus, Type 2

Keywords

Biomarker; Glitazone; Diabetes

Outcome Measures

Primary Outcomes (1)

• The performance of baseline biochemical biomarkers in plasma and urine in distinguishing patients who respond to rosiglitazone from those that do not, as classified by a change in HbA1C at 12 weeks.

  12 weeks

Secondary Outcomes (2)

• Variability in baseline levels of key biochemical markers in diabetic patients.

  12 weeks

• Effect of treatment on a variety of other novel potential predictive biomarkers and markers of insulin sensitisation in diabetic patients.

  12 weeks

Study Arms (2)

1

Rosiglitazone

Drug: Rosiglitazone

2

Diet control +/- metformin

Interventions

Rosiglitazone DRUG

Rosiglitazone 4mg od, increased to 4mg bg at 4 weeks if HbA1C above 7%.

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with type 2 diabetes attending clinic

You may qualify if:

• Male subjects aged 18 to 65 years.
• Eligible subjects must be free from clinically significant illness or disease (other than type 2 diabetes)with the exception of chronic stable-treated hypertension (BP\<160/90, and \>90/50), thyroid disease (TSH in the normal reference range) and/or dyslipidaemia.
• BMI must be \> or = 25kg/m2 to \< or = 40kg/m2,
• HbA1c between 7and 10%, fasting blood glucose above 7mmol/L (fasting means greater or = 8 hours prior to screening).
• On diet alone or diet plus metformin (GSK data indicate that the latter group more faithfully reflect the behaviour of 'naive' patients than those who have been washed off prior medications)for at least 1 month.
• On stable doses of anti-hypertensive medication, thyroid hormone replacement and statin therapy as required.

You may not qualify if:

• Prior treatment with thiazolidinedione, insulin or GLP-1 analogue (Byetta)
• History of hepatic disease, impairment or abnormal liver function test i.e. AST, ALT\>2 times upper limit of normal range (ULN), bilirubin\>1.5 time ULN.
• History of renal disease or serum creatinine greater than 1.5 X ULN.
• Contraindications to rosiglitazone treatment.
• Serum creatinine greater than 1.5 X upper limit of normal range.
• Any other clinically significant laboratory abnormality.
• Claustrophobic or other contraindication to MRI scan
• Females of child-bearing age who are unwilling to use appropriate methods of contraception.
• Unable to give informed consent.
• Unable to comply with study protocol.
• Clinically significant co-morbidity. -

Sponsors & Collaborators

• Imperial College London: lead
• GlaxoSmithKline: collaborator

Study Sites (4)

Addenbrooke's Hospital

Cambridge, CB2 2GG, United Kingdom

Location

Ealing Hospital

London, UB1 3HW, United Kingdom

Location

Imperial College London - Hammersmith Campus

London, W12 ONN, United Kingdom

Location

Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and urine

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Martin R Wilkins, MD FRCP

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2007
• First Posted: June 1, 2007
• Study Start: May 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: July 10, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)