CClinicalTrials.gg
WithdrawnNCT00481429Updated Jul 10, 2019

Predictive Markers of Glitazone Efficacy in Diabetic Patients - Pilot Study

An observational study in Diabetes Mellitus, Type 2, sponsored by Imperial College London. Withdrawn at 4 sites in United Kingdom. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-07-10.

Sponsored by Imperial College London · Observational

Why this study was withdrawn
Unable to recruit enough participants
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
0
Ages
18 Years to 65 Years
Sex
Male
01

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

Rosiglitazone (Avandia) is a medicine used to treat type 2 diabetes. It works by increasing the sensitivity of body tissues to insulin.

This pilot study will examine the possibility that baseline biochemistry might predict the response to rosiglitazone. The study will be conducted in males and the biomarkers of interest measured by specific assays. In addition, since the biomarkers to be measured come from body fat, interpretation of the data would be facilitated by accurate measurements of changes in body fat mass during treatment and these data can be obtained from Echo-MRI scans.

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • Biomarker
  • Glitazone
  • Diabetes
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with type 2 diabetes attending clinic

Inclusion criteria

  1. Male subjects aged 18 to 65 years.
  2. 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.
  3. BMI must be > or = 25kg/m2 to \< or = 40kg/m2,
  4. HbA1c between 7and 10%, fasting blood glucose above 7mmol/L (fasting means greater or = 8 hours prior to screening).
  5. 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.
  6. On stable doses of anti-hypertensive medication, thyroid hormone replacement and statin therapy as required.

Exclusion criteria

Exclusion Criteria:

  1. Prior treatment with thiazolidinedione, insulin or GLP-1 analogue (Byetta)
  2. 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.

  3. Contraindications to rosiglitazone treatment.
  4. Serum creatinine greater than 1.5 X upper limit of normal range.
  5. Any other clinically significant laboratory abnormality.
  6. Claustrophobic or other contraindication to MRI scan
  7. Females of child-bearing age who are unwilling to use appropriate methods of contraception.
  8. Unable to give informed consent.
  9. Unable to comply with study protocol.
  10. Clinically significant co-morbidity. -
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 1

    Rosiglitazone

    Drug: Rosiglitazone

  • 2

    Diet control +/- metformin

Interventions

  • DrugRosiglitazone

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

06

What researchers measure

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.

    Time frame: 12 weeks

Secondary outcomes

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

    Time frame: 12 weeks

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

    Time frame: 12 weeks

07

Study locations

4 sites
  • Addenbrooke's Hospital
    Cambridge, CB2 2GG, United Kingdom
  • Ealing Hospital
    London, UB1 3HW, United Kingdom
  • Imperial College London - Hammersmith Campus
    London, W12 ONN, United Kingdom
  • Charing Cross Hospital
    London, W6 8RF, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00481429
Lead sponsor
Imperial College London
Collaborators
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jun 1, 2007
Start date
May 2007 (estimated)
Primary completion
Jan 2008 (estimated)
Completion
Jan 2008 (estimated)
Last update
Jul 10, 2019

Study contacts

Martin R Wilkins, MD FRCP
principal investigator · Imperial College London

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion