Diabetes Mellitus, Type 2NCT00481429
Predictive Markers of Glitazone Efficacy in Diabetic Patients - Pilot Study
An observational study of Diabetes Mellitus, Type 2, run by Imperial College London at 4 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Rosiglitazone
- How many people
- 0 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- May 2007to Jan 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with type 2 diabetes attending clinic
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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. -
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Addenbrooke's Hospital
Cambridge, CB2 2GG
Ealing Hospital
London, UB1 3HW
Imperial College London - Hammersmith Campus
London, W12 ONN
Charing Cross Hospital
London, W6 8RF
About this study
Official title: Evaluation of Predictive Markers of Glitazone Efficacy in Diabetic Patients - Pilot Study
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:
- Do baseline measurements of a selected panel of biomarkers predict the patients' response to rosiglitazone over 12 weeks?
- 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Rosiglitazone
- Keywords
- Biomarker, Glitazone, Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosiglitazoneDrug
Rosiglitazone 4mg od, increased to 4mg bg at 4 weeks if HbA1C above 7%.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Rosiglitazone Receives: Drug: Rosiglitazone | |
| 2 | Diet control +/- metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (2)
Variability in baseline levels of key biochemical markers in diabetic patients.
Measured: 12 weeks
Effect of treatment on a variety of other novel potential predictive biomarkers and markers of insulin sensitisation in diabetic patients.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2007 (estimated)
- Study startMay 2007 (estimated)
- Primary completionJan 2008 (estimated)
- Study completionJan 2008 (estimated)
Why it stopped: Unable to recruit enough participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Martin R Wilkins, MD FRCP, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00481429
- Sponsor's protocol ID
- cro700
- Status last verified
- Jul 2019
- First submitted
- 31 May 2007
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Predictive Markers of Glitazone Efficacy in Diabetic Patients - Pilot Study
- ClinicalTrials.gov ID
- NCT00481429
- Acronym / sponsor ID
- cro700
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Biomarker, Glitazone, Diabetes
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to recruit enough participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- May 2007 (estimated)
- Primary completion
- Jan 2008 (estimated)
- Study completion
- Jan 2008 (estimated)
- First posted
- 1 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Do baseline measurements of a selected panel of biomarkers predict the patients' response to rosiglitazone over 12 weeks?
- How does the panel of biomarkers change over that 12 week treatment period?
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: RosiglitazoneRosiglitazone |
| 2 | – | –Diet control +/- metformin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 2 diabetes attending clinic
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RosiglitazoneRosiglitazone 4mg od, increased to 4mg bg at 4 weeks if HbA1C above 7%. | Drug | 1 |
Primary outcome
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
2 secondary outcomes
Variability in baseline levels of key biochemical markers in diabetic patients.
Time frame: 12 weeks
Effect of treatment on a variety of other novel potential predictive biomarkers and markers of insulin sensitisation in diabetic patients.
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin R Wilkins, MD FRCP principal investigator
Imperial College London
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Imperial College London at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.