Diabetes Mellitus, Type 2Phase 4NCT00738088
Variation in Sulphonylurea Response in Type 2 Diabetes
A Phase 4 study testing gliclazide in people with Diabetes Mellitus, Type 2, run by NHS Tayside at 1 site in United Kingdom.
Trial summary
The study hypothesis is that people who respond well to sulphonylureas have a different underlying cause for their diabetes than people who respond poorly to this medication. We are using two approaches to study this. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- gliclazide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2007to 3 Mar 2011
- Phase
- Phase 4
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- Age >35 and < 70
- Age of diabetes diagnosis >35 and <70
- White European
- Pre-SU HbA1c <=10%
- HbA1c (on treatment) <= 9%
Show all 14Show fewer
- No myocardial infarction or Acute coronary syndrome in previous year
- No stroke or transient ischaemic attack in previous year
- No or stable (background) retinopathy (no unscheduled laser treatment in the last 6 months)
- eGFR > 60mls/min
- No Proteinuria >30mg/dl on multistix 10SG
- No active foot ulceration or infection
- Liver ALT ≤ twice the upper limit of the reference range
- Contactable by telephone
Who cannot join
- Type 1 diabetes
- HbA1c >10% prior to commencing SU
- HbA1c>9% on SU treatment
- Recent MI or Stroke within last 12 months
- Pre-proliferative or proliferative retinopathy
- eGFR<60 ml/min
Show all 11Show fewer
- Proteinuria >30mg/dl on multistix 10SG
- Active foot ulceration or infection
- Liver ALT > twice the upper limit of the reference range
- Female planning to conceive within the study period
- Any other significant medical reason for exclusion as determined by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Glycaemic Response to Sulphonylureas as a Tool to Investigate Type 2 Diabetes Pathophysiology
The study hypothesis is that people who respond well to sulphonylureas have a different underlying cause for their diabetes than people who respond poorly to this medication. We are using two approaches to study this. In one approach we look at people who have previously responded well or poorly, confirm this by rechallenging them with a sulphonylurea drug, and then looking at how well they produce insulin in response to glucose and an intravenous sulphonylurea called tolbutamide. The second approach identifies people with a certain genetic predisposition to diabetes (due to changes in the TCF7L2 gene) and then looks at how well they respond to sulphonylurea medication.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- gliclazide
- Keywords
- Sulphonylurea, Pharmacogenetics
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gliclazideDrug
Also called Diamicron
Gliclazide 80mg bd for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Withdrawal of sulphonylurea for 6 weeks, then re-introduction for 6 weeks, assessed by fasting glucose and HbA1c Receives: Drug: gliclazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c reduction
Measured: 6 weeks
Secondary outcomes (1)
insulin secretory response to glucose and tolbutamide
Measured: acute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startJun 2007
- Primary completion3 Mar 2011
- Study completion3 Mar 2011
Why it stopped: Following Regulator inspection in 2009, study terminated as inadequate approvals were in place
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.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Tayside
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ewan Pearson, NHS Tayside
- Investigators
- Ewan R Pearson, Principal investigator, NHS Tayside
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738088
- Sponsor's protocol ID
- 2007DM02
- Other IDs
- EudraCT 2007-000594-29
- Status last verified
- May 2018
- First submitted
- 18 Aug 2008
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Glycaemic Response to Sulphonylureas as a Tool to Investigate Type 2 Diabetes Pathophysiology
- ClinicalTrials.gov ID
- NCT00738088
- Acronym / sponsor ID
- 2007DM02
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Sulphonylurea, Pharmacogenetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Following Regulator inspection in 2009, study terminated as inadequate approvals were in place
- Enrolment
- 14 participants (actual)
- Lead sponsor
- NHS TaysideOther government
- Study start
- Jun 2007 (actual)
- Primary completion
- 3 Mar 2011 (actual)
- Study completion
- 3 Mar 2011 (actual)
- First posted
- 20 Aug 2008 (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.
The study hypothesis is that people who respond well to sulphonylureas have a different underlying cause for their diabetes than people who respond poorly to this medication. We are using two approaches to study this. In one approach we look at people who have previously responded well or poorly, confirm this by rechallenging them with a sulphonylurea drug, and then looking at how well they produce insulin in response to glucose and an intravenous sulphonylurea called tolbutamide. The second approach identifies people with a certain genetic predisposition to diabetes (due to changes in the TCF7L2 gene) and then looks at how well they respond to sulphonylurea medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: gliclazideWithdrawal of sulphonylurea for 6 weeks, then re-introduction for 6 weeks, assessed by fasting glucose and HbA1c |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Type 2 diabetes
- Age >35 and < 70
- Age of diabetes diagnosis >35 and <70
- White European
- Pre-SU HbA1c <=10%
Key exclusion criteria (11 listed)
- Type 1 diabetes
- HbA1c >10% prior to commencing SU
- HbA1c>9% on SU treatment
- Recent MI or Stroke within last 12 months
- Pre-proliferative or proliferative retinopathy
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 |
|---|---|---|
| gliclazideAlso: DiamicronGliclazide 80mg bd for 6 weeks | Drug | 1 |
Primary outcome
HbA1c reduction
Time frame: 6 weeks
1 secondary outcome
insulin secretory response to glucose and tolbutamide
Time frame: acute
Results and safety
The study was stopped early (reason given: Following Regulator inspection in 2009, study terminated as inadequate approvals were in place). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
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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.
Ewan R Pearson principal investigator
NHS Tayside
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing gliclazide in people with Diabetes Mellitus, Type 2, run by NHS Tayside at 1 site 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 14 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: stopped early, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Following Regulator inspection in 2009, study terminated as inadequate approvals were in place). Results are not available in the source record.
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?
HbA1c reduction (time frame: 6 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 3 May 2018.