Diabetes Mellitus, Type 2Phase 4ROADNCT00780715
Response To Oral Agents in Diabetes (ROAD)- Pilot Study
A Phase 4 study testing Gliclazide MR, Sitagliptin and Pioglitazone in people with Diabetes Mellitus, Type 2, run by University of Dundee at 1 site in United Kingdom.
Trial summary
This proposal is to fund a pilot study to assess feasibility and refine methodology for an intended large Scotland wide study on Response to Oral Agents in Diabetes (ROAD). The study will collect cohorts of patients who have carefully controlled standardised dose titration and monitoring with an assessment of drug… Read more about this study
- Who is it for?
- Ages 36 to 79 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Gliclazide MR, Sitagliptin and Pioglitazone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2008to Oct 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 36 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cohort 1 - metformin treatment
- Type 2 diabetes diagnosed more than 6 weeks prior to visit 1
- GP considers adequate diet and lifestyle advice given
- Age >35 and < 80
- Age of diabetes diagnosis >35
- White European
Show all 23Show fewer
- HbA1c >7% \& <=9%
- eGFR>=50 ml/min
- ALT <= 2.5*ULN
- Contactable by telephone
- Cohort 2 - 2nd line treatment
- Type 2 diabetes
- Treated with metformin for more than 3 months; or metformin intolerant
- Age >35 and < 80
- Age of diabetes diagnosis >35
- White European
- HbA1c >7% \& <=9%
- eGFR>=50 ml/min
- ALT <= 2.5*ULN
- No previous history of heart failure; No patients with documented evidence of left ventricular systolic dysfunction OR with symptoms and signs consistent with a clinical diagnosis of heart failure
- No treatment with Gemfibrozil or Rifampicin (CYP2C8 inhibitor or inducer respectively); or with Miconazole or phenylbutazone (increased hypoglycemic effect of gliclazide).
- No diagnosis of osteoporosis
- Contactable by telephone
Who cannot join
- Cohort 1
- Type 1 diabetes
- HbA1c >9% or <=7%
- eGFR<50 ml/min
- ALT > 2.5*ULN
- Alcohol consumption in excess of 50 units per week
Show all 18Show fewer
- Pregnancy, lactation or a female planning to conceive within the study period
- Any other significant medical reason for exclusion as determined by the investigator
- Cohort 2
- Type 1 diabetes
- HbA1c >9% or <=7%
- eGFR< 50 ml/min
- ALT > 2.5*ULN
- Previous history of heart failure OR documented evidence of left ventricular systolic dysfunction OR symptoms and signs consistent with a clinical diagnosis of heart failure
- Ongoing treatment with Gemfibrozil or Rifampicin (CYP2C8 inhibitor or inducer respectively); or with Miconazole or phenylbutazone (increased hypoglycemic effect of gliclazide).
- Previous diagnosis of osteoporosis
- Pregnancy, lactation or a 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.
United Kingdom1 site
Ninewells Hospital & Medical School
Dundee, DD1 9SY
About this study
This proposal is to fund a pilot study to assess feasibility and refine methodology for an intended large Scotland wide study on Response to Oral Agents in Diabetes (ROAD). The study will collect cohorts of patients who have carefully controlled standardised dose titration and monitoring with an assessment of drug response and side effects over a 6 month period. The primary aim will be to use these cohorts to investigate phenotypic and genotypic (pharmacogenetic) determinants of response.
Drug naïve patients will be treated with Metformin. Patients who have failed on Metformin or are intolerant of Metformin will be randomised to gliclazide, pioglitazone or sitagliptin. With the ability to capture patient data beyond 6 months via data linkage we will monitor time to treatment failure and therefore compare which of the 3 oral agents is the best therapy to use after Metformin in a cost efficient and "real world" RCT.
Read the detailed description
The Response to Oral Agents in Diabetes (ROAD) study aims to address the limitations of observational data by creating a prospective study of incident users of oral agents. For the first six months the research team will ensure a protocol driven dose titration, standardised monitoring of adherence, response and side effects and standardised deviations from therapy. Thereafter patients will receive 6 monthly monitoring and further protocol led dose titration by the GP. Biochemistry, prescribing data, morbidity and mortality data will be captured for up to 10 years from drug initiation. The ROAD study will provide a highly powered prospective cohort to investigate phenotypic and genotypic determinants of response in its own right. However, this cohort will be used synergistically with ongoing observational pharmacogenetics studies, allowing for crucial replication of 'positive' signals. Furthermore, by randomisation at drug initiation, long term community follow up will allow a comparison of time to treatment failure in patients treated with gliclazide, pioglitazone and sitagliptin in a much more cost effective and 'real-world' setting than traditional prospective randomised trials This pilot study is to assess the feasibility of the larger complex intervention. The primary outcome of the pilot is HbA1c change. Other measures regarding recruitment and dose titration will be assessed. With knowledge from this pilot, an application will be made for a large region or Scotland wide study to collect 2000 patients incident to oral diabetes treatment.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Gliclazide MR, Sitagliptin, Pioglitazone, Metformin
- Keywords
- Diabetes therapies, 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.
Gliclazide MRDrug
Also called Diamicron MR
30mg daily increased to 60mg if HbA1c > 7% at 3 months
SitagliptinDrug
Sitagliptin 100mg daily for 6 months
PioglitazoneDrug
Also called Actos
Pioglitazone 30mg daily , increased to 45mg daily if HbA1c >7% at 3 months. 6 months duration
MetforminDrug
Metformin 500 mg od for 1 week, bd for 1 week, 1g mane 500 mg nocte 1 week, 1g bd there after. Total of 6 months treatment
| Study group | Role | What they receive |
|---|---|---|
| Gliclazide MR | Active comparator | Not described Receives: Drug: Gliclazide MR |
| Sitagliptin | Active comparator | Not described Receives: Drug: Sitagliptin |
| Pioglitazone | Active comparator | Not described Receives: Drug: Pioglitazone |
| Metformin | Experimental | Not described Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c Change
Units are absolute difference in %HbA1c (HbA1c being the percentage of glycated Haemoglobin, reflecting glucose exposure over the last 3 months)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2008 (estimated)
- Study startDec 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ewan Pearson, University of Dundee
- Investigators
- Ewan R Pearson, Principal investigator, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780715
- Sponsor's protocol ID
- 2008DM05
- Other IDs
- EudraCT 2008-004790-18
- Acronym
- ROAD
- Status last verified
- Oct 2017
- First submitted
- 27 Oct 2008
- Last updated
- 26 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response To Oral Agents in Diabetes (ROAD)- Pilot Study
- ClinicalTrials.gov ID
- NCT00780715
- Acronym / sponsor ID
- ROAD / 2008DM05
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes therapies, Pharmacogenetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 28 Oct 2008 (estimated)
- Results
- Posted 26 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposal is to fund a pilot study to assess feasibility and refine methodology for an intended large Scotland wide study on Response to Oral Agents in Diabetes (ROAD). The study will collect cohorts of patients who have carefully controlled standardised dose titration and monitoring with an assessment of drug response and side effects over a 6 month period. The primary aim will be to use these cohorts to investigate phenotypic and genotypic (pharmacogenetic) determinants of response.
Drug naïve patients will be treated with Metformin. Patients who have failed on Metformin or are intolerant of Metformin will be randomised to gliclazide, pioglitazone or sitagliptin. With the ability to capture patient data beyond 6 months via data linkage we will monitor time to treatment failure and therefore compare which of the 3 oral agents is the best therapy to use after Metformin in a cost efficient and "real world" RCT.
Detailed description
The Response to Oral Agents in Diabetes (ROAD) study aims to address the limitations of observational data by creating a prospective study of incident users of oral agents. For the first six months the research team will ensure a protocol driven dose titration, standardised monitoring of adherence, response and side effects and standardised deviations from therapy. Thereafter patients will receive 6 monthly monitoring and further protocol led dose titration by the GP. Biochemistry, prescribing data, morbidity and mortality data will be captured for up to 10 years from drug initiation. The ROAD study will provide a highly powered prospective cohort to investigate phenotypic and genotypic determinants of response in its own right. However, this cohort will be used synergistically with ongoing observational pharmacogenetics studies, allowing for crucial replication of 'positive' signals. Furthermore, by randomisation at drug initiation, long term community follow up will allow a comparison of time to treatment failure in patients treated with gliclazide, pioglitazone and sitagliptin in a much more cost effective and 'real-world' setting than traditional prospective randomised trials This pilot study is to assess the feasibility of the larger complex intervention. The primary outcome of the pilot is HbA1c change. Other measures regarding recruitment and dose titration will be assessed. With knowledge from this pilot, an application will be made for a large region or Scotland wide study to collect 2000 patients incident to oral diabetes treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Gliclazide MR | Active comparator | Drug: Gliclazide MR |
| Sitagliptin | Active comparator | Drug: Sitagliptin |
| Pioglitazone | Active comparator | Drug: Pioglitazone |
| Metformin | Experimental | Drug: Metformin |
Who may qualify
- Ages
- 36 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Cohort 1 - metformin treatment
- Cohort 2 - 2nd line treatment
Key exclusion criteria (18 listed)
- Cohort 1
- Cohort 2
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 |
|---|---|---|
| Gliclazide MRAlso: Diamicron MR30mg daily increased to 60mg if HbA1c > 7% at 3 months | Drug | Gliclazide MR |
| SitagliptinSitagliptin 100mg daily for 6 months | Drug | Sitagliptin |
| PioglitazoneAlso: ActosPioglitazone 30mg daily , increased to 45mg daily if HbA1c >7% at 3 months. 6 months duration | Drug | Pioglitazone |
| MetforminMetformin 500 mg od for 1 week, bd for 1 week, 1g mane 500 mg nocte 1 week, 1g bd there after. Total of 6 months treatment | Drug | Metformin |
Primary outcome
HbA1c Change
Time frame: 6 months
Units are absolute difference in %HbA1c (HbA1c being the percentage of glycated Haemoglobin, reflecting glucose exposure over the last 3 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
University of Dundee
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 MR, Sitagliptin and Pioglitazone in people with Diabetes Mellitus, Type 2, run by University of Dundee 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 23 inclusion and 18 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: finished, as of the sponsor's last update on 26 Oct 2017. 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?
Yes. Results are posted in the registry (first posted 26 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Change (time frame: 6 months). 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 26 Oct 2017.