DiabetesPROMASTERNCT02105792
PROMASTER - PROspective Cohort MRC ABPI STratification and Extreme Response Mechanism in Diabetes
An observational study of Diabetes, run by Royal Devon and Exeter NHS Foundation Trust at 5 sites in United Kingdom.
Trial summary
This study will examine extreme responders to second- and third-line Type 2 diabetes therapy using a prospective approach, and patients with slow or fast diabetes progression using a retrospective approach. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes
- What is being tested?
- second- or third-line glucose-lowering diabetes treatment
- How many people
- 820 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Mar 2013to May 2016
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be identified in primary care and secondary care. The method for patient identification may differ between sites and could involve: GP Searches; Secondary Care Clinician Referral; Research Database Searches.
Who may be able to join
- Demographics: Age 18-90 inclusive
- Ethnicity: Reflective of local demographic
- Medical History: Clinical diagnosis of Type 2 diabetes
- Mental Capacity: Capacity to Consent
Who cannot join
- Age less than 18 years old and greater than 90 years old
- Incapacity to consent
- Type 1 diabetes.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
University of Exeter
Exeter, Devon, EX2 5DW
University of Glasgow
Glasgow, G12 8TA
King's College University of London
London, SE1 9NH
University of Newcastle
Newcastle upon Tyne, Tyne and Wear, NE1 7RU
Oxford University Hospitals NHS Trust
Oxford, Oxfordshire, OX3 7LE
About this study
Official title: PROspective Cohort MRC ABPI STratification and Extreme Response Mechanism in Diabetes
This study will examine extreme responders to second- and third-line Type 2 diabetes therapy using a prospective approach, and patients with slow or fast diabetes progression using a retrospective approach.
Read the detailed description
PILOT Phase (March 2013 - Dec 2014) Participants will be recruited initially from 4 centres. Patients due to start second- and third-line Type 2 diabetes treatments, and patients progressing to insulin either particularly quickly or particularly slowly, will be recruited from primary care, secondary care, or community settings. Fasting blood and urine samples will be collected, together with standard biomeasures and information about medical history and prescribing history. Participants in Responders Arm will be contacted by telephone approximately 3 months after starting their new second/third-line agent to review their current medication and blood glucose level. If a 3 month HbA1c has not been collected as part of routine clinical care, the research team will arrange this. Participants will be asked to return for a blood and urine test approximately 6 months after their new treatment was started. This visit will be brought forward should the participant advise they are about to further change their treatment, to enable their samples to be collected in advance of their proposed treatment change.
All study documentation and sample materials will be distributed to sites from the Coordinating Centre. Sites will be expected to process and freeze samples and send them to the Chief Investigator's Central Laboratory where they will be analysed for genetic factors, glycaemic markers and other markers related to drug response.
POST-PILOT Phase (Jan 2015 - Oct 2017) Subject to feasibility, interim analysis and continuation of funding from Medical Research Council (MRC), this study will continue for another 3 years.
- Conditions
- Diabetes
- Being tested
- second- or third-line glucose-lowering diabetes treatment
- Keywords
- Diabetes, Type 2 diabetes, Diabetes therapy response, Diabetes progression
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
second- or third-line glucose-lowering diabetes treatmentDrug
Also called Sulphonylurea, DPP-4 inhibitor, GLP-1R agonist, SGLT2 inhibitor
Observation of response and disease progression following clinician's addition of a glucose-lowering diabetes therapy (Sulphonylurea, DPP-4 inhibitor, GLP-1R agonist, SGLT2 inhibitor or Glitazone) to existing therapy.
| Study group | Role | What they receive |
|---|---|---|
| Responders | Patients with Type 2 diabetes about to commence a second- or third-line glucose-lowering treatment (Sulphonylurea, DPP-4 inhibitors, GLP-1R agonists, SGLT2 inhibitors or Glitazone or insulin). Receives: Drug: second- or third-line glucose-lowering diabetes treatment | |
| Progressors | Patients with Type 2 diabetes that progress to requiring insulin treatment ≤10 years from diagnosis or have no requirement for insulin treatment >10 years from diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to diabetes therapy
The primary outcome will be to compare the clinical characteristics of the patients who show an excellent response or a poor response to specific second- and third-line classes of treatment for Type 2 diabetes.
Measured: Up to 9 months from commencement of new therapy
Secondary outcomes (1)
Collection of samples for analysis of potential biomarkers
To collect a set of DNA, serum and urine samples to allow analysis of potential genetic and non genetic biomarkers for drug response and diabetes progression.
Measured: within 9 months of recruitment date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startMar 2013
- Primary completionMay 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 820 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Exeter, King's College London, King's College Hospital NHS Trust, University of Glasgow, NHS Greater Glasgow and Clyde, Newcastle University, Newcastle-upon-Tyne Hospitals NHS Trust, Oxford University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Andrew T Hattersley, FRCP, DM, BM, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105792
- Sponsor's protocol ID
- CRF112
- Other IDs
- 12/SW/0347
- Acronym
- PROMASTER
- Status last verified
- Jun 2018
- First submitted
- 2 Apr 2014
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROspective Cohort MRC ABPI STratification and Extreme Response Mechanism in Diabetes
- ClinicalTrials.gov ID
- NCT02105792
- Acronym / sponsor ID
- PROMASTER / CRF112
- Conditions
- Diabetes
- Keywords
- Diabetes, Type 2 diabetes, Diabetes therapy response, Diabetes progression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 820 participants (actual)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Exeter, King's College London, King's College Hospital NHS Trust, University of Glasgow, NHS Greater Glasgow and Clyde, Newcastle University, Newcastle-upon-Tyne Hospitals NHS Trust, Oxford University Hospitals NHS Trust
- Study start
- Mar 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 7 Apr 2014 (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.
This study will examine extreme responders to second- and third-line Type 2 diabetes therapy using a prospective approach, and patients with slow or fast diabetes progression using a retrospective approach.
Detailed description
PILOT Phase (March 2013 - Dec 2014) Participants will be recruited initially from 4 centres. Patients due to start second- and third-line Type 2 diabetes treatments, and patients progressing to insulin either particularly quickly or particularly slowly, will be recruited from primary care, secondary care, or community settings. Fasting blood and urine samples will be collected, together with standard biomeasures and information about medical history and prescribing history. Participants in Responders Arm will be contacted by telephone approximately 3 months after starting their new second/third-line agent to review their current medication and blood glucose level. If a 3 month HbA1c has not been collected as part of routine clinical care, the research team will arrange this. Participants will be asked to return for a blood and urine test approximately 6 months after their new treatment was started. This visit will be brought forward should the participant advise they are about to further change their treatment, to enable their samples to be collected in advance of their proposed treatment change.
All study documentation and sample materials will be distributed to sites from the Coordinating Centre. Sites will be expected to process and freeze samples and send them to the Chief Investigator's Central Laboratory where they will be analysed for genetic factors, glycaemic markers and other markers related to drug response.
POST-PILOT Phase (Jan 2015 - Oct 2017) Subject to feasibility, interim analysis and continuation of funding from Medical Research Council (MRC), this study will continue for another 3 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Responders | – | Drug: second- or third-line glucose-lowering diabetes treatmentPatients with Type 2 diabetes about to commence a second- or third-line glucose-lowering treatment (Sulphonylurea, DPP-4 inhibitors, GLP-1R agonists, SGLT2 inhibitors or Glitazone or insulin). |
| Progressors | – | –Patients with Type 2 diabetes that progress to requiring insulin treatment ≤10 years from diagnosis or have no requirement for insulin treatment >10 years from diagnosis. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be identified in primary care and secondary care. The method for patient identification may differ between sites and could involve: GP Searches; Secondary Care Clinician Referral; Research Database Searches.
Key inclusion criteria (4 listed)
- Demographics: Age 18-90 inclusive
- Ethnicity: Reflective of local demographic
- Medical History: Clinical diagnosis of Type 2 diabetes
- Mental Capacity: Capacity to Consent
Key exclusion criteria (3 listed)
- Age less than 18 years old and greater than 90 years old
- Incapacity to consent
- Type 1 diabetes.
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 |
|---|---|---|
| second- or third-line glucose-lowering diabetes treatmentAlso: Sulphonylurea, DPP-4 inhibitor, GLP-1R agonist, SGLT2 inhibitorObservation of response and disease progression following clinician's addition of a glucose-lowering diabetes therapy (Sulphonylurea, DPP-4 inhibitor, GLP-1R agonist, SGLT2 inhibitor or Glitazone) to existing therapy. | Drug | Responders |
Primary outcome
Response to diabetes therapy
Time frame: Up to 9 months from commencement of new therapy
The primary outcome will be to compare the clinical characteristics of the patients who show an excellent response or a poor response to specific second- and third-line classes of treatment for Type 2 diabetes.
1 secondary outcome
Collection of samples for analysis of potential biomarkers
Time frame: within 9 months of recruitment date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
- 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.
Andrew T Hattersley, FRCP, DM, BM principal investigator
University of Exeter
5 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, run by Royal Devon and Exeter NHS Foundation Trust at 5 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 4 inclusion and 3 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 21 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Response to diabetes therapy (time frame: Up to 9 months from commencement of new therapy). 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 21 Jun 2018.