Type 2 DiabetesPhase 4MastermindNCT01847144
MASTERMIND - Understanding Individual Variation in Treatment Response in Type 2 Diabetes
A Phase 4 study testing Gliclazide 80mg OD and Sitagliptin 100mg OD in people with Type 2 Diabetes, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Response to treatment in Type 2 Diabetes is highly variable; the same medicine may have little effect in one person but a large effect in another. Understanding mechanisms of altered response to treatment could aid treatment selection and assist the design of new medications with lower nonresponse rates. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Gliclazide 80mg OD and Sitagliptin 100mg OD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2013to Feb 2015
- 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 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 and <80
- Clinical diagnosis of Type 2 Diabetes
- Currently treated with sulphonylurea tablets
- No change in diabetes treatment (new treatments or dose change) within last 3 months
- Last HbA1c (taken within last 12 months) of ≥42 mmol/mol and ≤75 mmol/mol (6-9%)
- Able and willing to monitor home blood glucose
- Able and willing to give informed consent
Who cannot join
- Current treatment includes: insulin, GLP-1 agonists, DPP-IV inhibitors, glinides
- Renal impairment (eGFR <30 ml/min/1.73m2)
- Active infection (any infection requiring antibiotics at present)
- Recent (within 3 months) surgery or planned surgery
- Cardiovascular disease (angina, myocardial infarction, stroke, transient ischemic episode) occurring within the previous 3 months
- Previous history of pancreatitis
- Pregnant, breastfeeding or planning a pregnancy over the study period
- Unable/unwilling to monitor home blood glucose
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NIHR Exeter Clinical Research Facility, Royal Devon & Exeter NHS Foundation Trust
Exeter, Devon, EX2 5DW
About this study
Official title: MASTERMIND - Understanding Individual Variation in Treatment Response in Type 2
Response to treatment in Type 2 Diabetes is highly variable; the same medicine may have little effect in one person but a large effect in another. Understanding mechanisms of altered response to treatment could aid treatment selection and assist the design of new medications with lower nonresponse rates.
This study will examine the physiological mechanisms and potential clinical/biomarker predictors of altered response to sulphonylurea and DPPIV inhibitor glucose lowering medication and answer fundamental methodological questions for the future study of variation in treatment response in Type 2 Diabetes. Participants will withdraw sulphonylurea therapy for up to 2 weeks with assessment of baseline characteristics and glycaemic response. Participants will then enter an optional extension where they receive sulphonylurea or DPPIV inhibitor therapy in crossover fashion.
Read the detailed description
Participants will withdraw sulphonylurea therapy for up to 2 weeks (part 1) followed by an optional cross-over extension (part 2)where they are randomized to 4 weeks of treatment with Gliclazide (DPP-IV thera) or Sitagliptin (sulphonylurea), followed by 4 weeks of the second treatment with a 2 week wash-out period in between.
Part 1 will allow assessment of response rates to long standing sulphonylurea treatment in clinical practice and potential predictors of this, as well as whether a very brief period (1 week) of treatment withdrawal is a valid assessment of an individual's response to therapy. Part 2 will allow comparison of the approach in part one with response to the same treatment in a trial setting and will allow assessment on whether response is consistent across therapies with different mechanisms of action.
- Conditions
- Type 2 Diabetes
- Being tested
- Gliclazide 80mg OD, Sitagliptin 100mg OD
- 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 80mg ODDrug
Also called DPP-IV inhibitor
Gliclazide 80mg OD (DPP-IV inhibitor) - for 4 weeks duration followed by a 2 week wash-out period.
Sitagliptin 100mg ODDrug
Also called sulphonylurea OD
Sitagliptin 100mg OD (sulphonylurea)- for 4 weeks duration followed by a 2 week wash-out period.
| Study group | Role | What they receive |
|---|---|---|
| Gliclazide - Sitagliptin | Active comparator | Gliclazide 80mg OD and Sitagliptin 100mg OD Receives: Drug: Gliclazide 80mg OD |
| Sitagliptin - Gliclazide | Active comparator | Gliclazide 80mg OD and Sitagliptin 100mg OD Receives: Drug: Sitagliptin 100mg OD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting glucose
Change in fasting glucose from 0 to 4 weeks post treatment change.
Measured: 4 weeks post treatment change
Secondary outcomes (1)
Additional changes in biochemical results
Secondary outcome measures will include change in glycosylated albumin, HbA1c, home glucose day profile and mixed meal area under the curve glucose
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2013 (estimated)
- Study startApr 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Exeter
- Responsible party
- Sponsor
- Investigators
- Andrew T Hattersley, FRCP, DM, BM, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847144
- Sponsor's protocol ID
- CRF111
- Other IDs
- MR/K005707/1
- Acronym
- Mastermind
- Status last verified
- Jun 2018
- First submitted
- 13 Mar 2013
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- 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
- MASTERMIND - Understanding Individual Variation in Treatment Response in Type 2
- ClinicalTrials.gov ID
- NCT01847144
- Acronym / sponsor ID
- Mastermind / CRF111
- Conditions
- Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Exeter
- Study start
- Apr 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 6 May 2013 (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.
Response to treatment in Type 2 Diabetes is highly variable; the same medicine may have little effect in one person but a large effect in another. Understanding mechanisms of altered response to treatment could aid treatment selection and assist the design of new medications with lower nonresponse rates.
This study will examine the physiological mechanisms and potential clinical/biomarker predictors of altered response to sulphonylurea and DPPIV inhibitor glucose lowering medication and answer fundamental methodological questions for the future study of variation in treatment response in Type 2 Diabetes. Participants will withdraw sulphonylurea therapy for up to 2 weeks with assessment of baseline characteristics and glycaemic response. Participants will then enter an optional extension where they receive sulphonylurea or DPPIV inhibitor therapy in crossover fashion.
Detailed description
Participants will withdraw sulphonylurea therapy for up to 2 weeks (part 1) followed by an optional cross-over extension (part 2)where they are randomized to 4 weeks of treatment with Gliclazide (DPP-IV thera) or Sitagliptin (sulphonylurea), followed by 4 weeks of the second treatment with a 2 week wash-out period in between.
Part 1 will allow assessment of response rates to long standing sulphonylurea treatment in clinical practice and potential predictors of this, as well as whether a very brief period (1 week) of treatment withdrawal is a valid assessment of an individual's response to therapy. Part 2 will allow comparison of the approach in part one with response to the same treatment in a trial setting and will allow assessment on whether response is consistent across therapies with different mechanisms of action.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gliclazide - Sitagliptin | Active comparator | Drug: Gliclazide 80mg ODGliclazide 80mg OD and Sitagliptin 100mg OD |
| Sitagliptin - Gliclazide | Active comparator | Drug: Sitagliptin 100mg ODGliclazide 80mg OD and Sitagliptin 100mg OD |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >18 and <80
- Clinical diagnosis of Type 2 Diabetes
- Currently treated with sulphonylurea tablets
- No change in diabetes treatment (new treatments or dose change) within last 3 months
- Last HbA1c (taken within last 12 months) of ≥42 mmol/mol and ≤75 mmol/mol (6-9%)
Key exclusion criteria (8 listed)
- Current treatment includes: insulin, GLP-1 agonists, DPP-IV inhibitors, glinides
- Renal impairment (eGFR <30 ml/min/1.73m2)
- Active infection (any infection requiring antibiotics at present)
- Recent (within 3 months) surgery or planned surgery
- Cardiovascular disease (angina, myocardial infarction, stroke, transient ischemic episode) occurring within the previous 3 months
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 80mg ODAlso: DPP-IV inhibitorGliclazide 80mg OD (DPP-IV inhibitor) - for 4 weeks duration followed by a 2 week wash-out period. | Drug | Gliclazide - Sitagliptin |
| Sitagliptin 100mg ODAlso: sulphonylurea ODSitagliptin 100mg OD (sulphonylurea)- for 4 weeks duration followed by a 2 week wash-out period. | Drug | Sitagliptin - Gliclazide |
Primary outcome
Change in fasting glucose
Time frame: 4 weeks post treatment change
Change in fasting glucose from 0 to 4 weeks post treatment change.
1 secondary outcome
Additional changes in biochemical results
Time frame: 4 weeks
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.
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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
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 80mg OD and Sitagliptin 100mg OD in people with Type 2 Diabetes, run by Royal Devon and Exeter NHS Foundation Trust 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 7 inclusion and 8 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 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 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?
Change in fasting glucose (time frame: 4 weeks post treatment change). 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.