Contact information
Type
Scientific
Primary contact
Ms Catherine Angwin
ORCID ID
Contact details
Royal Devon and Exeter Hospital
Barrack Road
Exeter
EX2 5DW
United Kingdom
-
C.Angwin@exeter.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01847144
Protocol/serial number
14154
Study information
Scientific title
MASTERMIND: Understanding individual variation in treatment response in type 2 diabetes
Acronym
DRN 788 (MASTERMIND)
Study hypothesis
Response to treatment in type 2 diabetes is highly variable. The same medicine may have little effect on one person but a huge effect on another. Understanding mechanisms of altered response to treatment could aid treatment selection and assist the design of new medications with lower non- response rates.
This study will examine the physiological mechanisms and potential clinical/biomarker predictors of altered response to sulphonylurea and DPP-IV 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 4 weeks with assessment of baseline characteristics and glycaemic response. Participants will then enter an optional extension where they receive sulphonylurea or DPP-IV inhibitor therapy in crossover fashion.
Ethics approval
12SW0346
Study design
Both; Interventional; Design type: Treatment, Cohort study
Primary study design
Interventional
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Topic: Diabetes Research Network; Subtopic: Type 2; Disease: Diabetic Control
Intervention
Gliclazide 80mg OD, Gliclazide 80mg OD; Sitagliptin 100mg OD, Sitagliptin 100mg OD; Study Entry : Registration only
Intervention type
Drug
Phase
Not Applicable
Drug names
Gliclazide, sitagliptin
Primary outcome measure
Understanding mechanisms of individual response to glucose lowering therapies in type 2 diabetes; Timepoint(s): End of study
Secondary outcome measures
Not provided at time of registration
Overall trial start date
18/04/2013
Overall trial end date
31/10/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age between 19 and 79 years
2. Clinical diagnosis of Type 2 Diabetes
3. Currently treated with sulphonylurea tablets
4. No change in diabetes treatment (new treatments or dose change) within last 3 months
5. Last HbA1c (taken within last 12 months) of =42 mmol/mol and =75 mmol/mol (6-9%)
6. Able and willing to monitor home blood glucose
7. Able and willing to give informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 200; UK Sample Size: 200
Participant exclusion criteria
1. Current treatment includes: insulin, GLP-1 agonists, DPP-IV inhibitors, glinides, Renal impairment (eGFR <30 ml/min/1.73m2)
2. Active infection (any infection requiring antibiotics at present)
3. Recent (within 3 months) surgery or planned surgery
4. Cardiovascular disease (angina, myocardial infarction, stroke, transient ischemic episode) occurring within the previous 3 months
5. Previous history of pancreatitis
6. Pregnant, breastfeeding or planning a pregnancy over the study period
7. Unable/unwilling to monitor home blood glucose
Recruitment start date
18/04/2013
Recruitment end date
31/10/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Devon and Exeter Hospital
Exeter
EX2 5DW
United Kingdom
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list