Understanding individual variation in treatment response in type 2 diabetes

ISRCTN	ISRCTN91540163
DOI	https://doi.org/10.1186/ISRCTN91540163
ClinicalTrials.gov (NCT)	NCT01847144
Protocol serial number	14154
Sponsor	Royal Devon and Exeter NHS Foundation Trust (UK)
Funder	Medical Research Council (MRC) (UK)

Submission date: 12/06/2013
Registration date: 12/06/2013
Last edited: 20/08/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Catherine Angwin
Scientific

Royal Devon and Exeter Hospital
Barrack Road
Exeter
EX2 5DW
United Kingdom

Email	C.Angwin@exeter.ac.uk

Study information

Primary study design	Interventional
Study design	Both; Interventional; Design type: Treatment, Cohort study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	MASTERMIND: Understanding individual variation in treatment response in type 2 diabetes
Study acronym	DRN 788 (MASTERMIND)
Study objectives	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(s)	12SW0346
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Gliclazide, sitagliptin
Primary outcome measure(s)	Understanding mechanisms of individual response to glucose lowering therapies in type 2 diabetes; Timepoint(s): End of study
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/10/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	200
Key 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
Key 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
Date of first enrolment	18/04/2013
Date of final enrolment	31/10/2014

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Royal Devon and Exeter Hospital

Exeter
EX2 5DW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

20/08/2019: ClinicalTrials.gov number added.
12/01/2017: No publications found, verifying study status with principal investigator.