Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/06/2013
Date assigned
12/06/2013
Last edited
27/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Protocol/serial number

14154

Study information

Scientific title

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

Other

Trial type

Treatment

Patient 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 Specified

Drug names

Gliclazide and Sitagliptin

Primary outcome measures

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

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

Sponsor information

Organisation

Royal Devon and Exeter NHS Foundation Trust (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes