Status:
COMPLETED
MASTERMIND - Understanding Individual Variation in Treatment Response in Type 2 Diabetes
Lead Sponsor:
Royal Devon and Exeter NHS Foundation Trust
Collaborating Sponsors:
University of Exeter
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
19-79 years
Phase:
PHASE4
Brief 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 treat...
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-...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT01847144
Start Date
April 1 2013
End Date
February 1 2015
Last Update
June 21 2018
Active Locations (1)
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1
NIHR Exeter Clinical Research Facility, Royal Devon & Exeter NHS Foundation Trust
Exeter, Devon, United Kingdom, EX2 5DW