MASTERMIND - Understanding Individual Variation in Treatment Response in Type 2 Diabetes

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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.

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NIHR Exeter Clinical Research Facility; Royal Devon and Exeter NHS Foundation Trust
• Collaborator: University of Exeter
• Treatments: Dipeptidyl-Peptidase IV Inhibitors; Gliclazide; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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