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

NCT01847144 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2018-06-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Gliclazide 80mg OD

Gliclazide 80mg OD (DPP-IV inhibitor) - for 4 weeks duration followed by a 2 week wash-out period.

DRUG

Sitagliptin 100mg OD

Sitagliptin 100mg OD (sulphonylurea)- for 4 weeks duration followed by a 2 week wash-out period.

Sponsors & Collaborators

  • University of Exeter

    collaborator OTHER

  • Royal Devon and Exeter NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Andrew T Hattersley, FRCP, DM, BM · University of Exeter

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01847144 on ClinicalTrials.gov