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MASTERMIND - Understanding Individual Variation in Treatment Response in Type 2 Diabetes (Mastermind)

NHS Foundation Trust logo

NHS Foundation Trust

Status and phase

Completed
Phase 4

Conditions

Type 2 Diabetes

Treatments

Drug: Sitagliptin 100mg OD
Drug: Gliclazide 80mg OD

Study type

Interventional

Funder types

Other

Identifiers

NCT01847144
CRF111
MR/K005707/1 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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-IV thera) or Sitagliptin (sulphonylurea), followed by 4 weeks of the second treatment with a 2 week wash-out period in between.

Part 1 will allow assessment of response rates to long standing sulphonylurea treatment in clinical practice and potential predictors of this, as well as whether a very brief period (1 week) of treatment withdrawal is a valid assessment of an individual's response to therapy. Part 2 will allow comparison of the approach in part one with response to the same treatment in a trial setting and will allow assessment on whether response is consistent across therapies with different mechanisms of action.

Enrollment

143 patients

Sex

All

Ages

19 to 79 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

143 participants in 2 patient groups

Gliclazide - Sitagliptin
Active Comparator group
Description:
Gliclazide 80mg OD and Sitagliptin 100mg OD
Treatment:
Drug: Gliclazide 80mg OD
Sitagliptin - Gliclazide
Active Comparator group
Description:
Gliclazide 80mg OD and Sitagliptin 100mg OD
Treatment:
Drug: Sitagliptin 100mg OD

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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