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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by NIHR Exeter Clinical Research Facility
Sponsor:
Collaborator:
University of Exeter
Information provided by (Responsible Party):
NIHR Exeter Clinical Research Facility
ClinicalTrials.gov Identifier:
NCT01847144
First received: March 13, 2013
Last updated: May 3, 2013
Last verified: March 2013

March 13, 2013
May 3, 2013
April 2013
October 2015   (final data collection date for primary outcome measure)
Change in fasting glucose [ Time Frame: 4 weeks post treatment change ] [ Designated as safety issue: Yes ]
Change in fasting glucose from 0 to 4 weeks post treatment change.
Same as current
Complete list of historical versions of study NCT01847144 on ClinicalTrials.gov Archive Site
Additional changes in biochemical results [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Secondary outcome measures will include change in glycosylated albumin, HbA1c, home glucose day profile and mixed meal area under the curve glucose
Same as current
Not Provided
Not Provided
 
MASTERMIND - Understanding Individual Variation in Treatment Response in Type 2 Diabetes
MASTERMIND - Understanding Individual Variation in Treatment Response in Type 2

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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Type 2 Diabetes
  • Drug: Gliclazide 80mg OD
    Gliclazide 80mg OD (DPP-IV inhibitor) - for 4 weeks duration followed by a 2 week wash-out period.
    Other Name: DPP-IV inhibitor
  • Drug: Sitagliptin 100mg OD
    Sitagliptin 100mg OD (sulphonylurea)- for 4 weeks duration followed by a 2 week wash-out period.
    Other Name: sulphonylurea OD
  • Active Comparator: Gliclazide - Sitagliptin
    Gliclazide 80mg OD and Sitagliptin 100mg OD
    Intervention: Drug: Gliclazide 80mg OD
  • Active Comparator: Sitagliptin - Gliclazide
    Gliclazide 80mg OD and Sitagliptin 100mg OD
    Intervention: Drug: Sitagliptin 100mg OD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
200
October 2015
October 2015   (final data collection date for primary outcome measure)

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
Both
19 Years to 79 Years
No
Contact: Catherine D Angwin, MSc +44 1392 406813 C.Angwin@exeter.ac.uk
Contact: Gillian C Baker, PhD +44 1392 406791 G.C.Baker@exeter.ac.uk
United Kingdom
 
NCT01847144
CRF111, MR/K005707/1
No
NIHR Exeter Clinical Research Facility
NIHR Exeter Clinical Research Facility
University of Exeter
Principal Investigator: Andrew T Hattersley, FRCP, DM, BM University of Exeter
NIHR Exeter Clinical Research Facility
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP