Back to resultsMASTERMIND - Understanding Individual Variation in Treatment Response in Type 2 Diabetes (Mastermind)
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Gliclazide 80mg OD
Sitagliptin 100mg OD
Sponsored by
About this trial
This is an interventional basic science trial for Type 2 Diabetes
Eligibility 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
Sites / Locations
- NIHR Exeter Clinical Research Facility, Royal Devon & Exeter NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Gliclazide - Sitagliptin
Sitagliptin - Gliclazide
Arm Description
Gliclazide 80mg OD and Sitagliptin 100mg OD
Gliclazide 80mg OD and Sitagliptin 100mg OD
Outcomes
Primary Outcome Measures
Change in fasting glucose
Change in fasting glucose from 0 to 4 weeks post treatment change.
Secondary Outcome Measures
Additional changes in biochemical results
Secondary outcome measures will include change in glycosylated albumin, HbA1c, home glucose day profile and mixed meal area under the curve glucose
Full Information
NCT ID
NCT01847144
First Posted
March 13, 2013
Last Updated
June 19, 2018
Sponsor
Royal Devon and Exeter NHS Foundation Trust
Collaborators
University of Exeter
1. Study Identification
Unique Protocol Identification Number
NCT01847144
Brief Title
MASTERMIND - Understanding Individual Variation in Treatment Response in Type 2 Diabetes
Acronym
Mastermind
Official Title
MASTERMIND - Understanding Individual Variation in Treatment Response in Type 2
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Devon and Exeter NHS Foundation Trust
Collaborators
University of Exeter
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
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-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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gliclazide - Sitagliptin
Arm Type
Active Comparator
Arm Description
Gliclazide 80mg OD and Sitagliptin 100mg OD
Arm Title
Sitagliptin - Gliclazide
Arm Type
Active Comparator
Arm Description
Gliclazide 80mg OD and Sitagliptin 100mg OD
Intervention Type
Drug
Intervention Name(s)
Gliclazide 80mg OD
Other Intervention Name(s)
DPP-IV inhibitor
Intervention Description
Gliclazide 80mg OD (DPP-IV inhibitor) - for 4 weeks duration followed by a 2 week wash-out period.
Intervention Type
Drug
Intervention Name(s)
Sitagliptin 100mg OD
Other Intervention Name(s)
sulphonylurea OD
Intervention Description
Sitagliptin 100mg OD (sulphonylurea)- for 4 weeks duration followed by a 2 week wash-out period.
Primary Outcome Measure Information:
Title
Change in fasting glucose
Description
Change in fasting glucose from 0 to 4 weeks post treatment change.
Time Frame
4 weeks post treatment change
Secondary Outcome Measure Information:
Title
Additional changes in biochemical results
Description
Secondary outcome measures will include change in glycosylated albumin, HbA1c, home glucose day profile and mixed meal area under the curve glucose
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew T Hattersley, FRCP, DM, BM
Organizational Affiliation
University of Exeter
Official's Role
Principal Investigator
Facility Information:
Facility Name
NIHR Exeter Clinical Research Facility, Royal Devon & Exeter NHS Foundation Trust
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
12. IPD Sharing Statement
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MASTERMIND - Understanding Individual Variation in Treatment Response in Type 2 Diabetes
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