Understanding individual variation in treatment response in type 2 diabetes
| ISRCTN | ISRCTN91540163 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91540163 |
| ClinicalTrials.gov number | NCT01847144 |
| Secondary identifying numbers | 14154 |
- Submission date
- 12/06/2013
- Registration date
- 12/06/2013
- Last edited
- 20/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Catherine Angwin
Scientific
Scientific
Royal Devon and Exeter Hospital
Barrack Road
Exeter
EX2 5DW
United Kingdom
| C.Angwin@exeter.ac.uk |
Study information
| Study design | Both; Interventional; Design type: Treatment, Cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | MASTERMIND: Understanding individual variation in treatment response in type 2 diabetes |
| Study acronym | DRN 788 (MASTERMIND) |
| Study objectives | Response to treatment in type 2 diabetes is highly variable. The same medicine may have little effect on one person but a huge effect on another. Understanding mechanisms of altered response to treatment could aid treatment selection and assist the design of new medications with lower non- response rates. This study will examine the physiological mechanisms and potential clinical/biomarker predictors of altered response to sulphonylurea and DPP-IV 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 4 weeks with assessment of baseline characteristics and glycaemic response. Participants will then enter an optional extension where they receive sulphonylurea or DPP-IV inhibitor therapy in crossover fashion. |
| Ethics approval(s) | 12SW0346 |
| Health condition(s) or problem(s) studied | Topic: Diabetes Research Network; Subtopic: Type 2; Disease: Diabetic Control |
| Intervention | Gliclazide 80mg OD, Gliclazide 80mg OD; Sitagliptin 100mg OD, Sitagliptin 100mg OD; Study Entry : Registration only |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Gliclazide, sitagliptin |
| Primary outcome measure | Understanding mechanisms of individual response to glucose lowering therapies in type 2 diabetes; Timepoint(s): End of study |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 18/04/2013 |
| Completion date | 31/10/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 200; UK Sample Size: 200 |
| Key inclusion criteria | 1. Age between 19 and 79 years 2. Clinical diagnosis of Type 2 Diabetes 3. Currently treated with sulphonylurea tablets 4. No change in diabetes treatment (new treatments or dose change) within last 3 months 5. Last HbA1c (taken within last 12 months) of =42 mmol/mol and =75 mmol/mol (6-9%) 6. Able and willing to monitor home blood glucose 7. Able and willing to give informed consent |
| Key exclusion criteria | 1. Current treatment includes: insulin, GLP-1 agonists, DPP-IV inhibitors, glinides, Renal impairment (eGFR <30 ml/min/1.73m2) 2. Active infection (any infection requiring antibiotics at present) 3. Recent (within 3 months) surgery or planned surgery 4. Cardiovascular disease (angina, myocardial infarction, stroke, transient ischemic episode) occurring within the previous 3 months 5. Previous history of pancreatitis 6. Pregnant, breastfeeding or planning a pregnancy over the study period 7. Unable/unwilling to monitor home blood glucose |
| Date of first enrolment | 18/04/2013 |
| Date of final enrolment | 31/10/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Devon and Exeter Hospital
Exeter
EX2 5DW
United Kingdom
EX2 5DW
United Kingdom
Sponsor information
Royal Devon and Exeter NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Royal Devon and Exeter Hospital
Barrack Road
Exeter
EX2 5DW
England
United Kingdom
"ROR" |
https://ror.org/03085z545 |
|---|
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
20/08/2019: ClinicalTrials.gov number added.
12/01/2017: No publications found, verifying study status with principal investigator.
