| Trial ID: | L4282 |
| Source ID: | NCT02506296
|
| Associated Drug: |
Dppiv Inhibitor -
|
| Title: |
Glucose Response, Excursions And Treatment (GREAT) Study
|
| Acronym: |
GREAT
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: DPPIV inhibitor -|DEVICE: Continuous glucose monitoring system.
|
| Outcome Measures: |
Primary: difference in glucose variability, defined by mean average glucose excursions (MAGE) assessed by CGMS between groups., over a 4-6 day period|Difference in response to a standard DPPIV therapy, change in incremental area under the curve glucose after mixed meal test with vildagliptin vs without vildagliptin) between groups, During a standardised Mixed meal Tolerance Test blood samples will be taken immediately before and at 30, 60, 90, 120, 150 and 180 minutes following consumption of a meal replacement drink. | Secondary: Differences in hypoglycemia scores, Clarke and Gold Hypoglycaemia scoring questionnaire, snapshot covering last 6 months|differences in time spent in hypoglycaemia, CGMS glucose \<3mmol/l, 4-6 days
|
| Sponsor/Collaborators: |
Sponsor: Royal Devon and Exeter NHS Foundation Trust | Collaborators: NIHR Exeter Clinical Research Facility
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
53
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose:
|
| Start Date: |
2014-10
|
| Completion Date: |
2015-11
|
| Results First Posted: |
|
| Last Update Posted: |
2016-04-12
|
| Locations: |
NIHR Exeter Clinical Research Facility, Exeter, Devon, EX1 2TD, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT02506296
|
