| Trial ID: | L2648 |
| Source ID: | NCT04192292
|
| Associated Drug: |
Sulfonylurea
|
| Title: |
Study of Sulphonylurea Synergy With DPP4 Inhibitors
|
| Acronym: |
SSS
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Sulfonylurea|DRUG: DPP4 Inhibitor
|
| Outcome Measures: |
Primary: Difference in incretin effect between mixed meal tests, Comparison of four mixed meal tests performed at the end of each intervention block. Meal tests will evaluate 1) No intervention 2) Low dose sulphonylurea alone 3) DPP4 inhibitor alone 4) Low dose sulphonylurea + DPP4 inhibitor. Measures of the incretin effect will be compared between the different blocks., Through four mixed meal tests which take place at the end of each 14 day intervention block. The four intervention blocks will be completed during an 8 week clinical phase of study. | Secondary: Insulin secretory response analysed by KCNJ11 genotype, Difference in insulin secretory response to low dose gliclazide calculated by insulin/cpeptide levels in each meal test visit. Differences will then be compared by participants genotype e.g. insulin secretory response for E23K, E23E, K23K variants., Through 4 meal test visits completed over an 8 week clinical phase of study. Outcome will also be evaluated through variability of glucose levels observed on continuous glucose monitoring worn for duration of 8 week clinical phase.|Variation in blood glucose during intervention blocks analysed by continuous glucose monitoring, Comparison time-in-range of blood sugars as low, target and high on continuous glucose monitoring between each intervention block, Meansurements taken via continuous glucose monitoring sensors worn by participants for duration of 8 week clinical phase
|
| Sponsor/Collaborators: |
Sponsor: University of Dundee
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
30
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2019-10-08
|
| Completion Date: |
2020-12-02
|
| Results First Posted: |
|
| Last Update Posted: |
2021-03-04
|
| Locations: |
Ninewells Hospital and Medical School, Dundee, DD1 9SY, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT04192292
|
