Study of Sulphonylurea Synergy With DPP4 Inhibitors
SSS
1 other identifier
interventional
30
1 country
1
Brief Summary
The Study of Sulphonylurea Synergy with DPP4 Inhibitors (SSS Study) will establish whether a very low dose of sulphonylurea will have a synergistic role on augmentation of insulin secretion when given in combination with a DPP4 inhibitor as a primary outcome. The study will recruit 30 patients with type 2 diabetes mellitus controlled with no treatment or metformin monotherapy with an HbA1c \<64mmol/mol (\<8%). In this unblinded, randomised physiological study, participants will receive four 14-day intervention blocks: low dose sulphonylurea alone, DPP4 inhibitor alone, low dose sulphonylurea + DPP4 inhibitor or no treatment change. The primary outcome will be assessed through evaulation of insulin secretion and sensitivity at mixed meal test at the end of each treatment block. Glycaemic variability on continuous glucose monitoring for each intervention block will be evaluated as a secondary outcome. In addition, the primary outcome will be evaulated for KCNJ11 genotype as an additional secondary outcome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable type-2-diabetes
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 8, 2019
CompletedFirst Submitted
Initial submission to the registry
October 9, 2019
CompletedFirst Posted
Study publicly available on registry
December 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 2, 2020
CompletedMarch 4, 2021
March 1, 2021
1.2 years
October 9, 2019
March 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Insulin secretory response analysed by KCNJ11 genotype
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
Meansurements taken via continuous glucose monitoring sensors worn by participants for duration of 8 week clinical phase
Study Arms (4)
No Treatment
NO INTERVENTIONNo change to participants standard care
Low dose sulphonylurea alone
EXPERIMENTALParticipants will be given a single dose of low dose sulphonylurea once daily for 14 days as a physiological stimulus. The sulphonylurea given in this study will be gliclazide 20mg orally once daily.
DPP4 inhibitor alone
EXPERIMENTALParticipants will be given a single dose of DPP4 inhibitor once daily for 14 days as a physiological stimulus. The DPP inhibitor given in this study will be sitagliption 100mg orally once daily.
Low dose sulphonylurea + DPP4 inhibitor
EXPERIMENTALParticipants will be given a single dose of low dose sulphonylurea once daily and a single dose of DPP4 inhibitor for 14 days as a physiological stimulus. The sulphonylurea given in this study will be gliclazide 20mg orally once daily and the DPP4 inhibitor will be sitagliptin orally100mg once daily.
Interventions
Given at very low dose as a physiological stimulus on the beta cell not as medical treatment. 20mg gliclazide is being used in this study.
Given as a physiological stimulus to augment endogenous incretin hormone levels, not as a medical treatment. 100mg sitagliptin is being used in this study.
Eligibility Criteria
You may qualify if:
- Age ≧40 and ≦80
- Age of diabetes diagnosis ≧35
- T2DM on no treatment, or metformin monotherapy
- White British
- HbA1c ≦8% (64mmol/mol) in last 6 months
- eGFR ≧50ml/min-1
- ALT ≦2.5\*ULN
- Able to consent
You may not qualify if:
- Pregnancy, lactation or a female planning to conceive within the study period
- Previous acute pancreatitis
- Established pancreatic disease
- Participating in clinical phase of another interventional trial/study or have done so within the last 30 days.
- Inability or unwillingness to comply with protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ninewells Hospital and Medical School
Dundee, DD1 9SY, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2019
First Posted
December 10, 2019
Study Start
October 8, 2019
Primary Completion
December 2, 2020
Study Completion
December 2, 2020
Last Updated
March 4, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share