Low dosE GlibENclamide in Diabetes Part A (LEGEND-A)
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|ClinicalTrials.gov Identifier: NCT02830048|
Recruitment Status : Completed
First Posted : July 12, 2016
Last Update Posted : May 31, 2017
Diabetes is a chronic condition that affects 1 in 16 people in the UK, and leads to difficulty controlling blood sugar levels. This is due to an imbalance between two main hormones: insulin, which lowers blood sugar, and glucagon, which causes it to rise. Most current anti-diabetic medications work to improve insulin levels, however research is now shifting to better understand how glucagon levels play a key role in this disease.
Glibenclamide is a type of anti-diabetic medication (sulfonylurea) which is commonly used to increase the amount of insulin released by the pancreatic beta-cells. Studies in mice and human cells from donors with type 2 diabetes have shown that sulfonylureas can also improve glucagon levels when used in very small doses by working on different cells in the pancreas (alpha-cells).
The aim of this study is to find out whether low doses of glibenclamide can improve glucagon levels in patients with type 2 diabetes, and whether in the future this could be used to better control high blood sugar levels, without the risk of causing low blood sugar.
Participants with type 2 diabetes who are diet-controlled or on metformin will be given a liquid containing a low dose of glibenclamide. They will need to attend the OCDEM Clinical Research Unit at the Churchill Hospital, Oxford, for early morning blood tests every 3-4 days over a period of 3 weeks. A continuous glucose monitor will also be fitted during this time.
This study is funded by the NIHR OxBRC.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: Glibenclamide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Low-dose Glibenclamide in Type 2 Diabetes Mellitus - Part A|
|Study Start Date :||July 2016|
|Actual Primary Completion Date :||March 9, 2017|
|Actual Study Completion Date :||March 9, 2017|
Experimental: Glibenclamide dose titration
Increasing doses of glibenclamide oral suspension from 0.3mg/day to 6mg/day.
Other Name: GlibenTek
- Decrease in fasting plasma glucagon concentration [ Time Frame: After 3-4 days of treatment at each dose increment ]Concentration of plasma glucagon using fasting blood samples prior to each dose change.
- Overall improvement in glycaemic control throughout the day [ Time Frame: After 3-4 days of treatment at each dose increment ]Change in the percentage of Continuous Glucose Monitoring (CGM) readings under 4 mmol/L, between 4-10 mmol/L and above 10 mmol/L before starting glibenclamide and prior to each change in dose.
- Effect on fasting glucose, insulin and C-peptide levels [ Time Frame: After 3-4 days of treatment at each dose increment ]Concentration of glucose, insulin and C-peptide using fasting blood samples prior to each dose change.
- Pre-dose plasma concentration of glibenclamide [ Time Frame: After 3-4 days of treatment at each dose increment ]Concentration of plasma glibenclamide using fasting blood samples prior to each dose change.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830048
|Clinical Research Unit, OCDEM, Churchill Hospital|
|Oxford, Oxfordshire, United Kingdom, OX3 7LE|
|Principal Investigator:||Ioannis Spiliotis, MD||University of Oxford|