Low dosE GlibENclamide in Diabetes Part A

• Status: Completed
• Trial end date: 2017-03-09
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Collaborator: Oxford University Hospitals NHS Trust
• Treatments: Glyburide

Criteria

Inclusion Criteria:

• Diagnosis of T2DM.

• Age 18 years or over.

• Diet controlled or on metformin only for diabetic control.

• Body mass index 40 kg/m2 or less.

• HbA1c 6.0% to 9.5% (42mmol/mol to 80mmol/mol) inclusive.

Exclusion Criteria:

• Taking anti-diabetic therapies other than metformin

• Pregnancy or women of childbearing age without adequate contraception

• Women who are breastfeeding

• Major psychiatric disease including diagnosed eating disorders, history of drug or alcohol abuse

• Known sight-threatening retinopathy

• Renal impairment (eGFR < 60 ml/min; CKD Stage 3)

• Abnormal liver function tests (> 1.5 x upper limit of normal range)

• Known ischaemic heart disease or heart failure

• Known history of a stroke

• Known history of porphyria

• Concomitant use of miconazole or other oral antifungal medication.

• Known or suspected allergy to trial product or related products

• Oral steroid treatment 30 days prior to the start or at any time during the trial period.

• Known malignancy or any other condition or circumstance which, in the opinion of the investigator, would affect the patient's ability to participate in the protocol.

• Ketoacidosis

• Felt to be unsuitable to participate in the trial in the opinion of the Chief Investigator.

• Receipt of any investigational trial drug within 3 month prior to participation in the current trial.