DPP4inhibitors in Type 1 Diabetes

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

A small, pilot, randomised, cross over trial that investigates the potential for DPPIVi therapy to reduce insulin requirements in type 1 diabetes was studied. We investigated whether this drug reduces daily insulin doses, leads to weight reduction, reduces blood glucose fluctuation and improves glucose control. Through reduction of blood glucose variability, we want investigated, whether it has the capability of improving the magnitude of epinephrine responses at 2.5mmol/L by performing a hyperinsulinaemic, hypoglycaemia clamp study after each arm. A successful outcome would then lead to an application for funds for a larger, multicentre intervention study. The benefits of this therapeutic advance are clear and this has the potential to make a dramatic improvement to the lives of people with type 1 diabetes in our community.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Dundee
• Treatments: Dipeptidyl-Peptidase IV Inhibitors; Saxagliptin

Criteria

Inclusion criteria;

• Type 1 diabetes over 5 years duration

• HbA1c less than 10%

• Age 18 and over

• Current use of intensive insulin therapy (injections or pump)

• BMI 19-35

• Ability to give written informed consent to participate in the study

Exclusion criteria;

• Previous history of pancreatic disease/cancer

• Significant renal disease estimated glomerular filtration rate (eGFR) less than 50

• Significant microvascular disease

• Personal/family history of Medullary thyroid cancer

• Personal/family history of multiple endocrine neoplasia (MEN) Type 2

• Moderate/Severe hepatic impairment

• Pregnancy or breast feeding

• History of epilepsy/hypoglycaemia induced seizure

• Those on any other hypoglycaemia drug apart from insulin for their diabetes.

• Currently on CYP3A4 inducers like carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampicin

• Currently on CYP3A4 inhibitors like ketoconazole, diltiazem

• Less than 30 days since participation in another drug trial or longer depending on the drug half life.