Type 1 Diabetes Clinical Trial
Official title:
A Dipeptidyl Peptidase 4 (DPP-4) Inhibitor in Type 1 Diabetes
NCT number | NCT01922817 |
Other study ID # | 2012DM07 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | September 2012 |
Est. completion date | April 2014 |
Verified date | October 2019 |
Source | University of Dundee |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Clinical research centre, Ninewells Hospital and Medical School | Dundee |
Lead Sponsor | Collaborator |
---|---|
University of Dundee |
United Kingdom,
George PS, McCrimmon RJ. Saxagliptin co-therapy in C-peptide negative Type 1 diabetes does not improve counter-regulatory responses to hypoglycaemia. Diabet Med. 2016 Sep;33(9):1283-90. doi: 10.1111/dme.13046. Epub 2015 Dec 28. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Magnitude of epinephrine release at 2.5mmol/L | During hyperinsulinaemic hypoglycaemia clamp |
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