DPP4inhibitors in Type 1 Diabetes

Phase 1

• Conditions: Type 1 Diabetes; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2012-002407-18-GB
• Lead Sponsor: niversity of Dundee and NHS Tayside

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-10
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

?Type 1 diabetes with greater than 5 years disease duration
?HbA1C<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

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

?Previous history of pancreatic disease/cancer
?Significant renal disease eGFR <50
?Personal/family history of Medullary thyroid cancer
?Personal/family history of MEN Type 2
?Moderate/Severe hepatic impairment (Child Pugh B,C)
?Pregnancy/Breast feeding
?History of epilepsy/hypoglycaemia induced seizure
?Those on any other hypoglycaemic drug apart from insulin for their diabetes.
?Currently on CYP3A4 inducers like carbamazepine, dexamethasone, phenobarbital, phenytoin and rifampicin
?Currently on CYP3A4 inhibitors like ketoconazole, diltiazem

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified