Therapeutic implications of the effects of oral hypoglycaemic therapy on the enteroinsular axis in type 2 diabetes.
Phase 1
- Conditions
- Type 2 diabetes
- Registration Number
- EUCTR2005-004748-30-GB
- Lead Sponsor
- Royal Victoria Hospital Belfast
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
Type 2 diabetes - controlled with diet or single oral hypoglycaemic agent.
- HbA1C<7.5%
Serum creat<150
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Type 2 diabetes - on 2 or more hypoglycaemic agents or on insulin
- HbA1C >7.5%
Creat>150
Significant cardiac or liver disease.
Women of child bearing age (pre-menopausal) including pregnant and breast feeding women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Effects of exogenous GLP-1 with or without metformin or nateglinide on plasma DPPIV, GLP-1 and the metabolic response to feeding in subjects with type 2 diabetes. ;Secondary Objective: ;Primary end point(s): Plasma glucose, insulin, C-peptide, glucagon, DPPIV, GLP-1
- Secondary Outcome Measures
Name Time Method