The effects of lipoic acid on glycaemic control in type 2 diabetes.
Phase 1
- Conditions
- Type 2 diabetes mellitus.
- Registration Number
- EUCTR2005-001543-36-GB
- Lead Sponsor
- HS Lothian
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 18
Inclusion Criteria
Age > 18, capable of giving informed consent.
Type 2 diabetes receiving oral therapy only (not insulin).
HbA1c 7.0 - 8.5%.
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
Significant/unstable cardiac, renal or hepatic disease.
Pregnancy.
History of significant hypoglycaemia.
Involvement in other clinical trial within last three months.
Known or suspected sensitivity to trial products.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine whether oral administration of alpha-lipoic acid, in addition to usual treatment, improves glycaemic control in patients with type 2 diabetes.;Secondary Objective: ;Primary end point(s): Change in HbA1c (measure of control of diabetes) with alpha-lipoic acid versus placebo.
- Secondary Outcome Measures
Name Time Method