Clinical trial

The Effects of Lipoic Acid on Glycaemic Control in Type 2 Diabetes

Name
2005-001543-36
Description
Hypothesis: that lipoic acid supplements taken orally will improve control of blood sugar levels in people with type 2 diabetes. This study will recruit 18 people with type 2 diabetes, whose diabetes is currently managed on oral agents. Each subject will then either take placebo for 12 weeks followed by lipoic acid for 12 weeks, or lipoic acid followed by placebo. A blood test for overall diabetes control will be taken at the start and end of each 12 week period, and the change in control will be compared for lipoic acid vs placebo.
Trial arms
Trial start
2009-12-01
Estimated PCD
2011-01-01
Trial end
2011-01-01
Status
Withdrawn
Phase
Early phase I
Treatment
Lipoic acid
Lipoic acid capsules
Arms:
1, 2
Primary endpoint
HbA1c change for lipoic acid vs placebo
12 weeks
Eligibility criteria
Inclusion Criteria: * Type 2 diabetes * Age \> 18 years * Capable of giving informed consent * Treated with oral antidiabetic agents (not insulin) * HbA1c 7.0 - 8.5% at last measurement (must be within 6 months of study) * Most recent HbA1c within 1% of all measurements within preceding year * Prepared to self-test blood glucose on a regular basis * Prepared to use contraception during study if of child-bearing potential Exclusion Criteria: * Unstable cardiac disease (NYHA class III or IV heart failure, or unstable angina or myocardial infarction within last three months) * Significant renal or hepatic impairment (creatinine\>170 micromol/L, alanine transaminase or alkaline phosphatase \> 3x upper limit of normal) * Other medical condition or treatment likely to affect glycaemic control * Previous history of significant hypoglycaemia * Pregnancy * Involvement in other clinical trial in last three months * Known or suspected sensitivity to trial products
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2024-05-29

1 organization

1 product

2 indications

Indication
Type 2