Vildagliptin in type 1 diabetes mellitus added to insuli
Phase 3
Completed
- Conditions
- type 1 diabetesGlycamic variabilityHypoglycaemiaMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12613001056785
- Lead Sponsor
- BakerIDI Heart and Diabetes Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
Type 1 diabetes duration> 2 years
HbA1c 7.0% to 10.0%
MDI or CSII therapy
Exclusion Criteria
Premix insulin regime
Type 2 diabetes
Severe hypoglycaemia in past 3 months
Pregnant, lactating or planning pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Glycaemic variability. This will be assesed by continuous glucose monitoring and measurement of standard deviation of blood glucose levels over the period of one week[3 months]
- Secondary Outcome Measures
Name Time Method Post prandial blood glucose rise. This will be assessed by continuous glucose monitoring and mean glucose rise after meals [3 months];HbA1c. This will be measured by high-performance liquid chromatography (HPLC)[3 months];Insulin dose. This will be measured by patient diary[3 months];Body weight. This wil be measured at clinic visits using calibrated digital scales[3 months];CGMS glycaemic parameters. % time in normoglycaemia, hypoglycaemia and hyperglycaemia will be assesed from CGMS tracings[3 months];Effect of ultra sensitive c peptide as a measure of residual beta cell function on vildagliptin response. Ultra sensitive c peptide is available through Mercodia: Mercodia Ultrasensitive C-peptide ELISA [3 months];Effect of ultra sensitive c peptide on glycaemic variability. Correlation of c peptide with glycaemic variability will be assessed[Study initiation]