LANN-study: Lantus, Amaryl, Novorapid, Novomix Study
|Diabetes Mellitus Type II||Drug: Novomix 30 Drug: Novorapid and Amaryl Drug: Lantus||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||New Approach to Treat Type II Diabetes Failing on Maximal Oral Treatment|
- glycemic control based on HbA1c
- Body weight
- 8-point glucose day curve of three consecutive days
- 24-hour glycemic control measured by continuous glucose monitoring for three consecutive days
- recorded number of hypoglycemic events per month
- waist circumference
- dexa measurements of body composition
- plasma lipid levels
- basal and stimulated C-peptide levels
- adverse effects
|Study Start Date:||May 2005|
Diabetic patients failing on maximal oral treatment usually switch to twice daily administration of a mixture of short- and longacting insulin. Although this improves glycemic control, it is generally accompanied by a substantial gain in body weight. This may lead to an increase in body fat resulting in a worsening of insulin resistance, leading to an increase in insulin dose needed to maintain glycemic control.
The combination of glimepiride(amaryl) and short-acting insulin (novorapid) is thought to attain glycemic control with a smaller increase in body weight.
In this randomized controlled trial, 150 diabetics failing on maximal oral treatment will be randomized to preprandial use of Novorapid combined with Amaryl at 20.00 hours, twice daily Novomix 30, or once daily Lantus. Metformin will be continued.
In the year after randomisation, patients will be followed for glycemic control, body weight, body composition, recorded number of hypoglycemic events, plasma lipid levels, basal and stimulated C-peptide levels and adverse effects.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00151697
|Arnhem, Netherlands, 6800 TA|
|Principal Investigator:||Hans de Boer, MD, PhD||Rijnstate Hospital|