LANN-study: Lantus, Amaryl, Novorapid, Novomix Study
Many diabetics gain weight while on insulin therapy. In this study, we evaluate the efficacy of the combination of glimepiride and short-acting insulin on weight control and glucose control. In this study, 150 diabetics whose diabetic control is inadequate while on maximal oral treatment will be randomized to either the new combination treatment or twice daily injections with a mixture of short- and longacting insulin or once-daily injection with a basal insulin analog. The study will compare glucose control and weight gain during a year after randomisation between the three treatments.
Diabetes Mellitus Type II
Drug: Novomix 30
Drug: Novorapid and Amaryl
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.