LANN-study: Lantus, Amaryl, Novorapid, Novomix Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00151697|
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : August 9, 2011
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Type II||Drug: Novomix 30 Drug: Novorapid and Amaryl Drug: Lantus||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||New Approach to Treat Type II Diabetes Failing on Maximal Oral Treatment|
|Study Start Date :||May 2005|
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00151697
|Arnhem, Netherlands, 6800 TA|
|Principal Investigator:||Hans de Boer, MD, PhD||Rijnstate Hospital|