Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00151697
Status:
COMPLETED
Last Update Posted:
2011-08-09
First Post:
2005-09-08
Brief Title:
LANN-study Lantus Amaryl Novorapid Novomix Study
Sponsor:
Rijnstate Hospital
Organization:
Rijnstate Hospital
Study Overview
Official Title:
New Approach to Treat Type II Diabetes Failing on Maximal Oral Treatment
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 glimepirideamaryl 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 2000 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
The combination of glimepirideamaryl 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 2000 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None