| Trial ID: | L6924 |
| Source ID: | NCT00151697
|
| Associated Drug: |
Novomix 30
|
| Title: |
LANN-study: Lantus, Amaryl, Novorapid, Novomix Study
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus Type II
|
| Interventions: |
DRUG: Novomix 30|DRUG: Novorapid and Amaryl|DRUG: Lantus
|
| Outcome Measures: |
Primary: glycemic control based on HbA1c|Body weight | Secondary: 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
|
| Sponsor/Collaborators: |
Sponsor: Rijnstate Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
150
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2005-05
|
| Completion Date: |
|
| Results First Posted: |
|
| Last Update Posted: |
2011-08-09
|
| Locations: |
Rijnstate Hospital, Arnhem, 6800 TA, Netherlands
|
| URL: |
https://clinicaltrials.gov/show/NCT00151697
|
