| Trial ID: | L6726 |
| Source ID: | NCT00641407
|
| Associated Drug: |
Npl Insulin
|
| Title: |
Bedtime Insulins and Oral Antihyperglycemic Drugs in Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus|Hypoglycemia
|
| Interventions: |
DRUG: NPL insulin|DRUG: Insulin glargine
|
| Outcome Measures: |
Primary: Change in hemoglobin A1c (HbA1c) level from baseline to end point for each treatment group., 9 months | Secondary: Percentage of subjects achieving HbA1c ≤7%, incidence of self-reported hypoglycaemic episodes, comparison of SMPG values from 8-point profiles, insulin doses, and body weight., 9 months
|
| Sponsor/Collaborators: |
Sponsor: University of Campania Luigi Vanvitelli
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
100
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2007-01
|
| Completion Date: |
2008-03
|
| Results First Posted: |
|
| Last Update Posted: |
2008-03-31
|
| Locations: |
Department of Geriatrics and Metabolic Disease, Naples, 80138, Italy
|
| URL: |
https://clinicaltrials.gov/show/NCT00641407
|
