| Trial ID: | L7185 |
| Source ID: | NCT00659477
|
| Associated Drug: |
Insulin Glargine
|
| Title: |
Comparison Safety and Efficacy of Basal Insulin Lantus® (Insulin Glargine) vs NPH Insulin in Combination With Oral Antidiabetic Drugs (OADs) in Patients With Diabetes Mellitus, Type 2 (DMT2)
|
| Acronym: |
COBIN 2
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: insulin glargine
|
| Outcome Measures: |
Primary: The change in blood glucose variability, before start with insulin glargine treatment and at the end of the study | Secondary: Occurrence of adverse events, From signing of informed consent to the end of study|Development of diabetes compensation - fastig blood glucose and HbA1, before starting therapy with Lantus and at the end of study|Development of weight of patients, Before starting Lantus vs at the end of the study|Comparison of dose of insulins NPH vs Lantus, Before starting Lantus and at the end of the study
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
117
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2008-03
|
| Completion Date: |
2009-06
|
| Results First Posted: |
|
| Last Update Posted: |
2010-07-30
|
| Locations: |
Sanofi-Aventis Administrative Office, Praha, Czech Republic
|
| URL: |
https://clinicaltrials.gov/show/NCT00659477
|
