| Trial ID: | L7346 |
| Source ID: | NCT01336751
|
| Associated Drug: |
Insulin Glargine
|
| Title: |
Lantus Versus Humalog Mix as add-on Therapy in Type Diabetes Patients Failing Sulfonylurea and Metformin Combination Treatment
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Insulin glargine|DRUG: 75% insulin lispro protamine suspension and 25 % insulin lispro injection
|
| Outcome Measures: |
Primary: Change from baseline in hemoglobin A1c (HbA1c) levels at week 24, 24 weeks | Secondary: Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) values ≤ 7.0% at Week 24, 24 weeks|Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) values ≤ 8.0% at Week 24, 24 weeks|Change from baseline in fasting plasma glucose (FBG) values at week 24, 24 weeks|Change from baseline in serum lipid values at week 24, 24 weeks|Number and severity of hypoglycemic events and time of occurrence of hypoglycemic events, 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
212
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2001-07
|
| Completion Date: |
2002-12
|
| Results First Posted: |
|
| Last Update Posted: |
2011-04-18
|
| Locations: |
Sanofi-Aventis Administrative Office, Bridgewater, New Jersey, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01336751
|
