| Trial ID: | L7234 |
| Source ID: | NCT01195454
|
| Associated Drug: |
Insulin Glargine (Hoe901)
|
| Title: |
Euglycemic Clamp Dose-response Study Comparing a New Insulin Glargine Formulation With Lantus®
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes Mellitus
|
| Interventions: |
DRUG: Insulin glargine (HOE901)|DRUG: Insulin glargine (HOE901)
|
| Outcome Measures: |
Primary: The area under the body weight standardized glucose infusion rate curve (GIR) within 36 hours (GIR-AUC0-36), 36 hours (D1 to D2) in all four treatment periods | Secondary: The area under the insulin glargine concentration curve within 36 hours (INS-AUC0-36) -, 36 hours (D1 to D2) in all four treatment periods|Time to 50% of the GIR-AUC0-36 (T50%-GIR AUC0-36), 36 hours (D1 to D2) in all four treatment periods|Time to 50% of INS-AUC0-36 (T50% INS-AUC0-36), 36 hours (D1 to D2) in all four treatment periods|Duration of blood glucose control (time to elevation of smoothed blood glucose profile above clamp level and to elevation above different pre-specified blood glucose levels), 36 hours (D1 to D2) in all four treatment periods|Maximum smoothed body weight standardized glucose infusion rate GIRmax, and time to GIRmax (GIR-Tmax), 36 hours (D1 to D2) in all four treatment periods|Maximum insulin concentration INS-Cmax, and time to Cmax (INS-Tmax), 36 hours (D1 to D2) in all four treatment periods
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2010-08
|
| Completion Date: |
2010-12
|
| Results First Posted: |
|
| Last Update Posted: |
2011-10-31
|
| Locations: |
Sanofi-Aventis Administrative Office, Berlin, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01195454
|
