| Trial ID: | L4902 |
| Source ID: | NCT01349855
|
| Associated Drug: |
Insulin Glargine Hoe901
|
| Title: |
Repeated Dosing Study With a New Insulin Glargine Formulation and Lantus® in Patients With Type 1 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes Mellitus
|
| Interventions: |
DRUG: Insulin glargine HOE901
|
| Outcome Measures: |
Primary: Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory, up to day 10 of each period | Secondary: Glucose infusion rate, up to day 10 of each period|Pharmacokinetic parameter : Cmax, up to day 10 of each period|Pharmacokinetic parameter : Tmax, up to day 10 of each period|Pharmacokinetic parameter : AUC, up to day 10 of each period
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
30
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-03
|
| Completion Date: |
2011-05
|
| Results First Posted: |
|
| Last Update Posted: |
2011-06-01
|
| Locations: |
Investigational site number 276001, Neuss, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01349855
|
