| Trial ID: | L5585 |
| Source ID: | NCT01493115
|
| Associated Drug: |
Insulin Glargine Hoe901
|
| Title: |
Single Dose Study With a New Insulin Glargine Formulation and Lantus® in Japanese Patients With Type 1 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes Mellitus
|
| Interventions: |
DRUG: Insulin glargine HOE901|DRUG: Insulin glargine - New formulation HOE901
|
| Outcome Measures: |
Primary: Glucose infusion rate, up to day 2 of each period | Secondary: Pharmacokinetic parameter : Cmax, up to day 2 of each period|Pharmacokinetic parameter : Tmax, up to day 2 of each period|Pharmacokinetic parameter : AUC, up to day 2 of each period|Number of patients with adverse events, up to day 3 of each period|Safety-related parameters including electrocardiogram, vital signs and laboratory tests, up to day 3 of each period
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
18
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-11
|
| Completion Date: |
2012-04
|
| Results First Posted: |
|
| Last Update Posted: |
2012-05-01
|
| Locations: |
Investigational Site Number 392001, Fukuoka-Shi, 812-0025, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01493115
|
