| Trial ID: | L6638 |
| Source ID: | NCT01053728
|
| Associated Drug: |
Sar161271
|
| Title: |
Study of How Single Rising Doses of SAR161271 Are Absorbed and Act in Patients With Type 1 Diabetes Mellitus (T1DM)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes Mellitus
|
| Interventions: |
DRUG: SAR161271|DRUG: Insulin glargine HOE901
|
| Outcome Measures: |
Primary: - Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory for each cohort, up to 7 days after dose|- Pharmacodynamics (Glucose infusion rate) time-action profile, up to 30 hours after dose | Secondary: - Pharmacokinetic parameters, up to 168 hours after dose|- anti-insulin antibody production, pre-dose and after 4th dose
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
46
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2010-02
|
| Completion Date: |
2010-11
|
| Results First Posted: |
|
| Last Update Posted: |
2011-07-26
|
| Locations: |
Sanofi-Aventis Administrative Office, Berlin, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01053728
|
