| Trial ID: | L4402 |
| Source ID: | NCT01572649
|
| Associated Drug: |
Lixisenatide (Ave0010)
|
| Title: |
Evaluation of the Blood Levels of the Drug (Lixisenatide), the Plasma Glucose Levels and Safety in Paediatric and Adult Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Lixisenatide (AVE0010)|DRUG: Placebo
|
| Outcome Measures: |
Primary: GLU-AUC 0:30-4:30h: area under the plasma glucose concentration time profile from time of the standardized breakfast start (30 min after IMP injection and pre-meal plasma glucose) until 4 hours later subtracting the pre-meal value, D1 at each period up to 4h30 after study drug injection (8 timepoints) | Secondary: Pharmacokinetics: lixisenatide plasma concentration, 0 (predose), 30 min, 1h, 1h30, 2h30, 3h30, 4h30 and 6h30 post-dose at D1 of each study period (8 timepoints)|Pharmacokinetic parameter (Cmax), calculated over the period of timepoints at D1 of each study period|Pharmacokinetic parameter (Tmax), calculated over the period of timepoints at D1 of each study period|Pharmacokinetic parameter (AUC last), estimated over the period of timepoints at D1 of each study period|Pharmacokinetic parameter (AUC), extrapolated based on the period of timepoints at D1 of each study period|Area under the concentration time profile from time of standardized breakfast start (30 min after IMP injection) until 4 hours later for insulin, C-peptide and glucagon, D1 at each period up to 4h30 after study drug injection (7 timepoints)
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
CHILD, 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: |
2012-05
|
| Completion Date: |
2014-03
|
| Results First Posted: |
|
| Last Update Posted: |
2014-05-23
|
| Locations: |
Investigational Site Number 840005, Chula Vista, California, 91911, United States|Investigational Site Number 840001, Overland Park, Kansas, 66212, United States|Investigational Site Number 840003, Louisville, Kentucky, 40202, United States|Investigational Site Number 484001, Puebla, 72190, Mexico|Investigational Site Number 710002, Cape Town, 7530, South Africa|Investigational Site Number 826001, Leeds, LS2 9LH, United Kingdom
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| URL: |
https://clinicaltrials.gov/show/NCT01572649
|
