| Trial ID: | L7186 |
| Source ID: | NCT02713477
|
| Associated Drug: |
Insulin Glargine/ Lixisenatide Fixed-Ratio Combination Hoe901/Ave0010
|
| Title: |
Postprandial Glucodynamic Response to Insulin Glargine/Lixisenatide Fixed Ratio Combination in Japanese Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010|DRUG: Insulin glargine HOE901|DRUG: Placebo
|
| Outcome Measures: |
Primary: Measurement of plasma glucose concentrations, 1 day (D1) in each treatment period | Secondary: Measurement of serum insulin concentrations, 1 day (D1) in each treatment period|Measurement of serum C-peptide concentrations, 1 day (D1) in each treatment period|Measurement of plasma glucagon concentrations, 1 day (D1) in each treatment period|Measurement of plasma lixisenatide concentrations, 1 day (D1) in each treatment period|Number of patients with hypoglycemic events, Up to 2 weeks after each treatment|Number of patients with adverse events, Up to 2 weeks after each treatment|Measurement of anti-lixisenatide antibodies, 2 days (prior to first dosing and end of study visit)|Measurement of anti-insulin antibodies, 2 days (prior to first dosing and end of study visit)
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
20
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2016-04
|
| Completion Date: |
2016-06
|
| Results First Posted: |
|
| Last Update Posted: |
2020-06-16
|
| Locations: |
Investigational Site Number 392001, Fukuoka-Shi, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT02713477
|
