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LixiLan vs Lixisenatide in Japanese T2DM Patients
NCT02749890Phase 3
Key facts
- Status
- Completed
- Start
- May 2016
- Primary completion
- May 2018
- Countries
- 1
- Sponsor
- Sanofi
- Modality
- Peptides, Recombinant Proteins and Enzymes
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 3, randomised, open-label trial of insulin glargine + lixisenatide in type 2 diabetes mellitus (T2DM) (2 arms), sponsored by Sanofi. Primary endpoint: Change from baseline in HbA1c at 26 weeks. Started May 2016; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
LixiLan
Insulin glargine/Lixisenatide fixed ratio combination once daily + OADs
Lixisenatide
Lixisenatide once daily + OADs
03
Who it enrols
Japanese patients with T2DM diagnosed for at least 1 year, treated with 1-2 OADs, with HbA1c 7.5-10%.
04
Endpoints
Primary
Change from baseline in HbA1c
Secondary
Percentage of patients reaching HbA1c <7% or <=6.5%
Change from baseline in fasting plasma glucose
Change from baseline in 7 point self-monitored plasma profiles
Change from baseline in body weight
Percentage of patients requiring a rescue therapy
Change in daily dose of insulin glargine
Number of hypoglycemic events
Number of adverse events
05
Results
Primary endpoints met
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