Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Lixisenatide on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: Insulin glargine/Lixisenatide (HOE901/AVE0010)Drug: Oral anti-diabetic drugs
- Registration Number
- NCT02749890
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To compare LixiLan to lixisenatide in glycated hemoglobin (HbA1c) change from baseline to Week 26 in patients with type 2 diabetes mellitus.
Secondary Objective:
To compare the overall efficacy and safety of LixiLan to lixisenatide (with or without OADs) over a 52 week treatment period in patients with type 2 diabetes mellitus.
- Detailed Description
Approximately 55 weeks: an up-to 2-week screening period, a 26-week randomized open-label treatment period, a 26-week safety extension treatment period and a 3-day post-treatment safety follow up period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 321
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description lixisenatide Lixisenatide (AVE0010) Lixisenatide (AVE0010) is injected subcutaneously (under the skin) once daily. It will be initiated with Dose 1 for 1 week and then continue with Dose 2 for 1 week followed by the maintenance dose of Dose 3 up to the end of treatment period. Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period. lixisenatide Oral anti-diabetic drugs Lixisenatide (AVE0010) is injected subcutaneously (under the skin) once daily. It will be initiated with Dose 1 for 1 week and then continue with Dose 2 for 1 week followed by the maintenance dose of Dose 3 up to the end of treatment period. Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period. LixiLan Insulin glargine/Lixisenatide (HOE901/AVE0010) LixiLan (insulin glargine/lixisenatide fixed ratio combination) is injected subcutaneously (under the skin) once daily. Dose is individually adjusted. Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period. LixiLan Oral anti-diabetic drugs LixiLan (insulin glargine/lixisenatide fixed ratio combination) is injected subcutaneously (under the skin) once daily. Dose is individually adjusted. Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period.
- Primary Outcome Measures
Name Time Method Change from baseline in HbA1c Baseline, 26 weeks
- Secondary Outcome Measures
Name Time Method Percentage of patients reaching HbA1c <7% or ≤6.5% 26 weeks Change in from baseline in 7 point self-monitored plasma profiles Baseline, 26 weeks Change from baseline in body weight Baseline, 26 weeks Change in daily dose of insulin glargine for the combination group Day 1, 26 weeks Number of adverse events 26 weeks, 52 weeks Change from baseline in fasting plasma glucose Baseline, 26 weeks Percentage of patients reaching HbA1c <7% with no body weight gain 26 weeks Measurement of anti-insulin antibodies from baseline Baseline, 26 weeks, 52 weeks Percentage of patients requiring a rescue therapy 26 weeks Number of hypoglycemic events 26 weeks, 52 weeks Measurement of anti-lixisenatide antibodies from baseline Baseline, 26 weeks, 52 weeks
Trial Locations
- Locations (61)
Investigational Site Number 392068
🇯🇵Kitakyusyu-Shi, Japan
Investigational Site Number 392044
🇯🇵Koga-Shi, Japan
Investigational Site Number 392002
🇯🇵Adachi-Ku, Japan
Investigational Site Number 392009
🇯🇵Arakawa-Ku, Japan
Investigational Site Number 392013
🇯🇵Chiyoda-Ku, Japan
Investigational Site Number 392003
🇯🇵Chuo-Ku, Japan
Investigational Site Number 392017
🇯🇵Chuo-Ku, Japan
Investigational Site Number 392008
🇯🇵Fujimi-Shi, Japan
Investigational Site Number 392083
🇯🇵Hakodate-Shi, Japan
Investigational Site Number 392079
🇯🇵Hiki-Gun, Japan
Investigational Site Number 392065
🇯🇵Kawagoe-Shi, Japan
Investigational Site Number 392053
🇯🇵Kawagoe-Shi, Japan
Investigational Site Number 392006
🇯🇵Kasugai-Shi, Japan
Investigational Site Number 392007
🇯🇵Kawaguchi-Shi, Japan
Investigational Site Number 392062
🇯🇵Kawaguchi-Shi, Japan
Investigational Site Number 392077
🇯🇵Kawasaki-Shi, Japan
Investigational Site Number 392031
🇯🇵Kitakyushu-Shi, Japan
Investigational Site Number 392032
🇯🇵Kurume-Shi, Japan
Investigational Site Number 392088
🇯🇵Maebashi-Shi, Japan
Investigational Site Number 392014
🇯🇵Mitaka-Shi, Japan
Investigational Site Number 392042
🇯🇵Mito-Shi, Japan
Investigational Site Number 392078
🇯🇵Mito-Shi, Japan
Investigational Site Number 392026
🇯🇵Nagoya-Shi, Japan
Investigational Site Number 392030
🇯🇵Saitama-Shi, Japan
Investigational Site Number 392080
🇯🇵Okayama-Shi, Japan
Investigational Site Number 392040
🇯🇵Oyama-Shi, Japan
Investigational Site Number 392069
🇯🇵Saijo-Shi, Japan
Investigational Site Number 392047
🇯🇵Sapporo-Shi, Japan
Investigational Site Number 392004
🇯🇵Sendai-Shi, Japan
Investigational Site Number 392018
🇯🇵Shunan-Shi, Japan
Investigational Site Number 392037
🇯🇵Shizuoka-Shi, Japan
Investigational Site Number 392019
🇯🇵Shobara-Shi, Japan
Investigational Site Number 392027
🇯🇵Suita-Shi, Japan
Investigational Site Number 392056
🇯🇵Taito-Ku, Japan
Investigational Site Number 392061
🇯🇵Tokorozawa-Shi, Japan
Investigational Site Number 392051
🇯🇵Takatsuki-Shi, Japan
Investigational Site Number 392029
🇯🇵Toyonaka-Shi, Japan
Investigational Site Number 392093
🇯🇵Ube-Shi, Japan
Investigational Site Number 392067
🇯🇵Yatsushiro-Shi, Japan
Investigational Site Number 392035
🇯🇵Zentsuji-Shi, Japan
Investigational Site Number 392001
🇯🇵Koriyama-Shi, Japan
Investigational Site Number 392034
🇯🇵Shimotsuke-Shi, Japan
Investigational Site Number 392025
🇯🇵Atsugi-Shi, Japan
Investigational Site Number 392011
🇯🇵Chigasaki-Shi, Japan
Investigational Site Number 392094
🇯🇵Fukuoka-Shi, Japan
Investigational Site Number 392057
🇯🇵Iruma-Shi, Japan
Investigational Site Number 392041
🇯🇵Kitakyusyu-Shi, Japan
Investigational Site Number 392015
🇯🇵Satsumasendai-Shi, Japan
Investigational Site Number 392024
🇯🇵Chiba-Shi, Japan
Investigational Site Number 392059
🇯🇵Hachioji-Shi, Japan
Investigational Site Number 392023
🇯🇵Isehara-Shi, Japan
Investigational Site Number 392060
🇯🇵Bunkyo-Ku, Japan
Investigational Site Number 392066
🇯🇵Kashiwa-Shi, Japan
Investigational Site Number 392038
🇯🇵Sagamihara-Shi, Japan
Investigational Site Number 392054
🇯🇵Fukuoka-Shi, Japan
Investigational Site Number 392022
🇯🇵Ise-Shi, Japan
Investigational Site Number 392052
🇯🇵Chiyoda-Ku, Japan
Investigational Site Number 392048
🇯🇵Hamamatsu-Shi, Japan
Investigational Site Number 392082
🇯🇵Kawasaki-Shi, Japan
Investigational Site Number 392081
🇯🇵Shizuoka-Shi, Japan
Investigational Site Number 392020
🇯🇵Izumisano-Shi, Japan