Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Insulin Glargine Alone 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: Insulin glargine (HOE901)Drug: Oral anti-diabetic drugs
- Registration Number
- NCT02752828
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To compare LixiLan to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to Week 26 in patients with type 2 Diabetes.
Secondary Objective:
To compare the overall efficacy and safety of LixiLan to insulin glargine (with or without OADs) over a 26 Week treatment period in patients with type 2 Diabetes.
- Detailed Description
The maximum study duration per patient will be approximately 29 weeks: an up to 2-week screening period, a 26-week randomized open-label treatment period and a 3-day post-treatment safety follow up period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 521
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LixiLan Insulin glargine/lixisenatide (HOE901/AVE0010) LixiLan (insulin glargine/lixisenatide) 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. insulin glargine Insulin glargine (HOE901) Insulin glargine (HOE901) 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) 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. insulin glargine Oral anti-diabetic drugs Insulin glargine (HOE901) 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 Change from baseline in 7 point self monitored plasma glucose (SMPG) profiles during standardized meal test Baseline, 26 weeks Percentage of patients reaching HbA1c <7% or ≤6.5% 26 weeks Change from baseline in body weight Baseline, 26 weeks Percentage of patients reaching HbA1c <7% with no body weight gain and with no documented (PG ≤70 mg/dL [3.9 mmol/L]) symptomatic hypoglycemia 26 weeks Number of adverse events 26 weeks Change from baseline in 2-hour postprandial glucose (PPG) during standardized meal test Baseline, 26 weeks Percentage of patients reaching HbA1c <7% at Week 26 with no documented (PG ≤70 mg/dL [3.9 mmol/L]) symptomatic hypoglycemia 26 weeks Percentage of patients requiring a rescue therapy 26 weeks Number of hypoglycemic events 26 weeks Measurement of anti-lixisenatide antibodies from baseline Baseline, 26 weeks Measurement of anti-insulin antibodies from baseline Baseline, 26 weeks
Trial Locations
- Locations (113)
Investigational Site Number 392024
🇯🇵Chiba-Shi, Japan
Investigational Site Number 392025
🇯🇵Atsugi-Shi, Japan
Investigational Site Number 392008
🇯🇵Fujimi-Shi, Japan
Investigational Site Number 392048
🇯🇵Hamamatsu-Shi, Japan
Investigational Site Number 392136
🇯🇵Kamogawa-Shi, Japan
Investigational Site Number 392066
🇯🇵Kashiwa-Shi, Japan
Investigational Site Number 392045
🇯🇵Kashiwara-Shi, Japan
Investigational Site Number 392065
🇯🇵Kawagoe-Shi, Japan
Investigational Site Number 392007
🇯🇵Kawaguchi-Shi, Japan
Investigational Site Number 392077
🇯🇵Kawasaki-Shi, Japan
Investigational Site Number 392119
🇯🇵Kokubunji-Shi, Japan
Investigational Site Number 392086
🇯🇵Kobe-Shi, Japan
Investigational Site Number 392001
🇯🇵Koriyama-Shi, Japan
Investigational Site Number 392108
🇯🇵Kumamoto-Shi, Japan
Investigational Site Number 392032
🇯🇵Kurume-Shi, Japan
Investigational Site Number 392118
🇯🇵Kushiro-Shi, Japan
Investigational Site Number 392122
🇯🇵Minato-Ku, Japan
Investigational Site Number 392076
🇯🇵Misato-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 392148
🇯🇵Nagano-Shi, Japan
Investigational Site Number 392131
🇯🇵Nagoya-Shi, Japan
Investigational Site Number 392134
🇯🇵Nagoya-Shi, Japan
Investigational Site Number 392127
🇯🇵Niigata-Shi, Japan
Investigational Site Number 392144
🇯🇵Osaka-Shi, Japan
Investigational Site Number 392117
🇯🇵Osaka-Shi, Japan
Investigational Site Number 392040
🇯🇵Oyama-Shi, Japan
Investigational Site Number 392095
🇯🇵Onga-Gun, Japan
Investigational Site Number 392070
🇯🇵Shimonoseki-Shi, Japan
Investigational Site Number 392021
🇯🇵Shinjuku-Ku, Japan
Investigational Site Number 392081
🇯🇵Shizuoka-Shi, Japan
Investigational Site Number 392027
🇯🇵Suita-Shi, Japan
Investigational Site Number 392146
🇯🇵Takamatsu-Shi, Japan
Investigational Site Number 392073
🇯🇵Tsu-Shi, Japan
Investigational Site Number 392111
🇯🇵Tomakomai-Shi, Japan
Investigational Site Number 392067
🇯🇵Yatsushiro-Shi, Japan
Investigational Site Number 392012
🇯🇵Yokohama-Shi, Japan
Investigational Site Number 392039
🇯🇵Yamato-Shi, Japan
Investigational Site Number 392126
🇯🇵Yokohama-Shi, Japan
Investigational Site Number 392055
🇯🇵Chuo-Ku, Japan
Investigational Site Number 392147
🇯🇵Fukuoka-Shi, Japan
Investigational Site Number 392100
🇯🇵Gifu-Shi, Japan
Investigational Site Number 392079
🇯🇵Hiki-Gun, Japan
Investigational Site Number 392022
🇯🇵Ise-Shi, Japan
Investigational Site Number 392006
🇯🇵Kasugai-Shi, Japan
Investigational Site Number 392062
🇯🇵Kawaguchi-Shi, Japan
Investigational Site Number 392113
🇯🇵Matsumoto-Shi, Japan
Investigational Site Number 392132
🇯🇵Annaka-Shi, Japan
Investigational Site Number 392011
🇯🇵Chigasaki-Shi, Japan
Investigational Site Number 392091
🇯🇵Kawasaki-Shi, Japan
Investigational Site Number 392044
🇯🇵Koga-Shi, Japan
Investigational Site Number 392088
🇯🇵Maebashi-Shi, Japan
Investigational Site Number 392101
🇯🇵Nagoya-Shi, Japan
Investigational Site Number 392154
🇯🇵Naka-Shi, Japan
Investigational Site Number 392084
🇯🇵Saga-Shi, Japan
Investigational Site Number 392047
🇯🇵Sapporo-Shi, Japan
Investigational Site Number 392034
🇯🇵Shimotsuke-Shi, Japan
Investigational Site Number 392013
🇯🇵Chiyoda-Ku, Japan
Investigational Site Number 392109
🇯🇵Hofu-Shi, Japan
Investigational Site Number 392139
🇯🇵Kagoshima-Shi, Japan
Investigational Site Number 392002
🇯🇵Adachi-Ku, Japan
Investigational Site Number 392052
🇯🇵Chiyoda-Ku, Japan
Investigational Site Number 392155
🇯🇵Chuo-Ku, Japan
Investigational Site Number 392143
🇯🇵Fujisawa-Shi, Japan
Investigational Site Number 392054
🇯🇵Fukuoka-Shi, Japan
Investigational Site Number 392059
🇯🇵Hachioji-Shi, Japan
Investigational Site Number 392102
🇯🇵Hamamatsu-Shi, Japan
Investigational Site Number 392009
🇯🇵Arakawa-Ku, Japan
Investigational Site Number 392151
🇯🇵Chiba-Shi, Japan
Investigational Site Number 392003
🇯🇵Chuo-Ku, Japan
Investigational Site Number 392083
🇯🇵Hakodate-Shi, Japan
Investigational Site Number 392112
🇯🇵Hirosaki-Shi, Japan
Investigational Site Number 392053
🇯🇵Kawagoe-Shi, Japan
Investigational Site Number 392114
🇯🇵Kitamoto-Shi, Japan
Investigational Site Number 392089
🇯🇵Sapporo-Shi, Japan
Investigational Site Number 392004
🇯🇵Sendai-Shi, Japan
Investigational Site Number 392103
🇯🇵Sendai-Shi, Japan
Investigational Site Number 392098
🇯🇵Shinjuku-Ku, Japan
Investigational Site Number 392037
🇯🇵Shizuoka-Shi, Japan
Investigational Site Number 392057
🇯🇵Iruma-Shi, Japan
Investigational Site Number 392129
🇯🇵Kitakyushu-Shi, Japan
Investigational Site Number 392041
🇯🇵Kitakyusyu-Shi, Japan
Investigational Site Number 392068
🇯🇵Kitakyusyu-Shi, Japan
Investigational Site Number 392107
🇯🇵Kyoto-Shi, Japan
Investigational Site Number 392082
🇯🇵Kawasaki-Shi, Japan
Investigational Site Number 392142
🇯🇵Kawasaki-Shi, Japan
Investigational Site Number 392028
🇯🇵Kumamoto-Shi, Japan
Investigational Site Number 392092
🇯🇵Kumamoto-Shi, Japan
Investigational Site Number 392075
🇯🇵Kure-Shi, Japan
Investigational Site Number 392128
🇯🇵Nagoya-Shi, Japan
Investigational Site Number 392050
🇯🇵Niihama-Shi, Japan
Investigational Site Number 392115
🇯🇵Ogawa-Machi, Hikigun, Japan
Investigational Site Number 392071
🇯🇵Okayama-Shi, Japan
Investigational Site Number 392051
🇯🇵Takatsuki-Shi, Japan
Investigational Site Number 392069
🇯🇵Saijo-Shi, Japan
Investigational Site Number 392150
🇯🇵Sapporo-Shi, Japan
Investigational Site Number 392110
🇯🇵Shinagawa-Ku, Japan
Investigational Site Number 392063
🇯🇵Ube-Shi, Japan
Investigational Site Number 392030
🇯🇵Saitama-Shi, Japan
Investigational Site Number 392074
🇯🇵Sanda-Shi, Japan
Investigational Site Number 392097
🇯🇵Sasebo-Shi, Japan
Investigational Site Number 392019
🇯🇵Shobara-Shi, Japan
Investigational Site Number 392018
🇯🇵Shunan-Shi, Japan
Investigational Site Number 392056
🇯🇵Taito-Ku, Japan
Investigational Site Number 392061
🇯🇵Tokorozawa-Shi, Japan
Investigational Site Number 392035
🇯🇵Zentsuji-Shi, Japan
Investigational Site Number 392094
🇯🇵Fukuoka-Shi, Japan
Investigational Site Number 392017
🇯🇵Chuo-Ku, Japan
Investigational Site Number 392020
🇯🇵Izumisano-Shi, Japan
Investigational Site Number 392133
🇯🇵Kitaazumi-Gun, Japan
Investigational Site Number 392093
🇯🇵Ube-Shi, Japan
Investigational Site Number 392029
🇯🇵Toyonaka-Shi, Japan