Evaluation of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Patients With Type 2 Diabetes Insufficiently Controlled With Oral Antidiabetic Drug(s)
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: Lixisenatide (AVE0010)Drug: Insulin glargine/Lixisenatide (HOE901/AVE0010)Drug: Insulin glargine (HOE901)Drug: MetforminDrug: SGLT2 inhibitor
- Registration Number
- NCT03798054
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objectives:
The co-primary objective of this study is:
* To demonstrate the superiority of iGlarLixi (fixed ratio combination of insulin glargine and lixisenatide) versus lixisenatide on glycemic control as assessed by glycated hemoglobin A1c (HbA1c) change.
* To demonstrate the non-inferiority of iGlarLixi versus insulin glargine on glycemic control as assessed by HbA1c change.
Secondary Objectives:
* To assess the effects of iGlarLixi in comparison with insulin glargine alone and lixisenatide alone.
* To assess the safety in each treatment group.
- Detailed Description
The maximum study duration per patient will be approximately 31 weeks: an up-to 6-week screening and run-in period (with an up-to 2-week screening phase and a 4-week run-in phase), followed by a 24-week randomized treatment period and a 3-day post-treatment safety follow up period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 878
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lyxumia (lixisenatide) Lixisenatide (AVE0010) Lixisenatide will be self-administered subcutaneously once daily according to the locally approved label on top of metformin for 24 weeks. Injection time should be determined on the day of randomization, and should remain about the same until the end of the treatment period. Soliqua (insulin glargine/lixisenatide) SGLT2 inhibitor iGlarLixi (insulin glargine/lixisenatide) will be self-administered subcutaneously once daily in the morning on top of metformin for 24 weeks. Soliqua (insulin glargine/lixisenatide) Insulin glargine/Lixisenatide (HOE901/AVE0010) iGlarLixi (insulin glargine/lixisenatide) will be self-administered subcutaneously once daily in the morning on top of metformin for 24 weeks. Lantus (insulin glargine) SGLT2 inhibitor Insulin glargine will be self-administered subcutaneously once daily at any time of the day on top of metformin for 24 weeks. Injection time should be determined on the day of randomization, and should remain about the same until the end of the treatment period. Lyxumia (lixisenatide) SGLT2 inhibitor Lixisenatide will be self-administered subcutaneously once daily according to the locally approved label on top of metformin for 24 weeks. Injection time should be determined on the day of randomization, and should remain about the same until the end of the treatment period. Lantus (insulin glargine) Insulin glargine (HOE901) Insulin glargine will be self-administered subcutaneously once daily at any time of the day on top of metformin for 24 weeks. Injection time should be determined on the day of randomization, and should remain about the same until the end of the treatment period. Soliqua (insulin glargine/lixisenatide) Metformin iGlarLixi (insulin glargine/lixisenatide) will be self-administered subcutaneously once daily in the morning on top of metformin for 24 weeks. Lantus (insulin glargine) Metformin Insulin glargine will be self-administered subcutaneously once daily at any time of the day on top of metformin for 24 weeks. Injection time should be determined on the day of randomization, and should remain about the same until the end of the treatment period. Lyxumia (lixisenatide) Metformin Lixisenatide will be self-administered subcutaneously once daily according to the locally approved label on top of metformin for 24 weeks. Injection time should be determined on the day of randomization, and should remain about the same until the end of the treatment period.
- Primary Outcome Measures
Name Time Method Change in HbA1c From Baseline to Week 24 Change in glycated hemoglobin (HbA1c) from baseline to Week 24
- Secondary Outcome Measures
Name Time Method Patients with HbA1c <7.0% At Week 24 Percentage of patients reaching HbA1c \<7% at Week 24
Change in postprandial plasma glucose (PPG) From Baseline to Week 24 Absolute change in 2-hour blood glucose excursion and PPG during meal test from baseline to Week 24 (for all patients in iGlarLixi or insulin glargine group and patients who receive morning injection in the lixisenatide group)
Change in fasting plasma glucose (FPG) From Baseline to Week 24 Absolute change in FPG from baseline to Week 24
Patients with HbA1c ≤ 6.5% At Week 24 Percentage of patients reaching HbA1c ≤ 6.5% at Week 24
Change in body weight From Baseline to Week 24 Absolute change in body weight from baseline to Week 24
Adverse events (AEs) From Baseline to Week 24 Number of AEs, serious AEs, AEs of Special Interest, and AEs requiring specific monitoring from baseline to Week 24
Patients with HbA1c <7.0% with no body weight gain At Week 24 Percentage of patients reaching HbA1c \<7% with no body weight gain at Week 24
Confirmed hypoglycemia From Baseline to Week 24 Including severe hypoglycemia and episodes of hypoglycemia documented with PG ≤70 mg/dL (3.9 mmol/L) regardless of symptoms from baseline to Week 24
Change in self-monitored plasma glucose (SMPG) profile From Baseline to Week 24 Absolute change in 7-point SMPG profiles from baseline to Week 24 (each time point and average daily value)
Patients with HbA1c <7.0% with no body weight gain and no documented symptomatic hypoglycemia At Week 24 Percentage of patients reaching HbA1c \<7% with no body weight gain at Week 24 and no documented (plasma glucose \[PG\] ≤70 mg/dL \[3.9 mmol/L\]) symptomatic hypoglycemia during the 24 week treatment period
Immunogenicity (antibody variables) From Baseline to Week 24 Anti-lixisenatide antibodies and anti-insulin antibodies (depending on the treatment group) from baseline to Week 24
Trial Locations
- Locations (79)
Investigational Site Number 1560013
🇨🇳Shanghai, China
Investigational Site Number 1560004
🇨🇳Shanghai, China
Investigational Site Number 1560029
🇨🇳Shanghai, China
Investigational Site Number 1560016
🇨🇳Changsha, China
Investigational Site Number 1560059
🇨🇳Suzhou, China
Investigational Site Number 4100009
🇰🇷Ansan-Si, Korea, Republic of
Investigational Site Number 4580001
🇲🇾Kelantan, Malaysia
Investigational Site Number 1560005
🇨🇳Jinan, China
Investigational Site Number 1580005
🇨🇳Tainan Hsien, Taiwan
Investigational Site Number 1560006
🇨🇳Beijing, China
Investigational Site Number 1560001
🇨🇳Beijing, China
Investigational Site Number 1560039
🇨🇳Cangzhou, China
Investigational Site Number 1560049
🇨🇳Beijing, China
Investigational Site Number 1560009
🇨🇳Changchun, China
Investigational Site Number 1560027
🇨🇳Changchun, China
Investigational Site Number 1560053
🇨🇳Chengdu, China
Investigational Site Number 1560056
🇨🇳Chengdu, China
Investigational Site Number 1560037
🇨🇳Chongqing, China
Investigational Site Number 1560010
🇨🇳Chenzhou, China
Investigational Site Number 1560044
🇨🇳Dongguan, China
Investigational Site Number 1560050
🇨🇳Chongqing, China
Investigational Site Number 1560033
🇨🇳Guangzhou, China
Investigational Site Number 1560023
🇨🇳Hangzhou, China
Investigational Site Number 1560012
🇨🇳Handan, China
Investigational Site Number 1560028
🇨🇳Guangzhou, China
Investigational Site Number 1560035
🇨🇳Harbin, China
Investigational Site Number 1560036
🇨🇳Harbin, China
Investigational Site Number 1560011
🇨🇳Hengshui, China
Investigational Site Number 1560024
🇨🇳Hohhot, China
Investigational Site Number 1560047
🇨🇳Hohhot, China
Investigational Site Number 1560026
🇨🇳Huanggang, China
Investigational Site Number 3440001
🇨🇳Hong Kong, China
Investigational Site Number 1560025
🇨🇳Huang Shi, China
Investigational Site Number 1560048
🇨🇳Huizhou, China
Investigational Site Number 1560034
🇨🇳Huzhou, China
Investigational Site Number 1560052
🇨🇳Jinhua, China
Investigational Site Number 1560031
🇨🇳Jinzhou, China
Investigational Site Number 1560014
🇨🇳Nanjing, China
Investigational Site Number 1560041
🇨🇳Nanning, China
Investigational Site Number 1560038
🇨🇳Qinhuangdao, China
Investigational Site Number 1560043
🇨🇳Nanjing, China
Investigational Site Number 1560032
🇨🇳Qingdao, China
Investigational Site Number 1560007
🇨🇳Shanghai, China
Investigational Site Number 1560019
🇨🇳Suzhou, China
Investigational Site Number 1560003
🇨🇳Shenyang, China
Investigational Site Number 1560054
🇨🇳Shenzhen, China
Investigational Site Number 1560021
🇨🇳Tianjin, China
Investigational Site Number 1560017
🇨🇳Tianjin, China
Investigational Site Number 1560058
🇨🇳Urumqi, China
Investigational Site Number 1560018
🇨🇳Wuhan, China
Investigational Site Number 1560008
🇨🇳Xi'An, China
Investigational Site Number 1560055
🇨🇳Xi'An, China
Investigational Site Number 1560040
🇨🇳Yanji, China
Investigational Site Number 1560051
🇨🇳Xingtai, China
Investigational Site Number 1560060
🇨🇳Yueyang, China
Investigational Site Number 1560030
🇨🇳Xining, China
Investigational Site Number 1560045
🇨🇳Zhengzhou, China
Investigational Site Number 1560046
🇨🇳Yueyang, China
Investigational Site Number 1560015
🇨🇳Zhuzhou, China
Investigational Site Number 1560002
🇨🇳Zhenjiang, China
Investigational Site Number 1560057
🇨🇳Zigong, China
Investigational Site Number 4100010
🇰🇷Guri-Si, Gyeonggi-Do, Korea, Republic of
Investigational Site Number 4100012
🇰🇷Busan, Korea, Republic of
Investigational Site Number 4100004
🇰🇷Gwangju, Korea, Republic of
Investigational Site Number 4100016
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 4100003
🇰🇷Seongnam-Si, Korea, Republic of
Investigational Site Number 4100011
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 4100002
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 4100005
🇰🇷Wonju, Korea, Republic of
Investigational Site Number 4580005
🇲🇾Kuala Lumpur, Malaysia
Investigational Site Number 4580003
🇲🇾Kuala Lumpur, Malaysia
Investigational Site Number 4580002
🇲🇾Putrajaya, Malaysia
Investigational Site Number 4580004
🇲🇾Seremban, Malaysia
Investigational Site Number 4580006
🇲🇾Kuching, Malaysia
Investigational Site Number 1580003
🇨🇳Taichung, Taiwan
Investigational Site Number 1580004
🇨🇳Taipei, Taiwan
Investigational Site Number 4100013
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 4100001
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 1560022
🇨🇳Nanjing, China