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Clinical Trial Details

Trial ID: L7165
Source ID: NCT03798054
Associated Drug: Insulin Glargine/Lixisenatide (Hoe901/Ave0010)
Title: Evaluation of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Patients With Type 2 Diabetes Insufficiently Controlled With Oral Antidiabetic Drug(s)
Acronym: Lixilan-O-AP
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Insulin glargine/Lixisenatide (HOE901/AVE0010)|DRUG: Insulin glargine (HOE901)|DRUG: Lixisenatide (AVE0010)|DRUG: Metformin|DRUG: SGLT2 inhibitor
Outcome Measures: Primary: Change in HbA1c, Change in glycated hemoglobin (HbA1c) from baseline to Week 24, From Baseline to Week 24 | Secondary: Change in postprandial plasma glucose (PPG), 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), From Baseline to Week 24|Change in fasting plasma glucose (FPG), Absolute change in FPG from baseline to Week 24, From Baseline to Week 24|Change in self-monitored plasma glucose (SMPG) profile, Absolute change in 7-point SMPG profiles from baseline to Week 24 (each time point and average daily value), From Baseline to Week 24|Patients with HbA1c <7.0%, Percentage of patients reaching HbA1c \<7% at Week 24, At Week 24|Patients with HbA1c ≤ 6.5%, Percentage of patients reaching HbA1c ≤ 6.5% at Week 24, At Week 24|Change in body weight, Absolute change in body weight from baseline to Week 24, From Baseline to Week 24|Patients with HbA1c <7.0% with no body weight gain, Percentage of patients reaching HbA1c \<7% with no body weight gain at Week 24, At Week 24|Patients with HbA1c <7.0% with no body weight gain and no documented symptomatic hypoglycemia, 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, At Week 24|Confirmed hypoglycemia, 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, From Baseline to Week 24|Adverse events (AEs), Number of AEs, serious AEs, AEs of Special Interest, and AEs requiring specific monitoring from baseline to Week 24, From Baseline to Week 24|Immunogenicity (antibody variables), Anti-lixisenatide antibodies and anti-insulin antibodies (depending on the treatment group) from baseline to Week 24, From Baseline to Week 24
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 878
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-02-15
Completion Date: 2021-03-01
Results First Posted:
Last Update Posted: 2022-07-19
Locations: Investigational Site Number 1560001, Beijing, 1000029, China|Investigational Site Number 1560006, Beijing, 101200, China|Investigational Site Number 1560049, Beijing, 102218, China|Investigational Site Number 1560039, Cangzhou, 061000, China|Investigational Site Number 1560009, Changchun, 130033, China|Investigational Site Number 1560027, Changchun, 130041, China|Investigational Site Number 1560016, Changsha, 410013, China|Investigational Site Number 1560053, Chengdu, 610081, China|Investigational Site Number 1560056, Chengdu, 611130, China|Investigational Site Number 1560010, Chenzhou, China|Investigational Site Number 1560037, Chongqing, 400010, China|Investigational Site Number 1560050, Chongqing, 400013, China|Investigational Site Number 1560044, Dongguan, China|Investigational Site Number 1560033, Guangzhou, 510120, China|Investigational Site Number 1560028, Guangzhou, China|Investigational Site Number 1560012, Handan, 056002, China|Investigational Site Number 1560023, Hangzhou, China|Investigational Site Number 1560035, Harbin, 150001, China|Investigational Site Number 1560036, Harbin, 150001, China|Investigational Site Number 1560011, Hengshui, 053000, China|Investigational Site Number 1560024, Hohhot, 010017, China|Investigational Site Number 1560047, Hohhot, 010050, China|Investigational Site Number 3440001, Hong Kong, China|Investigational Site Number 1560025, Huang Shi, China|Investigational Site Number 1560026, Huanggang, China|Investigational Site Number 1560048, Huizhou, 516001, China|Investigational Site Number 1560034, Huzhou, China|Investigational Site Number 1560005, Jinan, 250013, China|Investigational Site Number 1560052, Jinhua, 321000, China|Investigational Site Number 1560031, Jinzhou, 121000, China|Investigational Site Number 1560022, Nanjing, 210029, China|Investigational Site Number 1560014, Nanjing, China|Investigational Site Number 1560043, Nanjing, China|Investigational Site Number 1560041, Nanning, 530021, China|Investigational Site Number 1560032, Qingdao, 266042, China|Investigational Site Number 1560038, Qinhuangdao, China|Investigational Site Number 1560013, Shanghai, 200072, China|Investigational Site Number 1560007, Shanghai, 200240, China|Investigational Site Number 1560004, Shanghai, 201700, China|Investigational Site Number 1560029, Shanghai, China|Investigational Site Number 1560003, Shenyang, 110022, China|Investigational Site Number 1560054, Shenzhen, 518000, China|Investigational Site Number 1560019, Suzhou, 215006, China|Investigational Site Number 1560059, Suzhou, China|Investigational Site Number 1560021, Tianjin, 300052, China|Investigational Site Number 1560017, Tianjin, 300121, China|Investigational Site Number 1560058, Urumqi, 830000, China|Investigational Site Number 1560018, Wuhan, 430014, China|Investigational Site Number 1560008, Xi'An, 710061, China|Investigational Site Number 1560055, Xi'An, China|Investigational Site Number 1560051, Xingtai, 054031, China|Investigational Site Number 1560030, Xining, 810007, China|Investigational Site Number 1560040, Yanji, 133000, China|Investigational Site Number 1560060, Yueyang, 414000, China|Investigational Site Number 1560046, Yueyang, China|Investigational Site Number 1560045, Zhengzhou, China|Investigational Site Number 1560002, Zhenjiang, 212001, China|Investigational Site Number 1560015, Zhuzhou, 412007, China|Investigational Site Number 1560057, Zigong, 643002, China|Investigational Site Number 4100009, Ansan-Si, 15355, Korea, Republic of|Investigational Site Number 4100012, Busan, 49241, Korea, Republic of|Investigational Site Number 4100010, Guri-Si, Gyeonggi-Do, 11923, Korea, Republic of|Investigational Site Number 4100004, Gwangju, 61469, Korea, Republic of|Investigational Site Number 4100003, Seongnam-Si, 13620, Korea, Republic of|Investigational Site Number 4100016, Seoul, 01832, Korea, Republic of|Investigational Site Number 4100011, Seoul, 03181, Korea, Republic of|Investigational Site Number 4100013, Seoul, 03722, Korea, Republic of|Investigational Site Number 4100001, Seoul, 05278, Korea, Republic of|Investigational Site Number 4100002, Seoul, 08308, Korea, Republic of|Investigational Site Number 4100005, Wonju, 26426, Korea, Republic of|Investigational Site Number 4580001, Kelantan, 16150, Malaysia|Investigational Site Number 4580005, Kuala Lumpur, 56000, Malaysia|Investigational Site Number 4580003, Kuala Lumpur, 59100, Malaysia|Investigational Site Number 4580006, Kuching, 93586, Malaysia|Investigational Site Number 4580002, Putrajaya, Malaysia|Investigational Site Number 4580004, Seremban, 70300, Malaysia|Investigational Site Number 1580003, Taichung, 407, Taiwan|Investigational Site Number 1580005, Tainan Hsien, 710, Taiwan|Investigational Site Number 1580004, Taipei, 11031, Taiwan
URL: https://clinicaltrials.gov/show/NCT03798054

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details