Evaluation of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Patients With Type 2 Diabetes Insufficiently Controlled With Oral Antidiabetic Drug(s)
NCT ID: NCT03798054
Last Updated: 2022-07-19
Study Results
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Basic Information
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COMPLETED
PHASE3
878 participants
INTERVENTIONAL
2019-02-15
2021-03-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Soliqua (insulin glargine/lixisenatide)
iGlarLixi (insulin glargine/lixisenatide) will be self-administered subcutaneously once daily in the morning on top of metformin for 24 weeks.
Insulin glargine/Lixisenatide (HOE901/AVE0010)
Pharmaceutical form: solution
Route of administration: subcutaneous
Metformin
Pharmaceutical form: tablet
Route of administration: oral
SGLT2 inhibitor
Pharmaceutical form:tablet
Route of administration: oral
Lantus (insulin glargine)
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.
Insulin glargine (HOE901)
Pharmaceutical form: solution
Route of administration: subcutaneous
Metformin
Pharmaceutical form: tablet
Route of administration: oral
SGLT2 inhibitor
Pharmaceutical form:tablet
Route of administration: oral
Lyxumia (lixisenatide)
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.
Lixisenatide (AVE0010)
Pharmaceutical form: solution
Route of administration: subcutaneous
Metformin
Pharmaceutical form: tablet
Route of administration: oral
SGLT2 inhibitor
Pharmaceutical form:tablet
Route of administration: oral
Interventions
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Insulin glargine/Lixisenatide (HOE901/AVE0010)
Pharmaceutical form: solution
Route of administration: subcutaneous
Insulin glargine (HOE901)
Pharmaceutical form: solution
Route of administration: subcutaneous
Lixisenatide (AVE0010)
Pharmaceutical form: solution
Route of administration: subcutaneous
Metformin
Pharmaceutical form: tablet
Route of administration: oral
SGLT2 inhibitor
Pharmaceutical form:tablet
Route of administration: oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed written informed consent.
* Previous treatment with insulin (except for short-term treatment due to intercurrent illness at the discretion of the Investigator) within 1 year prior to screening.
* History of discontinuation of a previous treatment with glucagon-like-peptide-1 receptor agonists (GLP-1 RAs) due to safety/tolerability reasons or lack of efficacy.
* Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1 week or more within 3 months prior to screening.
* Use of weight loss drugs within 3 months prior to screening.
* Use of any investigational drug other than specified in this protocol within 1 month or 5 half-lives, whichever is longer, prior to screening.
* Within 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization.
* Planned coronary, carotid, or peripheral artery revascularization procedures to be performed during the study period.
* Known history of drug or alcohol abuse within 6 months prior to screening.
* Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic blood pressure \>180 mmHg or diastolic blood pressure \>95 mmHg.
* Laboratory findings at screening visit (V1):
* Amylase and/or lipase \>3 times the upper limit of normal (ULN) laboratory range.
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 ULN.
* Total bilirubin \>1.5 ULN (except in case of Gilbert's syndrome).
* Calcitonin ≥20 pg/mL (5.9 pmol/L).
* Hemoglobin \<10.5 g/dL and/or neutrophils \<1500/mm3 and/or platelets \<100 000/mm3.
* Positive urine pregnancy test in female of childbearing potential.
* Patient who has a severe renal function impairment with an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2 or end-stage renal disease.
* History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy.
* Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes).
* Use of SU, glinide, alpha-GI, DPP-4 inhibitor, and SGLT-2 inhibitor after start of run-in (from V2 \[Week -4\]).
* HbA1c at V4 (Week -1) : \<7.0% or \>10%.
* Fasting plasma glucose \>250 mg/dL (13.9 mmol/L) at V4 (Week-1) (can be repeated once to confirm).
* Metformin maximal tolerated dose \<1500 mg/day.
* Amylase and/or lipase \>3 ULN at V4 (Week-1).
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion Criteria
* Body mass index (BMI) \>40 kg/m² at screening.
* Glycated hemoglobin A1c (HbA1c) at screening visit:
* \<7.5% or \>11% for patients previously treated with metformin alone;
* \<7.0% or \>10% for patients previously treated with metformin and a second oral antidiabetic treatment.
* History of hypoglycemia unawareness.
* History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 1560001
Beijing, , China
Investigational Site Number 1560006
Beijing, , China
Investigational Site Number 1560049
Beijing, , China
Investigational Site Number 1560039
Cangzhou, , China
Investigational Site Number 1560009
Changchun, , China
Investigational Site Number 1560027
Changchun, , China
Investigational Site Number 1560016
Changsha, , China
Investigational Site Number 1560053
Chengdu, , China
Investigational Site Number 1560056
Chengdu, , China
Investigational Site Number 1560010
Chenzhou, , China
Investigational Site Number 1560037
Chongqing, , China
Investigational Site Number 1560050
Chongqing, , China
Investigational Site Number 1560044
Dongguan, , China
Investigational Site Number 1560033
Guangzhou, , China
Investigational Site Number 1560028
Guangzhou, , China
Investigational Site Number 1560012
Handan, , China
Investigational Site Number 1560023
Hangzhou, , 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 3440001
Hong Kong, , China
Investigational Site Number 1560026
Huanggang, , China
Investigational Site Number 1560025
Huangshi, , China
Investigational Site Number 1560048
Huizhou, , China
Investigational Site Number 1560034
Huzhou, , China
Investigational Site Number 1560005
Jinan, , China
Investigational Site Number 1560052
Jinhua, , China
Investigational Site Number 1560031
Jinzhou, , China
Investigational Site Number 1560022
Nanjing, , China
Investigational Site Number 1560014
Nanjing, , China
Investigational Site Number 1560043
Nanjing, , China
Investigational Site Number 1560041
Nanning, , China
Investigational Site Number 1560032
Qingdao, , China
Investigational Site Number 1560038
Qinhuangdao, , China
Investigational Site Number 1560013
Shanghai, , China
Investigational Site Number 1560007
Shanghai, , China
Investigational Site Number 1560004
Shanghai, , China
Investigational Site Number 1560029
Shanghai, , China
Investigational Site Number 1560003
Shenyang, , China
Investigational Site Number 1560054
Shenzhen, , China
Investigational Site Number 1560019
Suzhou, , China
Investigational Site Number 1560059
Suzhou, , China
Investigational Site Number 1560021
Tianjin, , China
Investigational Site Number 1560017
Tianjin, , China
Investigational Site Number 1560058
Ürümqi, , China
Investigational Site Number 1560018
Wuhan, , China
Investigational Site Number 1560008
Xi'an, , China
Investigational Site Number 1560055
Xi'an, , China
Investigational Site Number 1560051
Xingtai, , China
Investigational Site Number 1560030
Xining, , China
Investigational Site Number 1560040
Yanji, , China
Investigational Site Number 1560060
Yueyang, , China
Investigational Site Number 1560046
Yueyang, , China
Investigational Site Number 1560045
Zhengzhou, , China
Investigational Site Number 1560002
Zhenjiang, , China
Investigational Site Number 1560015
Zhuzhou, , China
Investigational Site Number 1560057
Zigong, , China
Investigational Site Number 4580001
Kelantan, , Malaysia
Investigational Site Number 4580005
Kuala Lumpur, , Malaysia
Investigational Site Number 4580003
Kuala Lumpur, , Malaysia
Investigational Site Number 4580006
Kuching, , Malaysia
Investigational Site Number 4580002
Putrajaya, , Malaysia
Investigational Site Number 4580004
Seremban, , Malaysia
Investigational Site Number 4100009
Ansan-si, , South Korea
Investigational Site Number 4100012
Busan, , South Korea
Investigational Site Number 4100010
Guri-Si, Gyeonggi-Do, , South Korea
Investigational Site Number 4100004
Gwangju, , South Korea
Investigational Site Number 4100003
Seongnam-si, , South Korea
Investigational Site Number 4100016
Seoul, , South Korea
Investigational Site Number 4100011
Seoul, , South Korea
Investigational Site Number 4100013
Seoul, , South Korea
Investigational Site Number 4100001
Seoul, , South Korea
Investigational Site Number 4100002
Seoul, , South Korea
Investigational Site Number 4100005
Wŏnju, , South Korea
Investigational Site Number 1580003
Taichung, , Taiwan
Investigational Site Number 1580005
Tainan Hsien, , Taiwan
Investigational Site Number 1580004
Taipei, , Taiwan
Countries
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References
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Yang W, Dong X, Li Q, Cheng Z, Yuan G, Liu M, Xiao J, Gu S, Niemoeller E, Chen L, Ping L, Souhami E; LixiLan-O-AP trial investigators. Efficacy and safety benefits of iGlarLixi versus insulin glargine 100 U/mL or lixisenatide in Asian Pacific people with suboptimally controlled type 2 diabetes on oral agents: The LixiLan-O-AP randomized controlled trial. Diabetes Obes Metab. 2022 Aug;24(8):1522-1533. doi: 10.1111/dom.14722. Epub 2022 May 12.
Guo X, Yang W, Zhang J, Dong X, Liu M, Gu S, Lauand F, Li L, Huang Q, Kang L, Souhami E. iGlarLixi provides a higher derived time-in-range versus insulin glargine 100 U/mL or lixisenatide in Asian Pacific people with type 2 diabetes: A post hoc analysis. Diabetes Obes Metab. 2023 Jul;25(7):2005-2011. doi: 10.1111/dom.15074. Epub 2023 May 3.
Other Identifiers
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U1111-1190-7669
Identifier Type: OTHER
Identifier Source: secondary_id
EFC14943
Identifier Type: -
Identifier Source: org_study_id
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