Comparison of the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine in Patients With Type 2 Diabetes Insufficiently Controlled on Basal Insulin
NCT ID: NCT03798080
Last Updated: 2022-07-19
Study Results
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Basic Information
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COMPLETED
PHASE3
426 participants
INTERVENTIONAL
2019-02-19
2020-12-01
Brief Summary
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To demonstrate the superiority of iGlarLixi (fixed ratio combination of insulin glargine and lixisenatide) to insulin glargine on glycemic control as assessed by glycated hemoglobin A1c (HbA1c) change in patients with type 2 diabetes mellitus (T2DM) who are not sufficiently controlled with basal insulin.
Secondary Objectives:
* To assess the effects of iGlarLixi in comparison with insulin glargine
* 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 with or without metformin for 30 weeks
Insulin glargine/Lixisenatide (HOE901/AVE0010)
Pharmaceutical form: solution
Route of administration: subcutaneous
Metformin
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 with or without metformin for 30 weeks
Insulin glargine (HOE901)
Pharmaceutical form: solution
Route of administration: subcutaneous
Metformin
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
Metformin
Pharmaceutical form: tablet
Route of administration: oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who have been treated with a stable basal insulin regimen (ie, type of insulin and time/frequency of the injection), for at least 3 months before screening visit (V1).
* Stable total daily basal insulin dose (±20 %) in the range of 10 and 25 U/day for at least 2 months before screening visit (V1). Total daily dose should be within the range of 10-25 U, both inclusive, on the day of screening, but individual fluctuations of ±20% within 2 months prior to screening are acceptable.
* For patients receiving basal insulin AND 1 or 2 oral anti-diabetic drugs (OADs): the OAD dose(s) must be stable during the 3 months prior to screening. The OAD(s) can be 1 to 2 out of:
* Metformin (≥1500 mg/day or maximal tolerated dose).
* Sulfonylurea (SU)/glinide.
* Alpha-glucosidase inhibitor (alpha-GI).
* Sodium-glucose co-transporter 2 (SGLT2) inhibitor.
* Dipeptidyl-peptidase-4 (DPP-4) inhibitor.
* Fasting plasma glucose (FPG) ≤160 mg/dL (8.9 mmol/L) at screening visit (V1) (can be repeated once to confirm).
* Signed written informed consent.
* Previous use of insulin regimen other than basal insulin, eg, prandial or pre-mixed insulin, within one year prior to screening (Note: Short term treatment \[≤10 days\] due to intercurrent illness is allowed).
* History of discontinuation of a previous treatment with glucagon-like-peptide-1 receptor agonists (GLP-1 RAs) due to safety/tolerability reason 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 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 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:
* 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 test for hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody (HCAb).
* Positive urine pregnancy test in female of childbearing potential.
* For patient not treated with metformin at screening: severe renal function impairment with an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2 or end-stage renal disease.
* Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (ie, worsening) or not controlled (ie, prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening visit; or history of surgery affecting gastric emptying.
* 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).
* Mean fasting self-monitored plasma glucose (SMPG) is \>160 mg/dL (8.9 mmol/L), calculated from all available (minimum of 4 self-measurements) values during the 7 days prior to randomization.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion Criteria
* Screening glycated hemoglobin A1c(HbA1c) \<7.0% or \>10.5%.
* History of hypoglycemia unawareness.
* History of metabolic acidosis, including diabetic ketoacidosis within one 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 1560044
Baotou, , China
Investigational Site Number 1560001
Beijing, , China
Investigational Site Number 1560039
Beijing, , China
Investigational Site Number 1560005
Changchun, , China
Investigational Site Number 1560054
Changchun, , China
Investigational Site Number 1560015
Changsha, , China
Investigational Site Number 1560010
Chenzhou, , China
Investigational Site Number 1560030
Chongqing, , China
Investigational Site Number 1560025
Fuzhou, , China
Investigational Site Number 1560016
Guangzhou, , China
Investigational Site Number 1560053
Guangzhou, , China
Investigational Site Number 1560045
Guangzhou, , China
Investigational Site Number 1560021
Hefei, , China
Investigational Site Number 1560018
Hohhot, , China
Investigational Site Number 1560019
Huanggang, , China
Investigational Site Number 1560041
Jiaxing, , China
Investigational Site Number 1560040
Jinan, , China
Investigational Site Number 1560007
Jinan, , China
Investigational Site Number 1560026
Jinzhou, , China
Investigational Site Number 1560042
Kaifeng, , China
Investigational Site Number 1560003
Kunming, , China
Investigational Site Number 1560032
Lanzhou, , China
Investigational Site Number 1560033
Luoyang, , China
Investigational Site Number 1560028
Nanjing, , China
Investigational Site Number 1560013
Nanjing, , China
Investigational Site Number 1560017
Nanjing, , China
Investigational Site Number 1560035
Nanjing, , China
Investigational Site Number 1560038
Nanjing, , China
Investigational Site Number 1560046
Nantong, , China
Investigational Site Number 1560008
Pingxiang, , China
Investigational Site Number 1560037
Qingdao, , China
Investigational Site Number 1560031
Qinhuangdao, , China
Investigational Site Number 1560011
Shanghai, , China
Investigational Site Number 1560002
Shanghai, , China
Investigational Site Number 1560027
Shanghai, , China
Investigational Site Number 1560047
Shanghai, , China
Investigational Site Number 1560012
Shenyang, , China
Investigational Site Number 1560006
Tianjin, , China
Investigational Site Number 1560049
Ürümqi, , China
Investigational Site Number 1560020
Xining, , China
Investigational Site Number 1560050
Xining, , China
Investigational Site Number 1560036
Xuzhou, , China
Investigational Site Number 1560023
Yangzhou, , China
Investigational Site Number 1560022
Zhuzhou, , China
Investigational Site Number 1560052
Zigong, , China
Countries
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References
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Yuan X, Guo X, Zhang J, Dong X, Lu Y, Pang W, Gu S, Niemoeller E, Ping L, Nian G, Souhami E; LixiLan-L-CN investigators. Improved glycaemic control and weight benefit with iGlarLixi versus insulin glargine 100 U/mL in Chinese people with type 2 diabetes advancing their therapy from basal insulin plus oral antihyperglycaemic drugs: Results from the LixiLan-L-CN randomized controlled trial. Diabetes Obes Metab. 2022 Nov;24(11):2182-2191. doi: 10.1111/dom.14803. Epub 2022 Jul 25.
Yuan X, Li D, Wang K, Lauand F, Zhang M, Fang H, Du Q, Kang L, Alvarez A, Guo X. iGlarLixi effectively reduces residual hyperglycaemia in Chinese people with type 2 diabetes on basal insulin: A post hoc analysis of the LixiLan-L-CN study. Diabetes Obes Metab. 2024 Dec;26(12):5942-5949. doi: 10.1111/dom.15968. Epub 2024 Oct 3.
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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U1111-1190-7781
Identifier Type: OTHER
Identifier Source: secondary_id
EFC14944
Identifier Type: -
Identifier Source: org_study_id
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