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

NCT03798080 | Completed Phase 3

• 2 other identifiers: EFC14944U1111-1190-7781
• Study Type: interventional
• Target: 426
• Locations: 1 country
• Sites: 45

Brief Summary

Primary Objective: 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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Change in glycated hemoglobin (HbA1c) from baseline to Week 30

  From Baseline to Week 30

Secondary Outcomes (12)

• Patients with HbA1c <7.0%

  At Week 30

• Patients with HbA1c ≤ 6.5%

  At Week 30

• Change in postprandial plasma glucose (PPG)

  From Baseline to Week 30

• Change in self-monitored plasma glucose (SMPG) profile

  From Baseline to Week 30

• Patients with HbA1c <7.0% with no body weight gain

  At Week 30

Study Arms (2)

Soliqua (insulin glargine/lixisenatide)

EXPERIMENTAL

iGlarLixi (insulin glargine/lixisenatide) will be self-administered subcutaneously once daily in the morning with or without metformin for 30 weeks

Drug: Insulin glargine/Lixisenatide (HOE901/AVE0010); Drug: Metformin

Lantus (insulin glargine)

ACTIVE COMPARATOR

Insulin glargine will be self-administered subcutaneously once daily at any time of the day with or without metformin for 30 weeks

Drug: Insulin glargine (HOE901); Drug: Metformin

Interventions

Insulin glargine/Lixisenatide (HOE901/AVE0010) DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Also known as: Soliqua, iGlarLixi

Soliqua (insulin glargine/lixisenatide)

Insulin glargine (HOE901) DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Also known as: Lantus

Lantus (insulin glargine)

Metformin DRUG

Pharmaceutical form: tablet Route of administration: oral

Lantus (insulin glargine); Soliqua (insulin glargine/lixisenatide)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year and treated with basal insulin for at least 6 months before screening visit (V1).
• 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.

You may not qualify if:

• Age \<18 years at screening visit (V1).
• 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.
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (45)

Investigational Site Number 1560044

Baotou, 014010, China

Location

Investigational Site Number 1560001

Beijing, 100034, China

Location

Investigational Site Number 1560039

Beijing, 102218, China

Location

Investigational Site Number 1560005

Changchun, 130033, China

Location

Investigational Site Number 1560054

Changchun, 130041, China

Location

Investigational Site Number 1560015

Changsha, 410013, China

Location

Investigational Site Number 1560010

Chenzhou, China

Location

Investigational Site Number 1560030

Chongqing, 400010, China

Location

Investigational Site Number 1560025

Fuzhou, 354200, China

Location

Investigational Site Number 1560016

Guangzhou, 510080, China

Location

Investigational Site Number 1560053

Guangzhou, 510080, China

Location

Investigational Site Number 1560045

Guangzhou, 510515, China

Location

Investigational Site Number 1560021

Hefei, 230022, China

Location

Investigational Site Number 1560018

Hohhot, 010017, China

Location

Investigational Site Number 1560019

Huanggang, China

Location

Investigational Site Number 1560041

Jiaxing, China

Location

Investigational Site Number 1560040

Jinan, 250000, China

Location

Investigational Site Number 1560007

Jinan, 250013, China

Location

Investigational Site Number 1560026

Jinzhou, 121000, China

Location

Investigational Site Number 1560042

Kaifeng, 475000, China

Location

Investigational Site Number 1560003

Kunming, 650032, China

Location

Investigational Site Number 1560032

Lanzhou, 730000, China

Location

Investigational Site Number 1560033

Luoyang, China

Location

Investigational Site Number 1560028

Nanjing, 210008, China

Location

Investigational Site Number 1560013

Nanjing, 210011, China

Location

Investigational Site Number 1560017

Nanjing, 210029, China

Location

Investigational Site Number 1560035

Nanjing, China

Location

Investigational Site Number 1560038

Nanjing, China

Location

Investigational Site Number 1560046

Nantong, 226001, China

Location

Investigational Site Number 1560008

Pingxiang, 337055, China

Location

Investigational Site Number 1560037

Qingdao, 266003, China

Location

Investigational Site Number 1560031

Qinhuangdao, China

Location

Investigational Site Number 1560011

Shanghai, 200240, China

Location

Investigational Site Number 1560002

Shanghai, 201700, China

Location

Investigational Site Number 1560027

Shanghai, China

Location

Investigational Site Number 1560047

Shanghai, China

Location

Investigational Site Number 1560012

Shenyang, 110004, China

Location

Investigational Site Number 1560006

Tianjin, 300121, China

Location

Investigational Site Number 1560049

Ürümqi, 830000, China

Location

Investigational Site Number 1560020

Xining, 810007, China

Location

Investigational Site Number 1560050

Xining, 810016, China

Location

Investigational Site Number 1560036

Xuzhou, China

Location

Investigational Site Number 1560023

Yangzhou, 225001, China

Location

Investigational Site Number 1560022

Zhuzhou, 412007, China

Location

Investigational Site Number 1560052

Zigong, 643002, China

Location

Related Publications (3)

• 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.

  PMID: 35762489 BACKGROUND

• 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.

  PMID: 39360440 DERIVED

• 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.

  PMID: 36999231 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; lixisenatide; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 9, 2019
• Study Start: February 19, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (45)