iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)

NCT05413369 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: LPS17396U1111-1267-2772
• Study Type: interventional
• Target: 582
• Locations: 1 country
• Sites: 60

Brief Summary

This was a parallel-group treatment, Phase 3, randomized, 2-arm study that assessed the efficacy and safety of iGlarLixi to IDegAsp in Chinese T2DM participants insufficiently controlled with oral antidiabetic drug(s). Study details included:

• Study duration per participant: approximately up to 27 weeks
• Treatment duration: 24 weeks
• Visit frequency: after screening (an on-site visit), on-site or phone call visit every 1 week from randomization till Week 4, every 2 weeks till week 12 and then every 3 weeks till Week 24 (End of Treatment). There were 14 visits that included 7 phone calls and 7 on-site visits in total during screening and treatment periods. There was a safety follow-up by a phone call visit (End of Study) in 3 days after the last dose of the treatment.
• Health measurement/Observation: change in HbA1c as the primary endpoint.
• Intervention name: iGlarLixi and IDegAsp
• Participant sex: male and female
• Participant age range: adults at least 18 years of age
• Condition/disease: Type 2 diabetes mellitus

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c From Baseline to Week 24: Non-Inferiority Analysis

  Blood samples were collected at indicated timepoints for analysis of HbA1c. Baseline was defined as the last available pre-dose assessment (on or before Day 1).

  Baseline, Week 24

Secondary Outcomes (18)

• Change in HbA1c From Baseline to Week 24: Superiority Analysis

  Baseline, Week 24

• Change in Body Weight From Baseline to Week 24

  Baseline, Week 24

• Percentage of Participants Reaching HbA1c <7% at Week 24

  Week 24

• Percentage of Participants Reaching HbA1c <7% With no Body Weight Gain at Week 24

  Week 24

• Percentage of Participants Reaching HbA1c <7% With no Body Weight Gain at Week 24 and no Hypoglycemia During 24-Week Treatment Period

  Baseline up to Week 24

Study Arms (2)

iGlarLixi

EXPERIMENTAL

Participants self-administered iGlarLixi (100 units per milliliter \[U/mL\] insulin glargine + 100 or 50 microgram \[mcg\]/mL lixisenatide respectively) subcutaneous (SC) injection once daily on top of metformin +/- sodium-glucose co-transporter 2 inhibitor (SGLT-2i) for 24 weeks. Dose was individually adjusted.

Drug: Insulin glargine/Lixisenatide; Drug: Metformin; Drug: SGLT2 inhibitor

IDegAsp

ACTIVE COMPARATOR

Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.

Drug: IDegAsp; Drug: Metformin; Drug: SGLT2 inhibitor

Interventions

Insulin glargine/Lixisenatide DRUG

solution, by subcutaneous injection

iGlarLixi

IDegAsp DRUG

solution, by subcutaneous injection

IDegAsp

Metformin DRUG

Tablet, orally

IDegAsp; iGlarLixi

SGLT2 inhibitor DRUG

Tablet, orally

IDegAsp; iGlarLixi

Eligibility Criteria

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

You may qualify if:

• Participant had at least 18 of age inclusive, at the time of signing the informed consent.
• Participants who were diagnosed with T2DM for at least 1 year before the screening visit
• Participants who were treated for at least 3 months prior to the screening visit with a stable dose of metformin (at least 1000 mg/day or the maximum tolerated dose) alone or in combination with a second oral antidiabetic treatment that can be a sulfonylurea (SU), a glinide, an alpha-glucosidase inhibitor (alpha-GI), a dipeptidyl-peptidase-4 (DPP-4) inhibitor or a sodium-glucose co-transporter 2 (SGLT-2) inhibitor
• HbA1c at screening visit:
• between 7.5% and 11%, both inclusive, for participants previously treated with metformin alone or + SGLT-2 inhibitor, or
• between 7.0% and 10%, both inclusive, for participants previously treated with metformin + a second oral antidiabetic treatment other than SGLT-2 inhibitor.
• Participants who were overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
• Body mass index (BMI) \<40 kg/m² at screening
• Male or female, including females of childbearing potential who agreed to use contraception during the study duration
• Participants were capable of giving signed informed consent as described in Appendix 1 of the protocol which included compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

You may not qualify if:

• Participant who had a severe renal function impairment with an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m²
• Pregnant or breast-feeding woman.
• Woman of childbearing potential not protected by highly effective contraceptive method of birth control and/or who is unwilling or unable to be tested for pregnancy
• Conditions/situations such as:
• Participant with short life expectancy.
• Participant with conditions/concomitant diseases making him/her not evaluable for the primary efficacy endpoint (eg, hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within 3 months prior to screening).
• Participant with conditions/concomitant diseases precluding his/her safe participation in this study (eg, active malignant tumor, major systemic diseases, presence of clinically significant diabetic retinopathy or presence of macular edema likely to require laser treatment within the study period).
• Uncooperative or any condition that could make the participant potentially non-compliant to the study procedures (e.g., participant unable or unwilling to do self-injections or blood glucose monitoring using the Sponsor-provided blood glucometer at home).
• Previous treatment with insulin (except for short-term treatment ≤14 days due to intercurrent illness at the discretion of the Investigator) within 1 year prior to screening.
• 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.
• History of discontinuation of a previous treatment with GLP-1 RAs due to safety/tolerability reasons or lack of efficacy.
• Use of any investigational drug other than specified in this protocol within 1 month or 5 half-lives, whichever is longer, prior to screening.
• Laboratory findings tested at the screening visit:
• Amylase and/or lipase \>3 times the upper limit of normal (ULN) laboratory range.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (60)

Investigational Site Number : 1560008

Baotou, 014010, China

Location

Investigational Site Number : 1560001

Beijing, 100853, China

Location

Investigational Site Number : 1560027

Beijing, 101200, China

Location

Investigational Site Number : 1560019

Beijing, China

Location

Investigational Site Number : 1560023

Cangzhou, 061000, China

Location

Investigational Site Number : 1560059

Changchun, 130021, China

Location

Investigational Site Number : 1560046

Changchun, 130041, China

Location

Investigational Site Number : 1560052

Changde, 415000, China

Location

Investigational Site Number : 1560011

Changsha, 410013, China

Location

Investigational Site Number : 1560054

Chengdu, 610081, China

Location

Investigational Site Number : 1560024

Chengdu, 611130, China

Location

Investigational Site Number : 1560004

Chenzhou, China

Location

Investigational Site Number : 1560044

Chongqing, 400010, China

Location

Investigational Site Number : 1560053

Dalian, 116011, China

Location

Investigational Site Number : 1560030

Foshan, 528399, China

Location

Investigational Site Number : 1560043

Guangzhou, 510080, China

Location

Investigational Site Number : 1560029

Guangzhou, 510150, China

Location

Investigational Site Number : 1560021

Handan, 056002, China

Location

Investigational Site Number : 1560010

Hangzhou, 310014, China

Location

Investigational Site Number : 1560045

Harbin, 150001, China

Location

Investigational Site Number : 1560025

Harbin, China

Location

Investigational Site Number : 1560038

Hohhot, China

Location

Investigational Site Number : 1560056

Huai'an, 223300, China

Location

Investigational Site Number : 1560035

Huanggang, 438000, China

Location

Investigational Site Number : 1560055

Huangshi, 435000, China

Location

Investigational Site Number : 1560022

Huizhou, 516001, China

Location

Investigational Site Number : 1560051

Huzhou, China

Location

Investigational Site Number : 1560040

Jinan, 250012, China

Location

Investigational Site Number : 1560014

Jinan, 250013, China

Location

Investigational Site Number : 1560058

Jingzhou, 434020, China

Location

Investigational Site Number : 1560041

Kaifeng, China

Location

Investigational Site Number : 1560039

Lanzhou, 730000, China

Location

Investigational Site Number : 1560060

Lianyungang, 222002, China

Location

Investigational Site Number : 1560031

Luoyang, 471003, China

Location

Investigational Site Number : 1560028

Nanjing, 210011, China

Location

Investigational Site Number : 1560017

Nanjing, China

Location

Investigational Site Number : 1560018

Nanjing, China

Location

Investigational Site Number : 1560057

Nantong, 226001, China

Location

Investigational Site Number : 1560037

Pingxiang, 337055, China

Location

Investigational Site Number : 1560048

Qingdao, 266042, China

Location

Investigational Site Number : 1560012

Qinhuangdao, China

Location

Investigational Site Number : 1560003

Shanghai, 200040, China

Location

Investigational Site Number : 1560020

Shanghai, 200040, China

Location

Investigational Site Number : 1560007

Shanghai, 201700, China

Location

Investigational Site Number : 1560006

Shanghai, China

Location

Investigational Site Number : 1560009

Shenyang, 110004, China

Location

Investigational Site Number : 1560050

Suzhou, China

Location

Investigational Site Number : 1560016

Tianjin, 300052, China

Location

Investigational Site Number : 1560013

Tianjin, 300121, China

Location

Investigational Site Number : 1560047

Tonghua, 130000, China

Location

Investigational Site Number : 1560042

Xingtai, 054031, China

Location

Investigational Site Number : 1560015

Xuzhou, China

Location

Investigational Site Number : 1560033

Yueyang, 414000, China

Location

Investigational Site Number : 1560032

Yueyang, China

Location

Investigational Site Number : 1560026

Yuncheng, 044000, China

Location

Investigational Site Number : 1560049

Zhengzhou, China

Location

Investigational Site Number : 1560034

Zhenjiang, 212001, China

Location

Investigational Site Number : 1560036

Zhongshan, China

Location

Investigational Site Number : 1560005

Zhuzhou, 412007, China

Location

Investigational Site Number : 1560002

Zigong, 643002, China

Location

Related Links

• LPS17396 Plain Language Results Summary

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; lixisenatide; Metformin; Sodium-Glucose Transporter 2 Inhibitors

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; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi aventis recherche & développement

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: June 7, 2022
• First Posted: June 10, 2022
• Study Start: July 7, 2022
• Primary Completion: October 20, 2023
• Study Completion: October 20, 2023
• Last Updated: September 24, 2025
• Results First Posted: October 30, 2024

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (60)