iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)

NCT ID: NCT05413369

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 582 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-07
• Study Completion Date: 2023-10-20

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

Detailed Description

27 weeks

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

iGlarLixi

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.

Group Type: EXPERIMENTAL

Insulin glargine/Lixisenatide

Intervention Type: DRUG

solution, by subcutaneous injection

Metformin

Intervention Type: DRUG

Tablet, orally

SGLT2 inhibitor

Intervention Type: DRUG

Tablet, orally

IDegAsp

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.

Group Type: ACTIVE_COMPARATOR

IDegAsp

Intervention Type: DRUG

solution, by subcutaneous injection

Metformin

Intervention Type: DRUG

Tablet, orally

SGLT2 inhibitor

Intervention Type: DRUG

Tablet, orally

Interventions

Insulin glargine/Lixisenatide

solution, by subcutaneous injection

Intervention Type: DRUG

IDegAsp

solution, by subcutaneous injection

Intervention Type: DRUG

Metformin

Tablet, orally

Intervention Type: DRUG

SGLT2 inhibitor

Tablet, orally

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.
• 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/mm^3 and/or platelets <100 000/mm^3.
• Positive urine pregnancy test in female of childbearing potential.
• Contraindication to metformin and/or SGLT-2 inhibitor use, for those who were taking it prior to the study, according to local labeling, warning/precaution of use (when appropriate) as displayed in the respective National regulation
• Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized
• Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures
• Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals (in conjunction with section 1.61 of the ICH-GCP Ordinance E6)
• Any specific situation during study implementation/course that may raise ethics considerations
• Sensitivity to any of the study interventions (insulin or, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
• Participants who withdrawn consent at randomization or were lost to follow up at randomization visit.

The above information was not intended to contain all considerations relevant to a potential participation in a clinical trial.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number : 1560008

Baotou, , China

Investigational Site Number : 1560001

Beijing, , China

Investigational Site Number : 1560027

Beijing, , China

Investigational Site Number : 1560019

Beijing, , China

Investigational Site Number : 1560023

Cangzhou, , China

Investigational Site Number : 1560059

Changchun, , China

Investigational Site Number : 1560046

Changchun, , China

Investigational Site Number : 1560052

Changde, , China

Investigational Site Number : 1560011

Changsha, , China

Investigational Site Number : 1560054

Chengdu, , China

Investigational Site Number : 1560024

Chengdu, , China

Investigational Site Number : 1560004

Chenzhou, , China

Investigational Site Number : 1560044

Chongqing, , China

Investigational Site Number : 1560053

Dalian, , China

Investigational Site Number : 1560030

Foshan, , China

Investigational Site Number : 1560043

Guangzhou, , China

Investigational Site Number : 1560029

Guangzhou, , China

Investigational Site Number : 1560021

Handan, , China

Investigational Site Number : 1560010

Hangzhou, , China

Investigational Site Number : 1560045

Harbin, , China

Investigational Site Number : 1560025

Harbin, , China

Investigational Site Number : 1560038

Hohhot, , China

Investigational Site Number : 1560056

Huai'an, , China

Investigational Site Number : 1560035

Huanggang, , China

Investigational Site Number : 1560055

Huangshi, , China

Investigational Site Number : 1560022

Huizhou, , China

Investigational Site Number : 1560051

Huzhou, , China

Investigational Site Number : 1560040

Jinan, , China

Investigational Site Number : 1560014

Jinan, , China

Investigational Site Number : 1560058

Jingzhou, , China

Investigational Site Number : 1560041

Kaifeng, , China

Investigational Site Number : 1560039

Lanzhou, , China

Investigational Site Number : 1560060

Lianyungang, , China

Investigational Site Number : 1560031

Luoyang, , China

Investigational Site Number : 1560028

Nanjing, , China

Investigational Site Number : 1560017

Nanjing, , China

Investigational Site Number : 1560018

Nanjing, , China

Investigational Site Number : 1560057

Nantong, , China

Investigational Site Number : 1560037

Pingxiang, , China

Investigational Site Number : 1560048

Qingdao, , China

Investigational Site Number : 1560012

Qinhuangdao, , China

Investigational Site Number : 1560003

Shanghai, , China

Investigational Site Number : 1560020

Shanghai, , China

Investigational Site Number : 1560007

Shanghai, , China

Investigational Site Number : 1560006

Shanghai, , China

Investigational Site Number : 1560009

Shenyang, , China

Investigational Site Number : 1560050

Suzhou, , China

Investigational Site Number : 1560016

Tianjin, , China

Investigational Site Number : 1560013

Tianjin, , China

Investigational Site Number : 1560047

Tonghua, , China

Investigational Site Number : 1560042

Xingtai, , China

Investigational Site Number : 1560015

Xuzhou, , China

Investigational Site Number : 1560033

Yueyang, , China

Investigational Site Number : 1560032

Yueyang, , China

Investigational Site Number : 1560026

Yuncheng, , China

Investigational Site Number : 1560049

Zhengzhou, , China

Investigational Site Number : 1560034

Zhenjiang, , China

Investigational Site Number : 1560036

Zhongshan, , China

Investigational Site Number : 1560005

Zhuzhou, , China

Investigational Site Number : 1560002

Zigong, , China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://sanofi.trialsummaries.com/Study/StudyDetails?id=25298&tenant=MT_SNY_9011

LPS17396 Plain Language Results Summary

Other Identifiers

U1111-1267-2772

Identifier Type: REGISTRY

Identifier Source: secondary_id

LPS17396

Identifier Type: -

Identifier Source: org_study_id