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COMPLETEDPHASE3

iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)

A Randomized, 24 Weeks, Active-controlled, Open-label, 2-arm Multicenter Study Comparing the Efficacy and Safety of iGlarLixi to IDegAsp in Chinese Type 2 Diabetes Mellitus Participants Insufficiently Controlled With Oral Antidiabetic Drug(s)

NCT05413369•Sanofi

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+19 more criteria

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.

Locations (60)

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

Key Dates

Start Date

July 7, 2022

Primary Completion Date

October 20, 2023

Completion Date

October 20, 2023

Last Updated

September 24, 2025

Enrollment

582

ACTUAL participants

Conditions

Type 2 Diabetes Mellitus

Interventions

Insulin glargine/Lixisenatide

DRUG

IDegAsp

DRUG

Metformin

DRUG

SGLT2 inhibitor

DRUG

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Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Achieving Routine Intervention and Screening for Emotional Health

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