New combo shot may beat standard insulin for diabetes control

NCT ID NCT05413369

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested two injectable diabetes drugs in 582 Chinese adults whose blood sugar was not well controlled with oral medications. One group received iGlarLixi (a mix of insulin and another drug), and the other received IDegAsp (a different insulin mix). The main goal was to see which one lowered blood sugar more over 24 weeks. Results could help doctors choose the best treatment for similar patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Insulin glargine/lixisenatide (iGlarLixi) and insulin degludec/aspart (IDegAsp)
What this could lead to: If iGlarLixi works better than IDegAsp, it could offer a new treatment option for people with type 2 diabetes who need better blood sugar control.
What could go wrong: This is a completed Phase 3 trial, so results are known. However, it only lasted 24 weeks and focused on Chinese participants, so benefits may not apply to other groups or long-term use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

582 people

The number who actually took part.

Started

Jul 2022

Finished

Oct 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. 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. * Use of oral or injectable glucose-lowering agents other than those stated in the inclusion criteria within 3 months 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. * 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.

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 2 diabetes mellitus

Contacts and locations

Locations

Investigational Site Number : 1560001

Beijing, 100853, China
Investigational Site Number : 1560002

Zigong, 643002, China
Investigational Site Number : 1560003

Shanghai, 200040, China
Investigational Site Number : 1560004

Chenzhou, China
Investigational Site Number : 1560005

Zhuzhou, 412007, China
Investigational Site Number : 1560006

Shanghai, China
Investigational Site Number : 1560007

Shanghai, 201700, China
Investigational Site Number : 1560008

Baotou, 014010, China
Investigational Site Number : 1560009

Shenyang, 110004, China
Investigational Site Number : 1560010

Hangzhou, 310014, China
Investigational Site Number : 1560011

Changsha, 410013, China
Investigational Site Number : 1560012

Qinhuangdao, China
Investigational Site Number : 1560013

Tianjin, 300121, China
Investigational Site Number : 1560014

Jinan, 250013, China
Investigational Site Number : 1560015

Xuzhou, China
Investigational Site Number : 1560016

Tianjin, 300052, China
Investigational Site Number : 1560017

Nanjing, China
Investigational Site Number : 1560018

Nanjing, China
Investigational Site Number : 1560019

Beijing, China
Investigational Site Number : 1560020

Shanghai, 200040, China
Investigational Site Number : 1560021

Handan, 056002, China
Investigational Site Number : 1560022

Huizhou, 516001, China
Investigational Site Number : 1560023

Cangzhou, 061000, China
Investigational Site Number : 1560024

Chengdu, 611130, China
Investigational Site Number : 1560025

Harbin, China
Investigational Site Number : 1560026

Yuncheng, 044000, China
Investigational Site Number : 1560027

Beijing, 101200, China
Investigational Site Number : 1560028

Nanjing, 210011, China
Investigational Site Number : 1560029

Guangzhou, 510150, China
Investigational Site Number : 1560030

Foshan, 528399, China
Investigational Site Number : 1560031

Luoyang, 471003, China
Investigational Site Number : 1560032

Yueyang, China
Investigational Site Number : 1560033

Yueyang, 414000, China
Investigational Site Number : 1560034

Zhenjiang, 212001, China
Investigational Site Number : 1560035

Huanggang, 438000, China
Investigational Site Number : 1560036

Zhongshan, China
Investigational Site Number : 1560037

Pingxiang, 337055, China
Investigational Site Number : 1560038

Hohhot, China
Investigational Site Number : 1560039

Lanzhou, 730000, China
Investigational Site Number : 1560040

Jinan, 250012, China
Investigational Site Number : 1560041

Kaifeng, China
Investigational Site Number : 1560042

Xingtai, 054031, China
Investigational Site Number : 1560043

Guangzhou, 510080, China
Investigational Site Number : 1560044

Chongqing, 400010, China
Investigational Site Number : 1560045

Harbin, 150001, China
Investigational Site Number : 1560046

Changchun, 130041, China
Investigational Site Number : 1560047

Tonghua, 130000, China
Investigational Site Number : 1560048

Qingdao, 266042, China
Investigational Site Number : 1560049

Zhengzhou, China
Investigational Site Number : 1560050

Suzhou, China
Investigational Site Number : 1560051

Huzhou, China
Investigational Site Number : 1560052

Changde, 415000, China
Investigational Site Number : 1560053

Dalian, 116011, China
Investigational Site Number : 1560054

Chengdu, 610081, China
Investigational Site Number : 1560055

Huangshi, 435000, China
Investigational Site Number : 1560056

Huai'an, 223300, China
Investigational Site Number : 1560057

Nantong, 226001, China
Investigational Site Number : 1560058

Jingzhou, 434020, China
Investigational Site Number : 1560059

Changchun, 130021, China
Investigational Site Number : 1560060

Lianyungang, 222002, China

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