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New insulin combo aims to tame blood sugar in Tough-to-Treat diabetes

NCT ID NCT07307235

Disease control Sponsor: Shanghai Zhongshan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This study compares a new injectable medicine called iGlarLixi with standard diabetes treatments in adults with type 2 diabetes whose blood sugar is not well controlled by pills alone. About 1,300 people in China will take part. The goal is to see if iGlarLixi helps lower blood sugar more safely and effectively than usual care.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 1,316 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: 1. Participant must be at least 18 of age inclusive, at the time of signing the informed consent. 2. Type 2 diabetes mellitus diagnosis. 3. Participants who are treated for at least 3 months prior to the screening visit with an adequate dose of 1-3 OADs. 4. HbA1c 7.5-11% 5. Further intensification with an additional antidiabetic injectable medication is indicated to achieve glycaemic target at the discretion of the study physician according to approval labelling. Participants who have signed informed consent form (ICF). Exclusion Criteria: 1. Diagnosed with T1DM 2. BMI \<20 kg/m2 or BMI ≥40 kg/m2 3. Treatment with more than 3 oral antidiabetic medications, or any injectable medication in a period of 30 days before the day of eligibility assessment. Temporary/emergency use of insulin is allowed, as is prior insulin treatment for gestational diabetes. 4. Contraindications to iGlarLixi according to the China NMPA approved label. 5. Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the patient's successful participation for the duration of the study. 6. Participants who involved in other clinical trial within 3 months prior to the time of screening visit. 7. Participant who has a severe renal function impairment with an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2 8. Pregnant or breast-feeding woman. 9. 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. 10. 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.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus type 2 diabetes mellitus

As listed by the trial registrant

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

Type 2 diabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Nanhua Hospital, University of South China

    RECRUITING

    Hengyang, Hunan, 421002, China

  • Heilongjiang Provincial Hospital

    RECRUITING

    Harbin, Heilongjiang, 150036, China

  • Hengyang Central Hospital

    RECRUITING

    Hengyang, Hunan, 421001, China

  • Hunan Provincial People's Hospital / The First Affiliated Hospital of Hunan Normal University

    RECRUITING

    Changsha, Hunan, 410005, China

  • Jiaxing First Hospital

    RECRUITING

    Jiaxing, Zhejiang, 314001, China

  • Minhang Hospital, Fudan University / Central Hospital of Minhang District, Shanghai

    RECRUITING

    Shanghai, Shanghai Municipality, 201199, China

  • Ningbo Medical Center Lihuili Hospital

    RECRUITING

    Ningbo, Zhejiang, 315040, China

  • Ningbo No. 2 Hospital

    RECRUITING

    Ningbo, Zhejiang, 315010, China

  • Shanghai East Hospital, Tongji University

    RECRUITING

    Shanghai, Shanghai Municipality, 200120, China

  • Shanghai Pudong New Area Punan Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200125, China

  • Shanghai Qingpu District Central Hospital / Qingpu Branch of Zhongshan Hospital, Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 201700, China

  • Shanghai Tenth People's Hospital / Tenth People's Hospital of Tongji University

    RECRUITING

    Shanghai, Shanghai Municipality, 200072, China

  • Shanghai Tongren Hospital, Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 200336, China

  • Shenzhen Third People's Hospital

    RECRUITING

    Shenzhen, Guangdong, 518112, China

  • The First Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, 230022, China

  • The First Affiliated Hospital of USTC / Anhui Provincial Hospital

    RECRUITING

    Hefei, Anhui, 230001, China

  • The First Clinical Hospital of Jilin Academy of Chinese Medicine Sciences

    RECRUITING

    Changchun, Jilin, 130021, China

  • The First People's Hospital of Huizhou

    RECRUITING

    Huizhou, Guangdong, 516003, China

  • The Second Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • The Second Affiliated Hospital of Nanjing Medical University

    RECRUITING

    Nanjing, Jiangsu, 210003, China

  • Wuhan Fourth Hospital / Wuhan Puai Hospital

    RECRUITING

    Wuhan, Hubei, 430030, China

  • Xinxiang Central Hospital

    RECRUITING

    Xinxiang, Henan, 453003, China

  • Zhejiang Provincial People's Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310014, China

  • Zhongshan Hospital, Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.