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IDegAsp

Phase 3

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Sanofi|Last Updated: Sep 24, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment582

FDA Designations

No designations recorded

Clinical trial landscape

IDegAsp · 1 trial · 1 indication

Phase 3 1
NCT05413369iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)Type 2 Diabetes Mellitus
COMPLETED582 Analytics
PHASE3COMPLETED
iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)
Type 2 Diabetes MellitusUnlock trial analytics

Study Endpoints

Primary Endpoints

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

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).

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
iGlarLixiEXPERIMENTALParticipants 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.
IDegAspACTIVE_COMPARATORParticipants 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.

Interventions

NameTypeDescription
Insulin glargine/LixisenatideDRUGsolution, by subcutaneous injection
IDegAspDRUGsolution, by subcutaneous injection
MetforminDRUGTablet, orally
SGLT2 inhibitorDRUGTablet, orally
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites60

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 stabl...

Countries:China
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Frequently asked questions about IDegAsp

What is IDegAsp used for in Type 2 Diabetes Mellitus?

IDegAsp is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 3 clinical development. The drug has been studied in a completed Phase 3 trial involving 582 participants in China, where it was compared against iGlarLixi in patients who had previously been treated with oral antidiabetic drugs.

Who makes IDegAsp?

IDegAsp is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical trials to evaluate the safety and efficacy of IDegAsp for the treatment of Type 2 Diabetes Mellitus.

What phase is IDegAsp in?

IDegAsp is in Phase 3 clinical development for Type 2 Diabetes Mellitus. The drug has completed one Phase 3 trial, which was an active-controlled study. As of the available data, IDegAsp is still investigational and has not been approved by regulatory authorities.

What clinical trials is IDegAsp in?

IDegAsp has been studied in one completed Phase 3 clinical trial with the identifier NCT05413369. This trial, titled 'iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)', enrolled 582 participants with Type 2 Diabetes Mellitus in China. The study was active-controlled and included participants aged 18 years and older.

Is IDegAsp the same as iGlarLixi?

No, IDegAsp is not the same as iGlarLixi. In the clinical trial NCT05413369, iGlarLixi was used as the active comparator against IDegAsp. The trial was designed to compare the two treatments in Chinese participants with Type 2 Diabetes Mellitus who had previously been treated with oral antidiabetic drugs.