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anti-diabetic drugs

Phase 3

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Sanofi|Last Updated: Jun 16, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment521

FDA Designations

No designations recorded

Clinical trial landscape

anti-diabetic drugs · 1 trial · 1 indication

Phase 3 1
NCT02752828Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Insulin Glargine Alone on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in JapanType 2 Diabetes Mellitus
COMPLETED521 Analytics
PHASE3COMPLETED
Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Insulin Glargine Alone on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan
Type 2 Diabetes MellitusUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in HbA1c
Baseline, 26 weeks

Secondary Endpoints

Percentage of patients reaching HbA1c <7% or ≤6.5%
26 weeks
Change from baseline in 2-hour postprandial glucose (PPG) during standardized meal test
Baseline, 26 weeks
Change from baseline in 7 point self monitored plasma glucose (SMPG) profiles during standardized meal test
Baseline, 26 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LixiLanEXPERIMENTALLixiLan (insulin glargine/lixisenatide) is injected subcutaneously (under the skin) once daily. Dose is individually adjusted. Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period.
insulin glargineACTIVE_COMPARATORInsulin glargine (HOE901) is injected subcutaneously (under the skin) once daily. Dose is individually adjusted. Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period.

Interventions

NameTypeDescription
Insulin glargine/lixisenatide (HOE901/AVE0010)DRUGPharmaceutical form: solution Route of administration: subcutaneous
Insulin glargine (HOE901)DRUGPharmaceutical form: solution Route of administration: subcutaneous
Oral anti-diabetic drugsDRUGPharmaceutical form: tablet Route of administration: oral
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites113

Inclusion criteria : * Patient with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year before the screening visit, receiving 1 or 2 OADs that can be Biguanide,Thiazolidinedione (TZD), -Alpha-glucosidase-inhibitor (alpha-GI),Sodium glucose co-transporter 2 (SGLT2) inhibitor,Sulfonylurea (...

Countries:Japan
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Frequently asked questions about anti-diabetic drugs

What is anti-diabetic drugs used for?

Anti-diabetic drugs are used for the treatment of Type 2 Diabetes Mellitus. The drug is being developed by Sanofi and is currently in Phase 3 clinical development. It is a small molecule therapeutic intended to help manage blood glucose levels in patients with this condition.

What does anti-diabetic drugs target?

Anti-diabetic drugs target pathways involved in glucose regulation, specifically through the combination of insulin glargine and lixisenatide. This fixed ratio combination aims to improve glycemic control in patients with Type 2 Diabetes Mellitus by addressing both basal insulin and postprandial glucose excursions.

Who makes anti-diabetic drugs?

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

What phase is anti-diabetic drugs in?

Anti-diabetic drugs is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug is being evaluated for its efficacy and safety in patients with Type 2 Diabetes Mellitus.

What clinical trials is anti-diabetic drugs in?

Anti-diabetic drugs has been studied in a Phase 3 clinical trial with the identifier NCT02752828. This trial, titled 'Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Insulin Glargine Alone on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan,' enrolled 521 participants and has been completed.

Is anti-diabetic drugs the same as LixiLan?

Anti-diabetic drugs is also known as LixiLan, which is the insulin glargine/lixisenatide fixed ratio combination. This combination is being developed by Sanofi for the treatment of Type 2 Diabetes Mellitus. The Phase 3 trial NCT02752828 evaluated this fixed ratio combination against insulin glargine alone.