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Also known as Soliqua, AVE0010-1
iGlarLixi · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Intervention | EXPERIMENTAL | Drug: iGlarLixi - sc injection; Drug: metformin - oral administration; Drug: insulin glargine - sc injection; Behavioral: lifestyle therapy, diet and exercise |
| Standard Care | NO_INTERVENTION | Standard glycemic care as informed by the current clinical practice guidelines |
| Name | Type | Description |
|---|---|---|
| iGlarLixi | DRUG | Dose is titrated to achieve fasting normoglycemia |
| Insulin Glargine | DRUG | In those who need additional insulin or who cannot tolerate iGlarLixi, insulin glargine will be used. Dose is titrated to achieve fasting normoglycemia. |
| Metformin | DRUG | Dose is titrated to 2000 mg daily or maximal tolerated dose |
| Lifestyle therapy | BEHAVIORAL | Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving |
Inclusion Criteria: 1. men and women aged 30-80 years; 2. type 2 diabetes mellitus within 5 years of diagnosis; 3. stable diabetes drug regimen in the 10 weeks before randomization; 4. HbA1c 6.5-9.5% on no glucose lowering drugs, or \</= 8.5% on 1 glucose-lowering drug, or \</= 8.0% on 2 glucose lo...
iGlarLixi is used for the treatment of Type 2 Diabetes Mellitus. It is a metabolic therapy developed by Sanofi. It has been studied in a Phase 3 clinical trial evaluating a metabolic intervention for Type 2 Diabetes, and it is not described as approved.
iGlarLixi is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the Phase 3 trial studying the drug in Type 2 Diabetes Mellitus.
iGlarLixi is in Phase 3 clinical development. The Phase 3 study of iGlarLixi has been completed, and no trials of the drug are currently active. It is an investigational therapy for Type 2 Diabetes Mellitus.
iGlarLixi has been studied in the Phase 3 trial NCT03130426, titled Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IGlarLixi. That trial enrolled 161 participants in Canada, included adults aged 30 years and older of all sexes, and has been completed.
iGlarLixi is an investigational therapy and is not described as approved. It has completed a Phase 3 trial in Type 2 Diabetes Mellitus, and no active trials of the drug are ongoing. Development status should be confirmed with Sanofi, which develops the drug.