Approval Probability
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Adjusted LOA
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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 an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities. The drug is being studied for its potential to manage blood sugar levels in adults with this condition.
iGlarLixi is being developed by Sanofi, a global biopharmaceutical company. Sanofi is listed on the stock exchange under the ticker symbol SNY. The company is conducting clinical trials to evaluate the safety and efficacy of iGlarLixi for the treatment of Type 2 Diabetes Mellitus.
iGlarLixi is in Phase 3 clinical development. This phase involves large-scale studies to confirm the drug's effectiveness, monitor side effects, and compare it with commonly used treatments. The drug is still investigational and has not yet received regulatory approval for any use.
iGlarLixi has been studied in one completed Phase 3 clinical trial with the identifier NCT03130426. This trial, titled 'Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IGlarLixi,' enrolled 161 participants in Canada. The study was randomized but not double-blinded, and it did not use a treatment control group.
iGlarLixi is a combination product that contains two active ingredients: insulin glargine and lixisenatide. It is being developed as a fixed-dose combination for the treatment of Type 2 Diabetes Mellitus. The drug is not known by any other single name, but it combines the effects of these two established diabetes medications.