A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate the Safety and Efficacy in Diminishing Insulin Requirements Utilizing Oral Cyclosporine With Oral Lansoprazole in Children and Adults With Existing Type 1 Diabetes Mellitus
Perle Bioscience, Inc. is investigating a novel combination therapy for Type 1 Diabetes Mellitus that leverages two FDA-approved drugs: Cyclosporine A and Lansoprazole. The potential to achieve insulin independence in patients could address a significant unmet need in the diabetes market, which is projected to grow substantially due to increasing prevalence. However, the study has been withdrawn prior to patient enrollment, which raises concerns regarding the feasibility of the trial design or potential regulatory hurdles. Competitive analysis indicates that while there are various therapies in development for Type 1 Diabetes, none have successfully sustained insulin independence, positioning this combination therapy as a potentially innovative approach if proven effective.
Indication: Type 1 Diabetes
Modality: small molecule
Target: Oral Cyclosporine A (immune tolerance agent) and Oral Lansoprazole (proton-pump inhibitor) to enhance beta cell regeneration and insulin independence in Type 1 Diabetes Mellitus.
Sponsor: Perle Bioscience, Inc.
Source URL: ClinicalTrials.gov
Source updated: Apr 19, 2016
Ingested: Jun 19, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by target_normalized: Oral Cyclosporine A (immune tolerance agent) and Oral Lansoprazole (proton-pump inhibitor) to enhance beta cell regeneration and insulin independence in Type 1 Diabetes Mellitus.
View original source fields
Condition raw: Type 1 Diabetes
Condition normalized: Type 1 Diabetes
Modality raw: small molecule
Modality normalized: small molecule
Target raw: Oral Cyclosporine A (immune tolerance agent) and Oral Lansoprazole (proton-pump inhibitor) to enhance beta cell regeneration and insulin independence in Type 1 Diabetes Mellitus.
Target normalized: Oral Cyclosporine A (immune tolerance agent) and Oral Lansoprazole (proton-pump inhibitor) to enhance beta cell regeneration and insulin independence in Type 1 Diabetes Mellitus.