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Clinical trial intelligence report
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
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jun 20, 2026
NCT ID
NCT01762657
Status
WITHDRAWN
Phase
Phase 3
Sponsor
Perle Bioscience, Inc.
Executive brief
Investment-Ready Snapshot
Perle Bioscience, Inc. is investigating a novel combination therapy for Type 1 Diabetes Mellitus that leverages two FDA-approved drugs, Cyclosporine A and Lansoprazole, to potentially achieve insulin independence in patients. The market for Type 1 Diabetes therapies is significant, with a growing demand for innovative treatments that can improve patient outcomes. The competitive landscape includes existing therapies that focus on insulin management rather than addressing the underlying autoimmune mechanisms. The withdrawal of this trial prior to patient enrollment raises concerns about the feasibility of the study design or potential regulatory hurdles, which may necessitate further diligence regarding the clinical and commercial viability of this approach.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT01762657
Indication
Type 1 Diabetes
Modality
small molecule
Target
Oral Cyclosporine A (immune tolerance agent) and Oral Lansoprazole (proton-pump inhibitor) aimed at enhancing beta cell regeneration and reducing insulin requirements in Type 1 Diabetes Mellitus.
Intervention
Oral Cyclosporine and Oral Lansoprazole, Placebos
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.