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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
Aug 04, 2026
Report code
NCT01762657-Aug 04, 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WITHDRAWN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 agents, Cyclosporine A and Lansoprazole, to potentially achieve insulin independence in patients. The market for Type 1 Diabetes therapies is substantial, with a growing demand for innovative treatments that address the underlying autoimmune mechanisms and promote beta cell regeneration. The competitive landscape includes existing therapies that primarily focus on insulin management rather than addressing the root causes of the disease. The withdrawal of this study prior to patient enrollment raises concerns regarding the feasibility of the trial design or potential regulatory hurdles, necessitating further diligence on the company's strategic direction and alternative pathways for development.
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) to enhance beta cell regeneration and reduce 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.