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NCT01762657WITHDRAWNanonymous

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

Sponsor

Source record

Perle Bioscience, Inc.

Phase

Source record

Phase 3

Modality

AI-normalized

small molecule

Target

AI-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.

Indication / condition

AI-normalized

Type 1 Diabetes

Intervention

Source record

Oral Cyclosporine and Oral Lansoprazole, Placebos

Related intelligence directories

Indication directory: Type 1 DiabetesModality directory: small moleculeTarget directory: 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.

Source & freshness

Source record

NCT ID

NCT01762657

Original source

ClinicalTrials.gov

Source last updated

Apr 19, 2016

Ingested at

Jun 19, 2026

Internal sync

Jun 19, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT01762657

Title

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

Sponsor

Perle Bioscience, Inc.

Status

WITHDRAWN

Phase

Phase 3

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.

Interventions

Oral Cyclosporine and Oral Lansoprazole, Placebos

Public preview

Source record

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.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

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 19, 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. 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.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedApr 19, 2016
Internal syncJun 19, 2026
Model versiontrialsignal-ai-v1

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 insulin independence 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.