Trials Sponsors Conditions Drugs Pricing

Conditions

Diabetes Mellitus, Insulin-Dependent, 1 Diabetes Mellitus, Type I IDDM Insulin-Dependent Diabetes Mellitus 1 Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

Area Under the Stimulated C-peptide Curve (AUC) Mean Over the First 2 Hours of a 4 Hour Mixed Meal Tolerance Test at the 1 Year Visit
The primary outcome of each participant is the area under the stimulated c-peptide curve (AUC) mean based on data collected at time 0 to 2 hours of a 4-hour mixed meal tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30, 60, 90, and 120 minutes. The term "AUC mean" comes from the mean value theorem in calculus. It is the value on the scale of the y-axis that is equal to the AUC divided by the range on the x-axis (in this case 120 minutes).
Visit 9 (Week 52) at 0, 15, 30, 60, 90, 120 minutes post-dose

Secondary Outcomes (5)

Area Under the Stimulated C-peptide Curve (AUC) Mean Over 4 Hours at 24 Months
Visit 13 (Week 104)

Study Arms (2)

Imatinib Mesylate

EXPERIMENTAL

400 mg imatinib given once daily basis.

Drug: Imatinib Mesylate

Placebo

PLACEBO COMPARATOR

Placebo given once daily basis.

Drug: Placebo (For imatinib mesylate)

Interventions

Imatinib MesylateDrug

Also known as: GLEEVEC, Glivec

Imatinib Mesylate

Placebo (For imatinib mesylate)Drug

Placebo

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 45 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Males and females age 12-45 years of age who meet the ADA standard T1DM criteria1. Positive for at least one islet cell autoantibody. Initial enrollment will be for subjects ages 18-45, with the goal to lower the age down to 12 upon acceptable safety review and prospect of benefit for this initial older cohort.
Diagnosis of T1DM within 100 days of Visit 0.

Sponsors & Collaborators

University of California, San Francisco
Otherlead
Juvenile Diabetes Research Foundation
Othercollaborator

Study Sites (9)

University of California-San Francisco

San Francisco, California, 94143, United States

Barbara Davis Center

Aurora, Colorado, 80045, United States

Emory University

Atlanta, Georgia, 30322, United States

Indiana University

Indianapolis, Indiana, 46202, United States

University of Iowa

Iowa City, Iowa, 52242, United States

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Related Publications (2)

Gitelman SE, Bundy BN, Ferrannini E, Lim N, Blanchfield JL, DiMeglio LA, Felner EI, Gaglia JL, Gottlieb PA, Long SA, Mari A, Mirmira RG, Raskin P, Sanda S, Tsalikian E, Wentworth JM, Willi SM, Krischer JP, Bluestone JA; Gleevec Trial Study Group. Imatinib therapy for patients with recent-onset type 1 diabetes: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Diabetes Endocrinol. 2021 Aug;9(8):502-514. doi: 10.1016/S2213-8587(21)00139-X. Epub 2021 Jun 29.
PMID: 34214479DERIVED
Robertson MA, Padgett LR, Fine JA, Chopra G, Mastracci TL. Targeting polyamine biosynthesis to stimulate beta cell regeneration in zebrafish. Islets. 2020 Sep 2;12(5):99-107. doi: 10.1080/19382014.2020.1791530. Epub 2020 Jul 25.
PMID: 32715853DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic Chemicals

Limitations and Caveats

FDA did not approve for hold on enrollment of pediatric population to be lifted; only adult population was recruited.

Results Point of Contact

Title: Melissa Parker
Organization: University of South Florida

Study Officials

Stephen E Gitelman, MD
University of California, San Francisco
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: LTE60
Restrictive Agreement: Yes

Enrollment

67 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Director, Pediatric Diabetes Program

Study Record Dates

First Submitted

January 17, 2013

First Posted

February 1, 2013

Study Start

January 2014

Actual (reported)

You may not qualify if:

Prior history of any significant cardiac disease such as congestive heart failure, myocardial infarction, arrhythmia, or structural defects or suspicion thereof.
Leukopenia (\<3,000 leukocytes/μL), neutropenia (\<1,500 neutrophils/μL), or thrombocytopenia (\<125,000 platelets/μL).
Low Hemoglobin (baseline hemoglobin below lower limit of normal)
Prior history of anaphylaxis, angioedema or serious cutaneous drug reactions
Any sign of significant chronic active infection (e.g., hepatitis, tuberculosis, EBV, CMV, or toxoplasmosis), or screening laboratory evidence consistent with a significant chronic active infection (such as positive for HIV, PPD, or HBSAg). Significant acute infections must be resolved before treatment may commence, e.g., acute respiratory tract, urinary tract, or gastrointestinal tract infections.
Anticipated ongoing use of diabetes medications other than insulin that affect glucose homeostasis, such as metformin, sulfonylureas, thiazolidinediones, glucagon-like peptide 1 (GLP-1) mimetics, dipeptidyl peptidase IV (DPP-IV) inhibitors, or amylin.
Prior or current treatment that is known to cause a significant, ongoing change in the course of T1DM or immunologic status, including high-dose inhaled, extensive topical or systemic glucocorticoids.
Evidence of liver dysfunction, with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.0 times the upper limit of normal persistent for 1 week or greater.
Evidence of renal insufficiency as indicated by serum creatinine \> 1.2 times the upper limit of normal and confirmed in a repeat test at least one week apart. Evidence of clinically significant metabolic bone disease (except adequately treated rickets).
Females who are pregnant at the time of screening or unwilling to defer pregnancy during the 24-month study period.
Prior treatment with imatinib or related tyrosine kinase inhibitor.
Unable to avoid medications that affect CYP3A4: either inducers that may decrease imatinib levels, or inhibitors that may increase drug concentrations. (Refer to section 1.5.1.12 for a complete list of inducers and inhibitors.)
Height standard deviation score ≥2 standard deviations below mean
Any sign of QT prolongation on Visit -1 noted on ECG (\> 450 ms in males and \> 470 ms in females)
Known coagulation disorders or use of anticoagulants
+2 more criteria

Imatinib Treatment in Recent Onset Type 1 Diabetes Mellitus

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Imatinib Mesylate

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Imatinib Mesylate

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations