Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE2
Total Enrollment
70 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-03-14
Study Completion Date
2028-05-31
Brief Summary
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The goal of this clinical trial is to test a drug known as DFMO in people with Type 1 Diabetes (T1D). The main question\[s\] it aims to answer are:
* Does it reduce stress on the cells that make insulin?
* Does it preserve what is left of the body's insulin production? Participants will take either DFMO or a placebo (looks like DFMO but has no active ingredients) two times a day for about 6 months. Participants will have 6 in person visits and 1 phone visit over a period of 12 months. Visits will include blood draws urine collection and other tests.
* Does it reduce stress on the cells that make insulin?
* Does it preserve what is left of the body's insulin production? Participants will take either DFMO or a placebo (looks like DFMO but has no active ingredients) two times a day for about 6 months. Participants will have 6 in person visits and 1 phone visit over a period of 12 months. Visits will include blood draws urine collection and other tests.
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Detailed Description
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This study will be a multicenter, double-blind, placebo-controlled, 2:1 random assigned, phase II clinical trial for individuals with recent onset type 1 diabetes. The investigators are conducting a double masked placebo-controlled intention to treat study enrolling persons with new onset T1D with documented continued residual C-peptide production. Within 45 days of screening and a run-in period during which eligibility will be determined and glycemic control optimized, subjects will have a 6-month double-masked treatment period with either DFMO or placebo. After a 6-month wash-out period the durability of effect will be assessed. Subjects will be randomly assigned either 1000mg/m2/day oral DFMO or placebo treatment at a 2:1 ratio.
Conditions
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Type 1 Diabetes
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Subject are randomized to either treatment or placebo arm.
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
Participant, Care provider and Investigator blinded
Study Groups
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Treatment Arm
Difluoromethylornithine (DFMO) pill ,1000mg/m2/day, for 6 months
Group Type
ACTIVE_COMPARATOR
DFMO
Intervention Type
DRUG
DFMO orally twice a day
Placebo Arm
Placebo pill taken twice a day orally for 6 months
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Placebo orally twice a day
Interventions
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DFMO
DFMO orally twice a day
Intervention Type
DRUG
Placebo
Placebo orally twice a day
Intervention Type
DRUG
Other Intervention Names
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Difluoromethylornithine
Eligibility Criteria
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Inclusion Criteria
1. Males and females 4- ≥40 years of age with a clinical diagnosis of T1D
2. T1D clinical diagnosis with insulin start date no more than 100 days prior to the time of randomization
3. Random non-fasting C-peptide level of \>0.2 pmol/mL (equivalent to \>0.6ng/ml) at screening.
4. Positive for any one of the following diabetes-related autoantibodies (IAA, GAA, IA-2, or ZnT8)
5. Treatment naïve of any immunomodulatory agent
6. Normal hearing at screening, defined as acceptable results of pure-tone audiometry (\<20 decibel \[dB\] baseline thresholds forall frequencies tested
2. T1D clinical diagnosis with insulin start date no more than 100 days prior to the time of randomization
3. Random non-fasting C-peptide level of \>0.2 pmol/mL (equivalent to \>0.6ng/ml) at screening.
4. Positive for any one of the following diabetes-related autoantibodies (IAA, GAA, IA-2, or ZnT8)
5. Treatment naïve of any immunomodulatory agent
6. Normal hearing at screening, defined as acceptable results of pure-tone audiometry (\<20 decibel \[dB\] baseline thresholds forall frequencies tested
Exclusion Criteria
1. Presence of severe, active disease that interferes with dietary intake or requires the use of chronic medication, with the exception of well-controlled hypothyroidism and mild asthma not requiring oral steroids. Presence of any psychiatric disorder that will affect ability to participate in study.
2. Diabetes other than T1D
3. Chronic illness known to affect glucose metabolism (e.g. Cushing syndrome, polycystic ovarian disorder, cystic fibrosis) or taking medications that affect glucose metabolism (e.g. steroids, metformin)
4. Inability to swallow pills
5. Psychiatric impairment or current use of anti-psychotic medication
6. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results.
7. Neutropenia (\< 1,500 neutrophils/μL)
8. Leukopenia (\< 3,000 leukocytes /μL)
9. Lymphopenia ( \< 800 lymphocytes/μL)
10. Thrombocytopenia (\<100,000 platelets/μL)
11. Clinically significant anemia or Hemoglobin as defined below:
In Adults: Hgb \<12.0g/dL in females and \<13.0g/dL in males In Children: 12- \<18: \<11.4 g/dL in females and \<12.4 g/dL in males In Children: 4- \<12: Hgb \<11.2 g/dL
12. Impaired renal function (assessed by history and BUN/Creatinine, DFMO is renally excreted)
13. Allergy to milk or soy (components of Boost® drink used for mixed meal tolerance testing)
14. Female participants of child-bearing age with reproductive potential, must not be pregnant and agree to use 2 effective forms of birth control or be abstinent during the study period (see below). Male participants (including men who have had vasectomies) whose partners are pregnant or may be pregnant should use condoms while on study drug, until 2 weeks after discontinuation of drug, while the partner is pregnant.
15. Active seizure disorder, defined as requiring chronic medication at the time of study or having had a seizure within the past 12 months at the time of screening
16. Enrollment into another intervention trial.
2. Diabetes other than T1D
3. Chronic illness known to affect glucose metabolism (e.g. Cushing syndrome, polycystic ovarian disorder, cystic fibrosis) or taking medications that affect glucose metabolism (e.g. steroids, metformin)
4. Inability to swallow pills
5. Psychiatric impairment or current use of anti-psychotic medication
6. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results.
7. Neutropenia (\< 1,500 neutrophils/μL)
8. Leukopenia (\< 3,000 leukocytes /μL)
9. Lymphopenia ( \< 800 lymphocytes/μL)
10. Thrombocytopenia (\<100,000 platelets/μL)
11. Clinically significant anemia or Hemoglobin as defined below:
In Adults: Hgb \<12.0g/dL in females and \<13.0g/dL in males In Children: 12- \<18: \<11.4 g/dL in females and \<12.4 g/dL in males In Children: 4- \<12: Hgb \<11.2 g/dL
12. Impaired renal function (assessed by history and BUN/Creatinine, DFMO is renally excreted)
13. Allergy to milk or soy (components of Boost® drink used for mixed meal tolerance testing)
14. Female participants of child-bearing age with reproductive potential, must not be pregnant and agree to use 2 effective forms of birth control or be abstinent during the study period (see below). Male participants (including men who have had vasectomies) whose partners are pregnant or may be pregnant should use condoms while on study drug, until 2 weeks after discontinuation of drug, while the partner is pregnant.
15. Active seizure disorder, defined as requiring chronic medication at the time of study or having had a seizure within the past 12 months at the time of screening
16. Enrollment into another intervention trial.
Minimum Eligible Age
4 Years
Maximum Eligible Age
40 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Juvenile Diabetes Research Foundation
OTHER
Sponsor Role
collaborator
Cancer Prevention Pharmaceuticals, Inc.
INDUSTRY
Sponsor Role
collaborator
Emily K. Sims
OTHER
Sponsor Role
lead
Responsible Party
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Emily K. Sims
Associate Professor of Pediatrics
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Emily K Sims, MD,MS
Role: STUDY_CHAIR
Indiana University School of Medicine
Locations
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Barbara Davis Center
Aurora, Colorado, United States
Site Status
RECRUITING
University of Chicago
Chicago, Illinois, United States
Site Status
RECRUITING
IU Health Riley Hospital for Children
Indianapolis, Indiana, United States
Site Status
RECRUITING
Children's Mercy Hospital
Kansas City, Kansas, United States
Site Status
RECRUITING
University of Michigan
Ann Arbor, Michigan, United States
Site Status
RECRUITING
MHealth Fairview Masonic Children's Hospital and Specialty Clinics
Minneapolis, Minnesota, United States
Site Status
RECRUITING
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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4-SRA-2022-1205-M-B
Identifier Type: -
Identifier Source: org_study_id
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Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop.
NCT06050642
RECRUITING
NA
Transplantation of Autologous Stem Cells for the Treatment of Type 1 Diabetes Mellitus
NCT02644759
COMPLETED
PHASE1/PHASE2
Islet Transplantation in Type 1 Diabetics Using the Edmonton Protocol of Steroid Free Immunosuppression
NCT00133809
COMPLETED
PHASE2
Cellular Therapy for Type 1 Diabetes Using Mesenchymal Stem Cells
NCT04061746
RECRUITING
PHASE1
Efficacy of Diazoxide in Type 1 Diabetes
NCT00131755
COMPLETED
PHASE4
T1DM Immunotherapy Using CD4+CD127lo/-CD25+ Polyclonal Tregs
NCT01210664
COMPLETED
PHASE1
Treatment Satisfaction of Using OmniPod System Compared With Conventional Insulin Pump in Adults With Type 1 Diabetes
NCT00935129
COMPLETED
NA
T1DM Immunotherapy Using Polyclonal Tregs + IL-2
NCT02772679
COMPLETED
PHASE1
A Study of SIMPONI® to Arrest Beta-cell Loss in Type 1 Diabetes
NCT02846545
COMPLETED
PHASE2
Effect of Basal-Bolus Closed-Loop Co-Administration of Insulin and Pramlintide on Improving the Glycemic Control in Type 1 Diabetes
NCT02814123
COMPLETED
PHASE2
A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BioChaperone® Pramlintide Insulin in Patients With Type 1 Diabetes Mellitus
NCT03512236
COMPLETED
PHASE1
Hematopoietic Stem Cell Support Versus Insulin in T1D
NCT01285934
WITHDRAWN
PHASE1/PHASE2
Fr1da Insulin Intervention
NCT02620072
COMPLETED
PHASE2
Alleviating Carbohydrate-Counting Burden in T1DM Using Artificial Pancreas and Empagliflozin
NCT03510000
COMPLETED
NA
The Effect of Glucose-dependent Insulinotropic Polypeptide on the Alpha Cell Response to Hypoglycaemia in Patients with Type 1 Diabetes
NCT06137586
COMPLETED
NA
Islet Transplantation for Type 1 Diabetes
NCT00014911
COMPLETED
PHASE2
Diabetes teleMonitoring of Patients in Insulin Therapy
NCT04981808
COMPLETED
NA
Insulin Producing Stem Cell Transplantation Clinical Trial in Type 1 Diabetes
NCT06951074
RECRUITING
PHASE2/PHASE3