DFMO in Children With Type 1 Diabetes
Completed · Phase 1 · Has a placebo group
Conditions studied: Type 1 Diabetes
In brief
This study is a multicenter, double-blind, placebo-controlled, 2:1 randomly assigned, phase 1 clinical trial for individuals with type 1 diabetes. It is a blinded dose-ranging study enrolling patients with new onset type 1 diabetes with documented continued residual C-peptide production. After a 4 week screening and run-in period during which eligibility will be determined and glycemic control optimized, subjects will have a 3-month double-masked treatment period with either DFMO or placebo. After a 3 month wash-out period the durability of effect will be assessed. Subjects will be randomly assigned (6 to DFMO; 3 to placebo in each cohort) to 1 of 4 sequential dose cohorts.
Key facts
- Study ID
- NCT02384889
- Run by
- Indiana University
- People needed
- 41
- Starts
- 2015-04-01
- Expected to finish
- 2020-01-06
- Last updated by the study team
- 2021-09-05
Who can join
Age: 12 and older, up to 40. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males and females 12-40 years of age with a clinical diagnosis of T1D within 2 - 8 months after diagnosis at the time of visit 2.
- Random non-fasting C-peptide level of >0.2 pmol/mL at visit 1.
- Positive for any one of the following diabetes-related autoantibodies (mIAA, GADA, IA-2A, or ZnT8A)
- Treatment naïve of any immunomodulatory agent
- Normal hearing at screening, defined as acceptable results of pure-tone audiometry (<20 decibel [dB] baseline thresholds for frequencies 250, 500, 1000, and 2000 Hz
You may not qualify if…
- 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.
- Diabetes other than T1D
- 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)
- Inability to swallow pills
- Psychiatric impairment or current use of anti-psychotic medication
- Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results.
- Hematologic abnormalities at screening (anemia, leukopenia (particularly neutropenia), or thrombocytopenia)
- Impaired renal function (assessed by history and BUN/Creatinine, DFMO is renally excreted)
- Female participants of child-bearing age must not be pregnant and agree to use an effective form of birth control or be abstinent during the study period.
- BMI >95% for age and sex
Where it is running
- Riley Hospital for Children — Indianapolis, Indiana, United States
- Women and Children's Hospital of Buffalo — Buffalo, New York, United States
- Children's Hospital of Wisconsin — Wauwatosa, Wisconsin, United States
Full record on ClinicalTrials.gov
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