METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D)

Recruiting Phase 2 Interventional Study
Type 1 Diabetes (T1D) Metabolic Diseases Glucose Metabolism Disorders Endocrine System Diseases Autoimmune Diseases Immune System Diseases Diabetes Melletus, Type 1 Nutritional and Metabolic Diseases Combination Therapy
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 69
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
University of Washington · Other
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About This Trial
The study is a randomized, double-blind, parallel-group clinical trial to examine the effects of 24 weeks of oral AMX0035 (sodium phenylbutyrate + taurursodiol) versus placebo in 60 adults with Type 1 Diabetes (T1D) (n=30 per arm). Enrollment will be distributed equally between the University of Washington and Amsterdam University Medical Center/Diabetes Center Amsterdam. Participants will be recr…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Adults ≥18 years to \<70 years of age with established T1D (duration ≥1 year) 2. Currently on insulin therapy (multiple daily injections or insulin pump) 3. HbA1c \<9.5% 4. BMI 18.5-40 kg/m2 5. On stable dose of RASB or statin, if indicated 6. Willing and able to comply with …
Contacts

Amanda Bard, MMS, MS, CCRC

206-685-2069

abard@uw.edu

CONTACT