Find Type 1 Diabetes (T1D) Clinical Trials Near You
METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D)
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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 recruited through diabetes research registries, local T1D clinics, and community outreach.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 69
Healthy Volunteers: f
View:
• Adults ≥18 years to \<70 years of age with established T1D (duration ≥1 year)
• Currently on insulin therapy (multiple daily injections or insulin pump)
• HbA1c \<9.5%
• BMI 18.5-40 kg/m2
• On stable dose of RASB or statin, if indicated
• Willing and able to comply with all study procedures
Locations
United States
Washington
University of Washington Medicine Diabetes Institute (UWMDI)
RECRUITING
Seattle
Other Locations
Netherlands
Amsterdam UMC
NOT_YET_RECRUITING
Amsterdam
Contact Information
Primary
Amanda Bard, MMS, MS, CCRC
abard@uw.edu
206-685-2069
Time Frame
Start Date:2026-06
Estimated Completion Date:2029-12
Participants
Target number of participants:60
Treatments
Experimental: AMX0035
Participants will be instructed to take one packet of AMX0035 daily for the first 2 weeks, followed by 1 packet twice a day (morning and evening) thereafter for \~6 months.
Placebo_comparator: Placebo
Participants will be instructed to take one packet of placebo daily for the first 2 weeks, followed by 1 packet twice a day (morning and evening) thereafter for \~6 months.