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.
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