Denosumab for Type 1 Diabetes
ConditionType 1 Diabetes
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-50
SponsorCity of Hope Medical Center
About this trial
Type 1 diabetes (T1D) arises from abnormal immune cell-mediated injury to beta cells that make insulin. The injured beta cells can then no longer make the needed amount of insulin to stay healthy. However, in the early stages of T1D, some beta cells are still alive and functioning. Treatment to protect the beta cells against injury at this time could slow the progress of disease. Denosumab is an approved treatment for osteoporosis (a disease that thins and weakens the bones), high blood calcium levels, bone cancer, and other bone problems in patients who have cancer. The research team has found that the bone pathway that denosumab works on to treat these bone conditions also has effects on the health of the beta cells. Lab studies suggest that denosumab may protect and/or increase the number of beta cells and improve how well they work. This study will test whether denosumab is safe and improves beta cell function and blood sugar control in people with early T1D.
Eligibility criteria
Qualifiers
Hyperglycemia (glycosylated hemoglobin (HbA1c) ≥ 6.5%; OR
fasting plasma glucose ≥ 126 mg/dl (7.0 mmol/L); OR
2-hour plasma glucose ≥ 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test; OR
In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥ 200 mg/dl (11.1 mmol/L)
Disqualifiers
History of delayed puberty unless there is radiologic evidence of skeletal maturity
Use of other investigational agents within 3 months of enrollment
Vitamin D3 deficiency (< 30 ng/ml)
History of anorexia and/or eating disorder
Trial design
Treatments tested in this trial
- Denosumab
- Placebo
Treatment groups
45 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov