Denosumab for Type 1 Diabetes

Denosumab for Type 1 Diabetes

Recruiting Phase 1 Phase 2 Interventional Study
Type 1 Diabetes
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 50
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
45 (estimated)
Sponsor
City of Hope Medical Center · Other
Who this trial is looking for

This trial is looking for people with early type 1 diabetes. Participants will receive treatment with denosumab to see if it helps protect insulin-producing cells and improve blood sugar control.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am a female aged 18-50 years or a male aged 21-50 years.
  • I have been diagnosed with type 1 diabetes.
  • I have at least one type 1 diabetes related autoantibody.
  • It has been more than 12 months and less than 5 years since my diagnosis.
  • I have a non-fasting C-peptide level of at least 0.2 nmol/L.
  • My serum calcium level is within normal limits.
  • I agree to use a highly effective method of birth control during the study.

You may not be able to join if

  • I have a history of delayed puberty without evidence of skeletal maturity.
  • I have used other investigational agents in the last 3 months.
  • I have vitamin D3 deficiency.
  • I had anorexia or another eating disorder.
  • My HbA1c is above 9.5%.
  • I have had severe low blood sugar or diabetic ketoacidosis in the last 3 months.
  • I have used diabetes medications other than insulin in the last 3 months.
  • I am pregnant or breastfeeding.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

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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 a…
Trial Locations
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Eligibility Criteria
Main Inclusion Criteria * Age: Females 18-50 years; males 21-50 years (minimum age based on skeletal maturity) * Diagnosis of type 1 diabetes (T1D) based on ADA Criteria: * Hyperglycemia (glycosylated hemoglobin (HbA1c) ≥ 6.5%; OR * fasting plasma glucose ≥ 126 mg/dl (7.0 mmol/L); OR * 2-hou…
Contacts

Arthur Riggs Diabetes & Metabolism Research Institute at City of Hope

1-866-44-ISLET(1-866-444-7538)

Islets@coh.org

CONTACT