Denosumab for Type 1 Diabetes

This study is testing if denosumab, a medication approved for bone conditions, can help protect the insulin-making cells (beta cells) in people with early Type 1 Diabetes (T1D). Researchers believe denosumab might affect a pathway that also influences beta cell health. You may be able to join if you are between 18 and 50 years old (with specific age ranges for males and females) and have a recent diagnosis of T1D with certain blood sugar levels. The study will look for improvements in beta cell function and a meaningful reduction in your HbA1c (a measure of average blood sugar) over 12 months. The study is currently unclear about its recruitment status.

Study design: This is a randomized, double-blind study with 45 participants. Two out of three participants will receive denosumab, and one will receive a placebo (inactive substance).
What's involved: Participants will receive four injections, either denosumab or placebo, every three months for a total of 12 months. They will also be monitored for side effects and changes in beta cell function and blood sugar levels during this time.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for 12 months after starting treatment to monitor for side effects and changes in their health.

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Denosumab for Type 1 Diabetes

Recruiting

PHASE1Ages 18–50InterventionalTreatment

City of Hope Medical Center

~45 participants

Updated 2026-07-28 on ClinicalTrials.gov

What's tested:DenosumabPlacebo

At a glance

Recruiting sites

3 of 3 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Primary safety endpoint

Measured over up to 12 months

+1 more outcome measured

Conditions

Type 1 Diabetes

Where it's being run

3 sites across 3 states

Alabama1

California1

Indiana1

Study leadership

Fouad Kandeel, MD, PhD · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
Rupangi Vasavada, PhD · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Arthur Riggs Diabetes & Metabolism Research Institute at City of Hope

[email protected]

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

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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-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)

Documented history of at least one type 1 diabetes associated autoantibody

GAD specific autoantibodies (GADA);

Islet-antigen 2 specific autoantibody (IA-2A); and/or

Zinc Transporter 8 specific autoantibody (ZNT8A)

Time from T1D diagnosis to screening MMTT must be ≥ 12 months but ≤ 5 years

Non-fasting C-peptide concentrations of at least 0.2 nmol/L (0.6 ng/ml) at pre-screening and confirmed during a MMTT done at screening visit.

Serum calcium (corrected for albumin)\* within normal limits per site's local lab

Agreement by women of childbearing potential (WOCBP) and males of childbearing potential to use a highly effective method of birth control for the course of the study through at least 5 months from the last dose of protocol therapy

Exclusion

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

BMI \> 32 kg/m2

HbA1c \> 9.5%

Severe hypoglycemia or diabetic ketoacidosis (DKA) within 3 months prior to screening. Subjects who had such episodes within 3-6 months prior to screening, must have written clearance from their treating physician.

Use of any of the diabetes medications other than insulin within 3 months of enrollment (e.g., metformin, sulfonylurea, GLP-1 agonists, DPP4 inhibitors, Symlin, SGLT2-inhibitors, amylin)

Treatment with any of the following drugs in past year: immunosuppressants, anticonvulsant therapy, adrenal or anabolic steroids, calcitonin, selective estrogen receptor modulator, sodium fluoride (other than dental treatment), teriparatide, abaloparatide, strontium or aromatase inhibitors; any history of bisphosphonate treatment.

Bone fractures (excluding skull, facial bones, metacarpals, fingers, toes and spontaneous fractures associated with severe trauma) within the past 12 months

Disorders associated with altered skeletal structure or function (Paget's disease, chronic liver disease (liver enzymes \> twice the upper limit of normal), malignancy, hypoparathyroidism or hyperparathyroidism, acromegaly, Cushing's syndrome, hypopituitarism, chronic obstructive pulmonary disease, alcohol intake \> 3 units/day)

Significant dental/oral disease, including prior history or current evidence of osteonecrosis/osteomyelitis of the jaw, active dental or jaw condition requiring oral surgery, non-healed dental/oral surgery, or planned invasive dental procedures for the course of the study

Pregnancy or actively breastfeeding (within 6 months prior to screening), or planning to become pregnant with 5 months after last dose of protocol therapy

What this trial measures

Primary safety endpointup to 12 months
To evaluate the safety of denosumab as assessed by the occurrence of adverse events (primary safety endpoint). Occurrence of treatment-related adverse events in denosumab group compared to placebo group during the 12 months. Toxicity: Toxicity and adverse events (except hypoglycemia and DKA) will be recorded in the eCRFs using the NCI CTCAE v 5.0 (See Section 7.0 for specific AEs). Hypoglycemia and DKA events will be defined per Section 14.1.1. \- From treatment day through Month 12: All grade toxicities/AEs will be recorded. Safety will be assessed at baseline and at 3, 6, 9 and 12 months.
Primary efficacy endpointup to 12 months
To evaluate the efficacy of denosumab in improving beta cell function in T1D subjects as measured by difference of mean area under the curve (AUC) of plasma C-peptide during 2-hr mixed meal tolerance test (MMTT) at baseline and 12 months after initiation of treatment (primary efficacy endpoint). Beta cell function as determined by the change in C-peptide AUC during MMTT in denosumab group will be compared to placebo group at 12 months from baseline. Change in Beta cell function (baseline and at 12 months) \- Mixed meal tolerance test

Trialytics