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Type 1 DiabetesPhase 1/2NCT06524960

Denosumab for Type 1 Diabetes

A Phase 1/2 study testing Denosumab in people with Type 1 Diabetes, run by City of Hope Medical Center at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Denosumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
3 sitesUnited States
Study dates
5 May 2025to 11 Oct 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

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-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

Main Exclusion Criteria

  • 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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Arthur Riggs Diabetes & Metabolism Research Institute at City of Hope contact

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

Islets@coh.org

United States3 sites, 3 recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

    Tiffany Grimes, 205-996-4777, tdgrimes1@uabmc.edu

    Julia Smith, 205-224-7582, juliaparker@uabmc.edu

    Recruiting

  • City of Hope Medical Center

    Duarte, California, 91010

    Fouad Kandeel, MD, PhD, 1-866-444-7538, Islets@coh.org

    Fouad Kandeel, MD, PhD

    Recruiting

  • Indiana University

    Indianapolis, Indiana, 46202

    Hannah Lease, 317-278-2538, hlease@iu.edu

    Carmella Evans-Molina, MD

    Recruiting

Other trials in United States

About this study

Official title: A Phase 1/2 Prospective, Randomized, Double-blind, Placebo-controlled Multi-center Clinical Trial to Determine the Safety and Efficacy of Denosumab in Improving Beta Cell Function and Glycemic Control Among Patients With Type 1 Diabetes

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.

Read the detailed description

This is a Phase 1/2, prospective, randomized, double-blind, placebo-controlled, multi-center clinical trial to evaluate the safety and efficacy of denosumab for improving beta cell function and glycemic control among patients with early T1D and detectable C-peptide. The efficacy of denosumab will be evaluated by changes in C-peptide level during mixed meal tolerance test and achieving a clinically meaningful HbA1c reduction at 12 months. Subjects will be followed for 12 months for adverse events and for changes in beta cell function and glycemic control parameters.

Subjects will be randomized with a 2:1 treatment to placebo ratio. The treatment group will enroll 30 subjects with the denosumab regimen of 60 mg given subcutaneously every 3 months for a total of 4 injections. The placebo arm will enroll 15 subjects and be administered with normal saline placebo given subcutaneously every 3 months for a total of 4 doses.

Conditions
Type 1 Diabetes
Being tested
Denosumab, Placebo
Keywords
Type 1 diabetes, denosumab, HbA1c, beta cell function
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DenosumabDrug

    Denosumab is a sterile, preservative-free, clear, colorless to pale yellow solution. Each 1 mL single-dose prefilled syringe of denosumab contains 60 mg denosumab (60 mg/mL solution), 4.7% sorbitol, 17 mM acetate, 0.01% polysorbate 20, Water for Injection (USP), and sodium hydroxide to a pH of 5.2.

  • PlaceboOther

    Placebo is 1 mL of normal saline drawn up in a commercially available syringe.

Study groups in NCT06524960
Study groupRoleWhat they receive
DenosumabExperimentalDenosumab 60 mg subcutaneous injection
Receives: Drug: Denosumab
PlaceboPlacebo comparatorNormal Saline 1.0 ml subcutaneous injection
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary safety endpoint

    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.

    Measured: up to 12 months

  2. Primary efficacy endpoint

    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

    Measured: up to 12 months

Secondary outcomes (2)

  1. Beta cell function

    To evaluate the efficacy of denosumab in improving beta cell function as measured by C-peptide AUC during MMTT at 6 months. Beta cell function as determined by C-peptide AUC during MMTT in denosumab group will be compared to placebo group at 6 months.

    Beta cell function (baseline and at 6 months)

    • Mixed meal tolerance test

    Measured: Up to 6 months

  2. HbA1c improvement

    To evaluate the efficacy of denosumab in improving HbA1c and insulin-dose adjusted HbA1c (IDAAIC) at 12 months. Changes in HbA1c and IDAAIC in denosumab group compared to placebo group.

    Glycemic Control (baseline and at 3, 6, 9 and 12 months)

    • HbA1c
    • IDAAIC is calculated as HbA1c (%) + [4 x insulin dose (units/kg/24hr)].

    Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2024
  2. Study start5 May 2025
  3. Primary completion11 Oct 2027 (estimated)
  4. Study completion11 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06524960
Sponsor's protocol ID
23797
Other IDs
JDRF Award:3-SRA-2023-1421-M-B
Status last verified
Oct 2026
First submitted
24 Jul 2024
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Denosumab in people with Type 1 Diabetes, run by City of Hope Medical Center at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Arthur Riggs Diabetes & Metabolism Research Institute at City of Hope (1-866-44-ISLET(1-866-444-7538), Islets@coh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary safety endpoint (time frame: up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06524960.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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