Denosumab for Type 1 Diabetes
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 50 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 12 months
- Procedures mentioned: Injections
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Subjects will be followed for 12 months for adverse events and for changes in beta cell function and glycemic control parameters."
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether denosumab, a medicine used for bone problems, is safe and helps protect the cells that make insulin and control blood sugar. It is for adults who were diagnosed with type 1 diabetes 1 to 5 years ago.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Women ages 18–50 or men ages 21–50.
- Have type 1 diabetes diagnosed using standard blood sugar test rules.
- Have a past positive test for at least one of these immune proteins linked to type 1 diabetes: GADA, IA-2A, or ZNT8A.
- Were diagnosed 1 to 5 years before the screening meal test.
- Have a C-peptide level of at least 0.2 nmol/L (0.6 ng/ml) before screening and during the screening meal test. This shows your body still makes some insulin.
- Have a normal blood calcium level.
- If able to have or father a child, agree to use highly effective birth control during the study and for at least 5 months after the last dose.
Who can't join
- Had delayed puberty, unless an imaging test shows your bones are fully grown.
- Have low vitamin D3 (below 30 ng/ml), a history of an eating disorder, or a body mass index (BMI, a measure of weight compared with height) above 32.
- Have an HbA1c above 9.5%, a measure of average blood sugar. Had dangerously low blood sugar or diabetic ketoacidosis (dangerous acid buildup) in the past 3 months. Episodes 3–6 months ago require written approval from your doctor.
- Used another study drug or a diabetes medicine other than insulin in the past 3 months.
- Used certain medicines in the past year that affect the immune system, seizures, hormones, or bones, or ever used bisphosphonates, a type of bone medicine.
- Had certain broken bones in the past year, or have certain conditions that affect bone health. Drinking more than 3 units of alcohol a day also rules you out.
- Have serious tooth, mouth, or jaw problems, including jawbone damage or infection, a condition needing mouth surgery, surgery that has not healed, or planned invasive dental work during the study.
- Are pregnant, are breastfeeding or breastfed within 6 months before screening, or plan to become pregnant within 5 months after the last dose.
Simplified for readability. The official criteria below are what the study team uses.
Official 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-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
Study sites (3)
AL
- University of Alabama at Birmingham · Birmingham, AL 35233Tiffany Grimes · Study contact · 205-996-4777 · tdgrimes1@uabmc.eduJulia Smith · Study contact · 205-224-7582 · juliaparker@uabmc.eduAnath Shalev, MD · Principal investigatorMore trials in Birmingham
CA
- City of Hope Medical Center · Duarte, CA 91010Fouad Kandeel, MD, PhD · Study contact · 1-866-444-7538 · Islets@coh.orgFouad Kandeel, MD, PhD · Principal investigatorMore trials in Duarte
IN
- Indiana University · Indianapolis, IN 46202Hannah Lease · Study contact · 317-278-2538 · hlease@iu.eduCarmella Evans-Molina, MD · Principal investigatorMore trials in Indianapolis