Status:
RECRUITING
Denosumab for Type 1 Diabetes
Lead Sponsor:
City of Hope Medical Center
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
Brief 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. How...
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 glycem...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 11 2027
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06524960
Start Date
September 3 2024
End Date
October 11 2027
Last Update
July 28 2025
Active Locations (3)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
City of Hope Medical Center
Duarte, California, United States, 91010
3
Indiana University
Indianapolis, Indiana, United States, 46202