BridgeMD
New treatment option for Type 1 Diabetes
Official title Denosumab for Type 1 Diabetes
ClinicalTrials.gov ID: NCT06524960
What this study is testing
What is Denosumab?
Denosumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for type 1 diabetes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50
You may be able to join if
- Main 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
You likely can't join if
- 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%
See the full eligibility criteria
- Main 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...
- 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. people 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...
- 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...
- 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...
- Pregnancy or actively breastfeeding (within 6 months prior to screening), or planning to become pregnant with 5 months after last dose of protocol therapy
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Duarte, California, United States
- Indianapolis, Indiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Duarte, California, United States; Indianapolis, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.