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Monoclonal Antibodies
Denosumab for Type 1 Diabetes
Phase 1 & 2
Recruiting
Led By Rupangi Vasavada, PhD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Females aged 18-50 years; males aged 21-50 years with a diagnosis of type 1 diabetes (T1D) based on ADA Criteria
Must not have
Use of any diabetes medications other than insulin within 3 months of enrollment
Treatment with specific drugs in the 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Summary
"This trial will test if denosumab, a drug used for osteoporosis and other bone conditions, can protect and improve the function of beta cells in people with early Type 1 diabetes.
Who is the study for?
This trial is for individuals with early-stage Type 1 Diabetes, where some insulin-producing beta cells are still functioning. The study aims to protect these cells and slow disease progression.
What is being tested?
The trial is testing Denosumab, a drug normally used for bone-related conditions, to see if it can safeguard the remaining beta cells in Type 1 Diabetes patients and improve their blood sugar control.
What are the potential side effects?
Potential side effects of Denosumab may include weakened bones, low calcium levels in the blood, skin infections, or irritation at the injection site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My C-peptide levels are above 0.6 ng/ml, confirmed by a test.
Select...
I am within the age range and have type 1 diabetes.
Select...
I have antibodies linked to type 1 diabetes.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have only used insulin for my diabetes in the last 3 months.
Select...
I haven't taken drugs like immunosuppressants or steroids in the past year.
Select...
I do not have major dental issues or a history of jaw bone disease.
Select...
I have a history of anorexia or another eating disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Primary efficacy endpoint
Primary safety endpoint
Secondary study objectives
Beta cell function
HbA1c improvement
Other study objectives
Glucose variability
Insulin sensitivity
Side effects data
From 2022 Phase 4 trial • 37 Patients • NCT0402625631%
nausea
15%
headache
15%
rhinorrhea
8%
phototoxic dermatitis
8%
dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Teriparatide Only
Denosumab and Teriparatide
Denosumab Only
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DenosumabExperimental Treatment1 Intervention
Denosumab 60 mg subcutaneous injection
Group II: PlaceboPlacebo Group1 Intervention
Normal Saline 1.0 ml subcutaneous injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Denosumab
2020
Completed Phase 4
~12020
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
605 Previous Clinical Trials
1,923,560 Total Patients Enrolled
Rupangi Vasavada, PhDPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
165 Total Patients Enrolled
Fouad Kandeel, MD, PhDPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
30 Total Patients Enrolled
Fouad KandeelPrincipal InvestigatorCity of Hope Medical Center