- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05683990
Study to Evaluate the Safety and Feasibility of Diamyd® in Individuals at Risk for Type 1 Diabetes
November 14, 2023 updated by: Diamyd Medical AB
DiaPrecise, A Phase II Open Label Study to Evaluate the Safety and Feasibility of Intralymphatic Administration of Diamyd® in Individuals at Risk for Type 1 Diabetes Carrying the HLA DR3-DQ2 Haplotype
A 2-arm randomized Phase II Open Label Study to evaluate the safety and feasibility of intralymphatic administration of Diamyd® (Diamyd) in individuals at risk of Type 1 diabetes carrying the HLA DR3-DQ2 haplotype.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
The trial is a 2-arm, randomized, open label clinical trial in individuals aged 8 - <18 years with HLA DR3-DQ2 and multiple islet autoantibodies (Stage 1 or Stage 2) at increased risk for T1D.
At baseline eligible individuals at risk of T1D will be randomized 1:1 into 2 or 3 injections of Diamyd® administered into an inguinal lymph node.
Subjects will be followed for a total of 12 months post-enrollment.
Study Type
Interventional
Enrollment (Estimated)
16
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chief Operating Officer
- Phone Number: +46 (0) 8 661 00 26
- Email: clinicaltrials@diamyd.com
Study Locations
-
-
-
Malmö, Sweden
- Recruiting
- Lund University/CRC, Skåne University Hospital,
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Written informed consent/assent from the individual and the individual's parents or caretaker(s) according to local regulations.
- Males and females aged ≥8 and <18 years old at the time of Screening.
- Possess the HLA DR3-DQ2 haplotype.
- Seropositive for GADA and at least one additional T1D-associated autoantibody (IA-2A, ZnT8A or IAA).
Exclusion Criteria:
- Diagnosis of T1D (stage 3 T1D, according to the American Diabetes Association [ADA] classification).
- Fasting glucose > 7 mmol/L (126 mg/dl), 2-hour-OGTT plasma glucose > 11.1 mmol/L (200 mg/dL) or HbA1c > 6.5% (48 mmol/mol) at the screening Visit.
- Treatment with any anti-diabetic medication, including the use of external insulin.
- Participation in any other clinical trial testing pharmaceutical treatments.
- Recent (past 12 months) or current treatment with immunosuppressant therapy, including chronic use of glucocorticoid therapy. Inhaled, topical, and intranasal steroid use is acceptable. Short courses (e.g., ≤5 days) of oral or intra-articular injections of steroids will be permitted on trial.
- History of hyperparathyroidism, hypercalcemia and/or nephrolithiasis, unless appropriately treated, or any other contraindication to use of Vitamin D.
- History of epilepsy, serious head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles
- Any clinically significant history of an acute reaction to a vaccine or its constituents (e.g., Alhydrogel) or lidocaine (local anesthetic)
- Any acute or chronic skin infection or condition that would preclude intralymphatic injection.
- Treatment with any (live or inactive) vaccine, including influenza vaccine and Coronavirus Disease 2019 (COVID-19) vaccine, within 4 weeks prior to planned first dose of study drug; or planned treatment with any vaccine up to 4 weeks after the last injection with study drug.
- Ongoing diagnosed post-COVID19 syndrome.
- Known diagnosis of human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection. Individuals with previous hepatitis C infection that is now cured may be eligible.
- Any clinically significant concomitant medical condition, including but not limited to other autoimmune diseases, cardiovascular, gastrointestinal, hematological, immune, renal including a history of renal transplantation or neurological that in the opinion of the investigator would interfere with trial participation or procedures. Celiac disease with adequate diet as well as stable autoimmune thyroiditis will be permitted.
- Any clinically significant abnormal findings detected during Screening that might jeopardize the individual's safety or ability to complete the trial.
- Females who are lactating or pregnant (for females who have started menstruating the possibility of pregnancy must be excluded by urine βHCG onsite prior to the study drug administration).
- Males or females not willing to use adequate contraception, if sexually active, until 90 days after the last Diamyd administration. Adequate contraception is as follows:
For females of childbearing potential (FOCBP)
- oral (except low-dose gestagen (lynestrenol and norestisteron)), injectable, or implanted hormonal contraceptives
- intrauterine device
- intrauterine system (for example, progestin-releasing coil)
- refraining from heterosexual intercourse if that is the preferred and usual lifestyle of the subject.
For sexually active males
- condom
- Abstinence from heterosexual intercourse if that is the preferred and usual lifestyle of the subject.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
2 injections of Diamyd®
|
4 μg (0.1 mL) of Diamyd administered 1 month apart.
|
Experimental: Arm 2
3 injections of Diamyd®
|
4 μg (0.1 mL) of Diamyd administered 1 month apart.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence of AEs (including Injection site reactions) and SAEs
Time Frame: From screening to 12 months.
|
From screening to 12 months.
|
Number of Clinically Significant Abnormal Results from Physical examinations, including neurological and Vital Signs assessments
Time Frame: From screening to 12 months.
|
From screening to 12 months.
|
Number of Clinically Significant Abnormal Results From Laboratory measurements, including hematology, clinical chemistry, metabolic status parameters (fasting C-peptide, HbA1c, fasting glucose) and urine analysis
Time Frame: From screening to 12 months.
|
From screening to 12 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stage progression
Time Frame: From screening to 12 months.
|
Number of individuals progressing from stage 1 to stage 2 and from stage 2 to stage 3.
|
From screening to 12 months.
|
T1D diagnosis
Time Frame: From screening to 12 months.
|
Time to T1D diagnosis.
|
From screening to 12 months.
|
Time to stage progression
Time Frame: From screening to 12 months.
|
Time from stage 1 to stage 2 and time from stage 2 to stage 3.
|
From screening to 12 months.
|
OGTT stimulated C-peptide
Time Frame: From screening to 12 months.
|
Change in C-peptide /insulin /glucose (Area Under the Curve [AUC]mean 0-120 min) during a 2-hour Oral Glucose Tolerance Test (OGTT) from screening to 12 months.
|
From screening to 12 months.
|
Change in Hemoglobin A1c (HbA1c)
Time Frame: From baseline to 12 months.
|
Change in Hemoglobin A1c (HbA1c) from baseline to 12 months.
|
From baseline to 12 months.
|
Change in time in glycemic target range
Time Frame: From screening to 12 months.
|
Change in time in glycemic target range 3.9 to 10 mmol/L (70 to 180 mg/dL) and 3.9 to 7.8 mmol/L (70 to 140 mg/dL) evaluated from continuous glucose monitoring (CGM) data from screening to 12 months.
|
From screening to 12 months.
|
Change in time in range > 13.9 mmol/L
Time Frame: From screening to 12 months.
|
Change in time in range > 13.9 mmol/L (> 250 mg/dL) evaluated from CGM data from screening to 12 months.
|
From screening to 12 months.
|
Change in time in range > 10 mmol/L
Time Frame: From screening to 12 months.
|
Change in time in range > 10 mmol/L (> 180 mg/dL) evaluated from CGM data from screening to 12 months.
|
From screening to 12 months.
|
Change in time in range > 7.8 mmol/L
Time Frame: From screening to 12 months.
|
Change in time in range > 7.8 mmol/L (> 140 mg/dL) evaluated from CGM data from screening to 12 months.
|
From screening to 12 months.
|
Change in glycemic variation
Time Frame: From screening to 12 months.
|
Change in glycemic variation (Coefficient of variation [CV], SD) evaluated from CGM data from screening to 12 months.
|
From screening to 12 months.
|
Variables that indicate effects on the immune system
Time Frame: From baseline to 12 months.
|
Variables that indicate effects on the immune system such as the concentration of serum autoantibodies.
|
From baseline to 12 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 14, 2023
Primary Completion (Estimated)
February 28, 2025
Study Completion (Estimated)
February 28, 2025
Study Registration Dates
First Submitted
December 20, 2022
First Submitted That Met QC Criteria
January 4, 2023
First Posted (Actual)
January 13, 2023
Study Record Updates
Last Update Posted (Estimated)
November 16, 2023
Last Update Submitted That Met QC Criteria
November 14, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DiaPrecise (D/P2/22/8)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Autoimmune Diseases
-
SanofiRecruitingHealthy Volunteers | Autoimmune DisorderUnited States
-
National Eye Institute (NEI)Completed
-
The Eye Center and The Eye Foundation for Research...CompletedAutoimmune Polyglandular Syndrome Type I | Autoimmune Keratitis
-
Sinocelltech Ltd.Not yet recruiting
-
TakedaCompletedAutoimmune DiseaseUnited Kingdom
-
Ziv HospitalUnknownAutoimmune DiseaseIsrael
-
National Institute of Allergy and Infectious Diseases...Immune Tolerance Network (ITN)TerminatedAutoimmune DisordersUnited States
-
Muğla Sıtkı Koçman UniversityCompletedMultiple Sclerosis | Telerehabilitation | Autoimmune Disorder | Exercise ProgramTurkey
-
Fundación Pública Andaluza Progreso y SaludKarolinska Institutet; Eli Lilly and Company; Medical University of Vienna; Sanofi and other collaboratorsCompletedSystemic Autoimmune DiseasesFrance, Belgium, Germany, Italy, Spain, Switzerland
-
Ruijin HospitalRecruiting
Clinical Trials on Diamyd
-
Oslo University HospitalTerminatedEnterovirus Infections | Diabetes, Type I | AutoimmunityNorway
-
Lund UniversityRegion SkaneCompleted
-
Diamyd Medical ABCompletedGlucose Metabolism Disorders | Immune System Diseases | Autoimmune Diseases | Diabetes Mellitus | Endocrine System Diseases | Diabetes Mellitus, Type 1 | Metabolic Disease | Vitamin D | Autoimmune Diabetes | Physiological Effects of Drugs | Juvenile Diabetes | Insulin Dependent DiabetesCzechia, Netherlands, Spain, Sweden
-
National Institute of Diabetes and Digestive and...TerminatedAutoimmune Diabetes | Diabetes Mellitus Type 1United States
-
Linkoeping UniversityDiamyd Medical ABCompletedDiabetes Mellitus, Type 1Sweden
-
Diamyd Therapeutics ABTerminatedType 1 Diabetes MellitusFrance, Germany, Finland, Italy, Netherlands, Slovenia, Spain, Sweden, United Kingdom
-
Johnny LudvigssonOstergotland County Council, Sweden; Diamyd Medical AB; Swedish Child Diabetes...CompletedDiabetes Mellitus, Type 1Sweden
-
Johnny LudvigssonDiamyd Medical AB; Swedish Child Diabetes Foundation; The Research Council of...CompletedDiabetes Mellitus, Type 1Sweden
-
Diamyd Therapeutics ABCompletedLatent Autoimmune Diabetes in Adult (LADA)Sweden
-
Diamyd Therapeutics ABCompletedType 1 DiabetesSweden