GAD-Alum (Diamyd) Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 80
Summary
- Conditions
- Immune System Diseases
- Autoimmune Diabetes
- Autoimmune Diseases
- Diabetes Mellitus
- Diabetes Mellitus - Type 1
- Vitamin D
- Endocrine System Diseases
- Glucose Metabolism Disorders
- Insulin Dependent Diabetes
- Juvenile Diabetes
- Metabolic Disease
- Physiological Effects of Drugs
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The study is a 2-arm, randomized, double-blind, placebo-controlled, multicenter, clinical trial.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 12 years and 24 years
- Gender
- Both males and females
Description
The study is a 2-arm, randomized, double-blind, placebo-controlled, multicenter, clinical trial. Eligible patients will receive injections of Diamyd/placebo into an inguinal lymph gland at three occasions, with one month intervals in combination with an oral vitamin D/placebo regimen (starting 1 mon...
The study is a 2-arm, randomized, double-blind, placebo-controlled, multicenter, clinical trial. Eligible patients will receive injections of Diamyd/placebo into an inguinal lymph gland at three occasions, with one month intervals in combination with an oral vitamin D/placebo regimen (starting 1 month ahead of injections) during 4 months. All patients will continue to receive intensive insulin treatment from their personal physicians during the whole study period. The patients will be followed in a blinded manner for a total of 15 months. All patients that have not performed the 15 months visit when the updated protocol is implemented, will be asked to participate in the Extension Study Period which includes an additional visit at month 24.
Tracking Information
- NCT #
- NCT03345004
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Johnny Ludvigsson, MD, Prof Universitetssjukhuset i Linköping
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