Trials / Completed
CompletedNCT03345004
Diamyd Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes
A Phase IIb, 2-Arm, Randomized, Double-blind, Placebo-Controlled, Multicentre Study to Optimize Diamyd Therapy Administered Into Lymph Nodes Combined With Oral Vitamin D to Investigate the Impact on the Progression of Type 1 Diabetes
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 109 (actual)
- Sponsor
- Diamyd Medical AB · Industry
- Sex
- All
- Age
- 12 Years – 24 Years
- Healthy volunteers
- Not accepted
Summary
The objective of DIAGNODE-2 is to evaluate the efficacy of Diamyd compared to Placebo, upon administration directly into a lymph node in combination with an oral vitamin D/Placebo regimen, in terms of preserving endogenous insulin secretion as measured by C-peptide.
Detailed 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 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.
Conditions
- Diabetes Mellitus, Type 1
- Diabetes Mellitus
- Autoimmune Diseases
- Metabolic Disease
- Glucose Metabolism Disorders
- Immune System Diseases
- Endocrine System Diseases
- Juvenile Diabetes
- Insulin Dependent Diabetes
- Autoimmune Diabetes
- Vitamin D
- Physiological Effects of Drugs
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Diamyd | Alhydrogel®-formulated recombinant human glutamic acid decarboxylase (rhGAD65) |
| DIETARY_SUPPLEMENT | Vitamin D | Oil suspension of Vitamin D |
| BIOLOGICAL | Placebo for Diamyd | Alhydrogel® only |
| DIETARY_SUPPLEMENT | Placebo for Vitamin D | Placebo oil suspension for Vitamin D |
Timeline
- Start date
- 2017-12-20
- Primary completion
- 2020-07-13
- Completion
- 2021-04-27
- First posted
- 2017-11-17
- Last updated
- 2023-01-09
- Results posted
- 2023-01-09
Locations
18 sites across 4 countries: Czechia, Netherlands, Spain, Sweden
Source: ClinicalTrials.gov record NCT03345004. Inclusion in this directory is not an endorsement.