Type 1 Diabetes Clinical Trial
Official title:
A Phase II, Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Study to Investigate the Impact of Diamyd® on the Progression of Diabetes in Patients Newly Diagnosed With Type 1 Diabetes Mellitus
Verified date | January 2008 |
Source | Diamyd Therapeutics AB |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Medical Products Agency |
Study type | Interventional |
This is a randomized, placebo-controlled phase II study to investigate if a prime and boost of 20ug Diamyd® (rhGAD65 formulated in Alhydrogel®), administered subcutaneously four weeks apart, is safe and can preserve beta cell function in children and adolescents with type 1 diabetes with a diabetes duration less than 18 months at intervention.
Status | Completed |
Enrollment | 70 |
Est. completion date | December 2007 |
Est. primary completion date | October 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 10 Years to 18 Years |
Eligibility |
Key Inclusion Criteria: - Male and female patients between 10 and 18 years of age, diagnosed with type 1 diabetes within 18 months - Fasting C-peptide level above 0.1 nmol/l - Presence of GAD65 antibodies - Written informed consent (patient and parent/guardian) Key Exclusion Criteria: - Secondary diabetes mellitus or MODY - Treatment with immunosuppressants - Treatment with any vaccine within 1 month prior to first Diamyd® dose or planned treatment with vaccine up to 2 months after the second Diamyd® dose - Participation in other clinical trials with a new chemical entity within the previous 3 months - History of certain diseases or conditions (e.g. epilepsy, anaemia, alcohole or drug abuse) - HIV or hepatitis - Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study - Pregnancy (or planned pregnancy within one year after 2nd administration) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Borås Hospital | Borås | |
Sweden | The Queen Silvia Children´s Hospital | Göteborg | |
Sweden | Halmstad Hospital | Halmstad | |
Sweden | Ryhov Hospital | Jönköping | |
Sweden | Linköping University | Linköping | |
Sweden | University Hospital, MAS | Malmö | |
Sweden | Örebro University Hospital | Örebro | |
Sweden | Astrid Lindgren Children´s Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Diamyd Therapeutics AB |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the efficacy of Diamyd® 20ug versus placebo with respect to preserving residual insulin secretion as measured by C-peptide levels. The effect of intervention will be evaluated at month 15 (main study period) and at month 30 (Extension phase). | |||
Secondary | To evaluate the safety of Diamyd® 20ug. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05653518 -
Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes
|
N/A | |
Enrolling by invitation |
NCT05515939 -
Evaluating the InPen in Pediatric Type 1 Diabetes
|
||
Completed |
NCT05109520 -
Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
|
||
Recruiting |
NCT04016987 -
Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT04190368 -
Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes
|
N/A | |
Recruiting |
NCT05413005 -
Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus
|
Early Phase 1 | |
Active, not recruiting |
NCT04668612 -
Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes
|
N/A | |
Completed |
NCT02837094 -
Enhanced Epidermal Antigen Specific Immunotherapy Trial -1
|
Phase 1 | |
Recruiting |
NCT05414409 -
The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
|
Phase 2 | |
Recruiting |
NCT05670366 -
The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT05418699 -
Real-life Data From Diabetic Patients on Closed-loop Pumps
|
||
Completed |
NCT04084171 -
Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6
|
N/A | |
Recruiting |
NCT06144554 -
Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
|
||
Recruiting |
NCT05379686 -
Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
|
N/A | |
Recruiting |
NCT05153070 -
Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes
|
Phase 2 | |
Completed |
NCT05281614 -
Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D
|
Early Phase 1 | |
Withdrawn |
NCT04259775 -
Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT01600924 -
Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
|
||
Completed |
NCT02897557 -
Insulet Artificial Pancreas Early Feasibility Study
|
N/A | |
Completed |
NCT02914886 -
Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS)
|
Phase 4 |