DIABGAD - Trial to Preserve Insulin Secretion in Type 1 Diabetes Using GAD-Alum (Diamyd) in Combination With Vitamin D and Ibuprofen

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Pilot Trial to Preserve Residual Insulin Secretion in Children and Adolescents With Recent Onset Type 1 Diabetes by Using GAD-antigen (Diamyd) Therapy in Combination With Vitamin D and Ibuprofen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01785108
• Other study ID #: DIABGAD-1
• Status: Completed
• Phase: Phase 2
• First received: February 1, 2013
• Last updated: August 22, 2017
• Start date: February 2013
• Est. completion date: March 2017

Study information

• Verified date: August 2017
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objectives of this study is to

• evaluate the safety and influence of treatment with GAD-Alum (Diamyd) combined with Vitamin D and Ibuprofen on preservation of residual insulin secretion in recently diagnosed Type 1 Diabetes

• evaluate how the above mentioned treatments influence the immune system of the subjects and interact with any viral infections

• evaluate the safety and influence of treatment with double dose of GAD-Alum (Diamyd) plus Vitamin D on the immune system, viral infections, and on preservation of residual insulin secretion in recently diagnosed Type 1 Diabetes

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Main Inclusion Criteria:

• Male and female patients between 10 and 18 years of age

• Insulin dependent Type 1 Diabetes mellitus diagnosed within the previous 4 months at time of screening

• Fasting C-peptide level at time of screening above or equal to 0.12 nmol/L

• Elevated GAD65 antibodies (GADA) at time of screening

Main Exclusion Criteria:

• Treatment with immunosuppressants, continuous anti-inflammatory drug, Vitamin D or any anti-diabetic medications other than insulin

• A history of certain diseases or conditions (e.g. anemia, HIV, epilepsy, head trauma, neurological diseases or cerebrovascular accident, alcohol or drug abuse etc)

• Treatment with any vaccine within 4 months prior to first planned administration of GAD-Alum/placebo or planned treatment with vaccine up to 4 months after the last injections with GAD-Alum/Placebo, including influenza vaccines

• Participation in other clinical trials with a new chemical entity within the previous 3 months

• Pregnancy or planned pregnancy within 1 year after the last GAD-Alum/placebo dose

• Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Biological:
• GAD-Alum (Diamyd) 20 µg

• GAD-Alum (Diamyd) 20 µg X 2

Drug:
• Vitamin D

• Ibuprofen

Locations

Country	Name	City	State
Sweden	Halmstad Hospital	Halmstad
Sweden	Astrid Lindgren Children's Hospital - Huddinge	Huddinge
Sweden	Kalmar Hospital	Kalmar
Sweden	Linköping University	Linköping
Sweden	Lund University Hospital	Lund
Sweden	Skåne University Hospital, UMAS	Malmö
Sweden	Örebro University Hospital	Örebro
Sweden	Astrid Lindgren Children's Hospital	Stockholm
Sweden	Sachsska, Södersjukhuset	Stockholm
Sweden	Uddevalla Hospital	Uddevalla

Sponsors (4)

Lead Sponsor	Collaborator
Johnny Ludvigsson	Diamyd Medical AB, Swedish Child Diabetes Foundation, The Research Council of South East Sweden (FORSS)

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in C-peptide (90 minute value and AUC mean 0-120 min) during a Mixed Meal Tolerance Test from baseline to month 6, 15 and 30		6 months, 15 months and 30 months
Secondary	Proportion of patients with a stimulated maximum C-peptide level above 0.2 nmol/L		6, 15 and 30 months
Secondary	Hemoglobin A1c (HbA1c), change between baseline and subsequent visits		6, 15 and 30 months
Secondary	Exogenous insulin dose per kg body weight and 24 hours, change between baseline and subsequent visits		6, 15 and 30 months
Secondary	Th2-deviation of cell-mediated immune response seen, e.g. as increased ratio of IL-5, 10, 13 in comparison with IFN-gamma, TNF-alfa, IL-1 beta, IL-17, and increase of T-regulatory cells		6, 15 and 30 months
Secondary	Decrease in inflammatory markers, e.g. TNF-alfa, IL-1 beta, IL-2, IL-17		6, 15 and 30 months
Secondary	Fasting C-peptide, change between baseline and month 6, 15 and 30		6, 15 and 30 months