Type 1 diabetes MedDRA version: 20.0 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: Diamyd
Product Code: rhGAD65 formulated in alum (GAD-alum)
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: recombinant human GAD65
Current Sponsor code: RHGAD65
Other
Sponsors
Diamyd Medical AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent given by patients and/or patient’s parent(s) or legal acceptable representative(s) (guardian(s)) according to national regulations 2. T1D according to the ADA classification diagnosed =6 months at the time of screening 3. Age: =12 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted) 2. Continuous treatment with anti-inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted) 3. Treatment with any oral or injected anti-diabetic medications other than insulin 4. Treatment with Vitamin D, marketed or not, or unwilling to abstain from such medication during the trial 5. A history of anemia or significantly abnormal hematology results at screening 6. A history of epilepsy, head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles 7. Clinically significant history of acute reaction to vaccines or other drugs in the past 8. Treatment with any vaccine, including influenza vaccine, within 4 months prior to planned first study drug dose or planned treatment with any vaccine up to 4 months after the last injection with study drug. 9. Participation in other clinical trials with a new chemical entity within the previous 3 months 10. Inability or unwillingness to comply with the provisions of this protocol 11. A history of alcohol or drug abuse 12. A significant illness other than diabetes within 2 weeks prior to first dosing 13. Known HIV or hepatitis 14. Females who are lactating or pregnant (the possibility of pregnancy must be excluded by urine ßHCG on-site within 24 hours prior to the Diamyd/placebo treatment) 15. Presence of associated serious disease or condition, including active skin infections that preclude intralymphatic injection, which in the opinion of the investigator makes the patient non-eligible for the study 16. Deemed by the investigator not being able to follow instructions and/or follow the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy of Diamyd, administered into lymph nodes in combination with an oral vitamin D regimen, compared to placebo in terms of preserving endogenous insulin secretion as measured by C-peptide.;Secondary Objective: The secondary objectives are to compare Diamyd, administered into lymph nodes in combination with an oral vitamin D regimen and placebo treatment with respect to the effects on the diabetes status, treatment safety, immune system and quality of life (QoL) of the patients.;Primary end point(s): • Change in C-peptide (Area Under the Curve [AUC]mean 0-120 min-) during a Mixed Meal Tolerance Test (MMTT) between baseline to 15 months.;Timepoint(s) of evaluation of this end point: between baseline to 15 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The key secondary endpoints to evaluate diabetic status are: •Change in insulin-dose-adjusted HbA1c (IDAA1c) between baseline and 15 months. •Change in HbA1c between baseline and 15 months. •Change in daily exogenous insulin consumption between baseline and 15 months. The other secondary endpoints to evaluate diabetic status are: •Change in glycemic variability/fluctuations (evaluated from data from continuous glucose monitoring FreeStyle LibrePro, Flash Glucose Monitoring [FGM]) over 14 day period between Screening and 15 months. •Proportion of patients with IDAA1c = 9 at 15 months. • Proportion of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 15 months. • Proportion of patients with a stimulated 90min C-peptide level above 0.2 nmol/L at 15 months. •Number of self-reported episodes of severe hypoglycemia (Severe hypoglycemia defined as needing help from others and/or seizures and/or unconscious) between baseline and 15 months •Change in Rate of hypoglycemic events between baseline and 15 months. •Number of patients having at least 1 severe hypoglycemic event between baseline and 15 months • Change in maximum C-peptide during MMTT between baseline and 15 months. •Change in Fasting C-peptide between baseline and 15 months. • C-peptide measured at 30, 60, 90, es during MMTT at 15 months. •Change in body weight and body mass index (BMI) between baseline and 15 months The secondary endpoints to evaluate safety are: • Injection site reactions • Occurrence of AEs • Laboratory measurements (hematology and clinical chemistry) • Urinalysis (microalbuminuria, creatinine) • Physical examinations, including neurological assessments • GAD65A titer • Vital signs (blood pressure) The secondary endpoints to evaluate the influence on the immune system are: • Concentrations of serum autoantibodies towards GAD65 and IA • Concentrations of serum autoantibody isotypes towards GAD65. • Secretion of cytokines interleukin (IL)-1, IL-2, I | — |
Countries
Czech Republic, Netherlands, Spain, Sweden
Contacts
Public ContactProject Leader - Clinical Trial
TFS Trial Form Support International AB
Outcome results
None listed