Newly diagnosed Type 1 Diabetes diagnosed within the previous three weeks at time of screening. Female and male patients between the ages of 6 and 15 years will be recruited. MedDRA version: 19.1 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Division pf Paediatric and Adolescent Medicine, Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following conditions must apply to the prospective patient at screening prior to receiving study agent: 1. Diagnosed type 1 Diabetes (E10.9). First injection of insulin maximum three weeks prior to inclusion. 2. Must be willing and capable of taking the study drugs and meet for tests and follow up as described. 3. Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations. 4. Aged 6-15 years at inclusion. Are the trial subjects under 18? yes Number of subjects for this age range: 96 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded from taking part in the study if they meet any of the following criteria: 1. Treatment with any oral or injected anti-diabetic medications other than insulin or any of the study drugs. 2. A history of haemolytic anaemia or significantly abnormal haematology results at screening (Hb<11g/dl). 3. Participation in other clinical trials with a new chemical entity within the previous 3 months. 4. Inability or unwillingness to comply with the provisions of this protocol 5. Females who are lactating or pregnant. Males or females (after menarche) not willing to use adequate contraception, if sexually active, until 6 months after the last study drug administration. 6. Presence of serious disease or condition, which in the opinion of the investigator makes the patient non-eligible for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main study objective is to describe the influence of antiviral treatment (Pleconaril +Ribavirin) versus placebo on progression of disease and residual insulin secretion in patients diagnosed with type 1 diabetes at the age 6 -15 years. The study design a double-blind, placebo controlled, prospective, randomized trial examining the effect of antiviral treatment given for 6months on residual insulin secretion. ;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint is change in mean residual insulin secretion measured by Mixed Meal Tolerance Test (MMTT) stimulated C-peptide two-hour area under the curve profile from visit 1 to12 months after initiation of study treatment.;Timepoint(s) of evaluation of this end point: 12 months after inclusion in the study and initiation of study treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary end points are: 1. Change in mean residual insulin secretion measured by stimulated C-peptide two-hour area under the curve profile visit 1 to 3 months, 6 months, 24 months and 36 months 2. Proportion of patients with peak residual insulin secretion measured by MMTT: stimulated C-peptide >0,2 pmol/L. 3.Fasting and meal stimulated C-peptide from blood sampled on filter paper at home at two weekly intervals per month in 12 months and then at 4 weekly intervals 4. Mean Insulin dosage per kilo bodyweight for 24 hours one week before each control 5. HbA1c at every control 6. Number of severe hypoglycemic events 7. Insulin-dose-adjusted HbA1c (IDAA1c) 8. Proinsulin/c-peptide ratio in serum as a measure of beta cell stress 9. Change in presence of Enterovirus (PCR) in nose, blood and stool;Timepoint(s) of evaluation of this end point: 3 months, 6 months, 24 months and 36 months after inclusion in the study and initiation of study treatment. | — |
Countries
Denmark, Norway, Sweden
Contacts
Public ContactKnut Dahl-Jorgensen
Division of Paediatric and Adolescent Medicine, Oslo University Hospital
Outcome results
None listed