Itolizumab (T1h) combined with insulin in patients with Type I Diabetes Mellitus

Phase 1

Recruiting

• Conditions: Type 1 diabetes mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

• Registration Number: RPCEC00000225
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patient with a diagnosis of DM1 of not more than 12 weeks.
2. Patient under intensive treatment with insulin in stable dose, for at least 4 weeks before inclusion.
3. Patient aged 18-35 years (both included), of any sex or skin color.
4. Patient with stimulated C-peptide levels (MMTT) =0.2 pmol / ml, at not more than 8 weeks prior to inclusion.
5. Patient with clinical laboratory values: Hemogram: Hemoglobin-man = 12.0 g / dl, -women = 11.0 g / dl; Leukocytes> 4.5x109 cel / mL, Neutrophils> 1.8 x 109 / L, Lymphocytes> 1.2x109 cel / mL, Platelets> 150x109 / mL; Hepatic function: Transaminases within the normal reference values ??established in the institution (TGP <49 U / l and TGO <46 U / l); G-glutamyltransferase (GGT), men = 65 U / l, female = 45 U / l), Renal function: Creatinine <128 µmol / L
6. Patient who expressed in written form in their informed consent form their willingness to participate in the clinical trial.

Exclusion Criteria

1. Patient with severe malnutrition.
2. Patient with a history of severe chronic diseases of the Central Nervous System, Respiratory System, Cardiovascular Apparatus, Gastrointestinal Tract, or Genitourinary System.
3. Patient with a history of malignant neoplasia.
4. Patient suffering from acquired or congenital diseases of the hemolympho- opetic system.
5. Patient with clinically detected acute or chronic infection (laboratory tests and chest X-rays, including HIV infection, Hepatitis B and C, Epstein Bar and Cytomegalovirus).
6. Patient suffering from bronchial asthma, atopic dermatitis or chronic urticaria.
7. Patient receiving hyperglycemic drugs (beta-blockers, ACE inhibitors, Nicotinic Acid, Interferon).
8. Patient with ongoing treatment or in the last six months with high doses of steroids or other immunosuppressive agents (imuran, azatriopine, methotrexate, cyclophosphamide, cyclosporin A, tacrolimus, mycophenolate-mofetil, immunoglobulin ev [> 400 mg / kg]) .
9. Pregnancy, puerperium and / or breastfeeding.
10. Patient woman and man with reproductive capacity who refuse to avoid conception during the study.
11. Patient with a history of alcoholism or drug addiction.
12. Patient with history of allergy attributed to compounds of chemical or biological composition similar to the monoclonal antibody T1h.
13. Patient with intellectual or sensory psychological dysfunction that may impede the understanding and fulfillment of study requirements according to the Principal Investigator's criteria.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety outcomes:<br>Incidence of Adverse Events (AE) (type (name of AE), Intensity (Mild, Moderate, Severe), Gravity (Serious, Not serious), causality relationship (Very Likely, Likely, Possible, Not related, Unknown). Measuring time: 52 weeks.<br>

Secondary Outcome Measures

Name	Time	Method
Efficacy outcomes: <br>-Area under the curve (AUC) of stimulated C-peptide production. Measurement Time: Initial Evaluation, Weeks 25, 36 and 52<br>-Peak of stimulated C-peptide production. Measurement Time: Initial Evaluation, Weeks 25, 36 and 52<br>-Non-stimulated C-peptide. Measurement Time: Initial Evaluation, Weeks 25, 36 and 52<br>-Glycosylated hemoglobin, HbA1c (%). Measurement Time: Initial Evaluation, Weeks 25, 36 and 52<br>-Doses of basal, prandial and total daily insulin (IU, IU / kg). Measuring time: 52 weeks.<br>-Fasting and postprandial glycemia based on laboratory blood chemistry. Measurement time: initial evaluation, before receiving 5th administration, one week after administration 9, one week after administration 13 and during follow-up at weeks 36, 44 and 52<br>-Glucose by self-monitoring (glucometer). Measuring time: 52 weeks.