- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02204397
Study of Tolerability and Safety of Adding Ustekinumab to INGAP Peptide for 12 Weeks in Adult Patients With TD1 Melitis
A Single-center, Open-Label, Exploratory Study to Assess the Tolerability and Safety of the Addition of Ustekinumab to INGAP Peptide for 12 Weeks in Adult Patients With Type 1 Diabetes Mellitus
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The primary objective of this study is to assess the safety and tolerability of 12 weeks of subcutaneous (SC) daily administration of INGAP-P (600 mg SC once a day in three separate injection sites) with ustekinumab (two single injections of 45 mg SC, one as pretreatment two weeks before INGAP-P treatment begins and the second one after 2 weeks of INGAP-P treatment) in adult patients with established type 1 diabetes mellitus (T1DM). Safety will be evaluated by assessing local tolerability, recording incidence of hypoglycemia, performing safety laboratory measures at frequent intervals, and following subjects very closely for any adverse events (AEs).
Secondary objectives of this study are to generate preliminary data on the efficacy of INGAP-P and ustekinumab in adult patients with established T1DM, specifically by change from baseline to Week 12 in: 1) Maximal C-peptide (Cmax) during mixed meal test (MMT) and glucagon stimulated test (GST); 2) C-peptide release (AUC) during MMT and GST; 3) Fasting C-peptide; 4) Fasting glucose (before breakfast and after at least 8 hours of fasting); 5) Longer term glycemic control as reflected by glycosylated hemoglobin (HbA1c) and 1,5-anhydroglucitol (1,5-AG); and, 6) Total daily insulin dose relative to body weight.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Quebec
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Montreal, Quebec, Canada, H3G 1A4
- Montreal General Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Male and female patients between the ages of 19 and 40 years old, inclusive, with a history of T1DM for >2 years and ≤20 years;
- Female patients will not be breast-feeding during the study or within at least seven days after the study is completed;
- Receiving multiple daily insulin injections or insulin pump therapy for >2 years;
- Body mass index (BMI) ≤32 kg/m2 and total body weight <100 kg;
- HbA1c ≤8.2%,
- Fasting C-peptide levels >0.1 ng/mL and <1.0 ng/mL;
- CBC and platelet counts must be within normal limits, and specifically, the total absolute neutrophil count must not be <1500/μL;
- Willing to sign the study informed consent document;
- In good general health with no infections, active tuberculosis (TB), late severe complications, or concomitant medical conditions that would influence the outcome of the trial, at the discretion of the Investigator and the Sponsor;
- If treated with angiotensin-converting enzymes/angiotensin II receptor blockers (ACE/ARB), the doses should be unchanged for a month prior to enrollment;
Females of child bearing potential must have a negative urine pregnancy test on Day 0 prior to dispensing drug and should additionally fulfill one of the following criteria:
- Willing to use oral, implantable, transdermal, or injectable contraceptives for 21 days prior to the first dose and until 28 days after the last dose; or,
- Willing to use another reliable means of contraception approved by the Investigator (intrauterine device, female condom, diaphragm with spermicide, cervical cap, use of condom by sexual partner, or a sterile sexual partner) from Screening until after the last blood sample (at Week 16).
Exclusion Criteria:
- Total daily insulin dosage exceeding 1.0 U/kg/day or a change in total daily insulin dose level of more than 50% (increase or decrease) within the past 3 months;
- Treatment with any diabetes medication other than insulin;
- A score of 4 or more restricted responses on the Clarke Hypoglycemia Awareness Survey;
- Systolic or diastolic blood pressure >180 mmHg or >110 mmHg, respectively;
- Clinical worsening of retinopathy or neuropathy in the previous 3 months;
- Clinical worsening of nephropathy in the previous 3 months, or serum creatinine exceeding 2.0 mg/dL,;
- History or presence of acute or chronic pancreatitis, including a serum amylase level >1.5 times the upper limit of normal (ULN) or a serum lipase level >2 times ULN;
- Active infections at screening and during the study;
- History of asthma;
- History of TB;
- Administration of bacille Calmette-Guérin (BCG) vaccine for TB during the one year before the Screening Visit or one year after the last dose of ustekinumab;
- A history or presence of any illness, disease, or condition (including cancer) that could impact patient safety or evaluability of drug effect, in the Investigator"s opinion;
- An episode of severe hypoglycemia (change in mental status requiring assistance) during the previous 30 days;
- An episode of acute glycemic decompensation with associated hyperosmolar non-ketotic state or diabetic ketoacidosis during the past 6 months;
- A serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin level >2 times ULN;
- Received any investigational product within 30 days of admission into this study or had any prior or existing exposure to INGAP-P, glucagon-like peptides (GLP-1, GLP-2, or analogs), ustekinumab, or TNF blocking agents (Patients that participated in the placebo group of previous INGAP-P study E-201 are not excluded from this study.);
- Known hypersensitivity to INGAP-P or any excipient used in the formulation;
- Known hypersensitivity to ustekinumab or any components of the product;
- Concurrent or planned participation in any other clinical study during the conduct of this study;
- Positive urine test for cocaine, opiates, amphetamines, or cannabinoids;
- Inability to fill out and maintain a daily diary during the screening period prior to dosing;
- Human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C seropositivity in blood sample taken during screening.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: INGAP Peptide, Ustekinumab
INGAP Peptide, Ustekinumab subcutaneous
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Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Safety and tolerability
Délai: 6 months
|
The tolerability of injections and general safety will be assessed on the basis of patient recorded diaries, assessments of cutaneous injection sites during clinic visits, clinical observations, severity of AEs recorded by the Medical Dictionary for Regulatory Activities (MedDRA), measurement of vital signs, physical examinations, electrocardiograms (ECGs), and clinical laboratory evaluations.
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6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Composite C-Peptide efficacy according to specific parameters
Délai: 6 months
|
Composite secondary objectives of this study are to generate preliminary data on the efficacy of INGAP-P and ustekinumab in adult patients with established T1DM, specifically by change from baseline to Week 12-13 in:
|
6 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: George Tsoukas, MD, Department of Endocrinology and Metabolism, Montreal General Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- JewishGH
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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