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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Jewish General Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

A proof-of-concept for safety and preliminary clinical efficacy of a combined regimen of INGAP-P for β-cell regeneration and ustekinumab for IL-12-23 autoimmune modulation in patients with established T1DM.

Detailed description

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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	INGAP Peptide, Ustekinumab

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-03-08
• Completion: 2017-03-08
• First posted: 2014-07-30
• Last updated: 2017-05-30

Locations

1 site across 1 country: Canada