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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
No effect of the altered peptide ligand NBI-6024 on β-cell residual function and insulin needs in new-onset type 1 diabetes
Diabetes Care, Volume 32, No. 11, Year 2009
Notification
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Description
OBJECTIVE - This randomized, four-arm, placebo-controlled, dose-ranging phase 2 trial was conducted to determine whether repeated subcutaneous injections of the altered peptide ligand, NBI-6024, designed to inhibit autoreactive T-cells, improves β-cell function in patients with recently diagnosed type 1 diabetes. RESEARCH DESIGN AND METHODS - A total of 188 patients, aged 10-35 years, with recently diagnosed type 1 diabetes were randomly assigned for a treatment consisting of the subcutaneous administration of placebo or 1, 0.5, or 0.1 mg NBI-6024 at baseline, weeks 2 and 4, and then monthly until month 24. Fasting, peak, and area under the curve (AUC) C-peptide concentrations during a 2-h mixed-meal tolerance test were measured at 3-month intervals during treatment. Immune function parameters (islet antibodies and CD4 and CD8 T-cells) were also studied. RESULTS - The mean peak C-peptide concentration at 24 months after study entry showed no significant difference between the groups treated with 0.1 mg (0.59 pmol/ml), 0.5 mg (0.57 pmol/ml), and 1.0 mg NBI-6024 (0.48 pmol/ml) and the placebo group (0.54 pmol/ml). Fasting, stimulated peak, and AUC C-peptide concentrations declined linearly in all groups by ∼60% over the 24-month treatment period. The average daily insulin needs at month 24 were also comparable between the four groups. No treatment-related changes in islet antibodies and T cell numbers were observed. CONCLUSIONS - Treatment with altered peptide ligand NBI-6024 at repeated doses of 0.1, 0.5, or 1.0 mg did not improve or maintain β-cell function. © 2009 by the American Diabetes Association.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC2768201/bin/supp_32_11_2036__index.html
https://efashare.b-cdn.net/share/pmc/articles/PMC2768201/bin/supp_dc09-0449_dc09-0449_Online_Appendix.doc
Authors & Co-Authors
Walter, Markus
Germany, Munich
Institut Für Diabetesforschung
Philotheou, Areti
South Africa, Cape Town
Faculty of Health Sciences
Bonnici, François B.
South Africa, Cape Town
Faculty of Health Sciences
Ziegler, Anette Gabriele
Germany, Munich
Institut Für Diabetesforschung
Jimenez, Roland G.
United States, San Diego
Clinical Development
Statistics
Citations: 121
Authors: 5
Affiliations: 3
Identifiers
Doi:
10.2337/dc09-0449
ISSN:
01495992
e-ISSN:
19355548
Research Areas
Noncommunicable Diseases