Journal article
Treatment of Recent- Onset Type 1 Diabetic Patients With DiaPep277: Results of a Double- Blind, PlaceboControlled, Randomized Phase 3 Trial
Diabetes Care, Vol.37(5), pp.1392-1400
May/2014
Abstract
OBJECTIVETo evaluate safety and efficacy of DiaPep277 in preserving -cell function in type 1 diabetic patients.RESEARCH DESIGN AND METHODSDIA-AID 1 is a multinational, phase 3, balanced-randomized, double-blind, placebo-controlled, parallel-group clinical study. Newly diagnosed patients (N = 457, aged 16-45 years) were randomized to subcutaneous injections of DiaPep277 or placebo quarterly for 2 years. The primary efficacy end point was the change from baseline in the area under the glucagon-stimulated C-peptide curve. Secondary end points were the change from baseline in mixed-meal stimulated C-peptide secretion and in fasting C-peptide and achieving target HbA(1c) 7% (53 mmol/mol). Partial remission (target HbA(1c) on insulin 0.5 units/kg/day) and hypoglycemic event rate were exploratory end points.RESULTSDiaPep277 was safe and well tolerated. Significant preservation of C-peptide secretion was observed in the DiaPep277-treated group compared with the placebo (relative treatment effects of 23.4%, P = 0.037, and 29.2%, P = 0.011, in the modified intent-to-treat [mITT] and per-protocol [PP] populations, respectively). The mixed-meal stimulation failed to distinguish between the groups. There was a trend toward efficacy in fasting C-peptide levels, though not statistically significant. Significantly more DiaPep277-treated than placebo-treated patients maintained target HbA(1c) (mITT 56% versus 44%, P = 0.03; PP 60% versus 45%, P = 0.0082) and entered partial remission (mITT 38% versus 29%, P = 0.08; PP 42% versus 30%, P = 0.035). DiaPep277 treatment reduced the relative hypoglycemic event risk (mITT by 20%; PP by 28%).CONCLUSIONSDiaPep277 safely contributes to preservation of -cell function and to improved glycemic control in patients with type 1 diabetes.
Details
- Title
- Treatment of Recent- Onset Type 1 Diabetic Patients With DiaPep277; Results of a Double- Blind, PlaceboControlled, Randomized Phase 3 Trial
- Creators
- Itamar Raz (null)Anette G. Ziegler (null)Thomas Linn (null)Guntram Schernthaner (null)Francois Bonnici (null)Larry A. Distiller (null)Carla Giordano (null)Francesco Giorgino (null)Vries, Liat de Vries (null)Didac Mauricio (null)Vlastimil Prochazka (null)Julio Wainstein (null)Dana Elias (null)Ann Avron (null)Merana Tamir (null)Rachel Eren (null)Dana Peled (null) - The Weizmann Institute of ScienceShlomo Dagan (null)Irun R. Cohen (null) - The Weizmann Institute of SciencePaolo Pozzilli (null)
- Resource Type
- Journal article
- Publication Details
- Diabetes Care, Vol.37(5), pp.1392-1400; May/2014
- Number of pages
- 9
- Language
- English
- DOI
- https://doi.org/10.2337/dc13-1391
- Grant note
- Andromeda BiotechThis clinical study was funded by Andromeda Biotech. I. R. is a consultant to Andromeda Biotech and was head of the steering committee for the trial. T. L. is a consultant to Andromeda Biotech. F. B. is a consultant to Andromeda Biotech. D. E., A. A., M. T., R. E., D. P., and S. D. are employees of Andromeda Biotech. I. R. C. is a consultant to Andromeda Biotech. D. E. and I. R. C. are also the inventors of DiaPep277. P. P. is a consultant to Andromeda Biotech and received travel grants. No other potential conflicts of interest relevant to this article were reported._ALMAME_DELIMITER_
- Record Identifier
- 993262478703596
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