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At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
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Published in: Trials 1/2019

Open Access 01-12-2019 | Study protocol

Effects of Lysulin™ supplementation on pre-diabetes: study protocol for a randomized controlled trial

Authors: Priyanga Ranasinghe, Ranil Jayawardena, Lal Chandrasena, Vivianne Noetzel, John Burd

Published in: Trials | Issue 1/2019

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Abstract

Background

Diabetes mellitus is rapidly becoming one of the leading causes of morbidity and mortality worldwide. Preventive measures have become important, especially in the South Asian region and other parts of the world where diabetes is becoming increasingly prevalent. We postulate that a product containing amino acid lysine, micronutrient zinc and vitamin C will have beneficial effects on glycemic control and disease progression in patients with pre-diabetes and we aim to evaluate this hypothesis using a phase II/III randomized double-blind controlled clinical trial design.

Methods/design

The study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for a period of 6 months. The study has been approved by the Ethics Review Committee of Faculty of Medicine, University of Colombo, Sri Lanka. A total of 110 adults with pre-diabetes will be recruited for the study. They will be randomly assigned to the test and placebo groups on a 1:1 ratio. The test group will receive two tablets of Lysulin™ three times a day and the control group will receive identical placebo tablets. The study drugs will be double blinded to both investigators and subjects. The visits and the evaluations will be done as follows: screening (visit 0), 1 month (visit 1), 3 months (visit 2) and 6 months (visit 4). The primary outcome will be defined as change in glycemic control measured by HbA1c from baseline. Data will be analyzed using SPSS v16.

Discussion

To our knowledge this is one of the first randomized controlled trials evaluating the effects of Lysulin™ (a combination of lysine, vitamin C and zinc) in pre-diabetes. This study will provide the necessary groundwork for future large-scale multicentered clinical trials. The result, positive or negative, should provide a step change in the evidence guiding current and future policies regarding management of pre-diabetes.

Trial registration

Sri Lanka Clinical Trials Registry, SLCTR/​2018/​022. Registered on 13 July 2018. Study protocol version 2.0 (23 March 2018).
Appendix
Available only for authorised users
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Metadata
Title
Effects of Lysulin™ supplementation on pre-diabetes: study protocol for a randomized controlled trial
Authors
Priyanga Ranasinghe
Ranil Jayawardena
Lal Chandrasena
Vivianne Noetzel
John Burd
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3269-8

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