INnoVative trial design for testing the Efficacy, Safety and Tolerability of 6-month treatment with incretin-based therapy to prevent type 1 DIAbetes in autoantibody positive participants : a protocol for three parallel double-blind, randomised controlled trials (INVESTDIA)
Kero, Jukka; Koskenniemi, Jaakko J.; Karsikas, Sara; Pokka, Tytti; Lou, Olivia; Toppari, Jorma; Veijola, Riitta (2022-07-07)
Kero, J., Koskenniemi, J. J., Karsikas, S., Pokka, T., Lou, O., Toppari, J., & Veijola, R. (2022). innovative trial design for testing the efficacy, safety and tolerability of 6‐month treatment with incretin‐based therapy to prevent type 1 diabetes in autoantibody positive participants: A protocol for three parallel double‐blind, randomised controlled trials(investdia). Diabetic Medicine, 39(10). https://doi.org/10.1111/dme.14913
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https://creativecommons.org/licenses/by-nc/4.0/
https://urn.fi/URN:NBN:fi-fe2022122873927
Tiivistelmä
Abstract
Aims: β-cell stress and dysfunction may contribute to islet autoimmunity and progression to clinical type 1 diabetes. We present a protocol of three randomised controlled trials assessing the effects of glucagon-like peptide 1 (GLP − 1) analogue liraglutide in three early stages of type 1 diabetes.
Methods: We will test 10- to 30-year-old people with multiple islet autoantibodies for their glucose metabolism and randomise participants with stage 1 (multiple islet autoantibodies and normoglycaemia), stage 2 (multiple islet autoantibodies and dysglycaemia) and early stage 3 (clinical diagnosis) type 1 diabetes, 10−14 persons in each, to a 6-month intervention with liraglutide or placebo with 6-month follow-up in the stage 2 and stage 3 trials and 18-month follow-up in the stage 1 trial. Primary efficacy outcome in the stage 1 and stage 2 trials is a first-phase insulin response in an intravenous glucose tolerance test and C-peptide area under the curve in a 2-h mixed-meal tolerance test in the stage 3 trial. In addition, safety and tolerability of liraglutide treatment will be assessed.
Conclusions: Most prevention trials of type 1 diabetes have targeted the immune system. Treatment with GLP-1 analogue liraglutide supports the pancreatic β-cells, which should likewise attenuate islet autoimmunity. Our innovative study design allows simultaneous investigation of an intervention in three groups of people who represent various early stages of type 1 diabetes and maximises the eligibility to participate.
Kokoelmat
- Avoin saatavuus [31995]