Cargando…
Efficacy and tolerability of novel triple combination therapy in drug-naïve patients with type 2 diabetes from the TRIPLE-AXEL trial: protocol for an open-label randomised controlled trial
INTRODUCTION: Patients with type 2 diabetes are at risk of microvascular and macrovascular complications. Intensive glycaemic control, especially in patients with short duration of diabetes, is the mainstay of management of type 2 diabetes to lower the risk of complications. However, despite the imp...
Autores principales: | , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2018
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6157558/ https://www.ncbi.nlm.nih.gov/pubmed/30249630 http://dx.doi.org/10.1136/bmjopen-2018-022448 |
_version_ | 1783358288445833216 |
---|---|
author | Kim, Nam Hoon Lim, Soo Kwak, Soo Heon Moon, Min Kyong Moon, Jun Sung Lee, Yong-ho Cho, Ho Chan Lee, Juneyoung Kim, Sin Gon |
author_facet | Kim, Nam Hoon Lim, Soo Kwak, Soo Heon Moon, Min Kyong Moon, Jun Sung Lee, Yong-ho Cho, Ho Chan Lee, Juneyoung Kim, Sin Gon |
author_sort | Kim, Nam Hoon |
collection | PubMed |
description | INTRODUCTION: Patients with type 2 diabetes are at risk of microvascular and macrovascular complications. Intensive glycaemic control, especially in patients with short duration of diabetes, is the mainstay of management of type 2 diabetes to lower the risk of complications. However, despite the improvement in the understanding of the pathophysiology of type 2 diabetes and development of novel glucose-lowering agents, long-term durable glycaemic control remains a difficult goal to achieve. Several challenging clinical trials proved that an early combination therapy with a variety of glucose-lowering agents had a more favourable effect than conventional stepwise therapy in terms of glycaemic control. We aim to evaluate the efficacy and tolerability of a novel, initial triple combination therapy with metformin, sodium glucose cotransporter 2 inhibitor (dapagliflozin) and dipeptidyl peptidase-4 inhibitor (saxagliptin) compared with conventional stepwise add-on therapy in drug-naïve patients with recent-onset type 2 diabetes. METHODS AND ANALYSIS: This study is a multicentre, prospective, randomised, open-label, parallel group, comparator-controlled trial. A total of 104 eligible participants will be randomised to either the initial combination therapy group or the conventional stepwise add-on therapy group for 104 weeks. The primary endpoint is the proportion of patients who achieved haemoglobin A1c level<6.5% without hypoglycaemia, weight gain or discontinuation due to adverse events at 104 weeks. This trial will determine whether a novel triple combination therapy with metformin, dapagliflozin and saxagliptin has a beneficial effect on durable glycaemic control compared with conventional therapy in drug-naïve patients with type 2 diabetes. ETHICS AND DISSEMINATION: This study protocol was approved by the local institutional review boards and independent ethics committees over the recruitment sites. Results of this study will be disseminated in scientific journals and scientific conferences. TRIAL REGISTRATION NUMBER: NCT02946632; Pre-results. |
format | Online Article Text |
id | pubmed-6157558 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-61575582018-09-28 Efficacy and tolerability of novel triple combination therapy in drug-naïve patients with type 2 diabetes from the TRIPLE-AXEL trial: protocol for an open-label randomised controlled trial Kim, Nam Hoon Lim, Soo Kwak, Soo Heon Moon, Min Kyong Moon, Jun Sung Lee, Yong-ho Cho, Ho Chan Lee, Juneyoung Kim, Sin Gon BMJ Open Diabetes and Endocrinology INTRODUCTION: Patients with type 2 diabetes are at risk of microvascular and macrovascular complications. Intensive glycaemic control, especially in patients with short duration of diabetes, is the mainstay of management of type 2 diabetes to lower the risk of complications. However, despite the improvement in the understanding of the pathophysiology of type 2 diabetes and development of novel glucose-lowering agents, long-term durable glycaemic control remains a difficult goal to achieve. Several challenging clinical trials proved that an early combination therapy with a variety of glucose-lowering agents had a more favourable effect than conventional stepwise therapy in terms of glycaemic control. We aim to evaluate the efficacy and tolerability of a novel, initial triple combination therapy with metformin, sodium glucose cotransporter 2 inhibitor (dapagliflozin) and dipeptidyl peptidase-4 inhibitor (saxagliptin) compared with conventional stepwise add-on therapy in drug-naïve patients with recent-onset type 2 diabetes. METHODS AND ANALYSIS: This study is a multicentre, prospective, randomised, open-label, parallel group, comparator-controlled trial. A total of 104 eligible participants will be randomised to either the initial combination therapy group or the conventional stepwise add-on therapy group for 104 weeks. The primary endpoint is the proportion of patients who achieved haemoglobin A1c level<6.5% without hypoglycaemia, weight gain or discontinuation due to adverse events at 104 weeks. This trial will determine whether a novel triple combination therapy with metformin, dapagliflozin and saxagliptin has a beneficial effect on durable glycaemic control compared with conventional therapy in drug-naïve patients with type 2 diabetes. ETHICS AND DISSEMINATION: This study protocol was approved by the local institutional review boards and independent ethics committees over the recruitment sites. Results of this study will be disseminated in scientific journals and scientific conferences. TRIAL REGISTRATION NUMBER: NCT02946632; Pre-results. BMJ Publishing Group 2018-09-24 /pmc/articles/PMC6157558/ /pubmed/30249630 http://dx.doi.org/10.1136/bmjopen-2018-022448 Text en © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
spellingShingle | Diabetes and Endocrinology Kim, Nam Hoon Lim, Soo Kwak, Soo Heon Moon, Min Kyong Moon, Jun Sung Lee, Yong-ho Cho, Ho Chan Lee, Juneyoung Kim, Sin Gon Efficacy and tolerability of novel triple combination therapy in drug-naïve patients with type 2 diabetes from the TRIPLE-AXEL trial: protocol for an open-label randomised controlled trial |
title | Efficacy and tolerability of novel triple combination therapy in drug-naïve patients with type 2 diabetes from the TRIPLE-AXEL trial: protocol for an open-label randomised controlled trial |
title_full | Efficacy and tolerability of novel triple combination therapy in drug-naïve patients with type 2 diabetes from the TRIPLE-AXEL trial: protocol for an open-label randomised controlled trial |
title_fullStr | Efficacy and tolerability of novel triple combination therapy in drug-naïve patients with type 2 diabetes from the TRIPLE-AXEL trial: protocol for an open-label randomised controlled trial |
title_full_unstemmed | Efficacy and tolerability of novel triple combination therapy in drug-naïve patients with type 2 diabetes from the TRIPLE-AXEL trial: protocol for an open-label randomised controlled trial |
title_short | Efficacy and tolerability of novel triple combination therapy in drug-naïve patients with type 2 diabetes from the TRIPLE-AXEL trial: protocol for an open-label randomised controlled trial |
title_sort | efficacy and tolerability of novel triple combination therapy in drug-naïve patients with type 2 diabetes from the triple-axel trial: protocol for an open-label randomised controlled trial |
topic | Diabetes and Endocrinology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6157558/ https://www.ncbi.nlm.nih.gov/pubmed/30249630 http://dx.doi.org/10.1136/bmjopen-2018-022448 |
work_keys_str_mv | AT kimnamhoon efficacyandtolerabilityofnoveltriplecombinationtherapyindrugnaivepatientswithtype2diabetesfromthetripleaxeltrialprotocolforanopenlabelrandomisedcontrolledtrial AT limsoo efficacyandtolerabilityofnoveltriplecombinationtherapyindrugnaivepatientswithtype2diabetesfromthetripleaxeltrialprotocolforanopenlabelrandomisedcontrolledtrial AT kwaksooheon efficacyandtolerabilityofnoveltriplecombinationtherapyindrugnaivepatientswithtype2diabetesfromthetripleaxeltrialprotocolforanopenlabelrandomisedcontrolledtrial AT moonminkyong efficacyandtolerabilityofnoveltriplecombinationtherapyindrugnaivepatientswithtype2diabetesfromthetripleaxeltrialprotocolforanopenlabelrandomisedcontrolledtrial AT moonjunsung efficacyandtolerabilityofnoveltriplecombinationtherapyindrugnaivepatientswithtype2diabetesfromthetripleaxeltrialprotocolforanopenlabelrandomisedcontrolledtrial AT leeyongho efficacyandtolerabilityofnoveltriplecombinationtherapyindrugnaivepatientswithtype2diabetesfromthetripleaxeltrialprotocolforanopenlabelrandomisedcontrolledtrial AT chohochan efficacyandtolerabilityofnoveltriplecombinationtherapyindrugnaivepatientswithtype2diabetesfromthetripleaxeltrialprotocolforanopenlabelrandomisedcontrolledtrial AT leejuneyoung efficacyandtolerabilityofnoveltriplecombinationtherapyindrugnaivepatientswithtype2diabetesfromthetripleaxeltrialprotocolforanopenlabelrandomisedcontrolledtrial AT kimsingon efficacyandtolerabilityofnoveltriplecombinationtherapyindrugnaivepatientswithtype2diabetesfromthetripleaxeltrialprotocolforanopenlabelrandomisedcontrolledtrial |