A treatment strategy implementing combination therapy with sitagliptin and metformin results in superior glycaemic control versus metformin monotherapy due to a low rate of addition of antihyperglycaemic agents

2011 ◽  
Vol 13 (9) ◽  
pp. 841-849 ◽  
Author(s):  
L. Olansky ◽  
C. Reasner ◽  
T. L. Seck ◽  
D. E. Williams-Herman ◽  
M. Chen ◽  
...  
BMJ Open ◽  
2018 ◽  
Vol 8 (9) ◽  
pp. e022448 ◽  
Author(s):  
Nam Hoon Kim ◽  
Soo Lim ◽  
Soo Heon Kwak ◽  
Min Kyong Moon ◽  
Jun Sung Moon ◽  
...  

IntroductionPatients 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 analysisThis 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 disseminationThis 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 numberNCT02946632; Pre-results.


2009 ◽  
Vol 137 (9-10) ◽  
pp. 490-496
Author(s):  
Branka Koprivica ◽  
Teodora Beljic-Zivkovic ◽  
Tatjana Ille

Introduction Secondary monotherapy failure in diabetes mellitus type 2 occurs early in the course of disease. Choosing the optimal combination therapy depends on the primary pathogenic mechanism. Evaluation of the residual beta cell function is of primary importance in deciding whether insulin should be included in the combination therapy. Objective To investigate the influence of standard meal test and homeostasis model assessment (HOMA-B) index, as markers of residual insulin secretion, on the efficacy of two different therapeutic strategies in secondary sulphonylurea (SU) failure. Methods In the group of thirty subjects with diabetes type 2, metabolic syndrome and secondary SU failure, metformin (MET) was added for the following six months. In the group of 30 subjects with diabetes type 2, secondary SU failure, with no metabolic syndrome, insulin (INS) was added for the same period. During the six-month follow-up period, fasting, postprandial, mean daily blood glucose and glycosylated haemoglobin (HbA1C) were evaluated. Fasting and meal stimulated C-peptide (CP) and insulin levels were measured at the beginning; absolute and relative increase of CP (delta CP, delta CP%), and HOMA-B were calculated. Correlation between CP secretion and HOMA-B at the beginning and glycaemic control after six months of therapy were evaluated by using Pearson correlation coefficient. Results Glycaemic control after six months was significantly improved in both therapeutic combinations (p<0.01). However, target values were not met in either group. Stimulated CP levels correlated best with all the parameters of glycaemic control in the group SU+MET (r -0.479 to -0.791; p<0.01), and in the group SU+INS (r 0.382 to 0.635; p<0.01). HOMA-B correlated only with HbA1C in the SU+MET group (r=-0.382; p<0.05). Conclusion Clinical diagnosis of metabolic syndrome and evaluation of residual insulin secretion are necessary in choosing the best combination therapy in secondary SU failure in subjects with type 2 diabetes. Stimulated standard meal CP level is a clinically useful marker of residual insulin secretion.


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