Sitagliptin add-on to low dosage sulphonylureas: efficacy and safety of combination therapy on glycaemic control and insulin secretion capacity in type 2 diabetes

2012 ◽  
Vol 66 (5) ◽  
pp. 465-476 ◽  
Author(s):  
S-I. Harashima ◽  
M. Ogura ◽  
D. Tanaka ◽  
T. Fukushima ◽  
Y. Wang ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Insulin Secretion ◽  
Glycaemic Control ◽  
Combination Therapy ◽  
Efficacy And Safety ◽  
Low Dosage

scholarly journals Role of standard test meal in initiation of insulin therapy in type 2 diabetes

2009 ◽  
Vol 137 (9-10) ◽  
pp. 490-496
Author(s):  
Branka Koprivica ◽  
Teodora Beljic-Zivkovic ◽  
Tatjana Ille
Keyword(s):  
Type 2 Diabetes ◽  
Metabolic Syndrome ◽  
Insulin Secretion ◽  
Glycaemic Control ◽  
Combination Therapy ◽  
Diabetes Type 2 ◽  
Diabetes Type ◽  
Standard Meal ◽  
Target Values

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.

scholarly journals 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

BMJ Open ◽  
2018 ◽  
Vol 8 (9) ◽  
pp. e022448 ◽  
Author(s):  
Nam Hoon Kim ◽  
Soo Lim ◽  
Soo Heon Kwak ◽  
Min Kyong Moon ◽  
Jun Sung Moon ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Glycaemic Control ◽  
Combination Therapy ◽  
Therapy Group ◽  
Controlled Trial ◽  
Triple Combination ◽  
Open Label ◽  
Triple Combination Therapy ◽  
Drug Naïve

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.

scholarly journals Efficacy and Safety of Linagliptin and Insulin in Patients of Type 2 Diabetes Mellitus with Grade 3-5 Chronic Kidney Disease in a Tertiary Care Hospital

2021 ◽  
Author(s):  
Saajid Hameed ◽  
Pankaj Kumar ◽  
Ved Prakash ◽  
Manish Kumar ◽  
Harihar Dikshit
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Chronic Kidney Disease ◽  
Glycaemic Control ◽  
Dose Adjustment ◽  
Efficacy And Safety ◽  
Insulin Group ◽  
Grade 3

Introduction: Insulin therapy is preferred as safest for glycaemic control in patients with elevated serum urea/creatinine level. Management of diabetes in grade 3-5 Chronic Kidney Disease (CKD) with oral hypoglycaemic is very challenging because most of them cause renal impairment and thus dose adjustment is needed in renal disease. Linagliptin, a DPP-4 (dipeptidyl peptidase-4) inhibitor has only 5% renal excretion; hence its dose adjustment is not needed in patients with CKD. Aim: To compare the efficacy and safety of linagliptin with insulin in patients of Type 2 Diabetes Mellitus (T2DM) with CKD. Materials and Methods: The present study was a longitudinal study, in which a total of 101 patients of grade 3-5 CKD with T2DM were divided into two groups, insulin group (n=54) and linagliptin group (n=47), based on their drug therapy. All the cases were tested for HbA1c (Glycated Haemoglobin), Random Blood Sugar (RBS), Creatinine clearance, Urine Protein-Creatinine Ratio (UPCR) and different adverse drug events at their first visit (baseline) and then during follow-up at 1st, 3rd, 6th and 12th month. Statistical analysis was done through GraphPad Instat by unpaired t-test for group comparison and Analysis of Variance (ANOVA) for intragroup comparison. Results: At the end of study, mean difference of RBS, Creatinine clearance and UPCR in both the groups were not significant. But mean HbA1c level was less in linagliptin group (6.62±0.10) as compared to insulin group (6.82±0.23) on long term therapy and the difference was statistically significant. Hypoglycaemia (33 vs 24), urinary tract infection (6 vs 5) and respiratory tract infection (5 vs 4) were more frequent in insulin group versus linagliptin group. Conclusion: Linagliptin for glycaemic control provides clinically meaningful improvements in long term glycaemic control without unacceptable side effects in CKD like vulnerable group of patients.

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