scholarly journals The OPT2MISE Study – A Review of the Major Findings and Clinical Implications

2015 ◽  
Vol 11 (02) ◽  
pp. 105
Author(s):  
Yves Reznik ◽  
Michael Joubert ◽  
◽  

Many patients with type 2 diabetes struggle to achieve adequate glucose control despite escalation of therapy including complex insulin regimens with multiple daily injections (MDIs). Previous randomised controlled trials failed to show a significant improvement in glycaemic control with pump therapy over multiple injections. The OPT2MISE study enrolled 495 adult patients with poorly controlled type 2 diabetes despite an intensified insulin regimen using rapid and slow-acting insulin analogues. After a 2-month run-in period, patients were randomised to switch to pump therapy or to maintain their MDI regimen. After 6 months, patients with pump therapy achieved a better glycaemic control than those who used multiple injections (glycated haemoglobin [HbA1c] difference of -0.7 %), and twice as many patients reached the target range of 8 % or less in the pump-therapy group compared with the injection group. Patients using pump therapy had a 20 % reduction of their total daily insulin dose. A moderate weight gain was observed with both treatments, and no severe hypoglycaemia nor ketoacidosis occurred in the pump therapy group. Pump therapy may now be considered as a valuable option in type 2 diabetes patients who fail to respond to an intensified insulin regimen.

2015 ◽  
Vol 11 (2) ◽  
pp. 70 ◽  
Author(s):  
Yves Reznik ◽  
Michael Joubert ◽  
◽  

Many patients with type 2 diabetes struggle to achieve adequate glucose control despite escalation of therapy including complex insulin regimens with multiple daily injections (MDIs). Previous randomised controlled trials failed to show a significant improvement in glycaemic control with pump therapy over multiple injections. The OPT2MISE study enrolled 495 adult patients with poorly controlled type 2 diabetes despite an intensified insulin regimen using rapid and slow-acting insulin analogues. After a 2-month run-in period, patients were randomised to switch to pump therapy or to maintain their MDI regimen. After 6 months, patients with pump therapy achieved a better glycaemic control than those who used multiple injections (glycated haemoglobin [HbA1c] difference of -0.7 %), and twice as many patients reached the target range of 8 % or less in the pump-therapy group compared with the injection group. Patients using pump therapy had a 20 % reduction of their total daily insulin dose. A moderate weight gain was observed with both treatments, and no severe hypoglycaemia nor ketoacidosis occurred in the pump therapy group. Pump therapy may now be considered as a valuable option in type 2 diabetes patients who fail to respond to an intensified insulin regimen.


2020 ◽  
Vol 17 ◽  
Author(s):  
Anand Shankar

Aim & Objective: The objective of this retrospective study was to investigate the efficacy of adding remogliflozin to current insulin glargine plus two oral drug i.e. metformin and teneligliptin therapy in poorly controlled Indian type 2 diabetes. Material and Methods: 173 study participants were initially selected from patient database who continued on their insulin glargine or received an increased dose of insulin glargine along with other OHA based therapy (Group A) and 187 were selected who had received remogliflozin (100 mg BD) (Group B) in addition to insulin glargine along with other OHA based therapy. Glycated haemoglobin (HbA1c), total daily insulin dose, body weight, and the number of hypoglycemic events were recorded at weeks 0, 12 and 24. Result: During the study, mean values of HbA1c, FBG and P2BG were significantly reduced in both groups. Insulin requirements decreased from 45.8 ± 16.7 IU/day to 38.5 ± 13.5 IU/day (P < 0.001) and at week 24 even further decreased to 29.5 ± 14.5 IU/Day . Twenty three patients in group B were able to cease insulin treatment altogether after 24 week treatment. It has been observed to attain tight blood glucose control we need to increase insulin dose in group A from 45.5 ± 16.5 IU/Day to 51.5 ± 14.5 at week 12 (P<0.01) and which further increased to 53.8 ± 12.8 IU/Day at week 24 (P<0.01). Adding remogliflozin showed significant effect on blood pressure (P < 0.001) and weight reduction (P < 0.001). It has been observed that 38% patients has achieves targeted HbA1c (≤7%) in group B where it was 22% in group A. Conclusion: Results demonstrate that in uncontrolled T2DM patients remogliflozin 100 mg BD can successfully lay a foundation for prolonged good glycemic control. Early addition of remogliflozin with insulin glargine plus OHAs may be an alternative compare to intensive up titration of insulin daily dose in people with uncontrolled T2DM. Clinical Trial Registration Number: A 2358


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.


2021 ◽  
Vol 19 (3) ◽  
pp. 2402
Author(s):  
Emmanuel A. David ◽  
Rebecca O. Soremekun ◽  
Isaac O. Abah ◽  
Roseline I. Aderemi-Williams

Background: Diabetes mellitus is a chronic, degenerative disease, requiring a multi-dimensional, multi-professional care by healthcare providers and substantial self-care by the patients, to achieve treatment goals. Objective: To evaluate the impact of pharmacist-led care on glycaemic control in patients with uncontrolled Type 2 Diabetes Methods: In a parallel group, single-blind randomised controlled study; type 2 diabetic patients, with greater than 7% glycated haemoglobin (A1C) were randomised into intervention and usual care groups and followed for six months. Glycated haemoglobin analyzer, lipid analyzer and blood pressure monitor/apparatus were used to measure patients’ laboratory parameters at baseline and six months. Intervention group patients received pharmacist-structured care, made up of patient education and phone calls, in addition to usual care. In an intention to treat analysis, Mann-Whitney U test was used to compare median change at six months in the primary (A1C) and secondary outcome measures. Effect size was computed and proportion of patients that reached target laboratory parameters were compared in both arms. Results: All enrolled participants (108) completed the study, 54 in each arm. Mean age was 51 (SD 11.75) and majority were females (68.5%). Participants in the intervention group had significant reduction in A1C of -0.75%, compared with an increase of 0.15% in the usual care group (p<0.001; eta-square= 0.144). The proportion of those that achieved target A1C of <7% at 6 months in the intervention and usual care group was 42.6% vs 20.8% (p=0.02). Furthermore, intervention patients were about 3 times more likely to have better glucose control; A1C<7% (aOR 2.72, 95%CI: 1.14-6.46) compared to usual care group, adjusted for sex, age, and duration of diabetes. Conclusions: Pharmacist-led care significantly improved glycaemic control in patients with uncontrolled T2DM.


2010 ◽  
Vol 9 (2) ◽  
pp. 76 ◽  
Author(s):  
Josep Vidal ◽  

Optimal glycaemic control is essential to managing risks in patients with type 2 diabetes. However, glycaemic control remains poor among type 2 diabetes patients, particularly the control of post-prandial glucose (PPG). Almost half of patients treated with basal insulin and oral anti-diabetic drugs (OADs) do not achieve their glycated haemoglobin (HbA1c) goals, despite achieving fasting plasma glucose (FPG) control. Glycaemic control targets have emphasised FPG targets, but PPG contributes significantly to overall glycaemic control in type 2 diabetes. Glucagon-like peptide 1 (GLP-1) receptor agonists have shown substantial efficacy in improving overall glycaemic control but have differing effects on PPG, which is a result of their different mechanisms of action. Lixisenatide is unique among existing GLP-1 receptor agonists in that it is short acting but given as a once daily dose, and exerts its main effects during the prandial period. It has demonstrated efficacy in an extensive clinical trial programme. In particular, it has shown a beneficial effect on PPG compared with existing GLP-1 receptor agonists, probably a result of its effect on slowing gastric emptying. This has provided a strong rationale for its use as add-on therapy to long-acting basal insulin analogues, in cases where the latter is not providing adequate glycaemic control. The additive effects on glycaemic control may lead to a new treatment approach to manage blood glucose and prevent long-term complications in patients with type 2 diabetes.


Author(s):  
TP Griffin ◽  
D Wall ◽  
GA Browne ◽  
MC Dennedy ◽  
PM O'Shea

Introduction Hyperglycaemia increases succinate concentrations and succinate receptor activation in the kidney resulting in renin release. The aim of our study was to determine if there is an association between glycaemic control as evidenced by glycated haemoglobin values and activation of the renin-angiotensin-aldosterone system in patients with type 2 diabetes mellitus and hypertension. Methods A cross-sectional study was conducted at Galway University Hospitals between December 2014 and March 2015. Participants ( n = 66) were identified following interrogation of the electronic database for patients with type 2 diabetes mellitus. Baseline clinical demographics, aldosterone, plasma renin activity, direct renin concentration, urea and electrolytes, glycated haemoglobin, cholesterol, urine sodium and albumin creatinine ratio were recorded. Results There was a significant positive linear correlation between glycated haemoglobin and renin (both plasma renin activity [ P = 0.002] and direct renin concentration [ P = 0.008]) and between serum creatinine and aldosterone measured using both radioimmunoassay ( P = 0.008) and immunochemiluminometric assay ( P = 0.008). A significant negative linear correlation was demonstrated between serum sodium and plasma renin activity ( P = 0.005) and direct renin concentration ( P = 0.015) and between estimated glomerular filtration rate and aldosterone measured using radioimmunoassay ( P = 0.02) and immunochemiluminometric assay ( P = 0.016). A significant negative linear correlation existed between urine sodium and plasma renin activity ( P = 0.04) and aldosterone measured using radioimmunoassay ( P = 0.045). Conclusions There is a direct positive association between glycaemic control and renin. We advocate for renin measurement to be part of the diabetologist's armamentarium to assess, guide and optimize therapeutic strategies in patients with diabetes.


Diabetologia ◽  
2014 ◽  
Vol 57 (9) ◽  
pp. 1812-1819 ◽  
Author(s):  
Helena M. de Wit ◽  
Gerald M. M. Vervoort ◽  
Henry J. Jansen ◽  
Wim J. C. de Grauw ◽  
Bastiaan E. de Galan ◽  
...  

2015 ◽  
Vol 18 (4) ◽  
pp. 41-47
Author(s):  
Oleg G. Motovilin ◽  
Shishkova Y. Andreevna ◽  
Elena V. Surkova

Background. Over the long disease course of diabetes mellitus (DM), with its demands in terms of everyday self-management of the disease, individual psychological characteristics may be associated with both emotional well-being (WB) and glycaemic control. The former includes various types of coping strategies (CSs) of the patients, which comprise the common ways for patients to overcome difficult situations.Aim. To study the relationships between CS and both glycaemic control and emotional WB in patients with Type 1 diabetes (T1D) and Type 2 diabetes (T2D) treated with insulin.Materials and methods. The study included 84 patients with T1D and 56 patients with insulin-treated T2D [age, 22.5 ± 3.3 and 61.0 ± 8.9 years; men/women, 29/55 and 11/45; duration of DM, 11.9 ± 5.36 and 11.6 ± 6.2 years and glycated haemoglobin (HbA1c), 9.1% ± 2.2% and 9.0% ± 1.4%, respectively]. The HbA1c levels were determined in all patients. The Strategic Approach to Coping Scale constructed by S. Hobfoll was used to study CS, and emotional WB was assessed based on the severity of anxiety and depression. Further, we used the State-Trait Anxiety Inventory developed by C.D. Spielberger and adapted by Y.L. Khanin and the Center for Epidemiologic Studies Depression Scale. Only Russian validated versions of the questionnaires were used in the study.Results. In both groups of patients, ‘Assertive (Persistent) Actions’ was positively associated with emotional WB. In patients with T2D, WB increases when using ‘Cautious Action’ and ‘Social Joining’. The deterioration of emotional WB was associated with ‘Aggressive Actions’ in both groups of patients. In patients with T1D, negative WB was also associated with ‘Avoidance’, while in patients with T2D, negative WB was associated with ‘Instinctive Actions’. In patients with T1D, ‘Instinctive Action’ was associated with higher HbA1c levels. In patients with T2D, ‘Cautious Action’, ‘Avoidance’ and ‘Antisocial Action’ were associated with lower HbA1c levels.Conclusion. In patients with T1D and T2D, CSs are associated with both emotional WB and glycaemic control. Emotional WB and lower HbA1c levels are associated with ‘Assertive Action’, ‘Cautious Action’, ‘Avoidance’ and ‘Asocial Action’. Negative WB and higher HbA1c levels are associated with ‘Aggressive Action’ and ‘Instinctive Action’.


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