Initiate Insulin by Aggressive Titration and Education (INITIATE)

Yki‐Järvinen, Hannele; Juurinen, Leena; Alvarsson, Michael; T, Bystedt; Caldwell, Ian W.; Davies, Melanie J.; Lahdenperä, Sanni; Nijpels, G.; Vähätalo, Markku

doi:10.2337/dc06-1357

Cited by 127 publications

(132 citation statements)

References 13 publications

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“…EXE was titrated to a maximum dose of three times (TID) 20 μg, or the maximum tolerated dose, when HbA1c value at two consecutive visits ranged between 7.1 and 7.5%, or when HbA1c was >7.6% at any given visit. Patients randomised to GLAR started with an initial dosage of 10 IU once daily (QD) at bedtime, followed by self-adjustment of the daily dose according to a fixed-dose treat-to-target (fasting plasma glucose (FPG) <5.6 mmol/L)) algorithm, as described previously (13). Loss of glucose control was defined by fasting blood glucose concentrations greater than or equal to 12.2 mmol/L for 4 or more days out of 7 days during the study, with the increase in glucose concentrations not secondary to a readily identified inter-current illness or pharmacological treatment.…”

Section: Methodsmentioning

confidence: 99%

Exenatide improves β-cell function up to 3 years of treatment in patients with type 2 diabetes: a randomised controlled trial

Raalte

Bunck

Hoekstra

et al. 2016

European Journal of Endocrinology

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Objective: Glucagon-like peptide (GLP)-1 receptor agonist treatment improves β-cell function. In this study, we investigated whether the improvements are sustained during a 3-year treatment period. Research design and methods: Sixty-nine metformin-treated type 2 diabetes patients were randomised to the GLP1 receptor agonist, exenatide (EXE) twice daily (BID) or to insulin glargine (GLAR). β-cell function parameters were derived using the Mari model from standardised breakfast and lunch meals that were administered before treatment, and after 1 and 3 years of treatment. EXE was administered before breakfast. Results: Fifty-nine (EXE: n = 30; GLAR: n = 29) and thirty-six (EXE: n = 16; GLAR: n = 20) patients completed the meal at 1-and 3-year treatment respectively. After 3 years, groups had comparable glycaemic control (HbA1c: EXE 6.6 ± 0.2% and GLAR 6.9 ± 0.2%; P = 0.216). Compared with GLAR, at 1 and 3 years, EXE induced a stronger reduction in post-breakfast glucose concentrations (P < 0.001), with lower C-peptide levels (P < 0.001). Compared with GLAR, EXE increased insulin secretion at 8 mmol/L glucose throughout the study period (P < 0.01). Both treatments improved β-cell glucose sensitivity after 1-year treatment. However, only EXE treatment sustained this improvement for 3 years. No consistent changes in other β-cell parameters including rate sensitivity and potentiation were observed. Conclusions: Compared with GLAR, EXE improved the parameters of β-cell function, especially insulin secretion at 8 mmol/L glucose and β-cell glucose sensitivity, which was sustained during the 3-year treatment period.

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Section: Methodsmentioning

confidence: 99%

Exenatide improves β-cell function up to 3 years of treatment in patients with type 2 diabetes: a randomised controlled trial

Raalte

Bunck

Hoekstra

et al. 2016

European Journal of Endocrinology

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“…During the other treatment period, patients were treated with insulin glargine, started at an initial dose of 10 IU q.d. Patients were instructed to increase the daily dose based on their fasting self-monitored blood glucose levels according to a predetermined treat-to-target algorithm (16).…”

Section: General Experimental Protocolmentioning

confidence: 99%

Liraglutide Reduces CNS Activation in Response to Visual Food Cues Only After Short-term Treatment in Patients With Type 2 Diabetes

et al. 2015

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OBJECTIVEGlucagon-like peptide-1 receptor agonists (GLP-1RAs) are associated with reduced appetite and body weight. We investigated whether these effects could be mediated by the central nervous system (CNS). RESEARCH DESIGN AND METHODSWe performed a randomized crossover study in obese patients with type 2 diabetes (n = 20, mean age 59.3 6 4.1 years, mean BMI 32 6 4.7 kg/m 2 ), consisting of two periods of 12-week treatment with either liraglutide 1.8 mg or insulin glargine. Using functional MRI, we determined the effects of treatment on CNS responses to viewing food pictures in the fasted condition and 30 min after meal intake. RESULTSAfter 12 weeks, the decrease in HbA 1c was larger with liraglutide versus insulin glargine (D20.7% vs. 20.2%, P < 0.001). Body weight decreased during liraglutide versus insulin glargine (D23.3 kg vs. 0.8 kg, P < 0.001). After 10 days, patients treated with liraglutide, compared with insulin glargine, showed decreased responses to food pictures in insula and putamen (P £ 0.02). In addition, liraglutide enhanced the satiating effect of meal intake on responses in putamen and amygdala (P £ 0.05). Differences between liraglutide and insulin glargine were not observed after 12 weeks. CONCLUSIONSCompared with insulin, liraglutide decreased CNS activation significantly only after short-term treatment, suggesting that these effects of GLP-1RA on the CNS may contribute to the induction of weight loss, but not necessarily to its maintenance, in view of the absence of an effect of liraglutide on CNS activation in response to food pictures after longer-term treatment.Obesity and diabetes constitute a major health burden due to their pandemic occurrence (1) and their association with adverse consequences, such as cardiovascular disease (2). Obesity is the result of a long-term excess energy intake relative to expenditure, leading to increased weight and body fat mass. The central nervous system (CNS) has a major role in the regulation of food intake and the maintenance

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“…80 In one randomized controlled trial, self-titration was taught to individuals and to groups, with the two approaches achieving similar reductions in HbA 1c (1.8% and 2.0% respectively); the group sessions required half the time. 81 Regarding titration of bolus insulin, simple titration based on postprandial values was as effective as carbohydrate counting, lowering HbA 1c by 1.5%. 83 The principles of insulin titration are described in Box 2, and sample protocols for insulin titration are described in Table 3.…”

Section: Who Should Initiate and Titrate Insulin?mentioning

confidence: 99%

“…78−83 Pa tients using these self-titration algorithms coupled with daily blood glucose monitoring were able to achieve HbA 1c levels similar to those achieved in clinics, reducing their HbA 1c by 1.0% to 2.5%. A variety of insulin types were used in these studies, including 30/70 twice-daily insulin, 79 detemir once daily, 80 glargine once daily 78,81 and rapidacting insulin before meals. 83 Self-titration by patients resulted in similar rates of hypoglycemia compared with physician-managed titration, even though the patients used higher doses of insulin (0.59 units/kg v. 0.40 units/kg).…”

Section: Who Should Initiate and Titrate Insulin?mentioning

confidence: 99%

Initiating insulin in patients with type 2 diabetes

Lau¹,

Tang²,

Halapy³

et al. 2012

CMAJ

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T ype 2 diabetes has become a worldwide epidemic 1 and is associated with multiple complications that can be prevented by modifying risk factors and optimizing glycemic control. 2 The optimization of glycemic control often requires the use of multiple agents, including insulin.Insulin is an important component of antihyperglycemic therapy, yet there are many perceived barriers.3 Existing guidelines do not specifically address the topic of insulin initiation. 4 We review and analyze the evidence from randomized controlled trials on insulin initiation and address adverse effects and barriers. We also discuss the selection of an insulin regimen, titration and delivery of care, as well as when and how to combine insulin therapy with oral antihyperglycemic agents. A summary of our systematic review and meta-analysis is available in Box 1. When should insulin be started?Clinical practice guidelines vary as to the recommended criteria for the initiation of insulin therapy in pa tients with type 2 diabetes. Factors that are considered include the control of blood glucose levels and comorbidities that affect choice of treatment. Glucose controlThe American Diabetes Association and the European Association for the Study of Diabetes developed a consensus algorithm wherein basal insulin is recommended as a second-line agent if the glycated hemoglobin (HbA 1 c ) value is greater than 7.0% after metformin monotherapy.5 Similarly, the International Diabetes Federation recommends that insulin be started if optimized oral antihyperglycemic therapy and lifestyle interventions are unable to maintain blood glucose at target levels. 6 In contrast, the Canadian Diabetes Association recommends that insulin be considered as a first-line agent if the HbA 1c value is 9.0% or greater in pa tients with newly diagnosed diabetes or if there is symptomatic hyperglycemia with metabolic decompensation (defined as polyuria, polydipsia and weight loss), and as a second-line agent if the HbA 1c is still not at target levels (consensus recommendation). 4Although no randomized controlled trials have looked at the impact on cardiovascular outcomes of insulin initiation early in the course of type 2 diabetes, early intensive control of blood glucose levels was assessed in the United Kingdom Prospective Diabetes Study (UKPDS). The study compared intensive glycemic control (with metformin, secretagogue or insulin therapy) and conventional glycemic control in patients with newly diagnosed diabetes and found that those in the intensive treatment group had reduced microvascular and macrovascular complications in long-term follow-up. 7,8 Early insulin initiation has been shown to improve and preserve β-cell function, 9 and the ongoing Outcome Reduction With Initial Glargine Intervention (ORIGIN) trial will assess the impact of an early basal insulin strategy on cardiovascular outcomes. 10 ComorbiditiesCareful monitoring of glycemic control is necessary when treating diabetes in patients with renal or hepatic failure. Many oral antihyperglycemic agents are c...

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Initiate Insulin by Aggressive Titration and Education (INITIATE)

Cited by 127 publications

References 13 publications

Exenatide improves β-cell function up to 3 years of treatment in patients with type 2 diabetes: a randomised controlled trial

Exenatide improves β-cell function up to 3 years of treatment in patients with type 2 diabetes: a randomised controlled trial

Liraglutide Reduces CNS Activation in Response to Visual Food Cues Only After Short-term Treatment in Patients With Type 2 Diabetes

Initiating insulin in patients with type 2 diabetes

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