Efficacy and safety of meal-time administration of short-acting exenatide for glycaemic control in type 1 diabetes (MAG1C): a randomised, double-blind, placebo-controlled trial

Johansen, Nicklas J.; Dejgaard, Thomas F.; Lund, Asger; Schlüntz, Camilla; Frandsen, Christian Seerup; Forman, Julie Lyng; Albrechtsen, Nicolai J. Wewer; Holst, Jens J.; Pedersen‐Bjergaard, Ulrik; Madsbad, Sten; Vilsbøll, Tina; Andersen, Henrik Ullits; Knop, Filip K.

doi:10.1016/s2213-8587(20)30030-9

Cited by 46 publications

(48 citation statements)

References 27 publications

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“…Indeed, with acute administration of exenatide we found a flattening of the glucose response during an MMTT, which was not seen in the present study 15 . Our findings suggest a more robust response of HbA1c than was seen in the recently reported trial of exenatide, given three times daily to patients with T1D 14 …”

Section: Discussioncontrasting

confidence: 58%

“…15 Our findings suggest a more robust response of HbA1c than was seen in the recently reported trial of exenatide, given three times daily to patients with T1D. 14 The observed rates of hypoglycaemia were high but not higher in the exenatide ER versus the placebo arm, but there were six severe hypoglycaemic events in three exenatide ER-treated patients. The rates were higher in the exenatide ER-treated group on versus off study drug.…”

Section: Discussionsupporting

confidence: 51%

“…13 Recently, short-acting exenatide did not improve HbA1c levels when given for 26 weeks as add-on therapy to insulin-treated patients with T1D. 14 A possible reason for these inconclusive data is that the metabolic effects of GLP-1RAs, particularly the augmentation of insulin production, might only be of value to patients with residual insulin production. In the ADJUNCT ONE trial, those with detectable C-peptide at baseline had improved responses to liraglutide compared to those without.…”

Section: Introductionmentioning

confidence: 99%

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Exenatide extended release in patients with type 1 diabetes with and without residual insulin production

Herold

Reynolds

Dziura

et al. 2020

Diabetes Obesity Metabolism

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Aims: To test whether a long-acting GLP-1 receptor agonist would improve glucose control in patients with type 1 diabetes (T1D) and to determine whether the presence of residual beta cell function would affect the response. In addition, we sought to determine whether the drug would affect beta cell function. Methods: We performed a randomized placebo-controlled trial of exenatide extended release (ER) in participants with T1D with and without detectable levels of C-peptide. Seventy-nine participants were randomized to exenatide ER 2 mcg weekly, or placebo, stratified by the presence or absence of detectable C-peptide levels. The primary outcome was the difference in glycated haemoglobin (HbA1c) levels at 24 weeks. Participants were followed for another 6 months off study drug. Results: At week 24, the time of the primary outcome, the least squares (LS) mean HbA1c level was 7.76% (95% confidence interval [CI] 7.42, 8.10) in the exenatide ER group versus 8.0% (95% CI 7.64, 8.35) in the placebo group (P = 0.08). At week 12 the LS mean HbA1c levels were 7.71% (95% CI 7.37, 8.05) in the exenatide ER group versus 8.05% (95% CI 7.7, 8.4) in the placebo group (P = 0.01). The improvement at week 12 was driven mainly by those with detectable levels of C-peptide. Those treated with exenatide ER lost weight at 12 and 24 weeks compared to those treated with placebo (P <0.001 and P = 0.007). The total insulin dose was lower, but not when corrected for body weight, and was not affected by residual insulin production.

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Section: Discussioncontrasting

confidence: 58%

Section: Discussionsupporting

confidence: 51%

Section: Introductionmentioning

confidence: 99%

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Exenatide extended release in patients with type 1 diabetes with and without residual insulin production

Herold

Reynolds

Dziura

et al. 2020

Diabetes Obesity Metabolism

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“…T1DM models that require extensive usage of mathematics are not structured in a way that patients and physicians can easily comprehend and apply. In order to develop artificial pancreases that will carry out all the stages of BG management independently, studies have been concentrated on insulin pumps, measurement sensors, and control algorithms [1][2][3].…”

Section: Introductionmentioning

confidence: 99%

Three Parameter Control Algorithm for Obtaining Ideal Postprandial Blood Glucose in Type 1 Diabetes Mellitus

Çankaya

Aydoğdu

2020

IEEE Access

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The three main parameters used by patients in diabetes management are initial blood glucose, carbohydrate amount, and mealtime difference. In this study, a novel open-loop control algorithm was proposed, which aims to determine the correct value of mealtime difference duration. Unlike current blood glucose estimation methods, this algorithm was focused on determining extreme points that only concern patients such as hyperglycemia and hypoglycemia, instead of predicting all blood glucose trace in the postprandial period. This new approach has made it possible to determine extreme blood glucose values with simple linear equations without using complex models. This algorithm has only three parameters and has been validated in the UVA Padova type 1 diabetes mellitus simulator, which has thirty in-silico patients. The regressions between real and predicted values for hypoglycemia, hyperglycemia, and mean blood glucose were 0.95, 0.99, and 0.98, respectively. Using the proposed algorithm, the severity of hyperglycemia, mean blood glucose, and standard deviation values were reduced, and hypoglycemia events were prevented. Postprandial blood glucose curves have occurred as desired and within normal limits. Furthermore, it was concluded that intersection points of blood glucose curves contain information about the metabolic parameters of the patients, in this study.

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“…The authors of the MAG1C study hypothesised that addition of the short-acting GLP-1 receptor agonist exenatide (Byetta), administered subcutaneously three times a day before meals, as an adjunct to basal bolus insulin injections could improve glycaemic control measured by HbA1c (primary endpoint) by reducing post-prandial glycaemic excursions without increasing the risk of hypoglycaemia, in combination with bodyweight reduction Editorial Commentary in people with T1D (14).…”

mentioning

confidence: 99%

Can exenatide flatten the post-prandial glucose curve in type 1 diabetes?

Boughton

Hovorka

2020

Ann Transl Med

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Attainment of recommended glycaemic control for people with type 1 diabetes (T1D) is challenging and requires lifelong self-management with insulin therapy. Approaches to restore pancreatic beta-cell function to reverse T1D such as islet/pancreas transplant, immunomodulatory therapies and stem cell therapies have not yielded acceptable safety and/or efficacy outcomes (1). Management of T1D therefore focuses on intensive insulin therapy to achieve near normoglycaemia and avoid long-term micro-and microvasculature complications (2). Despite improvements in insulin analogues and advances in diabetes technologies, less than 30% of people with T1D reach recommended glycaemic targets (3). Intensive insulin therapy is associated with increased risk of hypoglycaemia and weight gain (4).Even with intensive insulin therapy, management of postprandial hyperglycaemia remains challenging due to delays in subcutaneous insulin absorption. It has been proposed that high glycaemic variability is associated with increased risk of vascular complications in people with T1D (5), although this has not been consistently reported (6,7). Approaches to minimise post-prandial hyperglycaemia and improve glycaemic control, without increasing the risk of hypoglycaemia or weight gain are being pursued.Anti-hyperglycaemic agents licenced for use in type 2 diabetes (metformin, Glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase 4 (DPP 4) inhibitors and sodium-glucose transport protein 2 (SGLT2) inhibitors have been considered as candidate therapies to reduce postprandial hyperglycaemia and improve glycaemic control in people with T1D. Several of these medications have

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Efficacy and safety of meal-time administration of short-acting exenatide for glycaemic control in type 1 diabetes (MAG1C): a randomised, double-blind, placebo-controlled trial

Cited by 46 publications

References 27 publications

Exenatide extended release in patients with type 1 diabetes with and without residual insulin production

Exenatide extended release in patients with type 1 diabetes with and without residual insulin production

Three Parameter Control Algorithm for Obtaining Ideal Postprandial Blood Glucose in Type 1 Diabetes Mellitus

Can exenatide flatten the post-prandial glucose curve in type 1 diabetes?

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