Exenatide Add-on to Continuous Subcutaneous Insulin Infusion Therapy Reduces Bolus Insulin Doses in Patients with Type 2 Diabetes: A Randomized, Controlled, Open-Label Trial

Li, Fengfei; Jiang, Longfeng; Fu, Liyuan; Zhu, Hong-Hong; Zhou, Pei-hua; Zhang, Danfeng; Su, Xiaofei; Wu, Jindan; Ye, Lei; Ma, Jianhua

doi:10.1007/s13300-016-0222-7

Cited by 17 publications

(15 citation statements)

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“…CSII therapy was provided with aspart (Novo Nordisk, Bagsvaerd, Denmark) using a Medtronic insulin pump (Northridge, CA) as previously described [ 6 , 18 , 20 ]. After subjects achieved glycemic control, defined as a fasting and 2-h post prandial capillary blood glucose concentration between 6.1 and 8.0 mmol/l [ 21 ], patients were randomized 1:1 to two groups receiving: (1) 4 days of Novo Mix 30 (Novo Nordisk, Bagsværd, Denmark) followed by 2 days of Humalog Mix 50 (humalog ® Mix50™, Eli Lilly and Co., Indianapolis, IN, USA); (2) 4 days of Humalog Mix 50 followed by 2 days of Novo Mix 30. Initial premixed insulin doses were calculated as 0.4–0.5 IU/kg, and doses were subsequently adapted according to capillary glucose values obtained by self-monitoring during the first 2 days of the premixed insulin titration period.…”

Section: Methodsmentioning

confidence: 99%

Male Patients with Longstanding Type 2 Diabetes Have a Higher Incidence of Hypoglycemia Compared with Female Patients

Zhang

et al. 2018

Diabetes Ther

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IntroductionTo explore whether there was a gender difference in the risk of hypoglycemia during intensive insulin therapy in patients with longstanding type 2 diabetes (T2D). This was a post hoc analysis of a single-center, open-label and prospective trial.MethodsAll subjects were admitted as inpatients, underwent a standard bread meal test at baseline and received a 7-day continuous subcutaneous insulin infusion (CSII) therapy for achieving glycemic control. Patients then were randomized 1:1 to two groups receiving (1) 4 days of Novo Mix 30 followed by 2 days of Humalog Mix 50; (2) 4 days of Humalog Mix 50 followed by 2 days of Novo Mix 30. All patients were subjected to 4-day retrospective continuous glucose monitoring (CGM) during the last 4 days in this study. The primary outcome was the incidences of hypoglycemia monitored by CGM at the end point.ResultsA total of 102 patients met the inclusion criteria and completed the study. Our data revealed that 29 patients (28%) experienced hypoglycemia as detected by CGM at the end point. Binary logistic stepwise regression analysis showed that only gender significantly correlated with hypoglycemia (B = 1.17, p = 0.017). Importantly, male patients had a significantly higher incidence of hypoglycemia than female patients (male = 20/52, female = 9/50, p = 0.022), although male patients required significantly lower insulin doses to maintain glycemic control than female patient (p = 0.00).ConclusionMale patients with longstanding T2D had a higher incidence of hypoglycemia than female patients during intensive insulin therapy.Trial registrationClinicalTrials.gov identifier, ChiCTR-IPR-15007340.

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Section: Methodsmentioning

confidence: 99%

Male Patients with Longstanding Type 2 Diabetes Have a Higher Incidence of Hypoglycemia Compared with Female Patients

Zhang

et al. 2018

Diabetes Ther

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“…Not only did the SD, IQR, and LAGE, which reflect the intraday glycemic variability, improve, but the MODD, which represents the day-to-day glycemic variability, decreased. A clinical study on another GLP-1 analog, exenatide [25], also demonstrated that the addition of exenatide to CSII decreased glucose variability, exhibited by a significant reduction in MAGE. Our findings are in accordance with this previous study and corroborate the finding that the addition of GLP-1 analog to CSII in poorly controlled T2DM can improve GV.…”

Section: Discussionmentioning

confidence: 95%

Continuous subcutaneous insulin infusion combined with liraglutide reduced glycemic variability and oxidative stress in type 2 diabetes mellitus: a study based on the flash glucose monitoring system

Yao

et al. 2019

Endocr J

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We aimed to explore the use of the flash glucose monitoring (FGM) system in hospitalized newly diagnosed type 2 diabetes mellitus (T2DM) patients and to evaluate a new combination therapy of continuous subcutaneous insulin infusion (CSII) with or without liraglutide. This was an open-label, randomized study that was conducted in 60 newly diagnosed T2DM patients. The patients were randomized to receive either CSII (n = 30) or CSII + liraglutide (n = 30). The FGM system was used to assess the glycemic control and glycemic variability (GV) indices for 2 weeks. Mean blood glucose concentration (MBG), estimated hemoglobin A1c (HbA1c), and measures of GV, including the standard deviation of the mean glucose (SD), coefficient of variation (CV), interquartile range (IQR), mean amplitude of glycemic excursions (MAGE), largest amplitude of glycemic excursions (LAGE), and mean of daily difference (MODD) were compared between the two groups. Two oxidative stress biomarkers, 4-hydroxynonenal (4-HNE) and 8-hydroxydeoxyguanosine (8-OHdG), were measured before and after treatment. The estimated HbA1c and MBG decreased in both groups, especially the CSII + liraglutide group. SD, IQR, LAGE, and MODD were significantly lower in the CSII + liraglutide group than in the CSII group (all p < 0.05); there was no difference in CV or MAGE (p > 0.05). Similarly, the 4-HNE and 8-OHdG levels were significantly lower in the CSII + liraglutide group (p < 0.05). Our findings suggest that CSII with liraglutide was superior to CSII monotherapy in improving glycemic control and glycemic variability and in decreasing oxidative stress markers. Flash glucose monitoring can successfully provide ambulatory glucose profile data in the real world.

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“…CGM data were obtained with Medtronic Minimed CGMS Gold; this was performed as previously described [ 15 ]. The data collected from the CGMS were (1) 7 a.m. day 2 to 7 a.m. day 3 and (2) 7 a.m. day 4 to 7 a.m. day 5.…”

Section: Methodsmentioning

confidence: 99%

Comparison of Efficacy and Economic Value of Prandilin 25 and Humalog Mix 25 in Patients with Newly Diagnosed Type 2 Diabetes by a Continuous Glucose Monitoring System

Luo

Wang

et al. 2018

Diabetes Ther

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IntroductionTo determine the clinical efficacy and economic value of insulin lispro 25-Prandilin 25 vs. insulin lispro 25-Humalog mix 25 in treatment of newly diagnosed type 2 diabetes mellitus (T2DM) by a continuous glucose monitoring system (CGMS).MethodsThis was a single-center, randomized, case-crossover clinical trial. Participants were randomly allocated to two groups and underwent two kinds of insulin lispro 25 treatment separated by a 1-day washout period. In total, 81 patients with newly diagnosed T2DM with hemoglobin A1c (HbA1c) above 9% were hospitalized and randomly divided to receive Prandilin 25/Humalog mix 25 or Humalog mix 25/Prandilin 25 treatment. All participants were subjected to metformin therapy simultaneously. Glycemic control was reached after 7–8 days Prandilin 25 or Humalog mix 25 treatment; each patient received continuous glucose monitoring (CGM) for 5 consecutive days (from day 1 to day 5). On day 3 of CGM performance, Prandilin 25 treatment was switched to Humalog mix 25 treatment at the same dosage or vice versa. Parameters representing glycemic variability (GV) and postprandial glucose excursions, including 24-h mean blood glucose (24hMBG), 24-h standard deviation of blood glucose (24hSDBG), 24-h mean amplitude of glycemic excursion (24hMAGE), large amplitude of glycemic excursion (LAGE), incremental area under the curve (AUC) for different glucose levels, and postmeal relative areas under the CGM curve (AUCpp) for 1–4 h of each meal, were calculated for each patient.ResultsNo significant differences were found in the 24hMAGE, 24hMBG, 24hSDBG, LAGE, mean 1-h preprandial blood glucose and the incidence of hypoglycemia between the Prandilin 25 treatment group and Humalog mix 25 treatment group. Similarly, there were no between-treatment differences for AUC and time when blood glucose was below 3.9 mmol/l, between 3.9 mmol/l and 10.0 mmol/l, or above 10.0 mmol/l. Further analysis showed the AUCpp for 1–4 h of each meal for two kinds of treatments were similar. However, the mean estimated cost of Prandilin 25 was only 85% of Humalog mix 25 in one treatment course.ConclusionPrandilin 25 is non-inferior in clinical efficacy compared with Humalog mix 25. In view of the significant difference in the cost of the two kinds of insulin lispro 25, Prandilin 25 is a much more cost-effective anti-diabetes drug for management of T2DM.Trial RegistrationChinese Clinical Trial Register identifier, ChiCTR1800015829.

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Exenatide Add-on to Continuous Subcutaneous Insulin Infusion Therapy Reduces Bolus Insulin Doses in Patients with Type 2 Diabetes: A Randomized, Controlled, Open-Label Trial

Cited by 17 publications

References 44 publications

Male Patients with Longstanding Type 2 Diabetes Have a Higher Incidence of Hypoglycemia Compared with Female Patients

Male Patients with Longstanding Type 2 Diabetes Have a Higher Incidence of Hypoglycemia Compared with Female Patients

Continuous subcutaneous insulin infusion combined with liraglutide reduced glycemic variability and oxidative stress in type 2 diabetes mellitus: a study based on the flash glucose monitoring system

Comparison of Efficacy and Economic Value of Prandilin 25 and Humalog Mix 25 in Patients with Newly Diagnosed Type 2 Diabetes by a Continuous Glucose Monitoring System

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