Effects of Vildagliptin Add-on Insulin Therapy on Nocturnal Glycemic Variations in Uncontrolled Type 2 Diabetes

Li, Fengfei; Shen, Yun; Sun, Rui; Zhang, Danfeng; Jin, Xing; Zhai, Xiaofang; Chen, Mao-yuan; Su, Xiaofei; Wu, Jindan; Ye, Lei; Ma, Jianhua

doi:10.1007/s13300-017-0303-2

Cited by 10 publications

(14 citation statements)

References 55 publications

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“…All patients were subjected to 4-day retrospective CGM (Sof-sensor, CGMS-Gold, Medtronic Incorp., Northridge, CA, USA) at the last 4 days in this study [ 18 , 23 ]. All subjects were instructed to maintain moderate physical activity and received breakfast (0700), lunch (1100) and dinner (1700).…”

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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“…Diabetes is responsible for reducing blood levels of albumin, which is also indicative of liver failure. Vildagliptin add-on insulin therapy in T2DM also did not alter the level of liver enzymes 32 , whereas in a hepatic fibrosis model the administration of Quercetin resulted in maintenance of ALT/AST levels and increased serum albumin levels, suggesting a possible hepatoprotective effect 39 . Diabetes is characterized by redox imbalance in the kidneys that can lead to nephropathy 40 .…”

Section: Discussionmentioning

confidence: 89%

“…Atherosclerosis is a pathological condition resulting from lipid deposition and atheromatous plaque formation in the subendothelial layer of blood vessels, and oxidative stress and inflammatory responses are among the major triggers 31 . A study with patients with uncontrolled T2DM showed that Vildagliptin as an add-on to insulin therapy did not alter the lipid profile 32 , while Vildagliptin treatment ameliorated this parameter in diabetic mice 33 . The QV formulation had a beneficial effect in reducing atherogenic cholesterol fractions (decrease in non-HDL fraction accompanied by increase HDL fraction), while daily administration of insulin was responsible for increasing triacylglycerol levels when compared to treatment with the QV formulation.…”

Section: Discussionmentioning

confidence: 99%

Oral formulation of DPP-4 inhibitor plus Quercetin improves metabolic homeostasis in type 1 diabetic rats

Miranda

Lacerda

Araújo

et al. 2018

Sci Rep

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This study aimed to investigate the potential of an oral formulation (QV formulation) containing Quercetin and a Dipeptidyl Peptidase-4 Inhibitor (DPP-4 inhibitor), Vildagliptin, in improving metabolic homeostasis in type 1 diabetes model. Female albino Fischer rats were divided into four groups: untreated control animals (C), untreated diabetic animals (D), diabetic animals treated with QV formulation (DQV), and diabetic animals treated with insulin (DI). Diabetes was induced by injection of alloxan (135 mg kg body mass)−1 and confirmed by glycemic test. After the 30-day treatment period, biochemical parameters were analyzed in the pancreas, liver, and serum. Histopathological changes in pancreatic tissue were examined by Hematoxyline & Eosin staining and the insulin content in the islet measured by immunohistochemistry with anti-insulin antibody. The glycogen content in the hepatocytes was quantified by Periodic Schiff Acid staining. The QV formulation reduced the glycemia, preserved the pancreatic architecture, increased insulin levels, furthermore ameliorated lipid profile and to promote higher survival rate of animals. Together, our data suggest that the QV formulation treatment was able to normalize metabolic homeostasis in type 1 diabetic rats.

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“…Compared with the structured seven-point self-monitoring of blood glucose, CGMS can monitor the subcutaneous interstitial fluid glucose level automatically every 5 min and thus provide dynamic changes of blood glucose for no less than 72 h to show more comprehensively and accurately the blood glucose excursion throughout the day. Hence, the CGMS is a reliable and useful tool to measure the GV of patients with diabetes mellitus [ 23 , 24 ]. In the present study, we used CGMS to compare the efficacy, safety, risk of hypoglycemia, and glucose excursion profile of two low premixed insulin lispro 25s, Prandilin 25 and Humalog mix 25, in T2DM patients.…”

Section: Discussionmentioning

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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Effects of Vildagliptin Add-on Insulin Therapy on Nocturnal Glycemic Variations in Uncontrolled Type 2 Diabetes

Cited by 10 publications

References 55 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

Oral formulation of DPP-4 inhibitor plus Quercetin improves metabolic homeostasis in type 1 diabetic rats

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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