Polymeric drug delivery system for insulin controlled-release is one of the most active fields of research and development in the world. Up to date, several kinds of intelligent drug carriers for glucose-responsive insulin delivery have been reported. On the basis of a large quantity of references on this topic, a review has been made on the developments of the intelligent polymeric systems for glucose-responsive insulin delivery.
Delayed-Action Preparations ; Drug Carriers ; Drug Delivery Systems ; instrumentation ; Hypoglycemic Agents ; administration & dosage ; Insulin ; administration & dosage

OBJECTIVETo study the effect of phenformin hydrochloride that may be illegally added in traditional Chinese medicine preparations on the pharmacokinetics of puerarin in rats.

METHODRats were randomly divided into the single pueraria group and the phenformin hydrochloride combined with pueraria group. After oral administration in the two groups, their bloods were sampled at different time points to determine the drug concentration of puerarin in rat blood and calculate pharmacokinetic parameters.

RESULTAfter oral administration with pueraria extracts and phenformin hydrochloride combined with pueraria extracts, the two groups showed main pharmacokinetic parameters as follows: Cmax were (2.39 +/- 1.01), (1.03 +/- 0.35) mg x L(-1), respectively; Tmax were (0.50 +/- 0.09), (1.5 +/- 0.5) h, respectively; Ke were (0.153 +/- 0.028), (0.172 +/- 0.042) h(-1), respectively; t(1/2) were (4.65 +/- 0.86), (4.20 +/- 0.81) h, respectively; AUC(0-t), were (5.73 +/- 2.60), (5.45 +/- 1.81) mg x h x L(-1), respectively; AUC(0-infinity) were (6.72 +/- 2.89), (6.26 +/- 1.88) mg x h x L(-1), respectively. Compared with the single puerarin group, the Cmax was significantly decreased (P < 0.05) and the Tmax was markedly longer (P < 0.01) than the hydrochloride combined with pueraria group.

CONCLUSIONPhenformin hydrochloride can slow down the absorption process of puerarin and change the pharmacokinetic process of puerarin to some extent.

Administration, Oral ; Animals ; Drug Interactions ; Hypoglycemic Agents ; administration & dosage ; pharmacology ; Isoflavones ; administration & dosage ; pharmacokinetics ; Male ; Phenformin ; administration & dosage ; pharmacology ; Rats ; Rats, Wistar ; Vasodilator Agents ; administration & dosage ; pharmacokinetics

Since the US Food and Drug Administration issued guidance requiring cardiovascular safety for all antidiabetic drugs in 2008 (US FDA industry guidance for licensing of antidiabetic drugs), the number of cardiovascular outcome trials in diabetes has remarkably increased. Cardiovascular outcome trial is considered a gold standard for establishing the cardiovascular safety of antidiabetic agents. However, there are possible limitations in information gained from cardiovascular outcome trials and other issues such as cost. In this review, we summarize recent cardiovascular outcome trials in type 2 diabetes and provide an overview of the implications and limitations of those trials.
Cardiovascular Diseases ; Diabetes Mellitus ; Hypoglycemic Agents ; Licensure ; United States Food and Drug Administration

Diabetes mellitus is the leading cause of chronic kidney disease worldwide. At present, a variety of classes of oral hypoglycemic agents are available to improve glycemic control, including newer classes of drugs such as DPP-IV inhibitors. Decreased renal function with reduced glomerular filtration rate affects the choices, dosing, and monitoring of oral hypoglycemic agents, as some agents require dose adjustments in patients with chronic kidney disease and others are entirely contraindicated. This article reviews the clinical use of oral hypoglycemic agents, focusing on pharmacokinetic properties and dosing in patients with chronic kidney disease.
Administration, Oral ; Diabetes Mellitus ; Glomerular Filtration Rate ; Humans ; Hypoglycemic Agents ; Kidney Failure, Chronic ; Renal Insufficiency, Chronic

Adolescent ; Child ; Diabetes Mellitus ; drug therapy ; Drug Design ; Humans ; Hypoglycemic Agents ; administration & dosage ; therapeutic use ; Insulin ; administration & dosage ; therapeutic use

With the increasing incidence of diabetes mellitus in China, hypodermic injection of artificial insulin to control blood sugar has been popularized. Insulin pen needles are widely used in hospitals, communities and families. This article attempts to explore and think about the harm and countermeasures brought about by the reuse of insulin pen needles from the perspective of medical device supervision.
China ; Diabetes Mellitus, Type 1 ; Humans ; Hypoglycemic Agents ; administration & dosage ; Injections, Subcutaneous ; instrumentation ; Insulin ; administration & dosage ; Needles

Diabetes is a well-known risk factor of cardiovascular morbidity and mortality, and the beneficial effect of improved glycemic control on cardiovascular complications has been well established. However, the rosiglitazone experience aroused awareness of potential cardiovascular risk associated with diabetes drugs and prompted the U.S. Food and Drug Administration to issue new guidelines about cardiovascular risk. Through postmarketing cardiovascular safety trials, some drugs demonstrated cardiovascular benefits, while some antidiabetic drugs raised concern about a possible increased cardiovascular risk associated with drug use. With the development of new classes of drugs, treatment options became wider and the complexity of glycemic management in type 2 diabetes has increased. When choosing the appropriate treatment strategy for patients with type 2 diabetes at high cardiovascular risk, not only the glucose-lowering effects, but also overall benefits and risks for cardiovascular disease should be taken into consideration.
Cardiovascular Diseases ; Diabetes Mellitus ; Heart Failure ; Humans ; Hypoglycemic Agents ; Mortality ; Risk Assessment ; Risk Factors ; United States Food and Drug Administration

Cardiovascular disease is a major cause of morbidity and mortality in people with type 2 diabetes. Therefore, the prevention of cardiovascular diseases is of great importance in these patients. Antidiabetic drugs may have cardiovascular effects independent of their glycemic effects. The highly publicized meta-analysis of rosiglitazone has triggered much concern about the cardiovascular effects of antidiabetic drugs. Since 2008, the US Food and Drug Administration (FDA) has required that all new antidiabetic drugs show proof of an acceptable cardiovascular risk profile. Because there is a lack of well-designed definitive studies, the cardiovascular risk/benefit is not definite in many drugs. Large randomized trials assessing the cardiovascular risk of antidiabetic drugs have been recently completed or are ongoing. The first novel drug class designated after 2008 is the dipeptidyl peptidase-4 (DPP-4) inhibitors. Trials of DPP-4 inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists have shown a neutral effect on cardiovascular disease. Empagliflozin, a sodium-glucose co-transporter 2 inhibitor, significantly decreased the incidence of the primary cardiovascular end point, especially decreasing cardiovascular death and hospital admission for heart failure. Ongoing and future studies will provide better insight about the effects of each class and individual drug on cardiovascular disease.
Cardiovascular Diseases ; Glucagon-Like Peptide 1 ; Heart Failure ; Humans ; Hypoglycemic Agents* ; Incidence ; Mortality ; United States Food and Drug Administration

The present study was to estimate pharmacokinetic parameters of metformin hydrochloride in 20 Chinese healthy volunteers with a limited sampling strategy (LSS), which will provide scientific data for bioequivalence and clinical application. A single dose of metformin was administrated to 20 healthy volunteers. The concentration of metformin in whole blood was determined by validated high performance liquid chromatography (HPLC) method. Multi-linear regression analysis was performed to establish a model to estimate AUC(0-24 h) and Cmax of metformin by LSS method. The LSS models were validated by the Jackknife method. The result indicated: the linearity relationship between AUC(0-24 h) or Cmax and single concentration point was poor. Several models for metformin AUC(0-24 h) or Cmax, estimation were better (r2 > 0.9, P < 0.05). Validation tests indicated that most informative sampling points (C2, C6 for AUC(0-24 h), C1.5, C2 for Cmax) provided accurate estimations of these parameters. So, a multi-linear regression model for estimation pharmacokinetic parameters of metformin by using LSS method is feasible.
Adult ; Area Under Curve ; Chromatography, High Pressure Liquid ; methods ; Humans ; Hypoglycemic Agents ; administration & dosage ; pharmacokinetics ; Linear Models ; Male ; Metformin ; administration & dosage ; pharmacokinetics ; Sample Size ; Therapeutic Equivalency ; Young Adult

INTRODUCTIONThe use of oral hypoglycaemic drugs in pregnancy is not recommended because of reports of foetal anomalies and other adverse outcomes in animal studies and in some human cases. However, recent studies have suggested that some oral hypoglycaemic drugs may be used in pregnancy. This review will examine these studies critically.

METHODSLiterature review of articles obtained from a PubMed search of peer-reviewed journals on oral hypoglycaemic drug use in pregnancy.

RESULTSIn two prospective studies, one of which was a randomised controlled trial, glibenclamide was as effective and safe as insulin in gestational diabetes. In several studies, metformin did not increase foetal anomalies or malformations when used during pregnancy in women with polycystic ovary syndrome (PCOS). In one prospective study on infants born to mothers who used metformin in pregnancy, follow-up for 18 months showed no adverse effects. In several prospective and retrospective studies on women with PCOS, metformin was shown to prevent early pregnancy loss, decrease insulin resistance, reduce insulin and testosterone levels, and decrease the incidence of gestational diabetes when these women got pregnant while on metformin and continued to take it throughout their pregnancy. In a single small study, acarbose did not cause any adverse effects during pregnancy.

CONCLUSIONSRecent evidence shows promising findings in the safety and efficacy of some oral hypoglycaemic agents in treating pregnant diabetics. However, larger clinical studies will be needed to ensure the safety and efficacy of these drugs in pregnancy.

Administration, Oral ; Contraindications ; Evidence-Based Medicine ; Female ; Humans ; Hypoglycemic Agents ; administration & dosage ; therapeutic use ; Pregnancy ; Pregnancy in Diabetics ; drug therapy ; Safety Management ; Singapore