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Stephen Clement

Publications and source records attributed to Stephen Clement.

9 recordsLinked to original sources
PubMed2004

Oral modified insulin (HIM2) in patients with type 1 diabetes mellitus: results from a phase I/II clinical trial.

An effective, orally administered insulin product would be of substantial benefit in the treatment of patients with diabetes mellitus. This phase I/II clinical trial was the first to investigate the safety and effectiveness of a single oral dose of a modified human insulin in controlling postprandial plasma glucose levels in patients with type 1 diabetes mellitus who were receiving basal continuous subcutaneous insulin infusion (CSII) therapy. Fourteen patients with type 1 diabetes mellitus were evaluated in an open-label, 2-center, dose-escalation, nonrandomized study of oral hexyl-insulin monoconjugate 2 (HIM2). After an overnight fast and prior to receiving a standardized meal (50% carbohydrates, 30% fat, 20% proteins; 650 calories), the patients received either no additional insulin (day 1), or 0.5 to 1.0 mg/kg of HIM2 (day 2). All patients received a basal insulin regimen by CSII throughout the study. Blood samples were collected for determination of glucose and insulin levels for 240 minutes post-dose. The postprandial glucose excursion versus time curves showed clear reductions in glucose values after both HIM2 doses (day 2) relative to no treatment (day 1), although the differences in the reductions were not statistically significant. When the data for both HIM2 doses were pooled, a statistically significant effect of HIM2 on glucose excursion (as measured by AUCex(30-240)) was observed. Mean +/- SD values for AUCex(30-240) were 501.35 +/- 124.1 mg. h/dL after no treatment and 375.81 +/- 215.5 mg. h/dL after HIM2 (Wilcoxon signed-rank test, P =.042). The results of this study suggest that oral HIM2, when added to a basal insulin regimen, was safe and may prove effective in controlling postprandial hyperglycemia in patients with type 1 diabetes mellitus. Further clinical investigation is necessary.

Administration, Oral↗
PubMed2004

Guidelines for glycemic control.

Glycemic control in diabetes patients continues to evolve as new medications are introduced and clinical trial data become available. The American Diabetes Association (ADA) guidelines for 2004, for the first time, provide targets for both preprandial and postprandial glucose levels. The ADA, however, does not provide guidelines regarding specific medication therapy. This paper provides a detailed treatment algorithm that is easy to follow for nurse practitioners as well as primary care providers. Progress in our understanding of diabetes and new therapeutic agents will dictate modifications of treatment targets and guidelines, with the goal of making euglycemia achievable for all patients with diabetes.

Administration, Oral↗
PubMed2002

Oral insulin product hexyl-insulin monoconjugate 2 (HIM2) in type 1 diabetes mellitus: the glucose stabilization effects of HIM2.

This study was designed to determine plasma glucose and insulin levels after administration of three escalating doses of the oral insulin product hexyl-insulin monoconjugate 2 (HIM2) in fasting, insulin-deprived adult patients with type 1 diabetes. The study was also designed to assess the safety of the product. Sixteen patients with daily insulin requirements of 27-60 units and glycosylated hemoglobin levels of 5.8-11.1% completed the study. Patients' regular insulin regimens were discontinued at bedtime, and they fasted overnight. Blood glucose levels were stabilized overnight by intravenous insulin infusion. In the morning, intravenous insulin was discontinued 30 min prior to an oral dose of HIM2 (0.6, 0.8, or 1.0 mg/kg). A second oral dose of HIM2 was administered 120 min later. Plasma glucose and insulin levels were measured during a 240-min evaluation period after the first HIM2 dose. Identical HIM2 dosing and study procedures were repeated 1 week later with the same patients. Stable or declining plasma glucose levels were observed on 31 out of a total of 32 dosing days beginning at 20 min after the initial administration of HIM2. After plasma glucose levels declined or were stable for 30 min to 2 h, increases were observed for some patients. However, for the majority of patients (68.8%), plasma glucose levels were <150% of predose levels throughout the postdose evaluation period. Similar results were observed after repeating the study procedures 1 week later. Also, plasma glucose area under the concentration-time curves (AUCs) were inversely correlated with plasma insulin AUCs. HIM2 appeared to be safe and well-tolerated in this study; no episodes of symptomatic hypoglycemia were observed. Thus, HIM2 prevented the expected rise in plasma glucose concentrations in insulin-deprived adult patients with type 1 diabetes. The lack of hypoglycemic events in this exploratory study is encouraging and suggests that there may be less risk of severe hypoglycemia associated with HIM2 when compared with injectable insulin. The promising data in this study support the hypothesis that oral HIM2 reproduces the physiological pathway of insulin secreted by the pancreas - through the portal vein directly to the liver - suggesting a therapeutic advantage in the management of type 1 diabetes mellitus.

Administration, Oral↗
PubMedDate not supplied

Subcutaneous insulin therapy in the hospital setting: issues, concerns, and implementation.

OBJECTIVE: To summarize issues and recommendations regarding subcutaneous insulin therapy in various clinical settings in the hospital. RESULTS: The inpatient insulin regimen must be tailored to the specific clinical circumstance of the individual patient. Because nutritional intake is not necessarily provided as discrete meals in the hospital, the insulin dose requirement can be subclassified into "basal" and "nutritional" needs. In addition, the insulin requirement is generally increased in the presence of acute illness and stress. Thus, components of the insulin requirement are divided into basal, nutritional, and correction insulin. When the physician writes insulin orders, the basal and nutritional components are written as programmed or scheduled insulin, and the correction-dose insulin is written as an algorithm to supplement the scheduled insulin. Total insulin requirements may vary widely. Practical guidelines and suggestions are presented for selection of appropriate insulins, the delivery route, and the logical apportionment to programmed and correction insulin doses for hospitalized patients who are eating or not eating. Moreover, the role of bedside blood glucose monitoring in the hospital setting is discussed. CONCLUSION: Strict glycemic management in hospitalized patients has been shown to improve outcomes. Development and implementation of specific strategies for insulin delivery and improved methods for blood glucose monitoring should help to achieve target blood glucose levels safely.

Blood Glucose↗