MD Conference Express - (Page 9)

APIDRA® (insulin glulisine [rDNA origin] injection) solution for injection (dose resulting in an exposure 2 times the average human dose, based on body surface area comparison) and did not have any remarkable toxic effects on embryo-fetal development. Insulin glulisine was given to female rabbits throughout pregnancy at subcutaneous doses up to 1.5 Units/kg/day (dose resulting in an exposure 0.5 times the average human dose, based on body surface area comparison). Adverse effects on embryo-fetal development were only seen at maternal toxic dose levels inducing hypoglycemia. Increased incidence of postimplantation losses and skeletal defects were observed at a dose level of 1.5 Units/kg once daily (dose resulting in an exposure 0.5 times the average human dose, based on body surface area comparison) that also caused mortality in dams. A slight increased incidence of post-implantation losses was seen at the next lower dose level of 0.5 Units/kg once daily (dose resulting in an exposure 0.2 times the average human dose, based on body surface area comparison) which was also associated with severe hypoglycemia but there were no defects at that dose. No effects were observed in rabbits at a dose of 0.25 Units/kg once daily (dose resulting in an exposure 0.1 times the average human dose, based on body surface area comparison). The effects of insulin glulisine did not differ from those observed with subcutaneous regular human insulin at the same doses and were attributed to secondary effects of maternal hypoglycemia. There are no well-controlled clinical studies of the use of APIDRA in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential beneﬁt justiﬁes the potential risk to the fetus. It is essential for patients with diabetes or a history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy. Insulin requirements may decrease during the ﬁrst trimester, generally increase during the second and third trimesters, and rapidly decline after delivery. Careful monitoring of glucose control is essential in these patients. 8.3 Nursing mothers It is unknown whether insulin glulisine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when APIDRA is administered to a nursing woman. Use of APIDRA is compatible with breastfeeding, but women with diabetes who are lactating may require adjustments of their insulin doses. 8.4 Pediatric use The safety and effectiveness of subcutaneous injections of APIDRA have been established in pediatric patients (age 4 to 17 years) with type 1 diabetes [See Clinical Studies (14.4) in the full prescribing information]. APIDRA has not been studied in pediatric patients with type 1 diabetes younger than 4 years of age and in pediatric patients with type 2 diabetes. As in adults, the dosage of APIDRA must be individualized in pediatric patients based on metabolic needs and frequent monitoring of blood glucose. 8.5 Geriatric use In clinical trials (n=2408), APIDRA was administered to 147 patients ≥65 years of age and 27 patients ≥75 years of age. The majority of this small subset of elderly patients had type 2 diabetes. The change in HbA1c values and hypoglycemia frequencies did not differ by age. Nevertheless, caution should be exercised when APIDRA is administered to geriatric patients. 10 OVERDOSAGE Excess insulin may cause hypoglycemia and, particularly when given intravenously, hypokalemia. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately. sanoﬁ-aventis U.S. LLC Bridgewater, NJ 08807 ©2009 sanoﬁ-aventis U.S. LLC GLU-BPLR-SA-FEB09 Revised: February 2009 The world’s most influential key opinion leaders trust MD Conference Express® to deliver authoritative, balanced, and insightful reports of the conference news which will change practice DIABET ES eview Peer-R ed HIGHLI GHTS FROM THE ific Scient ns Sessio Breakin g New s y Therap s Update and oring e Monit valuabl cose vides ts. This s Glu ien M) pro nuou (RT-CG diabetic pat rove bolus Conti ent s in nitoring to imp n and Time Real- tes Treatm glucose mo and patternpotential ong childre hyper/ ous of rs the trends y am Diabe e tinu ns use e con ut glucos ement offe lin therap ugh the ist clinicia s. Real-timtion abo ic manag of insu DM) thro may ass basal rate informa of glycem ht control llitus (T1 data that rnight read use d me ective and ove widesp metho and overnigdiabetes osp 1 ratios ports the dosing with type ms and retr drate ohy that sup adults ycemia alar lin-to-carb evidence 4. e page hypoglimizing insu y provid M. See ma es in opt trial data ients with T1D Diabet ion of Recent M in pat Science CG balizat – The of RTThe Glo hlights MD Conference Express® is issued to the medical community only after passing rigorous peer-review A profes sional courtes y of ALSO IN THIS ISSU E • l Hig ical Tria 1C – • Clin ind Diabetes and HbA Beh e Devices k? nt of Car the Tas • Poi They Up to Are 5. Editors finalize publication 4. Independent expert peer-review ensures accuracy and fair balance 3. Presenting faculty confirm data and/or provide post-conference updates 2. Data-driven content referenced against primary sources 1. Scientific committee guides topic selection MD Conference Express is the first publication to put conference ‘news’ to the rigorous test of peer-review. Primary source data drives our evidence-based reporting. The news you read has been vetted, tested and thoroughly challenged by the very faculty who presented at the live congress. To subscribe, please visit: www.mdconferencexpress.com http://www.mdconferencexpress.com/

Table of Contents for the Digital Edition of MD Conference Express

MD Conference Express
Contents
Real-Time Continuous Glucose Monitoring and Diabetes Treatment
The Globalization of Diabetes
Treat the Individual, Tend to the Population
Microvascular Outcomes from the ACCORD Trial
Diabetic Retinopathy in the ACCORD Trial
Results from the STAR 3 Study
Findings from HELP PD
Insights from the BARI 2D Trial
Effect of Atorvastatin on Beta Cell Function
Caffeine Supplementation Reduces Exercise Induced Hypoglycemia
Cardiometabolic Risk
Point of Care Devides
Newer Insulins
Diabetes, Glycemia and Cardiovascular Disease: Is it Time to Rethink the Regulatory Approach?
Diabetes and Cancer: ADA Consensus Statement
The Diabetic Foot Wound
HEALTHY Study - Middle School-Based Intervention to Reduce Diabetes Risk

MD Conference Express

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