DOCSLIB.ORG

Dulaglutide Replaces Multiple Daily Insulin Injections from Dialysis Patients with Type 2 Diabetes

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Dulaglutide Replaces Multiple Daily Insulin Injections from Dialysis Patients with Type 2 Diabetes Sky Journal of Medicine and Medical Sciences Vol. 4(6), pp. 046 - 048, July, 2016 Available online http://www.skyjournals.org/SJMMS ISSN 2315-8808 ©2016 Sky Journals Case Report Dulaglutide replaces multiple daily insulin injections from dialysis patients with type 2 diabetes Satoshi Furukawa The Department of Legal Medicine, Shiga University of Medical Science. Setatsukinowa Otsu Shiga Japan. E-mail: [email protected]. Accepted 27 June, 2016 Glucagon-like peptide-1 (GLP-1) based therapy improves glycemic control through multiple mechanisms with a low risk of hypoglycemia. Dulaglutide is administered once weekly via subcutaneous injection. Two dialysis patients has used super-rapid insulin (3 shots/day) and one patient has done insulin aspart/aspart protamine 30/70 (2 shots/day). We switched injection regimen from multiple daily insulin injections to dulaglutide, and had glycemic control improved without hypoglycemia. The choice of injection regimen should consider the preferences, and resources of the individual and the family for adapting treatment of the patient needs. Dulaglutide minimizes the risk of hypoglycemia and injection burden. Key words: GLP-1 receptor agonist, dulaglutide, dialysis patients. INTRODUCTION The American Diabetes Association (ADA) recommends On September 18, 2014, dulaglutide (Trulicity; Eli Lilly), metformin as the initial for type 2 diabetes; if another a once-weekly subcutaneous injection, was approved by treatment or a combination therapy is needed, available the US Food and Drug Administration (FDA) as an agents include sulfonylureas, thiazolidinediones, adjunct to diet and exercise to reduce fasting and dipeptidyl peptidase (DPP)-4 inhibitors, glucagon-like postprandial glucose after a single dose (Indianapolis, peptide (GLP)-1 receptor agonists, insulin, and other 2014). agents (Insucchi et al., 201). The development of the Liraglutide is an analog of human GLP-1 produced by GLP-1 receptor agonist and the DPP-4 inhibitor classes, recombinant DNA technology. It was approved for clinical both of which target the incretin system, represents an use in Europe in 2009 and in USA in 2010 and has been important advancement in the management of type 2 available in India since 2010. We used liraglutide for 3 diabetes (2). The long-acting GLP-1 receptor agonists dialysis patients with type 2 diabetes. improve glycemic control and help to promote weight loss. Furthermore, based on their glucose-dependent mechanism of action, the GLP-1 receptor agonists have Case reports low risk for hypoglycemia (Garber, 2011). The most common adverse effect was mild to moderate Super-rapid insulin has a short duration of action and nausea and vomiting which decreased with time reduces blood glucose in a highly targeted fashion. (Princeton and Bristol-Myers, 2014). The incidence of Premixed insulin regimens are designed to maximize hypoglycemia was low when not given alongside patient convenience and reduce the number of daily concomitant sulfonylurea or insulin therapy (Princeton injections required by providing both rapid-acting and and Bristol-Myers, 2014). GLP-1 based therapies have intermediate-acting components in one formulation. We become integral in many treatment guidelines, such as had three dialysis patients with type 2 diabetes. Two ADA/ European Society for Study of Diabetes, the patients had used super-rapid insulin and one patient did American Association of Clinical Endocrinologists, and insulin aspart/aspart protamine 30/70 (Table 1). We the International Diabetes Federation (ADA, 2014; switched injection regimen from multiple daily insulin Garber et al., 2014; IDF, 2012). injections to dulaglutide. Their injection regimen changed Furukawa 47 Table 1. Insulin injection regimen with three dialysis patients. Age Sex Insulin Before Breakfast Before Lunch Before Dinner Case 1 75 M Super-rapid 4 3 3 Case 2 46 M Super-rapid 6 6 6 Case 3 75 M Aspart 30/70 6 0 4 Table 2. Blood glucose levels before-after hemodialysis (HD) therapy with three cases. Case 1 Before HD Under HD After HD 25th in March 200 165 179 28th 137 123 30th 239 120 111 1st in April 208 Dulaglutide 4th 136 107 103 6th 115 102 93 8th 152 133 111 Dulaglutide 11th 114 13th 161 134 117 15th 159 142 133 Dulaglutide 18th 146 96 20th 230 154 122 (mg/dl) Case 2 Before HD Under HD After HD 25th in March 192 162 119 28th 207 134 2nd in April 236 115 146 Dulaglutide 5th 154 119 118 7th 177 161 187 9th 184 129 93 Dulaglutide 12th 143 139 14th 102 77 16th 151 122 90 Dulaglutide 18th 241 134 97 21th 167 135 132 (mg/dl) Case 3 Before HD Under HD After HD 15th in April 105 121 136 18th 128 103 107 20th 195 170 22th 183 148 117 Dulaglutide 25th 152 107 100 27th 135 122 106 29th 152 119 109 Dulaglutide 2nd in May 143 106 92 4th 205 185 112 (mg/dl) from 2-3 shots daily to 1 shot weekly. We measured human GLP-1 (Rigato and Fadini, 2014). There is no blood glucose levels under hemodiafiltration therapy and structural modification to render it resistant to DPP-4, but showed their results (Table 2). the slow absorption from the site after subcutaneous administration can be attributed to self-association RESULTS leading to the formation of heptamers at the injection site (Rigato and Fadini, 2014). Once in plasma, 99% remains We had improved glycemic control without hypoglycemia bound to plasma albumin, with the bound molecule and enabled to reduce injection to be taken. Dulaglutide having a half-life of 13 h, thereby making it suitable for minimized the risk of hypoglycemia and injection burden. administration. Liraglutide should be initiated with the dose of 0.6 mg for a week (Rigato and Fadini, 2014; Bagsvaerd, 2013). Starting with such low dosage helps Discussion reduce gastrointestinal symptoms during initial stage but is not effective for glycemic control. After a week, the This engineered peptide shares 97% homology to native dose should be increased to 1.2 mg. If the 1.2 mg dose 48 Sky. J. Med. Med. Sci. does not result in an acceptable glycemic control, the 2014. Diabetes Care 2014; 37: 14-80. dose can be further increased to 1.8 mg. Liraglutide is Garber AJ, Abrahamson MJ, Barzilay JI, Blonde L, Bloomgarden ZT, Bush MA (2013). American Association of Clinical Endocrinologists’ available in disposable, prefilled, and multi-dose pens comprehensive diabetes management algorithm 2013 consensus (Bagsvaerd, 2013; Lund, 2014). Dulaglutide is statement. Endocrine Practical, 19: 536-557. administered once on a weekly basis at any time of the Brussels, Belgium: Internatinal Diabetes Federation (2012). day via subcutaneous injection into the abdomen, thigh, International Diabetes Federation. Clininal Guidelines Task Force. Global Guideline for Type 2 Diabetes. or upper arm (Indianapolis, 2014). Trulicity (dulaglutide) injection. Indianapolis, IN: Eli Lilly and Company; The initial dose of dulaglutide is 0.75 mg administered September 2014. subcutaneously once on a weekly basis. Dulaglutide can Rigato M, Fadini GP (2014). Comparative effectiveness of liraglutide in be administered with or without (Indianapolis, 2014). The the treatment of type 2 diabetes. Diabetes Metab. Syndr. Obes., 7: 107-120. rate of hypoglycemia was low, except when liraglutide Bagsvaerd, Denmark: Novo Nordisk 2013. US Prescribing Information. was used in combination with sulfonylureas when there Lund A, Knop FK, Vilsboll T (2014). Glucagon-like peptide-1 receptor was an increased risk of hypoglycemia. Anti-liragulutide agonists for the treatment of type 2 diabetes: Differences and antibodies were detected in 8.6% of liraglutide-treated similarities. Eur. J. Intern. Med., 25: 407-414. Loretta Fala. Trullicity (Dulaglutide) (2015). A new GLP-1 recepter patients, relatively lower than that seen with exenatide agonist once-weekly subcutaneous injection approved for the owing to high sequence identity with native GLP-1 treatment of patients with type 2 diabetes. Am Health Drug Benefits, (Bagsvaerd, 2013). In general, the presence of antibodies 8: 131-134. did not impact the clinical efficacy. In 6 clinical studies which included a total of 3342 patients with type 2 diabetes, treatment with dulaglutide resulted in greater reductions from baseline in HbA1c levels compared with placebo, with no overall differences in glycemic reductions across age, sex, race/ethnicity, or duration of disease (Loretta, 2015). With the recent FDA approval of dulaglutide, a new, once-weekly subcutaneous injection became available as an adjunct to diet and exercise for adult patients with type 2 diabetes. Dulaglutide, a GLP-1 receptor agonist, provides a once-weekly treatment option that can be used as monotherapy or as an add-on therapy to existing treatment regimens. The once-weekly therapy may provide another therapeutic alternative when oral antihyperglycemic medications are unable to provide adequate glycemic control. A once-weekly treatment may provide an attractive option for dialysis patients with type 2 diabetes. Conclusion The GLP-1 receptor agonist improves glycemic control through multiple mechanisms with a low risk of hypoglycemia. Dulaglutide is being recognized as an important therapy in management of dialysis patients with type 2 diabetes. REFERENCES Insucchi SE, Bergenstal RM, Buse JB (2012). Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2012; 35: 1364-1379. Garber AJ (2011). Long-acting glucagon-like peptide 1 receptor agonists: a review of their efficacy and tolerability. Diabetes Care; 34: 279-284. Princeton NJ, Bristol-Myers Squibb Company (2014). US Prescribing Information. American Diabetes Association. Standards of medical care in diabetes .
Load more

Recommended publications
  • Insulin Aspart Sanofi, If It Is Coloured Or It Has Solid Pieces in It
    ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Insulin aspart Sanofi 100 units/ml solution for injection in vial Insulin aspart Sanofi 100 units/ml solution for injection in cartridge Insulin aspart Sanofi 100 units/ml solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml solution contains 100 units insulin aspart* (equivalent to 3.5 mg). Insulin aspart Sanofi 100 units/ml solution for injection in vial Each vial contains 10 ml equivalent to 1,000 units insulin aspart. Insulin aspart Sanofi 100 units/ml solution for injection in cartridge Each cartridge contains 3 ml equivalent to 300 units insulin aspart. Insulin aspart Sanofi 100 units/ml solution for injection in pre-filled pen Each pre-filled pen contains 3 ml equivalent to 300 units insulin aspart. Each pre-filled pen delivers 1-80 units in steps of 1 unit. *produced in Escherichia coli by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear, colourless, aqueous solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Insulin aspart Sanofi is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above. 4.2 Posology and method of administration Posology The potency of insulin analogues, including insulin aspart, is expressed in units, whereas the potency of human insulin is expressed in international units.
    [Show full text]
  • A Critical Appraisal of the Role of Insulin Analogues in the Management of Diabetes Mellitus Ralph Oiknine, Marla Bernbaum and Arshag D
    Drugs 2005; 65 (3): 325-340 REVIEW ARTICLE 0012-6667/05/0003-0325/$39.95/0 2005 Adis Data Information BV. All rights reserved. A Critical Appraisal of the Role of Insulin Analogues in the Management of Diabetes Mellitus Ralph Oiknine, Marla Bernbaum and Arshag D. Mooradian Division of Endocrinology, Department of Internal Medicine, Diabetes, and Metabolism, St Louis University School of Medicine, St Louis, Missouri, USA Contents Abstract ....................................................................................325 1. Physiology of Insulin Secretion .............................................................326 2. Conventional Insulin Preparations ..........................................................327 3. Insulin Analogues ........................................................................328 3.1 Rapid-Acting Insulin Analogues .......................................................328 3.1.1 Insulin Lispro ...................................................................328 3.1.2 Insulin Aspart ..................................................................329 3.1.3 Insulin Glulisine .................................................................329 3.1.4 Clinical Utility of Rapid-Acting Insulin Analogues ...................................330 3.2 Premixed Insulins and Insulin Analogues ................................................331 3.3 Basal Insulin Analogues ...............................................................331 3.3.1 Insulin Glargine ................................................................331
    [Show full text]
  • (Pram) and Insulin A21G Improves Post-Prandial Glucose Vs Novolog
    ADO09, A Co-Formulation Of Pramlintide (Pram) and Insulin A21G improves Post-Prandial Glucose Vs Novolog® in Type 1 Diabetes (T1DM) G.Meiffren¹, G.Andersen², R.Eloy¹, C.Seroussi¹, C.Mégret¹, S.Famulla², Y.-P Chan¹, M.Gaudier¹, O.Soula¹, J.H. DeVries²,T.Heise² (1 Adocia, Lyon, France ; 2 Profil, Neuss, Germany) Introduction & Background Overall safety Outpatient period results - CGM metrics o ADO09 (M1Pram) is a co-formulation of pramlintide and insulin A21G o Both treatments were well tolerated without any treatment-related serious adverse events o Most of the CGM metrics (TiR [70-180], TiR [80-140], mean blood glucose per day), were significantly improved developed to leverage the beneficial effects of pramlintide on post-prandial (Table 2). As expected M1Pram had numerically more, mostly gastrointestinal adverse events with M1Pram (Table 4). Postprandial and mean 24-hour glucose profiles were improved with M1Pram (Fig. 3) glucose without additional injections than insulin aspart Table 4: CGM metrics, all days. Significant differences are marked in bold Objective and design o No severe hypoglycemia were seen, slightly more hypoglycemic events occurred with M1Pram Ratio of LSMean* o To compare the effect of M1Pram and insulin aspart (Novolog®, Novo than with aspart (Table 3) Difference Parameter Treatment LS Mean M1Pram / Aspart P-value Nordisk) on post-prandial glucose control, glycemic control assessed by Table 2: Incidence of adverse events throughout the trial (M1Pram-Aspart) (95% CI) CGM and safety/tolerability M1Pram Aspart M1Pram
    [Show full text]
  • TRULICITY, INN-Dulaglutide
    ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Trulicity 0.75 mg solution for injection in pre-filled pen Trulicity 1.5 mg solution for injection in pre-filled pen Trulicity 3 mg solution for injection in pre-filled pen Trulicity 4.5 mg solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Trulicity 0.75 mg solution for injection in pre-filled pen Each pre-filled pen contains 0.75 mg of dulaglutide* in 0.5 ml solution. Trulicity 1.5 mg solution for injection in pre-filled pen Each pre-filled pen contains 1.5 mg of dulaglutide* in 0.5 ml solution. Trulicity 3 mg solution for injection in pre-filled pen Each pre-filled pen contains 3 mg of dulaglutide* in 0.5 ml solution. Trulicity 4.5 mg solution for injection in pre-filled pen Each pre-filled pen contains 4.5 mg of dulaglutide* in 0.5 ml solution. *produced in CHO cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Type 2 Diabetes Mellitus Trulicity is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications • in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
    [Show full text]
  • Subcutaneous Semaglutide, Dulaglutide and Liraglutide 1.2Mg for the Treatment of Type
    North Central London Joint Formulary Committee Factsheet Subcutaneous SEMAGLUTIDE▼ (Ozempic®), DULAGLUTIDE▼ (Trulicity®) and LIRAGLUTIDE 1.2mg (Victoza®) Treatment of Type 2 Diabetes Mellitus Start date: December 2019 Review date: August 2022 Document Control Date Version Action July 2016 1.0 New guideline August 2019 1.1 Subcutaneous semaglutide added as the preferred GLP-1 receptor agonist November 2019 1.2 Supply quantities added Agreed by NCL Shared Care Group: December 2019 FACTSHEET TO FACILITATE PRESCRIBING PLEASE NOTE THIS IS NOT A SHARED CARE GUIDELINE, NOR IS IT A FULL SUMMARY OF DRUG INFORMATION. ALWAYS REFER TO THE MOST RECENT BNF AND/OR SUMMARY OF PRODUCT CHARACTERISTICS. Disclaimer This Fact Sheet is registered at North Central London (NCL) Joint Formulary Committee (JFC) and is intended solely for use by healthcare professionals to aid the treatment of patients within NCL. However, this fact sheet is for guidance only, its interpretation and application remains the responsibility of the individual clinician. If in doubt, contact a senior colleague or expert. Clinicians are advised to refer to the manufacturer’s current prescribing information before treating individual patients. The authors and NCL JFC accept no liability for use of this information from this beyond its intended use. While we have tried to compile accurate information in this document, and to keep it updated in a timely manner, we cannot guarantee that it is fully complete and correct at all times. If you identify information within this document that is inaccurate, please report this to the [email protected]. If a patient is harmed as a consequence of following this document, please complete a local incident report and inform [email protected].
    [Show full text]
  • Type 2 Diabetes Adult Outpatient Insulin Guidelines
    Diabetes Coalition of California TYPE 2 DIABETES ADULT OUTPATIENT INSULIN GUIDELINES GENERAL RECOMMENDATIONS Start insulin if A1C and glucose levels are above goal despite optimal use of other diabetes 6,7,8 medications. (Consider insulin as initial therapy if A1C very high, such as > 10.0%) 6,7,8 Start with BASAL INSULIN for most patients 1,6 Consider the following goals ADA A1C Goals: A1C < 7.0 for most patients A1C > 7.0 (consider 7.0-7.9) for higher risk patients 1. History of severe hypoglycemia 2. Multiple co-morbid conditions 3. Long standing diabetes 4. Limited life expectancy 5. Advanced complications or 6. Difficult to control despite use of insulin ADA Glucose Goals*: Fasting and premeal glucose < 130 Peak post-meal glucose (1-2 hours after meal) < 180 Difference between premeal and post-meal glucose < 50 *for higher risk patients individualize glucose goals in order to avoid hypoglycemia BASAL INSULIN Intermediate-acting: NPH Note: NPH insulin has elevated risk of hypoglycemia so use with extra caution6,8,15,17,25,32 Long-acting: Glargine (Lantus®) Detemir (Levemir®) 6,7,8 Basal insulin is best starting insulin choice for most patients (if fasting glucose above goal). 6,7 8 Start one of the intermediate-acting or long-acting insulins listed above. Start insulin at night. When starting basal insulin: Continue secretagogues. Continue metformin. 7,8,20,29 Note: if NPH causes nocturnal hypoglycemia, consider switching NPH to long-acting insulin. 17,25,32 STARTING DOSE: Start dose: 10 units6,7,8,11,12,13,14,16,19,20,21,22,25 Consider using a lower starting dose (such as 0.1 units/kg/day32) especially if 17,19 patient is thin or has a fasting glucose only minimally above goal.
    [Show full text]
  • Insulin Aspart (Nvolog): Important Patient Information
    What is most important to remember? If you have questions: Strong Internal Medicine • Insulin aspart (Novolog®) is used to lower blood sugar. It is Ask your doctor, nurse or pharmacist for important to use this medicine as more information about insulin aspart directed by your doctor (Novolog®) • Do not start any new medicines, over-the-counter drugs or herbal remedies without talking to your doctor • Tell all doctors, dentists and pharmacists that you are using insulin aspart (Novolog®) • insulin aspart (Novolog®) can cause low blood sugar. Always Strong Internal Medicine keep a source of sugar handy for 601 Elmwood Avenue times when your blood sugar gets Ambulatory Care Facility, 5th Floor too low Rochester, NY 14642 Phone: (585) 275 -7424 Insulin Aspart • Do not use your insulin if it (Novolog®): Visit our website at: becomes cloudy or has particles www.urmc.rochester.edu/medicine/ - Important Patient Information in it general-medicine/patientcare/ • Throw away all opened insulin after 28 days, even if it is not used up What does insulin aspart (Novolog®) do? Are there any interactions with other drugs that I need What are some things that I need to be aware of when to worry about? taking insulin aspart (Novolog®)? • It is used to lower blood sugar in patient with high blood sugar (diabetes) • There are many drug interactions that may increase • Tell your doctor or pharmacist if you have an allergy to How should insulin aspart (Novolog®) be used? your risk of side effects insulin, or any other drugs, foods, or substances • Use this
    [Show full text]
  • Considering Pramlintide Therapy for Postprandial Blood Glucose Control
    Feature Article/Considering Pramlintide Therapy Considering Pramlintide Therapy for Postprandial Blood Glucose Control Belinda P. Childs, ARNP, MN, BC-ADM, CDE; Nicole C. Kesty, PhD; Eric Klein, MD; Richard Rubin, PhD, CDE; and Allison Wick, MSN, ARNP, CDE Abstract Diabetes is a chronic disease affecting Several therapeutic options are cur- > 20 million Americans, and its inci- rently available to address postprandi- dence, especially in the form of type 2 al glucose fluctuations, including diabetes, is increasing. Multiple thera- rapid-acting insulin analogs, incretin peutics are available that address the mimetics, dipeptidyl peptidase IV dysregulation of the multiple hor- inhibitors, α-glucosidase inhibitors, mones responsible for glucose home- meglitinides, and amylinomimetics. ostasis. Despite the various options, This article presents the experiences of tight glycemic control is often elusive. three patients for whom pramlintide, Additionally, the pursuit of tight an amylinomimetic, was identified as glycemic control is generally accom- an appropriate therapeutic option. panied by various clinical challenges, Practical considerations for clinicians, such as hypoglycemia, weight gain, patient lifestyle factors, and percep- and glucose fluctuations, in particular, tions of pramlintide therapy are also postprandial fluctuations. presented. Diabetes, a chronic disease affecting postprandial hyperglycemia without ~ 20.8 million Americans,1 is character- causing concomitant weight gain, ized by chronic hyperglycemia resulting patients now have additional tools to from the body’s inadequate physiologi- manage their diabetes. cal response to glucose. In type 1 dia- betes, secretion of insulin and amylin Glucose Homeostasis into the circulatory system is absolutely Glucose homeostasis is maintained by deficient because of the destruction of a complex multihormonal system that pancreatic β-cells, whereas in type 2 continuously balances the appearance diabetes, secretion of insulin and and disappearance of glucose.
    [Show full text]
  • A Direct Comparison of Insulin Aspart and Insulin Lispro in Patients with Type 1 Diabetes
    Pathophysiology/Complications ORIGINAL ARTICLE A Direct Comparison of Insulin Aspart and Insulin Lispro in Patients With Type 1 Diabetes 1 1 JOHANNES PLANK, MD BARBARA SEMLITSCH, RN human soluble insulin is performed as 1 1 ANDREA WUTTE, MSC ROMANA SOMMER, MD standard treatment regimen by a majority 1 2 GERNOT BRUNNER, MD SABINE HIRSCHBERGER, MD 1 1 of patients (2,3). However, postprandial ANDREA SIEBENHOFER, MD THOMAS R. PIEBER, MD blood glucose peaks and excursions are not comparable with nondiabetic sub- jects. Absorption of unmodified insulin from the injection site is a complex pro- cess affected by only partially changeable OBJECTIVE — Both rapid-acting insulin analogs, insulin aspart and lispro, attenuate pran- factors, such as anatomic area, blood dial glucose excursion compared with human soluble insulin. This trial was performed to study flow, injection volume, concentration of the pharmacokinetic and pharmacodynamic profiles of insulin aspart and insulin lispro in type 1 diabetic patients in a direct comparison and to investigate whether the administration of one insulin, and possible local degradation analog results in favorable effects on prandial blood glucose control. process (4–6). Therefore, considerable attention has been devoted to the devel- RESEARCH DESIGN AND METHODS — A total of 24 type 1 diabetic patients (age opment of insulin molecules with accel- 36 Ϯ 8 years, 16 men and 8 women, BMI 24.3 Ϯ 2.6 kg/m2, diabetes duration 17 Ϯ 11 years, erated absorption kinetics (7–9). This Ϯ HbA1c 7.9 0.8%) on intensified insulin therapy were recruited into a single-center, random- more physiological profile of these short- ized, double-blind, two-period, cross-over, glucose clamp trial.
    [Show full text]
  • (Hmmc) Dulaglutide (Trulicity
    HERTFORDSHIRE MEDICINES MANAGEMENT COMMITTEE (HMMC) DULAGLUTIDE (TRULICITY®) FOR TYPE 2 DIABETES MELLITUS RECOMMENDED FOR RESTRICTED USE Name: What it is Indication Date Decision Decision NICE / SMC generic last revised Status Guidance (trade) dulaglutide glucagon‑like Type 2 diabetes June 2016 Final NICE - none ® (Trulicity ) peptide‑1 mellitus (T2DM) SMC – approved (GLP‑1) receptor for restricted use agonist Dulaglutide (Trulicity®) is RECOMMENDED FOR RESTRICTED USE as a GLP-1 receptor agonist option when a GLP-1 receptor agonist is indicated as add-on therapy in line with NICE guidelines for type 2 diabetes (see Policy Drivers overleaf) if a specialist service switches a patient from an alternative GLP-1 receptor agonist to dulaglutide clear information should be supplied on rationale and switch process to primary care colleagues. EFFICACY SAFETY From AWARD studies for change in HbA1c from According to SPC most common adverse events baseline, weekly dulaglutide was demonstrated to be: (≥1/10) are hypoglycaemia, particularly in o (1.5mg or 0.75mg) superior to placebo and exenatide combination with a sulfonylurea or insulin, and twice daily at 26 weeks gastrointestinal (GI) disorders. o (1.5mg or 0.75mg) superior to sitagliptin at 52 weeks According to the EPAR: o 1.5mg non-inferior to liraglutide 1.8mg daily at o across the phase II and III integrated safety 26 weeks population, incidence of common events are o (1.5mg or 0.75mg) non-inferior to insulin glargine at consistent with other GLP‑1 receptor agonists. 52 weeks. Superiority demonstrated for 1.5mg dose. o long‑term safety concerns of pancreatitis and Open label design of some of the AWARD studies pancreatic and thyroid cancers are consistent may have biased results with other GLP‑1 receptor agonists.
    [Show full text]
  • INSULIN-CONTAINING PRODUCTS from NOVO NORDISK Storage, and Savings Information
    Please see the following pages for Tresiba®, ® ® Xultophy 100/3.6, and Fiasp Dosing, 1 INSULIN-CONTAINING PRODUCTS FROM NOVO NORDISK Storage, and Savings Information. BASAL 100 units/mL; total of 200 units/mL; total of 100 units/mL; total of 300 units/pen; 5-pen pack1 600 units/pen; 3-pen pack1 1000 units/vial; 1 vial/pack1 NDC: 0169-2660-15 NDC: 0169-2550-13 NDC: 0169-2662-11 100 units/mL insulin degludec and 3.6 mg/mL liraglutide; total of 300 units insulin degludec and 10.8 mg liraglutide; 5-pen pack2 NDC: 0169-2911-15 BASAL/GLP-1 RA Approved for use in pumps3 Refer to the insulin infusion pump user manual to see if Fiasp® can be used. Use in accordance with the insulin pump’s Instructions for Use. 100 units/mL; total of 300 units; 100 units/mL; total of 100 units/mL; total of PRANDIAL 5-pen pack3 300 units/pen; 5-cartridge pack3 1000 units/vial; 1 vial/pack3 NDC: 0169-3204-15 NDC: 0169-3205-15 NDC: 0169-3201-11 GLP-1 RA=glucagon-like peptide-1 receptor agonist. Tresiba® Indications and Usage Xultophy® 100/3.6 Indications and Xultophy® 100/3.6 Important Safety Fiasp® Indications and Usage Tresiba® (insulin degludec injection) is indicated to Limitations of Use Information Fiasp® (insulin aspart injection) 100 U/mL is a improve glycemic control in patients 1 year of age and Xultophy® 100/3.6 (insulin degludec and liraglutide injection) rapid-acting insulin analog indicated to improve older with diabetes mellitus. WARNING: RISK OF THYROID C-CELL TUMORS 100 units/mL and 3.6 mg/mL is a combination of insulin ® glycemic control in adult and pediatric patients with degludec and liraglutide and is indicated as an adjunct to diet • Liraglutide, one of the components of Xultophy 100/3.6, causes dose-dependent and treatment-duration-dependent thyroid diabetes mellitus.
    [Show full text]
  • (Insulin Degludec/Liraglutide) a Match for Basal Bolus Therapy? Learnings from the DUAL™ VII Trial
    UK19XUM00029 Date of Preparation: Oct 2019 Is Xultophy® (insulin degludec/liraglutide) a match for basal bolus therapy? Learnings from the DUAL™ VII trial Dr Harsha Kasetty Medical affairs Manager Novo Nordisk UK This meeting is organised and funded by Novo Nordisk. Prescribing information and adverse event reporting are available at this meeting. Insulin degludec and Liraglutide prescribing information Xultophy® Insulin degludec and Liraglutide. Patients treated with Xultophy® should be advised of the potential risk of dehydration in relation to gastrointestinal side effects and take precautions to avoid fluid depletion. Patients must be instructed ® Please consult the full Summary of Product Characteristics (SmPC) before prescribing to always check the pen label before each injection to avoid accidental mix-ups between Xultophy and other injectable diabetes medicinal products. Transfer to Xultophy® from doses of basal insulin <20 ® Xultophy is a pre-filled dial-a-dose pen. 1 mL solution contains 100 units insulin degludec and 3.6 mg and >50 units has not been studied. There is no therapeutic experience in patients with congestive liraglutide. One pre-filled pen contains 3 mL equivalent to 300 units insulin degludec and 10.8 mg heart failure New York Heart Association (NYHA) class IV and Xultophy® is therefore not recommended liraglutide. One dose step contains 1 unit of insulin degludec and 0.036 mg of liraglutide. for use in these patients. Patients must be advised to take precautions to avoid hypoglycaemia while Indication: Xultophy® is indicated for the treatment of adults with insufficiently controlled type 2 driving. diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to other Fertility, pregnancy and lactation: There is no clinical experience with the use of Xultophy® in oral medicinal products for the treatment of diabetes.
    [Show full text]