Once-Weekly Semaglutide for Patients with Type 2 Diabetes
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
Semaglutide Versus Liraglutide for Treatment of Obesity
Archives of Diabetes & Obesity DOI: 10.32474/ADO.2021.03.000162 ISSN: 2638-5910 Review Article Semaglutide versus liraglutide for treatment of obesity Nasser Mikhail* *Department of Medicine, Endocrinology Division, David-Geffen UCLA Medical School, USA *Corresponding author: Nasser Mikhail, Endocrinology Division, Department of Medicine, Olive View-UCLA Medical Center, David- Geffen UCLA Medical School, CA, USA Received: April 02, 2021 Published: April 19, 2021 Abstract Background: Once weekly (OW) semaglutide is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) currently under evaluation for treatment of obesity at a dose of 2.4 mg OW. Objective Methods : To compare weight-loss efficacy and safety of once daily (OD) liraglutide 3.0 mg versus OW semaglutide 2.4 mg. : Pubmed research up to March 31, 2021. Randomized trials, pertinent animal studies, and reviews are included. Search Results terms were glucagon-like peptide-1 receptor agonists, weight loss, obesity, liraglutide, semaglutide, efficacy, safety. semaglutide 2.4 mg. However, marked resemblance between trials in terms of study protocols and subjects’ characteristics may allow indirect: No comparison. head to head In clinical trials are trials available of OW tosemaglutide, provide direct this comparison drug was consistently of efficacy ofassociated OD liraglutide with greater 3.0 mg weightversus lossOW than in trials of OD liraglutide. Thus, placebo-corrected percentage weight reduction was -10.3 to -12.4% and -5.4% with OW semaglutide and OD liraglutide, respectively. In patients with type 2 diabetes, corresponding weight reduction was less pronounced with both drugs being -6.2% and -4.3% with OW semaglutide and OD liraglutide, respectively. -
GLP-1 Receptor Agonists
Cognitive Vitality Reports® are reports written by neuroscientists at the Alzheimer’s Drug Discovery Foundation (ADDF). These scientific reports include analysis of drugs, drugs-in- development, drug targets, supplements, nutraceuticals, food/drink, non-pharmacologic interventions, and risk factors. Neuroscientists evaluate the potential benefit (or harm) for brain health, as well as for age-related health concerns that can affect brain health (e.g., cardiovascular diseases, cancers, diabetes/metabolic syndrome). In addition, these reports include evaluation of safety data, from clinical trials if available, and from preclinical models. GLP-1 Receptor Agonists Evidence Summary GLP-1 agonists are beneficial for patients with type 2 diabetes and obesity. Some evidence suggests benefits for Alzheimer’s disease. It is unclear whether it is beneficial for individuals without underlying metabolic disease. Semaglutide seems to be most effective for metabolic dysfunction, though liraglutide has more preclinical data for Alzheimer’s disease. Neuroprotective Benefit: Evidence from many preclinical studies and a pilot biomarker study suggest some neuroprotective benefits with GLP-1 agonists. However, whether they may be beneficial for everyone or only a subset of individuals (e.g. diabetics) is unclear. Aging and related health concerns: GLP-1 agonists are beneficial for treating diabetes and cardiovascular complications relating to diabetes. It is not clear whether they have beneficial effects in otherwise healthy individuals. Safety: GLP-1 agonists are generally safe for most people with minor side effects. However, long-term side effects are not known. 1 Availability: Available Dose: Varies - see Chemical formula: C172H265N43O51 (Liraglutide) as a prescription chart at the end of MW: 3751.262 g/mol medicine. -
LANTUS® (Insulin Glargine [Rdna Origin] Injection)
Rev. March 2007 Rx Only LANTUS® (insulin glargine [rDNA origin] injection) LANTUS® must NOT be diluted or mixed with any other insulin or solution. DESCRIPTION LANTUS® (insulin glargine [rDNA origin] injection) is a sterile solution of insulin glargine for use as an injection. Insulin glargine is a recombinant human insulin analog that is a long-acting (up to 24-hour duration of action), parenteral blood-glucose-lowering agent. (See CLINICAL PHARMACOLOGY). LANTUS is produced by recombinant DNA technology utilizing a non- pathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Chemically, it is 21A- B B Gly-30 a-L-Arg-30 b-L-Arg-human insulin and has the empirical formula C267H404N72O78S6 and a molecular weight of 6063. It has the following structural formula: LANTUS consists of insulin glargine dissolved in a clear aqueous fluid. Each milliliter of LANTUS (insulin glargine injection) contains 100 IU (3.6378 mg) insulin glargine. Inactive ingredients for the 10 mL vial are 30 mcg zinc, 2.7 mg m-cresol, 20 mg glycerol 85%, 20 mcg polysorbate 20, and water for injection. Inactive ingredients for the 3 mL cartridge are 30 mcg zinc, 2.7 mg m-cresol, 20 mg glycerol 85%, and water for injection. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. LANTUS has a pH of approximately 4. CLINICAL PHARMACOLOGY Mechanism of Action: The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. -
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 -
A 26-Week Randomized Controlled Trial of Semaglutide Once Daily Versus Liraglutide and Placebo in Patients with Type 2 Diabetes
1926 Diabetes Care Volume 41, September 2018 Ildiko Lingvay,1 Cyrus V. Desouza,2 A 26-Week Randomized Katarina S. Lalic,3 Ludger Rose,4 Thomas Hansen,5 Jeppe Zacho,5 and Controlled Trial of Semaglutide Thomas R. Pieber6 EMERGING THERAPIES: DRUGS AND REGIMENS Once Daily Versus Liraglutide and Placebo in Patients With Type 2 Diabetes Suboptimally Controlled on Diet and Exercise With or Without Metformin Diabetes Care 2018;41:1926–1937 | https://doi.org/10.2337/dc17-2381 OBJECTIVE To investigate the efficacy and safety of once-daily semaglutide in comparison with once-daily liraglutide and placebo in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS This 26-week, multicenter, double-blind trial involved patients diagnosed with 1University of Texas Southwestern Medical Cen- type 2 diabetes with HbA1c 7.0–10.0% (53–86 mmol/mol) and treated with diet ter at Dallas, Dallas, TX and exercise with or without metformin. Patients were randomized 2:2:1 to once- 2University of Nebraska Medical Center, Omaha, daily semaglutide, liraglutide, or placebo in one of four volume-matched doses NE 3Faculty of Medicine, University of Belgrade, and (semaglutide 0.05, 0.1, 0.2, or 0.3 mg and liraglutide 0.3, 0.6, 1.2, or 1.8 mg, with Clinic for Endocrinology, Diabetes and Metabolic both compared within each volume-matched dose group). Primary end point was Diseases, Clinical Center of Serbia, Belgrade, Serbia change in HbA1c from baseline to week 26. 4Institute for Diabetes Research in Munster,¨ RESULTS Munster,¨ Germany 5Novo Nordisk A/S, Søborg, Denmark In total, 705 randomized patients were exposed to trial products. -
Effects of Exenatide on Cardiac Function, Perfusion, and Energetics
Chen et al. Cardiovasc Diabetol (2017) 16:67 DOI 10.1186/s12933-017-0549-z Cardiovascular Diabetology ORIGINAL INVESTIGATION Open Access Efects of exenatide on cardiac function, perfusion, and energetics in type 2 diabetic patients with cardiomyopathy: a randomized controlled trial against insulin glargine Weena J. Y. Chen1*, Michaela Diamant1^, Karin de Boer2, Hendrik J. Harms3, Lourens F. H. J. Robbers2, Albert C. van Rossum2, Mark H. H. Kramer1, Adriaan A. Lammertsma3 and Paul Knaapen2 Abstract Background: Multiple bloodglucose-lowering agents have been linked to cardiovascular events. Preliminary studies showed improvement in left ventricular (LV) function during glucagon-like peptide-1 receptor agonist administration. Underlying mechanisms, however, are unclear. The purpose of this study was to investigate myocardial perfusion and oxidative metabolism in type 2 diabetic (T2DM) patients with LV systolic dysfunction as compared to healthy controls. Furthermore, efects of 26-weeks of exenatide versus insulin glargine administration on cardiac function, perfusion and oxidative metabolism in T2DM patients with LV dysfunction were explored. Methods and results: Twenty-six T2DM patients with LV systolic dysfunction (cardiac magnetic resonance (CMR) derived LV ejection fraction (LVEF) of 47 13%) and 10 controls (LVEF of 59 4%, P < 0.01 as compared to patients) were analyzed. Both myocardial perfusion± during adenosine-induced hyperemia± (P < 0.01), and coronary fow reserve 15 (P < 0.01), measured by [ O]H2O positron emission tomography (PET), were impaired in T2DM patients as compared to healthy controls. Myocardial oxygen consumption and myocardial efciency, measured using [11C]acetate PET and CMR derived stroke volume, were not diferent between the groups. -
OZEMPIC (Semaglutide) Injection, for Subcutaneous Use Initial U.S
HIGHLIGHTS OF PRESCRIBING INFORMATION ∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙CONTRAINDICATIONS∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙ These highlights do not include all the information needed to use Personal or family history of medullary thyroid carcinoma or in patients OZEMPIC® safely and effectively. See full prescribing information with Multiple Endocrine Neoplasia syndrome type 2 (4). for OZEMPIC. Known hypersensitivity to OZEMPIC or any of the product components (4). OZEMPIC (semaglutide) injection, for subcutaneous use Initial U.S. Approval: 2017 ∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙WARNINGS AND PRECAUTIONS∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙ Pancreatitis: Has been reported in clinical trials. Discontinue promptly if WARNING: RISK OF THYROID C-CELL TUMORS pancreatitis is suspected. Do not restart if pancreatitis is confirmed (5.2). See full prescribing information for complete boxed warning. Diabetic Retinopathy Complications: Has been reported in a clinical trial. Patients with a history of diabetic retinopathy should be monitored (5.3). In rodents, semaglutide causes thyroid C-cell tumors. It is Never share an OZEMPIC pen between patients, even if the needle is unknown whether OZEMPIC causes thyroid C-cell tumors, changed (5.4). including medullary thyroid carcinoma (MTC), in humans as Hypoglycemia: When OZEMPIC is used with an insulin secretagogue or the human relevance of semaglutide-induced rodent thyroid C- insulin, consider lowering the dose of the secretagogue or insulin to reduce cell tumors has not been determined (5.1, 13.1). the risk of hypoglycemia (5.5). OZEMPIC is contraindicated in patients with a personal or Acute Kidney Injury: Monitor renal function in patients with renal family history of MTC or in patients with Multiple Endocrine impairment reporting severe adverse gastrointestinal reactions (5.6). Neoplasia syndrome type 2 (MEN 2). -
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]. -
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. -
Predictors and Consequences of Severe Hypoglycemia in Adults with Diabetes – Systematic Review of the Evidence Evidence-Based Synthesis Program APPENDIX E
Predictors and Consequences of Severe Hypoglycemia in Adults with Diabetes – Systematic Review of the Evidence Evidence-based Synthesis Program APPENDIX E. EVIDENCE TABLES Table 1. Characteristics of Included Studies Author Study Design Intervention/ Date Data Sources Control Definition of Severe Inclusion/Exclusion Criteria Patient Characteristics Study Quality Country Length of Hypoglycemia Funding Source Follow-up Target HbA1c Abraira 199530 RCT Inclusion criteria: N=153 Intensive group: Impaired consciousness Allocation Men ages 40-69, with non-insulin Age: 60.2 years stepped regimen of requiring the help Concealment: Yes United States 27 months dependent diabetes who were being % male: 100 insulin goal of HbA1c of another person, (VA Cooperative treated with insulin or judged clinically to Race/ethnicity: =5.1+/-1% or coma, or seizure; Blinding: Yes Study) require insulin because of failure of other White=49.5 confirmed low blood therapy Black=24 Standard group: one or glucose concentration Intention-to-Treat Government Exclusion criteria: Other=3 two injections of insulin/ or rapid response to Analysis (ITT): No Serious illness or predicted poor BMI: 31.0 day treatments expected to compliance, diagnosed >15 years prior Duration of diabetes: 7.8 years Goal was to avoid raise the level of blood Withdrawals/dropouts History of MI: 13.7% diabetic symptoms, glucose also required adequately described: History of CHF: 2.0% excessive glycosuria, or Yes History of CVA: 6.5% overt hypoglycemia Current smoker: 15% ACCORD 2008;3 RCT Inclusion -
Diabetes Recommendations and Tier Coverage Chart
DIABETES RECOMMENDATIONS AND TIER COVERAGE CHART The American Diabetes Association guidelines for 2020, recommend metformin as the preferred initial treatment for type 2 diabetes (T2DM) along with weight management and physical activity. In patients who have established ASVD or at high risk, CKD, or HF, a SGLT2i or GLP-1 receptor with proven efficacy is recommended independent of A1C. • ASCVD dominates: o GLP-1RA with proven CVD benefit (dulaglutide, liraglutide, injectable semaglutide) OR o SGLT2i with proven CVD benefit (canagliflozin, empagliflozin) if adequate eGFR • HF or CKD dominates: o SGLT2i with evidence of reducing HF and/or CKD progression (empagliflozin, canagliflozin, dapagliflozin) if adequate eGFR OR o If SGLT2i intolerant/contraindicated or eGFR is inadequate, then GLP-1RA with proven CVD benefit In individuals without established cardiovascular disease, pharmacological treatment should be patient-centered taking into account side-effects, cost, impact on weight, risk of hypoglycemia, and other patient preferences. For more detailed information regarding ADA recommendations for pharmacological agents to treat T2DM click here. The following chart is a list of oral and injectable diabetes medications listed by class with their respective A1C reduction and insurance coverage and/or coverage requirements for BCBS, HPHC, Tufts, TMP, and MassHealth. Tufts Medicare Medications BCBSMA HPHC Tufts Preferred MassHealth Biguanides A1C reduction: 1-1.5% metformin Tier 1 Tier 1;2 Tier 1 Tier 1 Covered Glucoghage (metformin) NC NC NC;Tier -
Insulin Glargine (HOE901) First Responsibilities: Understanding the Data and Ensuring Safety
EDITORIAL Insulin Glargine (HOE901) First responsibilities: understanding the data and ensuring safety n this issue, Heinemann et al. (1) and Rat- decline in activity through the duration of other journals. They leave the reader with ner et al. (2) provide the results of stud- the 30-h study. The authors conclude that a sense of promise, but without the firm Iies of insulin glargine (formerly known as insulin glargine provides a flatter metabolic conviction that insulin glargine is clearly HOE901), the most recent addition to the profile than NPH insulin. Theoretically, this superior to other long-acting forms of growing family of insulin analogs and for- could prove to be advantageous in accom- insulin. The pharmacodynamic study sug- mulations. The authors report insulin modating the basal insulin requirements of gests that the peakless profile of action glargine’s pharmacodynamic characteristics patients with diabetes. should provide an advantage that can be (1) and data concerning its safety and effi- Ratner et al. (2) report initial results for used to produce clinically meaningful cacy when administered to subjects with the U.S. Study Group of Insulin Glargine in improvements in glycemic control. The type 1 diabetes who were treated with reg- Type 1 Diabetes. In their article, they clinical trial’s demonstration of a reduction ular insulin (2). Insulin glargine is produced describe the results of a large randomized in hypoglycemia and in fasting plasma glu- by recombinant DNA technology with 2 prospective 28-week trial of insulin cose levels appears to provide an opportu- modifications of the native human insulin glargine versus NPH insulin.