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Type 1 Diabetes Mellitus

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63. Ertugliflozin l-pyroglutamic acid (Steglatro) - Diabetes Mellitus, Type 2

the Fridericia formula R AC Accumulation ratio RH relative humidity RQ (Environmental) Risk Quotient SBP systolic blood pressure SGLT1 sodium-glucose co-transporter 1 SGLT2 sodium-glucose co-transporter 2 SmPC summary of product characteristics TAMC total aerobic microbial count TYMC total combined yeasts/moulds count T2DM type 2 diabetes mellitus t max time to C max UGE urinary glucose excretion UGT uridine 5’-diphospho-glucuronosyltransferase ULN upper limit of normal UV ultraviolet UV-Vis ultraviolet (...) Ertugliflozin is an oral, selective inhibitor of sodium glucose co-transporter-2 (SGLT2) which inhibits renal glucose reabsorption and results in urinary glucose excretion (UGE) and reductions in plasma glucose and haemoglobin A1c (A1C) in patients with type 2 diabetes mellitus (T2DM). It possesses a high selectivity for SGLT2 versus SGLT1 and other glucose transporters (GLUT1-4). Ertugliflozin is a new chemical entity with a chemical name of (1S,2S,3S,4R,5S)-5-[4-Chloro-3- (4- ethoxybenzyl)phenyl]-1

2018 European Medicines Agency - EPARs

64. Ertugliflozin l-pyroglutamic acid / sitagliptin phosphate monohydrate (Steglujan) - Diabetes Mellitus, Type 2

in the circulation in a glucose-dependent manner. Type of Application and aspects on development The development program has in all essentials followed the EMA Guideline “Clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus” (CHMP/EWP/1080/00 Rev. 1), the EMA guideline “Clinical development of fixed combination medicinal products” (CHMP/EWP/240/95 Rev. 1) and the scientific advice given on the following topics: Design of non-clinical and clinical phase 3 development (...) Ertugliflozin l-pyroglutamic acid / sitagliptin phosphate monohydrate (Steglujan) - Diabetes Mellitus, Type 2 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. 25 January 2018 EMA/86941/2018 Committee for Medicinal Products

2018 European Medicines Agency - EPARs

65. Ertugliflozin l-pyroglutamic acid / metformin hydrochloride (Segluromet) - Diabetes Mellitus, Type 2

analysis plan SGLT1 sodium-glucose co-transporter 1 SGLT2 sodium-glucose co-transporter 2 SmPC summary of product characteristics SMQ Standard MedDRA Query SOC System organ class T2DM type 2 diabetes mellitus TAMC total aerobic microbial count Tmax time to first occurrence of maximum observed concentration TYMC total combined yeasts/moulds count UGE urinary glucose excretion ULN upper limit of normal US United States USPI United States Prescribing Information UTI urinary tract infection UV ultraviolet (...) , decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Metformin is approved for use in the US, Europe, and other countries and has an established safety and tolerability profile. Type of Application and aspects on development The development program has in all essentials followed the EMA Guideline “Clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus” (CHMP/EWP/1080/00 Rev. 1

2018 European Medicines Agency - EPARs

66. Correlation between gene polymorphism in angiotensin II type 1 receptor and type 2 diabetes mellitus complicated by hypertension in a population of Inner Mongolia. (Full text)

Correlation between gene polymorphism in angiotensin II type 1 receptor and type 2 diabetes mellitus complicated by hypertension in a population of Inner Mongolia. The role of angiotensin II type 1 receptor (AT1R) as a key player in type 2 diabetes mellitus (T2DM) complicated with hypertension remains controversial. The present case-control study systematically investigated the association between gene the correct variation type in the angiotensin II type 1 receptor (AT1R) gene and type 2 (...) ). Genomic DNA was extracted from samples from 202 type 2 diabetic patients with hypertension and 216 type 2 diabetic patients without hypertension.Non-conditional regression analysis showed that in comparison with the TT genotype, the presence of the CC genotype for the T573 site of the AT1R gene increased the risk for diabetes mellitus complicated with hypertension by 3.219-fold (OR = 3.219, 95% CI: 1.042-9.941, P = 0.042). The results from multivariate linear regression analysis suggested the rs5182

2020 BMC Medical Genetics PubMed abstract

67. Efficacy and safety of insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi 1:1) in Japanese patients with type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs: A randomized, 26-week, open-label, multicenter study: The L (Full text)

Efficacy and safety of insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi 1:1) in Japanese patients with type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs: A randomized, 26-week, open-label, multicenter study: The L To assess efficacy and safety of 26-week treatment with insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi) compared with insulin glargine U100 (iGlar) in Japanese patients with type 2 diabetes mellitus (T2DM) inadequately (...) controlled on oral antidiabetic drugs (OADs).This phase 3, multicenter, open label, 1:1 randomized, parallel-group study compared efficacy of iGlarLixi and iGlar in patients with T2DM, HbA1c of ≥7.5% to ≤9.5% and fasting plasma glucose ≤10.0 mmol/L (180 mg/dL). The primary endpoint was change in HbA1c from baseline to week 26.Patients were randomized to iGlarLixi (n = 260) or iGlar (n = 261) (mean age 59.7 years, baseline BMI 26.04 kg/m2 , and HbA1c 8.04% [64.4 mmol/mol]). HbA1c reduction

2020 obesity & metabolism PubMed abstract

68. Dapagliflozin with insulin for treating type 1 diabetes

of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 5 of 242 2 Information about dapagliflozin Information about dapagliflozin Mark Marketing eting authorisation authorisation Dapagliflozin (Forxiga, AstraZeneca) is indicated for the treatment of 'type 1 diabetes mellitus as an adjunct to insulin in patients with a BMI = 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy' . Dapagliflozin should not be started in people (...) Dapagliflozin with insulin for treating type 1 diabetes Dapagliflozin with insulin for treating Dapagliflozin with insulin for treating type 1 diabetes type 1 diabetes T echnology appraisal guidance Published: 28 August 2019 www.nice.org.uk/guidance/ta597 © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y our responsibility our responsibility The recommendations in this guidance represent the view of NICE, arrived

2019 National Institute for Health and Clinical Excellence - Technology Appraisals

69. Metformin Improves Insulin Sensitivity and Vascular Health in Youth With Type 1 Diabetes Mellitus (Full text)

Metformin Improves Insulin Sensitivity and Vascular Health in Youth With Type 1 Diabetes Mellitus Cardiovascular disease is the leading cause of mortality in type 1 diabetes mellitus (T1DM) and relates strongly to insulin resistance (IR). Lean and obese adolescents with T1DM have marked IR. Metformin improves surrogate markers of IR in T1DM, but its effect on directly measured IR and vascular health in youth with T1DM is unclear. We hypothesized that adolescents with T1DM have impaired vascular (...) , fasting laboratories after overnight glycemic control, and insulin sensitivity by hyperinsulinemic-euglycemic clamp (glucose infusion rate/insulin). Adolescents with T1DM were randomized 1:1 to 3 months of 2000 mg metformin or placebo daily, after which baseline measures were repeated.Forty-eight adolescents with T1DM who were 12 to 21 years of age (40% body mass index [BMI] ≥90th percentile; 56% female) and 24 nondiabetic control participants of similar age, BMI, and sex distribution were enrolled

2019 EvidenceUpdates PubMed abstract

70. Management of adult patients with type 1 diabetes mellitus in Africa: A post-hoc cohort analysis of 12 African countries participating in the International Diabetes Management Practices Study (Wave 7). (Full text)

Management of adult patients with type 1 diabetes mellitus in Africa: A post-hoc cohort analysis of 12 African countries participating in the International Diabetes Management Practices Study (Wave 7). There is a paucity of information on real world management of African adult patients with type 1 diabetes mellitus (T1DM). We aimed to describe a cohort of African adults with T1DM.The International Diabetes Management Practices Study is an observational survey conducted from 2005 to 2017. Data (...) %. A total of 196 (24.9%) reported being hospitalized in the preceding year, with the most common reasons being diabetic ketoacidosis (58.1%, 93/160) and hypoglycaemia (31.1%; 52/167). Over half of the patients (55.4%) stated that the cost of test strips limited regular glycemic monitoring; a minority of patients (15%, 120/788) received structured diabetes education. Predictors of HbA1c <7% included patients receiving diabetes education (odds ratio [OR] [95% confidence interval, CI] = 2.707 [1.157-6.335

2020 Medicine PubMed abstract

71. The influence of maternal body mass index, maternal diabetes mellitus, and maternal smoking during pregnancy on the risk of childhood-onset type 1 diabetes mellitus in the offspring: Systematic review and meta-analysis of observational studies. (Abstract)

The influence of maternal body mass index, maternal diabetes mellitus, and maternal smoking during pregnancy on the risk of childhood-onset type 1 diabetes mellitus in the offspring: Systematic review and meta-analysis of observational studies. There is emerging evidence that events occurring before and shortly after birth may be important in determining the risk of childhood-onset type 1 diabetes mellitus (T1DM). We aimed to summarize and synthesize the associations between maternal body mass (...) of maternal DM, the greatest risk of T1DM in the offspring appeared to be conferred by maternal T1DM (RR 4.46, 95% CI, 2.89-6.89), followed by maternal gestational diabetes mellitus (RR 1.66, 95% CI, 1.16-2.36), and lastly by maternal type 2 diabetes mellitus (RR 1.11, 95% CI, 0.69-1.80). Additional analysis of studies comparing maternal versus paternal T1DM within the same population revealed that offspring of fathers with T1DM had a 1.5 times higher risk of developing childhood-onset T1DM than offspring

2019 Obesity Reviews

72. Empaglifozin linagliptin fixed-dose combination (Glyxambi) - type 2 diabetes mellitus:

Empaglifozin linagliptin fixed-dose combination (Glyxambi) - type 2 diabetes mellitus: Published 12 August 2019 1 Product Update: empagliflozin plus linagliptin 10mg/5mg, 25mg/5mg film-coated tablets (Glyxambi ® ) SMC No. (1236/17) Boehringer Ingelheim Ltd. 07 April 2017 (Issued July 2019) The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHS Scotland. The advice (...) is summarised as follows: ADVICE: following an abbreviated submission empagliflozin/linagliptin (Glyxambi ® ) is accepted for restricted use within NHS Scotland. Indication under review: in adults aged 18 years and older with type 2 diabetes mellitus: ? To improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Glyxambi ® do not provide adequate glycaemic control ? When already being treated with the free combination of empagliflozin and linagliptin SMC

2019 Scottish Medicines Consortium

73. Ertugliflozin (Steglatro) - type 2 diabetes mellitus

Ertugliflozin (Steglatro) - type 2 diabetes mellitus 1 Published 14 January 2019 1 SMC2102 ertugliflozin 5mg, 15mg film-coated tablet (Steglatro®) Merck Sharp & Dohme 7 December 2018 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following a full submission ertugliflozin (Steglatro ® ) is accepted (...) comparator. The target populations were: Adult patients with uncontrolled type 2 diabetes mellitus having previously received one of the following interventions: ? population 1 (monotherapy): diet and exercise, no background pharmacological therapy (eleven studies, including VERTIS MONO) ? population 2 (dual therapy): metformin alone (eight studies, including VERTIS MET and VERTIS FACTORIAL) ? population 3 (triple therapy): metformin plus a DPP-4 inhibitor (five studies, including VERTIS SITA2

2019 Scottish Medicines Consortium

74. Semaglutide (Ozempic) - the treatment of adults with insufficiently controlled type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise

Semaglutide (Ozempic) - the treatment of adults with insufficiently controlled type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise 1 Published 14 January 2019 1 SMC2092 semaglutide 0.25mg, 0.5mg and 1mg solution for injection in pre-filled pen (Ozempic®) Novo Nordisk Ltd. 9 November 2018 (Issued 7 December 2018) The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its (...) use in NHSScotland. The advice is summarised as follows: ADVICE: following a full submission semaglutide (Ozempic ® ) is accepted for restricted use within NHSScotland. Indication under review: the treatment of adults with insufficiently controlled type 2 diabetes mellitus (T2DM) 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. SMC

2019 Scottish Medicines Consortium

75. Type 2 Diabetes Mellitus and Heart Failure (Full text)

-1 receptor agonists if no recent HF decompensation) could be considered, but use with caution; may require dose adjustment DM indicates diabetes mellitus; DPP-4, dipeptidyl peptidase-4; EF, ejection fraction; eGFR, estimated glomerular filtration rate; GLP-1, glucagon-like peptide-1; HF, heart failure; HFpEF, heart failure with preserved ejection fraction; HFrEF, heart failure with reduced ejection fraction; SGLT-2, sodium glucose cotransporter type 2; and TZDs, thiazolidinedione drugs. Figure 3 (...) with either GLP-1 receptor agonists or DPP-4 inhibitors compared with other glucose-lowering therapies. Additional data are still needed to determine whether there is, in fact, a higher risk of HF with DPP-4 inhibitors in individuals with DM. Some additional information could come from the CARMELINA trial (Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus; URL: . Unique identifier: NCT01897532), which compares linagliptin versus placebo

2019 American Heart Association PubMed abstract

76. Newer Drugs for Type 2 Diabetes: An Emerging Adjunctive Therapy to Insulin for Type 1 Diabetes?

inhibitors, SGLT-2 inhibitors, and SGLT-1/SGLT-2 inhibitors may be considered experimental drugs being tested for adjunctive therapy in T1D adult patients. As such, their place in therapy in the management of T1D still needs to be defined. Background Diabetes mellitus is a metabolic disorder that results from defects in insulin secretion, insulin action, or both. 1 There are two major categories of diabetes. Type 1 diabetes (T1D) is characterized by severe impairment or an absolute deficiency of insulin (...) Newer Drugs for Type 2 Diabetes: An Emerging Adjunctive Therapy to Insulin for Type 1 Diabetes? Newer Drugs for Type 2 Diabetes: An Emerging Adjunctive Therapy to Insulin for Type 1 Diabetes? | CADTH.ca CADTH Document Viewer Newer Drugs for Type 2 Diabetes: An Emerging Adjunctive Therapy to Insulin for Type 1 Diabetes? Table of Contents Search this document Newer Drugs for Type 2 Diabetes: An Emerging Adjunctive Therapy to Insulin for Type 1 Diabetes? January 2018 Summary There are two major

2018 CADTH - Issues in Emerging Health Technologies

77. Illness perception of adolescents with well-controlled type 1 diabetes mellitus (Full text)

Illness perception of adolescents with well-controlled type 1 diabetes mellitus In this study, to explore the illness perceptions of adolescents with well-controlled type 1 diabetes mellitus in South Africa, semi-structured interviews were conducted with nine, purposively selected adolescents (mean = 13.9 years; median = 12). Themes that emerged from the thematic analysis include the following: accepting diabetes and the diabetes care plan as part of their lives; viewing diabetes as manageable (...) and as their responsibility; and the important role of gaining information on diabetes and diabetes management. These perceptions contributed to adherence to diabetes care plans and should be explored and developed among adolescents with type 1 diabetes mellitus to improve their diabetes management.

2018 Health psychology open PubMed abstract

78. A Practical Approach to the Management of Continuous Glucose Monitoring (CGM) / Real-Time Flash Glucose Scanning (FGS) in Type 1 Diabetes Mellitus in Children and Young People Under 18 Years

A Practical Approach to the Management of Continuous Glucose Monitoring (CGM) / Real-Time Flash Glucose Scanning (FGS) in Type 1 Diabetes Mellitus in Children and Young People Under 18 Years 1 Version 2, April 2017 Review 2020 Authors: ACDC Guideline Development Group N Wright, SM Ng, JC Agwu, P Adolfsson, J Drew, J Pemberton, M Kershaw, S Bissell, C Moudiotis, F Regan, C Gardner, A Astle, A Adams, G Adams, P Manning, A Timmis, A Soni, E Williams ssociation of Children’s Diabetes Clinicians (...) Clinicians FOR STAFF Healthcare professionals involved in care of children and young people with Type 1 Diabetes Mellitus PATIENTS Children and young people with diabetes mellitus This guideline is intended for use in managing continuous glucose monitoring (CGM) or real-time flash glucose scanning (FGS) for all children and young people under 18 years with Type 1 diabetes mellitus. Table of Contents Introduction 2 Overview of Pertinent NICE guidance 3 Devices Available for CGM and FGS 6 Section 1

2017 British Society for Paediatric Endocrinology and Diabetes

79. Effectiveness and safety of carbohydrate counting in the management of adult patients with type 1 diabetes mellitus: a systematic review and meta-analysis. (Full text)

Effectiveness and safety of carbohydrate counting in the management of adult patients with type 1 diabetes mellitus: a systematic review and meta-analysis. This study aimed to evaluate the effectiveness and safety of carbohydrate counting (CHOC) in the treatment of adult patients with type 1 diabetes mellitus (DM1).We performed a systematic review of randomized studies that compared CHOC with general dietary advice in adult patients with DM1. The primary outcomes were changes in glycated

2018 Archives of endocrinology and metabolism PubMed abstract

80. Effect of the treatment of Type 2 diabetes mellitus on the development of cognitive impairment and dementia. (Full text)

Effect of the treatment of Type 2 diabetes mellitus on the development of cognitive impairment and dementia. Prevention of cognitive impairment and dementia is an important public health goal. Epidemiological evidence shows a relationship between cognitive impairment and Type 2 diabetes mellitus. The risk of dementia increases with duration of disease. This updated systematic review investigated the effect on cognitive function of the type of treatment and level of metabolic control in people (...) with Type 2 diabetes.To assess the effects of different strategies for managing Type 2 diabetes mellitus on cognitive function and the incidence of dementia.We searched ALOIS (the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group (CDCIG)), the Cochrane Library, MEDLINE, Embase, PsycINFO, CINAHL and LILACS on 15 October 2016. ALOIS contains records from all major health care databases, (CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, LILACS), as well as from many trials' registers

2017 Cochrane PubMed abstract

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