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Insulin Dosing

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181. Efficacy and safety of oral basal insulin versus subcutaneous insulin glargine in type 2 diabetes: a randomised, double-blind, phase 2 trial. (PubMed)

drugs. Patients and investigators were masked to treatment assignment. Weekly insulin dose titration aimed to achieve a self-measured fasting plasma glucose (FPG) concentration of 4·4-7·0 mmol/L. The recommended daily starting doses were 2700 nmol I338 or 10 U IGlar, and maximum allowed doses throughout the trial were 16 200 nmol I338 or 60 U IGlar. The primary endpoint was treatment difference in FPG concentration at 8 weeks for all randomly assigned patients receiving at least one dose of trial (...) of a difference compared with insulin glargine, a widely used subcutaneously administered basal insulin. Further development of this particular oral insulin project was discontinued because I338 doses were high and, therefore, production of the required quantities of I338 for wide public use was deemed not commercially viable. Improvement of technologies involved in the product's development is the focus of ongoing research.Novo Nordisk.Copyright © 2019 Elsevier Ltd. All rights reserved.

2019 The lancet. Diabetes & endocrinology Controlled trial quality: predicted high

182. Comparison of subcutaneous insulin aspart and intravenous regular insulin for the treatment of mild and moderate diabetic ketoacidosis in pediatric patients. (PubMed)

Comparison of subcutaneous insulin aspart and intravenous regular insulin for the treatment of mild and moderate diabetic ketoacidosis in pediatric patients. To compare the safety/efficacy of intermittent subcutaneous rapid-acting insulin aspart with the standard low-dose intravenous infusion protocol of regular insulin for treatment of pediatric diabetic-ketoacidosis.For a prospective randomized-controlled clinical trial on 50 children/adolescents with mild/moderate diabetic-ketoacidosis (...)  ± 0.8 for intervention and 8.86 ± 0.7 for control group (p = 0.4) with 64% having moderate diabetic-ketoacidosis. The mean total-dose of insulin units needed for treatment of diabetic-ketoacidosis in intervention (subcutaneous insulin aspart) was lower than controls (intravenous regular insulin) (p < 0.001). No mortality/serious events happened. Three diabetic-ketoacidosis recurrences among interventions and one among controls occurred.To manage mild/moderate diabetic-ketoacidosis in children

2019 Endocrine Controlled trial quality: uncertain

183. Efficacy and safety of MK-1293 insulin glargine compared with originator insulin glargine (Lantus) in type 1 diabetes: A randomized, open-label clinical trial. (PubMed)

/mol) taking basal and prandial insulin. Participants were randomized 1:1 to once-daily Mk-Gla (n = 245) or Sa-Gla (n = 263). Dose titration of basal insulin was by a pre-breakfast plasma glucose dosing algorithm. The primary efficacy objective was assessment of the non-inferiority of HbA1c change from baseline (margin of 0.40% [4.4 mmol/mol]) for Mk-Gla compared with Sa-Gla over 24 weeks. The primary safety objective was assessment of anti-insulin antibody development over 24 weeks.The least (...) squares (LS) mean HbA1c change from baseline at week 24 was -0.62 (95% CI -0.79, -0.45)% (-6.8 [-8.7, -4.9] mmol/mol) and -0.66 (-0.82, -0.50)% (-7.2 [-9.0, -5.4] mmol/mol) for Mk-Gla and Sa-Gla. The LS mean HbA1c difference was 0.04 (-0.11, 0.19)% (0.4 [-1.2, 2.0] mmol/mol) for Mk-Gla minus Sa-Gla, meeting the primary and secondary objective criteria for non-inferiority and equivalence. Week 24 mean insulin glargine dose for Mk-Gla and Sa-Gla was 0.46 and 0.48 U/kg, respectively. Similarity of HbA1c

2019 Diabetes, obesity & metabolism Controlled trial quality: uncertain

184. Efficacy and safety of MK-1293 insulin glargine compared with originator insulin glargine (Lantus) in type 2 diabetes: A randomized, open-label clinical trial. (PubMed)

for or currently taking basal insulin (≥10 U/day). Participants were randomized 1:1 to once-daily Mk-Gla (n = 263) or Sa-Gla (n = 263). Titration of insulin was guided by a fasting plasma glucose (FPG)-based dosing algorithm. The primary efficacy objective was to demonstrate the non-inferiority of change from baseline in HbA1c (margin of 0.40% [4.4 mmol/mol]) with Mk-Gla versus Sa-Gla after 24 weeks. The primary safety objective was anti-insulin antibody development after 24 weeks.For Mk-Gla and Sa-Gla (...) , the least squares (LS) mean HbA1c change from baseline (95% CI) was -1.28 (-1.41, -1.15)% (-14.0 [-15.4, -12.6] mmol/mol) and -1.30 (-1.43, -1.18)% (-14.2 [-15.6, -12.8] mmol/mol). The LS mean HbA1c difference (Mk-Gla minus Sa-Gla) was 0.03 (-0.12, 0.18)% (0.3 [-1.4, 1.9] mmol/mol), meeting non-inferiority and equivalence (secondary objective) criteria. Insulin doses, FPG, and seven-point plasma glucose profiles were similar between groups. Safety and tolerability, including anti-insulin antibody

2019 Diabetes, obesity & metabolism Controlled trial quality: predicted high

185. Superior Efficacy of Insulin Degludec/Liraglutide versus Insulin Glargine U100 as Add-on to Sodium-Glucose Co-Transporter-2 Inhibitor Therapy: a Randomized Clinical Trial in Patients with Uncontrolled Type 2 Diabetes. (PubMed)

hypoglycaemia (rate ratio 0.42; 95%CI 0.23;0.75); total daily insulin dose (difference -15.37 U; 95%CI -19.60;-11.13). Overall treatment-emergent adverse event rate was higher with IDegLira, due to higher increased lipase and nausea rates.Due to the favourable safety and efficacy profile of IDegLira in patients with uncontrolled T2D on SGLT2 inhibitor, and lower weight gain and hypoglycaemia risk vs IGlar U100, clinicians may consider IDegLira initiation in this population. This article is protected (...) Superior Efficacy of Insulin Degludec/Liraglutide versus Insulin Glargine U100 as Add-on to Sodium-Glucose Co-Transporter-2 Inhibitor Therapy: a Randomized Clinical Trial in Patients with Uncontrolled Type 2 Diabetes. Progression of type 2 diabetes (T2D) necessitates intensification, often involving sequential combination of oral antidiabetic drugs (OADs) before initiation of insulin-based therapy. The DUAL IX trial (clinicaltrials.gov: NCT02773368) investigated the efficacy and safety

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2019 obesity & metabolism Controlled trial quality: predicted high

186. Relative effectiveness of insulin pump treatment over multiple daily injections and structured education during flexible intensive insulin treatment for type 1 diabetes: cluster randomised trial (REPOSE). (PubMed)

(Relative Effectiveness of Pumps Over MDI and Structured Education (REPOSE) trial).Setting Eight secondary care centres in England and Scotland.Participants Adults with type 1 diabetes who were willing to undertake intensive insulin treatment, with no preference for pumps or multiple daily injections. Participants were allocated a place on established group training courses that taught flexible intensive insulin treatment ("dose adjustment for normal eating," DAFNE). The course groups (the clusters (...) %. Secondary outcomes included body weight, insulin dose, and episodes of moderate and severe hypoglycaemia. Ancillary outcomes included quality of life and treatment satisfaction.Results 317 participants (46 courses) were randomised (156 pump and 161 injections). 267 attended courses and 260 were included in the intention to treat analysis, of which 235 (119 pump and 116 injection) had baseline HbA1c values of ≥7.5%. Glycaemic control and rates of severe hypoglycaemia improved in both groups. The mean

2017 BMJ Controlled trial quality: predicted high

187. Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 1 Diabetes: The SWITCH 1 Randomized Clinical Trial. (PubMed)

trial involving 501 adults with at least 1 hypoglycemia risk factor treated at 84 US and 6 Polish centers (January 2014-January 12, 2016) for two 32-week treatment periods, each with a 16-week titration and a 16-week maintenance period.Patients were randomized 1:1 to receive once-daily insulin degludec followed by insulin glargine U100 (n = 249) or to receive insulin glargine U100 followed by insulin degludec (n = 252) and randomized 1:1 to morning or evening dosing within each treatment (...) Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 1 Diabetes: The SWITCH 1 Randomized Clinical Trial. Hypoglycemia, common in patients with type 1 diabetes, is a major barrier to achieving good glycemic control. Severe hypoglycemia can lead to coma or death.To determine whether insulin degludec is noninferior or superior to insulin glargine U100 in reducing the rate of symptomatic hypoglycemic episodes.Double-blind, randomized, crossover noninferiority

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2017 JAMA Controlled trial quality: predicted high

188. Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 2 Diabetes: The SWITCH 2 Randomized Clinical Trial. (PubMed)

by insulin degludec (n = 360) and randomized 1:1 to morning or evening dosing within each treatment sequence.The primary end point was the rate of overall symptomatic hypoglycemic episodes (severe or blood glucose confirmed [<56 mg/dL]) during the maintenance period. Secondary end points were the rate of nocturnal symptomatic hypoglycemic episodes (severe or blood glucose confirmed, occurring between 12:01 am and 5:59 am) and the proportion of patients with severe hypoglycemia during the maintenance (...) Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 2 Diabetes: The SWITCH 2 Randomized Clinical Trial. Hypoglycemia, a serious risk for insulin-treated patients with type 2 diabetes, negatively affects glycemic control.To test whether treatment with basal insulin degludec is associated with a lower rate of hypoglycemia compared with insulin glargine U100 in patients with type 2 diabetes.Randomized, double-blind, treat-to-target crossover trial including

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2017 JAMA Controlled trial quality: predicted high

189. Efficacy and safety of alirocumab in insulin-treated individuals with type 1 or type 2 diabetes and high cardiovascular risk: The ODYSSEY DM-INSULIN randomized trial

Efficacy and safety of alirocumab in insulin-treated individuals with type 1 or type 2 diabetes and high cardiovascular risk: The ODYSSEY DM-INSULIN randomized trial To investigate the efficacy and safety of alirocumab in participants with type 2 (T2D) or type 1 diabetes (T1D) treated with insulin who have elevated LDL cholesterol levels despite maximally tolerated statin therapy.Participants at high cardiovascular risk with T2D (n = 441) or T1D (n = 76) and LDL cholesterol levels ≥1.8 mmol/L (...) (≥70 mg/dL) were randomized 2:1 to alirocumab:placebo administered subcutaneously every 2 weeks, for 24 weeks' double-blind treatment. Alirocumab-treated participants received 75 mg every 2 weeks, with blinded dose increase to 150 mg every 2 weeks at week 12 if week 8 LDL cholesterol levels were ≥1.8 mmol/L. Primary endpoints were percentage change in calculated LDL cholesterol from baseline to week 24, and safety assessments.Alirocumab reduced LDL cholesterol from baseline to week 24 by a mean

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2017 EvidenceUpdates

190. Long-term Cost-effectiveness of Insulin Degludec Versus Insulin Glargine U100 in the UK: Evidence from the Basal-bolus Subgroup of the DEVOTE Trial (DEVOTE 16). (PubMed)

using basal-bolus insulin therapy in DEVOTE (NCT01959529) and by the UKPDS Outcomes Model 2 risk equations, was used to model direct costs (2018 GBP) and effectiveness outcomes [quality-adjusted life years (QALYs)] with degludec versus glargine U100 over a 40-year time horizon. The model captured the development of eight diabetes-related complications, death, severe hypoglycemia and insulin dosing. This analysis was conducted from the perspective of National Health Service (NHS) England.Treatment (...) Long-term Cost-effectiveness of Insulin Degludec Versus Insulin Glargine U100 in the UK: Evidence from the Basal-bolus Subgroup of the DEVOTE Trial (DEVOTE 16). To evaluate the cost-effectiveness of insulin degludec (degludec) versus insulin glargine 100 units/mL (glargine U100) in basal-bolus regimens for patients with type 2 diabetes (T2D) at high cardiovascular (CV) risk based on the DEVOTE CV outcomes trial.A microsimulation model, informed by clinical outcomes from the subgroup of patients

2019 Applied Health Economics and Health Policy Controlled trial quality: uncertain

191. Efficacy and safety of three-times-daily versus twice-daily biphasic insulin aspart 30 in patients with type 2 diabetes mellitus inadequately controlled with basal insulin combined with oral antidiabetic drugs. (PubMed)

and BID dosing, respectively; estimated treatment difference: -0.09% [-0.23; 0.06]95% CI, -1 mmol/mol [-3; 1], p = 0.26). Safety profiles, including number of subjects experiencing hypoglycaemia, were similar.BIAsp 30 administered either TID or BID with metformin was a safe and effective option when intensifying treatment after failure of basal insulin and OADs in patients with T2DM. Adding a third injection at lunchtime may be preferable if HbA1c remains above target, if the lunchtime meal (...) Efficacy and safety of three-times-daily versus twice-daily biphasic insulin aspart 30 in patients with type 2 diabetes mellitus inadequately controlled with basal insulin combined with oral antidiabetic drugs. To compare the efficacy and safety of biphasic insulin aspart 30 (BIAsp 30) administered three times daily (TID) vs. twice daily (BID), plus metformin, in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on basal insulin ± 1 oral antidiabetic drug (OAD).Randomised

2019 Diabetes research and clinical practice Controlled trial quality: uncertain

192. Durability of insulin degludec plus liraglutide versus insulin glargine U100 as initial injectable therapy in type 2 diabetes (DUAL VIII): a multicentre, open-label, phase 3b, randomised controlled trial. (PubMed)

that mirrored routine clinical practice.In this 104-week international, multicentre, open-label, phase 3b randomised controlled trial, insulin-naive patients aged 18 years and older, with HbA1c between 7·0-11·0% (53-97 mmol/mol), BMI of 20 kg/m2 or higher, on stable doses of oral antidiabetic drugs, were recruited from outpatient clinics. Patients were randomly assigned 1:1, with a simple sequential allocation randomisation schedule (block size of four), to IDegLira or IGlar U100, each treatment being (...) Durability of insulin degludec plus liraglutide versus insulin glargine U100 as initial injectable therapy in type 2 diabetes (DUAL VIII): a multicentre, open-label, phase 3b, randomised controlled trial. Durability of glycaemic control might reduce disease burden and improve long-term outcomes. DUAL VIII investigated the durability of insulin degludec plus liraglutide (IDegLira) versus insulin glargine 100 units/mL (IGlar U100) in patients with type 2 diabetes with the use of a visit schedule

2019 The lancet. Diabetes & endocrinology Controlled trial quality: predicted high

193. Study Protocol for a Prospective, Multicenter, Randomized, Open-Label, Parallel-Group Clinical Trial Comparing the Efficacy and Safety of a Needle-Free Insulin Injector and a Conventional Insulin Pen in Controlling Blood Glucose Concentrations in Chinese (PubMed)

include measurements of blood glucose concentrations, the rate of achieving the target HbA1c level of less than 7%, patients' quality-of-life (as determined by the SF-36 questionnaire), the insulin dose administered, compliance with insulin therapy, and patients' satisfaction with their injection device.The study was approved by the Independent Ethics Committee (IEC) of Peking University Peoples Hospital and was conducted in accordance with the moral, ethical, and scientific principles (...) Study Protocol for a Prospective, Multicenter, Randomized, Open-Label, Parallel-Group Clinical Trial Comparing the Efficacy and Safety of a Needle-Free Insulin Injector and a Conventional Insulin Pen in Controlling Blood Glucose Concentrations in Chinese China has the largest number of diabetic patients in the world. In the past 2 decades, the prevalence of diabetes in China has increased dramatically, and the current status of diabetes control in the diabetic population is not satisfactory

2019 Advances in therapy Controlled trial quality: uncertain

194. The role of insulin sensitivity and intranasally applied insulin on olfactory perception. (PubMed)

- and overweight after administration of three different insulin doses (40 I.U., 100 I.U., 160 I.U.) or corresponding placebo volume in a within-subject design. Poor peripheral insulin sensitivity as quantified by HOMA-IR in baseline condition and increases in systemic insulin levels reactive to intranasal administration predicted poor olfactory performance. In contrast, intranasal insulin enhanced odor perception with a dose-dependent improvement of olfactory threshold. These findings indicate a new diametric (...) The role of insulin sensitivity and intranasally applied insulin on olfactory perception. Olfactory perception determines food selection behavior depending on energy homeostasis and nutritional status. The mechanisms, however, by which metabolic signals in turn regulate olfactory perception remain largely unclear. Given the evidence for direct insulin action on olfactory neurons, we tested olfactory performance (olfactory threshold, olfactory discrimination) in 36 subjects of normal

2019 Scientific reports Controlled trial quality: uncertain

195. Insulin degludec requires lower bolus insulin doses than does insulin glargine in Japanese diabetic patients with insulin-dependent state. (PubMed)

Insulin degludec requires lower bolus insulin doses than does insulin glargine in Japanese diabetic patients with insulin-dependent state. The study presents a comparison of the glucose-lowering effects, glycemic variability, and insulin doses during treatment with insulin degludec or insulin glargine.In this open-label, single-center, 2-way crossover study, 13 Japanese diabetic outpatients in the insulin-dependent state on basal-bolus therapy were assigned to receive either insulin glargine (...) followed by insulin degludec, or insulin degludec followed by insulin glargine. Basal insulin doses were fixed in principle, and patients self-adjusted their bolus insulin doses. Seventy-two-hour continuous glucose monitoring was performed 2 weeks after switching the basal insulin.Mean blood glucose (mg/dL) was not significantly different between insulin degludec and insulin glargine over 48 hours (141.8 ± 35.2 vs 151.8 ± 43.3), at nighttime (125.6 ± 40.0 vs 124.7 ± 50.4), or at daytime (149.3 ± 37.1

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2015 Journal of diabetes science and technology Controlled trial quality: uncertain

196. Prescribing Errors with Levetiracetam Oral Solution; Communicate Insulin Dose and Concentration on Separate Lines; Risperidone and Ropinirole Mix-ups; IV Line Disinfection Caps Can Become Foreign Bodies (PubMed)

Prescribing Errors with Levetiracetam Oral Solution; Communicate Insulin Dose and Concentration on Separate Lines; Risperidone and Ropinirole Mix-ups; IV Line Disinfection Caps Can Become Foreign Bodies These medication errors have occurred in health care facilities at least once. They will happen again-perhaps where you work. Through education and alertness of personnel and procedural safeguards, they can be avoided. You should consider publishing accounts of errors in your newsletters

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2016 Hospital pharmacy

197. Early Effects of Treatment Low-Dose Atorvastatin on Markers of Insulin Resistance and Inflammation in Patients with Myocardial Infarction (PubMed)

Early Effects of Treatment Low-Dose Atorvastatin on Markers of Insulin Resistance and Inflammation in Patients with Myocardial Infarction Dyslipidemia is one of the primary causes of cardiovascular disease. Therefore, attention has been focused on the development of drugs that normalize lipid levels and exert an effect on markers of atherothrombosis, insulin resistance (IR), and inflammation. Atorvastatin is a drug with not only lipid-lowering potential, but it has multiple non-lipid effects (...) . This study aimed to evaluate atorvastatin effects on lipid, adipokine, IR, and inflammatory statuses in patients with myocardial infarction (MI) in an in-hospital setting. This study included 66 patients with confirmed ST-segment elevation MI, who were treated with atorvastatin 20 mg/day starting on day 1 of MI, without any dose changes. The comparison group consisted of 60 patients receiving standard anti-anginal and anti-thrombotic therapy. During the hospital stay, both groups showed a reduction

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2016 Frontiers in pharmacology

198. Clinical study on local application of low-dose insulin for promoting wound healing after operation for deep burns (PubMed)

Clinical study on local application of low-dose insulin for promoting wound healing after operation for deep burns Transplanted free skin flaps are often needed to treat deep burns; their survival, however, is less than optimal. This study examined whether local low-dose insulin injections can promote flap survival and wound healing after surgery. A total of 165 patients who underwent free skin flap transplantation for simple deep burns were enrolled in the study and divided into 5 groups of 33 (...) patients each: Blank control group (no local subcutaneous drug injections), saline control group (saline injections), low-dose insulin group (0.5 units regular insulin injections), medium-dose group (1.0 units regular insulin injections) and high-dose group (2.0 units regular insulin injections). Wound healing and flap survival conditions were assessed and compared among groups. The best wound healing rate found was that of the low-dose insulin injection group where all the parameters measured improved

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2016 Experimental and therapeutic medicine

199. Prandial Insulin Dosing: How Long Does It Take to Go 80 Miles? (PubMed)

Prandial Insulin Dosing: How Long Does It Take to Go 80 Miles? 27182172 2016 05 16 2017 05 01 1040-9165 29 2 2016 May Diabetes spectrum : a publication of the American Diabetes Association Diabetes Spectr Prandial Insulin Dosing: How Long Does It Take to Go 80 Miles? 67-9 10.2337/diaspect.29.2.67 Mystkowski Paul P Division of Metabolism, Endocrinology, and Nutrition, University of Washington, Seattle, WA. Neumiller Joshua J JJ Washington State University, College of Pharmacy, Spokane, WA. eng

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2016 Diabetes spectrum : a publication of the American Diabetes Association

200. Evaluation of iDECIDE: A Smartphone App for Insulin Dosing Accounting for Alcohol and Exercise

Evaluation of iDECIDE: A Smartphone App for Insulin Dosing Accounting for Alcohol and Exercise Evaluation of iDECIDE: A Smartphone App for Insulin Dosing Accounting for Alcohol and Exercise - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one (...) or more studies before adding more. Evaluation of iDECIDE: A Smartphone App for Insulin Dosing Accounting for Alcohol and Exercise The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT02835183 Recruitment Status : Unknown Verified July 2016 by Adela Grando, Arizona State University. Recruitment status

2016 Clinical Trials

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