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Insulin Dosing

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181. A Phase IIIb Study of the Safety, Efficacy, and Tolerability of Switching to a Fixed-dose Combination of Abacavir/Dolutegravir/ Lamivudine From Current Antiretroviral Regimen

A Phase IIIb Study of the Safety, Efficacy, and Tolerability of Switching to a Fixed-dose Combination of Abacavir/Dolutegravir/ Lamivudine From Current Antiretroviral Regimen A Phase IIIb Study of the Safety, Efficacy, and Tolerability of Switching to a Fixed-dose Combination of Abacavir/Dolutegravir/ Lamivudine From Current Antiretroviral Regimen - 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. A Phase IIIb Study of the Safety, Efficacy, and Tolerability of Switching to a Fixed-dose Combination of Abacavir/Dolutegravir/ Lamivudine From Current Antiretroviral Regimen The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does

2014 Clinical Trials

182. A Phase IIIb Study of the Safety, Efficacy, and Tolerability of Switching to a Fixed-dose Combination of Abacavir/Dolutegravir/ Lamivudine From Current Antiretroviral Regimen

A Phase IIIb Study of the Safety, Efficacy, and Tolerability of Switching to a Fixed-dose Combination of Abacavir/Dolutegravir/ Lamivudine From Current Antiretroviral Regimen A Phase IIIb Study of the Safety, Efficacy, and Tolerability of Switching to a Fixed-dose Combination of Abacavir/Dolutegravir/ Lamivudine From Current Antiretroviral Regimen - 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. A Phase IIIb Study of the Safety, Efficacy, and Tolerability of Switching to a Fixed-dose Combination of Abacavir/Dolutegravir/ Lamivudine From Current Antiretroviral Regimen The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does

2014 Clinical Trials

183. Crossover Study to Compare the Pharmacokinetics and Bioavailability of a Novel Furosemide Regimen Administered Subcutaneously vs. the Same Dose Administered Intravenously in Subjects With Chronic Heart Failure

Crossover Study to Compare the Pharmacokinetics and Bioavailability of a Novel Furosemide Regimen Administered Subcutaneously vs. the Same Dose Administered Intravenously in Subjects With Chronic Heart Failure Crossover Study to Compare the Pharmacokinetics and Bioavailability of a Novel Furosemide Regimen Administered Subcutaneously vs. the Same Dose Administered Intravenously in Subjects With Chronic Heart Failure - 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. Crossover Study to Compare the Pharmacokinetics and Bioavailability of a Novel Furosemide Regimen Administered Subcutaneously vs. the Same Dose Administered Intravenously in Subjects With Chronic Heart Failure The safety and scientific

2014 Clinical Trials

184. Telmisartan and Insulin Resistance in HIV (TAILoR): protocol for a dose-ranging phase II randomised open-labelled trial of telmisartan as a strategy for the reduction of insulin resistance in HIV-positive individuals on combination antiretroviral therapy. Full Text available with Trip Pro

Telmisartan and Insulin Resistance in HIV (TAILoR): protocol for a dose-ranging phase II randomised open-labelled trial of telmisartan as a strategy for the reduction of insulin resistance in HIV-positive individuals on combination antiretroviral therapy. Telmisartan, an angiotensin receptor blocker, has beneficial effects on insulin resistance and cardiovascular health in non-HIV populations. This trial will evaluate whether telmisartan can reduce insulin resistance in HIV-positive individuals (...) on combination antiretroviral therapy.This is a phase II, multicentre, randomised, open-labelled, dose-ranging trial of telmisartan in 336 HIV-positive individuals over a period of 48 weeks. The trial will use an adaptive design to inform the optimal dose of telmisartan. Patients will be randomised initially 1:1:1:1 to receive one of the three doses of telmisartan (20, 40 and 80 mg) or no intervention (control). An interim analysis will be performed when half of the planned maximum of 336 patients have been

2015 BMJ open Controlled trial quality: uncertain

185. Insulin degludec/insulin aspart produces a dose-proportional glucose-lowering effect in subjects with type 1 diabetes mellitus. (Abstract)

Insulin degludec/insulin aspart produces a dose-proportional glucose-lowering effect in subjects with type 1 diabetes mellitus. To evaluate the pharmacodynamic dose-response relationship of insulin degludec/insulin aspart (IDegAsp), a novel, soluble co-formulation of the ultra-long-acting basal insulin, insulin degludec (IDeg), with the rapid-acting prandial insulin (IAsp), across different doses in patients with type 1 diabetes (T1DM).This was a randomized, single-centre, double-blind, four (...) -period, incomplete block, crossover trial. A cohort of 33 people with T1DM received single doses (0.4, 0.6 or 0.8 U/kg) of IDegAsp or the comparator, biphasic insulin aspart 30, in a randomized sequence of four treatment periods, each separated by a washout of 13-21 days. Pharmacodynamic response was assessed using a 26-h euglycaemic glucose clamp, with blood glucose stabilized at a target of 5.5 mmol/l (100 mg/dl).A rapid onset of action and a distinct peak attributable to IAsp was observed

2015 obesity & metabolism Controlled trial quality: uncertain

186. New digital tool to facilitate subcutaneous insulin therapy orders: an inpatient insulin dose calculator Full Text available with Trip Pro

New digital tool to facilitate subcutaneous insulin therapy orders: an inpatient insulin dose calculator Inpatient hyperglycemia is associated with adverse outcomes in hospitalized patients, with or without known diabetes. The adherence to American College of Endocrinology and American Diabetes Association guidelines recommendations for inpatient glycemic control is still poor, probably because of their complexity and fear of hypoglycemia.To create software system that can assist health care (...) providers and hospitalists to manage the insulin therapy orders and turn them into a less complicated issue.A software system was idealized and developed, according to recommendations of major consensus and medical literature.HTML software was developed to be readily accessed from a workstation, tablet or smartphone. Standard initial daily total dose of insulin was 0.4 units/kg and could be modified by distinct factors, such as chronological age, renal and liver function, and high dose corticosteroids

2015 Diabetology & metabolic syndrome

187. Two Treatment Approaches for Human Regular U-500 Insulin in Patients with Type 2 Diabetes Not Achieving Adequate Glycemic Control on High-Dose U-100 Insulin Therapy With or Without Oral Agents: A Randomized, Titration-To-Target Clinical Trial. (Abstract)

Two Treatment Approaches for Human Regular U-500 Insulin in Patients with Type 2 Diabetes Not Achieving Adequate Glycemic Control on High-Dose U-100 Insulin Therapy With or Without Oral Agents: A Randomized, Titration-To-Target Clinical Trial. To compare the efficacy and safety of 2 dosing regimens for human regular U-500 insulin (U-500R, 500 units/mL) replacing high-dose U-100 insulins with or without oral antihyperglycemic drugs in patients with inadequately controlled type 2 diabetes (T2D (...) ).We conducted a 24-week, open-label, parallel trial in 325 patients (demographics [means]: age, 55.4 years; diabetes duration, 15.2 years; body mass index, 41.9 kg/m(2); glycated hemoglobin [HbA1c], 8.7%; U-100 insulin dose, 287.5 units administered in 5 injections/day [median; range, 2 to 10]). Patients were randomized to thrice-daily (TID, n = 162) or twice-daily (BID, n = 163) U-500R after a 4-week lead-in period. The primary outcome was HbA1c change from baseline.After 24 weeks, both

2015 Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists Controlled trial quality: uncertain

188. More Similarities Than Differences Testing Insulin Glargine 300 Units/mL Versus Insulin Degludec 100 Units/mL in Insulin-Naive Type 2 Diabetes: The Randomized Head-to-Head BRIGHT Trial Full Text available with Trip Pro

More Similarities Than Differences Testing Insulin Glargine 300 Units/mL Versus Insulin Degludec 100 Units/mL in Insulin-Naive Type 2 Diabetes: The Randomized Head-to-Head BRIGHT Trial To compare insulin glargine 300 units/mL (Gla-300) versus insulin degludec 100 units/mL (IDeg-100) in this first head-to-head randomized controlled trial.BRIGHT (NCT02738151) was a multicenter, open-label, active-controlled, two-arm, parallel-group, 24-week, noninferiority study in insulin-naive patients (...) with uncontrolled type 2 diabetes. Participants were randomized 1:1 to evening dosing with Gla-300 (N = 466) or IDeg-100 (N = 463), titrated to fasting self-monitored plasma glucose of 80-100 mg/dL. The primary end point was HbA1c change from baseline to week 24. Safety end points included incidence and event rates of hypoglycemia.At week 24, HbA1c improved similarly from baseline values of 8.7% (72 mmol/mol) in the Gla-300 group and 8.6% (70 mmol/mol) in the IDeg-100 group to 7.0% (53 mmol/mol)-least squares

2018 EvidenceUpdates

189. Efficacy and safety of insulin glargine 300 U/mL versus insulin glargine 100 U/mL in Asia Pacific insulin-naïve people with type 2 diabetes: The EDITION AP randomized controlled trial. Full Text available with Trip Pro

randomized (2:1) to Gla-300 or Gla-100. The initial daily dose of basal insulin was 0.2 U/kg and was adjusted at least weekly for 8-12 weeks to a target fasting self-monitored plasma glucose (SMPG) of 4.4-5.6 mmol/L.Of the 604 participants randomized, 570 (Gla-300, n = 375; Gla-100, n = 195) completed the study. Non-inferiority of Gla-300 versus Gla-100 in HbA1c reduction from baseline to week 26 was confirmed. In the Gla-300 and Gla-100 groups, 51.1% and 52.2% of participants achieved the HbA1c target (...) Efficacy and safety of insulin glargine 300 U/mL versus insulin glargine 100 U/mL in Asia Pacific insulin-naïve people with type 2 diabetes: The EDITION AP randomized controlled trial. To compare the efficacy and safety of Gla-300 versus Gla-100 in insulin-naïve people with type 2 diabetes in Asia Pacific.In this open-label, randomized, active-controlled, 26-week study, insulin-naïve participants with type 2 diabetes inadequately controlled with non-insulin antihyperglycaemic drugs were

2020 obesity & metabolism

190. A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-response and Dose-exposure Relationship of BioChaperone Insulin Lispro in Three Different Doses in Subjects With Type 1 Diabetes

A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-response and Dose-exposure Relationship of BioChaperone Insulin Lispro in Three Different Doses in Subjects With Type 1 Diabetes A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-response and Dose-exposure Relationship of BioChaperone Insulin Lispro in Three Different Doses in Subjects With Type 1 Diabetes - 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. A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-response and Dose-exposure Relationship of BioChaperone Insulin Lispro in Three Different Doses in Subjects

2014 Clinical Trials

191. Dapagliflozin with insulin for treating type 1 diabetes

for treating type 1 diabetes (TA597) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 3 of 241 1 Recommendations Recommendations 1.1 Dapagliflozin with insulin is recommended as an option for treating type 1 diabetes in adults with a body mass index (BMI) of at least 27 kg/m 2 , when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy, only if: they are on insulin doses of more than 0.5 (...) with type 1 diabetes with a 'low insulin need' . It should not be started in people with a glomerular filtration rate (GFR) of less than 60 ml/min and should be stopped at a GFR persistently below 45 ml/min. During treatment with dapagliflozin, insulin therapy should be continuously optimised to prevent ketosis and diabetic ketoacidosis, and the insulin dose should only be reduced to avoid hypoglycaemia. This treatment should only be 'started and supervised by specialist doctors' . Patients should

2019 National Institute for Health and Clinical Excellence - Technology Appraisals

192. Insulin aspart - diabetes

in combination with a longer-acting insulin. The dose is worked out for each patient and depends on the patient’s weight and blood glucose level. A healthcare professional should explain to the patient how to use the medicine properly. For more information about using Insulin aspart Sanofi, see the package leaflet or contact your doctor or pharmacist. How does Insulin aspart Sanofi work? In diabetes, patients have high levels of blood glucose either because the body does not produce enough insulin (...) Insulin aspart - diabetes Official address Domenico Scarlattilaan 6 ? 1083 HS Amsterdam ? The Netherlands An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. EMA/242544/2020 EMEA/H/C/005033 Insulin aspart Sanofi (insulin aspart) An overview of Insulin aspart

2020 European Medicines Agency - EPARs

193. Development of a delayed-release nutrient for appetite control in adults with obesity and type 2 diabetes and initial clinical testing in a single dose randomized controlled trial. Full Text available with Trip Pro

be of therapeutic benefit in individuals with obesity and related comorbidities. The aim of this pilot study was to determine the effect of a single dose of a novel delayed-release nutrient (DRN) on glucose, GLP-1, c-peptide, insulin, and appetite in adults with obesity and type 2 diabetes.We formulated an all-natural, generally recognized as safe ('GRAS") DRN and conducted a randomized prospective crossover trial. Nineteen adults with obesity and type 2 diabetes underwent paired 3-h meal tolerance tests (MTT (...) ) in randomized order 1-4 weeks apart. Subjects ingested a single dose of DRN and the same nutrients as unformulated powders (UN).For DRN compared with UN, the maximal concentration (Cmax) was significantly lower for glucose, c-peptide, and insulin, and the time of maximal concentration (Tmax) was significantly delayed. While Tmax for GLP-1 was also significantly delayed following DRN compared with UN (45 min later; p = 0.26), Cmax did not differ significantly. GLP-1 rose significantly during the last 90 min

2019 Nutrition & diabetes Controlled trial quality: uncertain

194. A Single-Dose of a Polyphenol-Rich Fucus Vesiculosus Extract is Insufficient to Blunt the Elevated Postprandial Blood Glucose Responses Exhibited by Healthy Adults in the Evening: A Randomised Crossover Trial. Full Text available with Trip Pro

A Single-Dose of a Polyphenol-Rich Fucus Vesiculosus Extract is Insufficient to Blunt the Elevated Postprandial Blood Glucose Responses Exhibited by Healthy Adults in the Evening: A Randomised Crossover Trial. When healthy adults consume carbohydrates at night, postprandial blood glucose responses are elevated and prolonged compared to daytime.Extended postprandial hyperglycaemia is a risk factor for type 2 diabetes. Polyphenols are bioactive secondary metabolites of plants and algae (...) and insulin. A subset of participants (n = 8) completed the same protocol once in the morning with only the cellulose placebo (7:15 a.m.). No effect of the polyphenol-rich extract was observed on postprandial glycaemia in the evening, compared with placebos, in the group as a whole. However, in females only, peak blood glucose concentration was reduced following the polyphenol-rich extract. In the subset analysis, as expected, participants exhibited elevated postprandial blood glucose in the evening

2019 Antioxidants (Basel, Switzerland) Controlled trial quality: uncertain

195. Dose-Dependent Glycometabolic Effects of Sotagliflozin on Type 1 Diabetes Over 12 Weeks: the inTandem4 Trial. Full Text available with Trip Pro

Dose-Dependent Glycometabolic Effects of Sotagliflozin on Type 1 Diabetes Over 12 Weeks: the inTandem4 Trial. Assess dose-related effects of sotagliflozin, a novel dual inhibitor of sodium glucose cotransporters 1 and 2, in type 1 diabetes (T1D).In this 12-week, multicenter, randomized, double-blind, placebo-controlled dose-ranging trial, adults with T1D were randomized to once daily placebo (n=36) or sotagliflozin 75 (n=35), 200 (n=35), or 400 mg (n=35). Insulin was maintained at baseline (...) with sotagliflozin 400 mg.Combined with stable insulin doses, sotagliflozin 200 and 400 mg improved glycemic control and weight in adults with T1D. Sotagliflozin 400 mg reduced PPG. UGE increased with all sotagliflozin doses. Rates of severe hypoglycemia and DKA were low (NCT02459899). This article is protected by copyright. All rights reserved.This article is protected by copyright. All rights reserved.

2019 obesity & metabolism Controlled trial quality: predicted high

196. Long-term vitamin D and high-dose (Abstract)

Long-term vitamin D and high-dose This study was performed to evaluate the effects of vitamin D and n-3 fatty acids' co-supplementation on markers of cardiometabolic risk in diabetic patients with CHD. This randomised, double-blinded, placebo-controlled trial was conducted among sixty-one vitamin D-deficient diabetic patients with CHD. At baseline, the range of serum 25-hydroxyvitamin D levels in study participants was 6·3-19·9 ng/ml. Subjects were randomly assigned into two groups either (...) /l; 95 % CI -0·77, -0·03; P = 0·03), insulin (β -1·66 μIU/ml; 95 % CI -2·43, -0·89; P < 0·001), insulin resistance (β -0·49; 95 % CI -0·72, -0·25; P < 0·001) and LDL-cholesterol (β -0·21 mmol/l; 95 % CI -0·41, -0·01; P = 0·04), and a significant increase in insulin sensitivity (β +0·008; 95 % CI 0·004, 0·01; P = 0·001) and HDL-cholesterol (β +0·09 mmol/l; 95 % CI 0·01, 0·17; P = 0·02) compared with the placebo. Additionally, high-sensitivity C-reactive protein (β -1·56 mg/l; 95 % CI -2·65, -0·48

2019 The British journal of nutrition Controlled trial quality: predicted high

197. Comparison of the effects of a liquid breakfast meal with varying doses of plant-based soy protein on appetite profile, energy metabolism and intake. (Abstract)

Comparison of the effects of a liquid breakfast meal with varying doses of plant-based soy protein on appetite profile, energy metabolism and intake. A dose dependent satiating and thermogenic effect of animal-based protein has been observed, however, less is known wherever plant-based protein elicits same response. The purpose of the study was to examine the effects of a breakfast meal containing varying doses of plant-based soy protein (SP) on appetite profile, hormone response, energy (...) metabolism and energy intake.Seventeen participants (age: 27 ± 7 y, body fat: 21.5 ± 6.9%) in randomized order consumed one of three isoenergetic liquid breakfast meals (482 ± 5 kcals): high SP (HSP; 50 g), low SP (LSP; 25 g) and control (CON; 50 g carbohydrate) followed by an ad libitum lunch 3 h later. Appetite profile was measured before, immediately after and hourly during the 3 h postprandial period. Plasma concentrations of leptin and insulin were measured before, at 30 and 180 min.Energy intake

2019 Appetite Controlled trial quality: uncertain

198. Vamorolone trial in Duchenne muscular dystrophy shows dose-related improvement of muscle function. Full Text available with Trip Pro

formation, osteocalcin, increased in vamorolone-treated boys, suggesting possible loss of bone morbidities seen with glucocorticoids. Biomarker outcomes for adrenal suppression and insulin resistance were also lower in vamorolone-treated patients with DMD relative to published studies of glucocorticoid therapy.Daily vamorolone treatment suggested efficacy at doses of 2.0 and 6.0 mg/kg/d in an exploratory 24-week open-label study.This study provides Class IV evidence that for boys with DMD, vamorolone (...) Vamorolone trial in Duchenne muscular dystrophy shows dose-related improvement of muscle function. To study vamorolone, a first-in-class steroidal anti-inflammatory drug, in Duchenne muscular dystrophy (DMD).An open-label, multiple-ascending-dose study of vamorolone was conducted in 48 boys with DMD (age 4-<7 years, steroid-naive). Dose levels were 0.25, 0.75, 2.0, and 6.0 mg/kg/d in an oral suspension formulation (12 boys per dose level; one-third to 10 times the glucocorticoid dose in DMD

2019 Neurology

199. Efficacy and Safety of a Fixed-Dose Combination of Candesartan and Rosuvastatin on Blood Pressure and Cholesterol in Patients With Hypertension and Hypercholesterolemia: A Multicenter, Randomized, Double-Blind, Parallel Phase III Clinical Study. (Abstract)

Efficacy and Safety of a Fixed-Dose Combination of Candesartan and Rosuvastatin on Blood Pressure and Cholesterol in Patients With Hypertension and Hypercholesterolemia: A Multicenter, Randomized, Double-Blind, Parallel Phase III Clinical Study. The aim of this study was to evaluate the blood pressure-lowering and cholesterol-lowering effects of a fixed-dose combination therapy using candesartan (CND)/rosuvastatin (RSV) compared with CND or RSV monotherapy in patients with hypertension (...) and hypercholesterolemia.This study was a 12-week, randomized, double-blind, placebo-controlled, multicenter study. A total of 394 patients were screened. After a 4-week run-in period, 219 of these patients with hypertension and primary hypercholesterolemia were randomized. Patients received 1 of 3 regimens for 8 weeks: (1) CND 32 mg/RSV 20 mg, (2) RSV 20 mg, or (3) CND 32 mg. The primary outcome variables were changes in the systolic blood pressure (SBP) and diastolic blood pressure (DBP) and the percentage changes in LDL

2019 Clinical therapeutics Controlled trial quality: predicted high

200. Comparing the serum TAG response to high-dose supplementation of either DHA or EPA among individuals with increased cardiovascular risk: the ComparED study. Full Text available with Trip Pro

Comparing the serum TAG response to high-dose supplementation of either DHA or EPA among individuals with increased cardiovascular risk: the ComparED study. Studies have shown that the reduction in serum TAG concentrations with long-chain n-3 fatty acid supplementation is highly variable among individuals. The objectives of the present study were to compare the proportions of individuals whose TAG concentrations lowered after high-dose DHA and EPA, and to identify the predictors of response (...) after DHA and EPA, respectively. Although there was a greater proportion of participants with a reduction >0·25 mmol/l after DHA than after EPA (45 υ. 32 %; P 0·25 mmol/l after both DHA and EPA had higher non-HDL-cholesterol, TAG and insulin concentrations compared with other responders at baseline (all P < 0·05). In conclusion, supplementation with 2·7 g/d DHA or EPA had no meaningful effect on TAG concentrations in a large proportion of individuals with normal mean TAG concentrations

2019 The British journal of nutrition Controlled trial quality: uncertain

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