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First Generation Sulfonylurea

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181. A Study of the Efficacy and Safety of Relacorilant

of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome (GRACE) 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. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT03697109 Recruitment Status : Recruiting First Posted : October 5, 2018 Last Update (...) ) are: HbA1c has decreased by ≥0.5% from Baseline The 2-hour oGTT glucose is normalized (<140 mg/dL) or decreased by ≥50 mg/dL from Baseline Total daily insulin dose has decreased by ≥25% or daily sulfonylurea dose has decreased from Baseline by ≥50% and HbA1c is unchanged or decreased compared with Baseline In patients with hypertension, the proportion of patients who meet any of the hypertension response criteria at the end of the OL phase (Week OL22) [ Time Frame: Open Label Phase (Baseline to Week OL22

2018 Clinical Trials

182. A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes

. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT03689374 Recruitment Status : Recruiting First Posted : September 28, 2018 Last Update Posted : March 26, 2019 See Sponsor: Novo Nordisk A/S Information provided by (Responsible Party): Novo Nordisk A/S Study Details Study Description Go to Brief Summary: This study will compare the effect of semaglutide once weekly to insulin aspart 3 times daily as add on to metformin (...) U100 Run-in period: Subjects will receive s.c. injections of IGlar U100 OD in accordance with the approved local label of IGlar U100. The dose will be adjusted based on the mean of three pre-breakfast SMPG values (target SMPG: 4.0-6.9 mmol/L) Outcome Measures Go to Primary Outcome Measures : Change in HbA1c [ Time Frame: Baseline (week 0), week 52 ] Measured in %-point Secondary Outcome Measures : Time to first event adjudication committee (EAC) confirmed severe hypoglycaemic episode (ADA) [ Time

2018 Clinical Trials

183. SPIDER: A Research & QI Collaboration Supporting Practices in Improving Care for Complex Elderly Patients

). Please remove one or more studies before adding more. SPIDER: A Research & QI Collaboration Supporting Practices in Improving Care for Complex Elderly Patients (SPIDER) 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: NCT03689049 Recruitment Status : Enrolling by invitation First Posted : September 28 (...) , 2018 Last Update Posted : September 28, 2018 Sponsor: University of Toronto Practice Based Research Network Collaborators: Canadian Institutes of Health Research (CIHR) University of Toronto North York General Hospital College of Family Physicians of Canada University of Ottawa University of Alberta University of Calgary University of Manitoba Research Manitoba Fonds de la Recherche en Santé du Québec Université de Montréal Nova Scotia Health Authority Dalhousie University Dalhousie Medical

2018 Clinical Trials

184. Daily vs Intermittent Restriction of Energy: Controlled Trial to Reduce Diabetes Risk (DIRECT)

First Posted : September 28, 2018 Last Update Posted : October 11, 2018 See Sponsor: University of Adelaide Collaborator: Salk Institute for Biological Studies Information provided by (Responsible Party): A/Prof Leonie Heilbronn, University of Adelaide Study Details Study Description Go to Brief Summary: In this randomized trial study, the investigators will compare the glycaemic health benefits of intermittent fasting (IF) versus an energy matched daily restriction (DR) approach over 18-months (...) Experimental: Intermittent Fasting (IF) 3 days fasting per week Other: Intermittent Fasting (IF) Participants will fast 3 days per week. In fasting days, meal replacements at 30% of daily energy requirements will be provided for the first 6 months. Participants will have fortnightly nutrition assessment. Experimental: Daily Restriction (DR) daily energy restriction Other: Daily Restriction (DR) Participants are instructed to restrict energy intake by 30% of daily energy requirements. Meal replacements

2018 Clinical Trials

185. Impact of Rutin and Vitamin C Combination on Oxidative Stress, Insulin Sensitivity and Lipid Profile in Type 2 Diabetic Patients

Status : Completed First Posted : February 19, 2018 Last Update Posted : May 16, 2018 Sponsor: Ain Shams University Information provided by (Responsible Party): sara ramzy ragheb, Ain Shams University Study Details Study Description Go to Brief Summary: The objective of this study is to investigate the effect ofRutin and Vitamin C combination in comparison with vitamin C alone on the oxidative and antioxidative status , insulin resistance and lipid profile in type 2 diabetic patients. Condition (...) the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 35 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria

2018 Clinical Trials

186. Efficacy and Safety of Soliqua Versus Lantus in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents

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: NCT03434119 Recruitment Status : Terminated (("Trial terminated (recruitment delays)")) First Posted : February 15, 2018 Last Update Posted : January 29, 2019 Sponsor: Sanofi Information provided by (Responsible Party): Sanofi Study Details Study Description Go to Brief Summary: Primary Objective: To demonstrate the superiority of Soliqua 100/33 versus (...) of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion criteria

2018 Clinical Trials

187. Comparison of Secukinumab 300 mg Combined With a Lifestyle Intervention to Secukinumab Alone for the Treatment of Moderate to Severe Psoriasis Patients With Concomitant Metabolic Syndrome

and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT03440736 Recruitment Status : Recruiting First Posted : February 21, 2018 Last Update Posted : October 9, 2018 See Sponsor: Novartis Pharmaceuticals Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals ) Study Details Study Description Go to Brief (...) to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Written informed consent must be obtained before any assessment is performed. Men or women of at least 18 years of age at the time of screening

2018 Clinical Trials

188. A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk

Government. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT03730662 Recruitment Status : Recruiting First Posted : November 5, 2018 Last Update Posted : March 19, 2019 See Sponsor: Eli Lilly and Company Information provided by (Responsible Party): Eli Lilly and Company Study Details Study Description Go to Brief Summary: The purpose of the trial is to assess the efficacy and safety of tirzepatide taken once a week (...) . For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Participants must: Have been diagnosed with type 2 diabetes mellitus (T2DM) Have HbA1c between ≥7.5% and ≤10.5% Be on stable treatment with unchanged dose of at least 1 and no more than 3 types of oral antihyperglycemic drugs, which may only include metformin, SGLT-2 inhibitors

2018 Clinical Trials

189. Evaluation of the Safety, Tolerability and Bioavailability of Dasiglucagon Following Subcutaneous (SC) Compared to IV Administration

participating. Read our for details. ClinicalTrials.gov Identifier: NCT03735225 Recruitment Status : Recruiting First Posted : November 8, 2018 Last Update Posted : November 14, 2018 See Sponsor: Zealand Pharma Information provided by (Responsible Party): Zealand Pharma Study Details Study Description Go to Brief Summary: The purpose of the trial is to characterize the safety and tolerability of dasiglucagon 4 mg/mL following IV administration at increasing doses in healthy volunteers. One cohort (...) of an abnormally low plasma glucose concentration. Hypoglycemia is a common, unpredictable, and potentially dangerous side effect of treatment of diabetes mellitus, especially with insulin or sulfonylureas. Dasiglucagon (ZP4207) is a stable peptide analog of human glucagon, available in a ready-to-use liquid formulation. Dasiglucagon is in development for the treatment of severe hypoglycemia in patients with diabetes mellitus. Dasiglucagon is a specific and full glucagon receptor agonist designed to mimic

2018 Clinical Trials

190. Prescription medication use and antinuclear antibodies in the United States, 1999-2004. (PubMed)

Prescription medication use and antinuclear antibodies in the United States, 1999-2004. Clinical reports link specific medications with the development of antinuclear antibodies (ANA), but population-based evidence is limited.The present study investigated associations between prescription medication use and ANA in a representative sample of the adult noninstitutionalized US population, first focusing on medications previously related to ANA and then considering all medications reported (...) in the National Health and Nutrition Examination Survey (NHANES).Based on NHANES data (1999-2004) for 3608 adults (ages ≥18 years), we estimated odds ratios (ORs) and 95% confidence intervals (CIs) to assess associations between recent medication use and ANA (overall and in sex and age subgroups), adjusted for potential confounders and the survey sampling design.We found no evidence that most medications previously associated with ANA in specific individuals were risk factors for ANA in the general population

2018 Journal of Autoimmunity

191. The Role of Type 2 Diabetes on Skeletal Muscle Atrophy and Recovery Following Bed Rest in Older Adults

Recruitment Status : Recruiting First Posted : December 3, 2018 Last Update Posted : February 15, 2019 See Sponsor: Translational Research Institute for Metabolism and Diabetes, Florida Information provided by (Responsible Party): Translational Research Institute for Metabolism and Diabetes, Florida Study Details Study Description Go to Brief Summary: To gather data on the impact of type 2 diabetes on muscle mass atrophy during a period of bed rest and recovery of muscle mass, strength, and physical (...) is completed in a seated position on the machine and participants will extend and flex their leg against different resistance levels. Outcome Measures Go to Primary Outcome Measures : Leg Lean Mass [ Time Frame: 3 days ] DXA (dual energy x-ray absorptiometry) scans. Whole body and regional (including leg) fat and lean mass will be measured on a latest generation GE (General Electric) lunar iDXA. Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study

2018 Clinical Trials

192. Model Predictive Control (MPC) Artificial Pancreas vs. Sensor Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS) With Different Food Choices in the Outpatient Setting

not mean it has been evaluated by the U.S. Federal Government. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT03767790 Recruitment Status : Recruiting First Posted : December 7, 2018 Last Update Posted : January 7, 2019 See Sponsor: Sansum Diabetes Research Institute Collaborators: Harvard University Harvard School of Public Health Information provided by (Responsible Party): Sansum Diabetes Research Institute (...) the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year. Using an insulin pump for at least 3 months at the time of screening. Insulin pump use

2018 Clinical Trials

193. Influence of Dairy Protein Breakfast on Glycemia, Weight Loss and Clock Genes in T2D

adding more. Influence of Dairy Protein Breakfast on Glycemia, Weight Loss and Clock Genes in T2D (Mdiet) 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. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT03772067 Recruitment Status : Not yet recruiting First Posted (...) using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 30 Years to 75 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Patients diagnosed with T2D < 20 years; HgA1c ≥ 7.0 %. BMI - 28-40 kg/m2 Men and women 30 -75 years of age inclusive. Normal liver, kidney and thyroid functions, negative urinary microalbumin test (urMA) and estimated glomerular filtration rate

2018 Clinical Trials

194. Diabetic Retinopathy Guidelines

, Frimley Park Hospital, Surrey Mr Mahi Muqit, Manchester Royal Eye Hospital, Manchester Miss Rachel Pilling, Bradford Teaching Hospitals, Bradford Dr John Olson, Aberdeen Royal Infirmary, Aberdeen Mr Som Prasad, Arrowe Park Hospital, Wirral Professor Peter Scanlon, Cheltenham General Hospital, Cheltenham Professor Paulo Stanga, Manchester Royal Eye Hospital, Manchester Ms Gilli Vafidis, Central Middlesex Hospital, London Dr Alex Wright, Birmingham Hearlands Hospital, Birmingham Dr William Wykes (...) , Southern General Hospital, Glasgow External reviewer: Dr Lloyd Paul Aiello, M.D., Ph. D, Boston, Masachusetts, USA. Declarations of Interest: The Chair (FG) and authors (CB, UC, JG, GM, PS, WW) have declared receipt of educational grants from Allergan, Bauch & Lomb, Novartis, and associated with consultancy work for Allergan, Alimera, Bayer, and Novartis. AW has received educational grants from NovoNordisk and Takeda and consultant fee from Novartis. JG has received travel grants to attend meetings

2012 Royal College of Ophthalmologists

195. Empagliflozin - Benefit assessment

empagliflozin. The pharmaceutical company (hereinafter referred to as “the company”) submitted a first dossier of the drug to be evaluated on 15 August 2014 for the early benefit assessment. This dossier was assessed in dossier assessment A14-26 and in the corresponding addendum A14-50. The company now requested a new benefit assessment because of new scientific findings. The assessment was based on a dossier compiled by the company. The dossier was sent to IQWiG on 29 February 2016. Research question (...) of empagliflozin Research question Subindication a ACT specified by the G-BA A Monotherapy when diet and exercise alone do not provide adequate glycaemic control and the use of metformin is considered inappropriate due to intolerance Sulfonylurea (glibenclamide, glimepiride) B Combination with another blood-glucose lowering drug (except insulin), when this, together with diet and exercise, does not provide adequate glycaemic control Metformin plus sulfonylurea (glibenclamide, glimepiride) (note: if metformin

2016 Institute for Quality and Efficiency in Healthcare (IQWiG)

196. The cost-effectiveness of saxagliptin versus NPH insulin when used in combination with other oral antidiabetes agents in the treatment of type 2 diabetes mellitus in Poland

official tariffs set by the Ministry of Health or country-specific diabetes sources. Some data were obtained from personal communications with experts. Costs were in Polish zloty (PLN) and were also expressed in US dollars ($). The price year was 2009. A 5% annual discount rate was applied. Analysis of uncertainty: One- and two-way sensitivity analyses were carried out to identify key inputs of the model. A probabilistic sensitivity analysis was performed to generate cost-effectiveness acceptability (...) of the sensitivity analyses were reported clearly. No details of the distributions associated with the model parameters were given and it was unclear whether a first- or second-order probabilistic analysis was conducted. The authors acknowledged that, although the lack of head-to-head studies was a limitation of the analysis, it appeared that most assumptions favoured the insulin option and the results could be considered conservative against saxagliptin. The issue of transferability of study results

2012 NHS Economic Evaluation Database.

197. KHA-CARI adaptation of the KDIGO Guideline for the Care of Kidney Transplant Recipients

with the exception of a higher number of live donor recipients in the placebo arm (25/68 vs. 19/68) and more recipients of a first graft in the rituximab group (62/68 for placebo vs. 68/68 for rituximab). There were more episodes of BPAR in the placebo group (17.6% vs. 11.6% for rituximab) but the difference was not statistically different (P=0.317). There were 5 episodes of steroid resistant rejection in the placebo group and 2 in the rituximab group. In each group there was one patient death and 1 graft loss (...) , the need for IS decreases overtime and it should be tailored accordingly: greater IS during the first weeks or months in order to improve acceptance to the graft and lower IS after months or a few years. (Evidence level C) D. Non-compliance with immunosuppressive drugs and its consequences (deterioration and loss of kidney function) have been clearly overlooked and its frequency is currently estimated at ~25% of the recipients. It could be one of the major causes of late graft failure. Therefore, every

2012 KHA-CARI Guidelines

198. Insulin therapy in type 2 diabetes

. If the person has to work shifts, ensure that they know how to adjust their insulin treatment. Refer people who are unsure of what to do to their diabetes specialist team. Options may include a once-daily injection of a long-acting insulin analogue given at the same time each day. This can be supplemented with a rapid-acting insulin injection before meals, or a once-daily sulfonylurea taken before the first meal on waking. [ ; ] Hypoglycaemia How should I manage hypoglycaemia? Recognizing hypoglycaemia (...) that is suitable for all people with type 2 diabetes; treatment should be individualized for each person. Options include: One, two, or three insulin injections per day regimens. Multiple daily injection basal-bolus insulin regimens. The main adverse effect of insulin treatment is hypoglycaemia, which is generally defined as blood glucose levels less than 3.5 mmol/L. The severity of hypoglycemia is defined by the clinical manifestations: Mild hypoglycaemia presents with a wide variety of symptoms, including

2016 NICE Clinical Knowledge Summaries

199. Diabetes - type 2

study of vascular disease in diabetes , CVD accounted for 52% of deaths in people with type 2 diabetes [ ]. People with type 2 diabetes have a twofold increased risk of stroke within the first five years of diagnosis compared with the general population. About 20% of hospital admissions for heart failure, myocardial infarction, and stroke are in people with diabetes (type 1 or 2). Microvascular complications — nephropathy, retinopathy, and neuropathy. Nephropathy — kidney damage is the largest cause (...) who are pregnant, planning a pregnancy, or breastfeeding. It also does not cover the diagnosis and management of impaired glucose regulation, or make detailed recommendations on the diagnosis and management of other types of diabetes. There are separate CKS topics on and . The target audience for this CKS topic is healthcare professionals working within the NHS in the UK, and providing first contact or primary healthcare. How up-to-date is this topic? How up-to-date is this topic? Changes Changes

2016 NICE Clinical Knowledge Summaries

200. Comparative effectiveness and safety of medications for type 2 diabetes: an update including new drugs and 2-drug combinations

, Nicholson WK, Hutfless S, Bass EB, Bolen S CRD summary This review concluded that evidence supported use of metformin as a first-line agent for treatment of type 2 diabetes. This was a generally well-conducted review in which a vulnerability to publication bias and limitations of the evidence base were acknowledged. Provided these are borne in mind, the conclusions are likely to be reliable. Authors' objectives To assess the benefits and harms of metformin, second-generation sulfonylureas (...) studies were not reported. Metformin was more efficacious than DPP-4 inhibitors in reducing HbA1c as monotherapy (WMD -0.37, 95% CI -0.54 to -0.20; three studies) with both agents together more efficacious than monotherapy. There was low strength evidence for metformin plus GLP-1 agonist being more effective then metformin plus a DPP-4 inhibitor. Metformin decreased mean body weight relative to thiazolidinediones (WMD -2.6, 95% CI -4.1 to -1.2; eight studies), sulfonylureas (WMD -2.7, 95% CI -3.5

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2011 DARE.

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