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Type 1 Diabetes Mellitus

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41. Soliqua - lixisenatide + insulin glargine - Diabetes mellitus, Type 2

Soliqua - lixisenatide + insulin glargine - Diabetes mellitus, Type 2 lixisenatide + insulin glargine | CADTH.ca Find the information you need lixisenatide + insulin glargine lixisenatide + insulin glargine Last Updated: January 3, 2019 Result type: Reports Project Number: SR0564-000 Product Line: Generic Name: lixisenatide + insulin glargine Brand Name: Soliqua Manufacturer: sanofi-aventis Canada Inc. Indications: Diabetes mellitus, Type 2 Manufacturer Requested Reimbursement Criteria 1 (...) : Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when oral glucose-lowering medicinal products combined with basal insulin, or basal insulin alone do not provide adequate glycaemic control. Submission Type: New Combination Project Status: Complete Biosimilar: No Companion Diagnostics: No Date Recommendation Issued: December 24, 2018 Recommendation Type: Reimburse with clinical criteria and/or conditions Fee Schedule: Schedule

2018 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

42. Steglatro - ertugliflozin - Diabetes mellitus, Type 2

Steglatro - ertugliflozin - Diabetes mellitus, Type 2 ertugliflozin | CADTH.ca Find the information you need ertugliflozin ertugliflozin Last Updated: January 25, 2019 Result type: Reports Project Number: SR0565-000 Product Line: Generic Name: ertugliflozin Brand Name: Steglatro Manufacturer: Merck Canada Inc. Indications: Diabetes mellitus, Type 2 Manufacturer Requested Reimbursement Criteria 1 : As monotherapy for patients who have inadequate glycemic control and for whom metformin (...) or a sulfonylurea is inappropriate due to contraindications or intolerance. Add-on to metformin for patients who have inadequate glycemic control on metformin and have a contraindication or intolerance to a sulfonylurea. Submission Type: New Project Status: Complete Biosimilar: No Companion Diagnostics: No Date Recommendation Issued: January 23, 2019 Recommendation Type: Do not reimburse Fee Schedule: Schedule A The requested reimbursement criteria are provided by the applicant and do not necessarily reflect

2018 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

43. Segluromet - ertugliflozin and metformin hydrochloride - Diabetes mellitus, Type 2

Segluromet - ertugliflozin and metformin hydrochloride - Diabetes mellitus, Type 2 ertugliflozin and metformin | CADTH.ca Find the information you need ertugliflozin and metformin ertugliflozin and metformin Last Updated: January 25, 2019 Result type: Reports Project Number: SR0566-000 Product Line: Generic Name: ertugliflozin and metformin hydrochloride Brand Name: Segluromet Manufacturer: Merck Canada Inc. Indications: Diabetes mellitus, Type 2 Manufacturer Requested Reimbursement Criteria 1 (...) : Added on to metformin for patients who have inadequate glycemic control on metformin and have a contraindication or intolerance to a sulfonylurea, or To replace the individual components of ertugliflozin and metformin for those patients who are on both therapies Submission Type: New Combination Project Status: Complete Biosimilar: No Companion Diagnostics: No Date Recommendation Issued: January 23, 2019 Recommendation Type: Do not reimburse Fee Schedule: Schedule C The requested reimbursement

2018 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

44. Ozempic - semaglutide - Diabetes mellitus, type 2

Ozempic - semaglutide - Diabetes mellitus, type 2 semaglutide | CADTH.ca Find the information you need semaglutide semaglutide Last Updated: June 18, 2019 Result type: Reports Project Number: SR0594-000 Product Line: Generic Name: semaglutide Brand Name: Ozempic Manufacturer: Novo Nordisk Canada Inc. Indications: Diabetes mellitus, type 2 Manufacturer Requested Reimbursement Criteria 1 : For the treatment of adults patients with type 2 diabetes to improve glycemic control, in combination (...) with metformin (second line treatment) and in combination with metformin and sulfonylurea (third line treatment). Submission Type: New Project Status: Complete Biosimilar: No Date Recommendation Issued: May 15, 2019 Recommendation Type: Reimburse with clinical criteria and/or conditions Fee Schedule: Schedule A The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation

2018 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

45. Pharmacotherapy Management of Type 2 Diabetes Mellitus: Guidelines

Pharmacotherapy Management of Type 2 Diabetes Mellitus: Guidelines Pharmacotherapy Management of Type 2 Diabetes Mellitus: Guidelines | CADTH.ca Find the information you need Pharmacotherapy Management of Type 2 Diabetes Mellitus: Guidelines Pharmacotherapy Management of Type 2 Diabetes Mellitus: Guidelines Last updated: December 12, 2018 Project Number: RA0993-000 Product Line: Research Type: Drug Report Type: Reference List Result type: Report Question What are the evidence-based guidelines (...) regarding the optimal pharmacological management of Type 2 Diabetes Mellitus? Key Message Thirteen evidence-based guidelines were identified regarding the optimal pharmacological management of Type 2 Diabetes Mellitus. Files Rapid Response Reference List Published : December 12, 2018 Related Content Follow us: © 2019 Canadian Agency for Drugs and Technologies in Health Get our newsletter:

2018 Canadian Agency for Drugs and Technologies in Health - Rapid Review

46. Ertugliflozin (STEGLATRO) - type 2 diabetes mellitus

Ertugliflozin (STEGLATRO) - type 2 diabetes mellitus Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located below. Recent Activity for SBDs written for approved after September 1 (...) (PAAT) RowNum Activity/submission type, control number Date submitted Decision and date Summary of activities Summary Basis of Decision (SBD) for Date SBD issued: The following information relates to the new drug submission for . Drug Identification Number (DIN): 1 What was approved? 2 Why was approved? 3 What steps led to the approval of ? Submission Milestones: Submission Milestone Date 4 What follow-up measures will the company take? 5 What post-authorization activity has taken place for ? 6 What

2018 Health Canada - Drug and Health Product Register

47. Lixisenatide (Adlyxine) - type 2 diabetes mellitus

Lixisenatide (Adlyxine) - type 2 diabetes mellitus Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located below. Recent Activity for SBDs written for approved after September 1, 2012 (...) Activity/submission type, control number Date submitted Decision and date Summary of activities Summary Basis of Decision (SBD) for Date SBD issued: The following information relates to the new drug submission for . Drug Identification Number (DIN): 1 What was approved? 2 Why was approved? 3 What steps led to the approval of ? Submission Milestones: Submission Milestone Date 4 What follow-up measures will the company take? 5 What post-authorization activity has taken place for ? 6 What other

2018 Health Canada - Drug and Health Product Register

48. Albiglutide (Eperzan) - type 2 diabetes mellitus

Albiglutide (Eperzan) - type 2 diabetes mellitus Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located below. Recent Activity for SBDs written for approved after September 1, 2012 (...) Activity/submission type, control number Date submitted Decision and date Summary of activities Summary Basis of Decision (SBD) for Date SBD issued: The following information relates to the new drug submission for . Drug Identification Number (DIN): 1 What was approved? 2 Why was approved? 3 What steps led to the approval of ? Submission Milestones: Submission Milestone Date 4 What follow-up measures will the company take? 5 What post-authorization activity has taken place for ? 6 What other

2018 Health Canada - Drug and Health Product Register

49. Semaglutide (Ozempic) - To improve glycemic control in adults with type 2 diabetes mellitus

Semaglutide (Ozempic) - To improve glycemic control in adults with type 2 diabetes mellitus Ozempic (semaglutide) Injection U.S. Department of Health and Human Services Search FDA Submit search Ozempic (semaglutide) Injection Ozempic Company: Novo Nordisk Inc. Application No.: 209637 Approval Date: 12/05/2017 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF

2018 FDA - Drug Approval Package

50. Alogliptin (Nesina) - type 2 diabetes mellitus

Alogliptin (Nesina) - type 2 diabetes mellitus Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located below. Recent Activity for SBDs written for approved after September 1, 2012 (...) Activity/submission type, control number Date submitted Decision and date Summary of activities Summary Basis of Decision (SBD) for Date SBD issued: The following information relates to the new drug submission for . Drug Identification Number (DIN): 1 What was approved? 2 Why was approved? 3 What steps led to the approval of ? Submission Milestones: Submission Milestone Date 4 What follow-up measures will the company take? 5 What post-authorization activity has taken place for ? 6 What other

2018 Health Canada - Drug and Health Product Register

57. 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

58. 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

59. 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

60. A community-based primary prevention programme for type 2 diabetes mellitus integrating identification and lifestyle intervention for prevention: a cluster randomised controlled trial Full Text available with Trip Pro

A community-based primary prevention programme for type 2 diabetes mellitus integrating identification and lifestyle intervention for prevention: a cluster randomised controlled trial A community-based primary prevention programme for type 2 diabetes mellitus integrating identification and lifestyle intervention for prevention: a cluster randomised controlled trial Journals Library An error occurred retrieving content to display, please try again. >> >> >> Page Not Found Page not found (404 (...) Realf 4 , Timothy Skinner 6 , Bernie Stribling 4 , Jacqui Troughton 4 , Thomas Yates 1 , Kamlesh Khunti 1 1 Diabetes Research Centre, University of Leicester, Leicester, UK 2 Department of Health Sciences, University of Leicester, Leicester, UK 3 Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK 4 Leicester Diabetes Centre, University Hospitals of Leicester, Leicester, UK 5 Patient and Public Involvement Group, Leicester Diabetes Centre

2017 NIHR HTA programme

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