Latest & greatest articles for sitagliptin

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Top results for sitagliptin

61. Ristfor - sitagliptin / metformin hydrochloride

Ristfor - sitagliptin / metformin hydrochloride European Medicines Agency Evaluation of Medicines for Human Use 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 70 51 E-mail: mail@eme.europa.eu http://www.eme.europa.eu London, 17 December 2009 Doc.Ref.: EMA/55492/2010 CHMP ASSESSMENT REPORT FOR Ristfor International Nonproprietary Name: sitagliptin / metformin hydrochloride Procedure No. EMEA/H/C/001235 Assessment Report as adopted by the CHMP (...) quality, non-clinical and/or clinical data. The applicant applied for the following indication: For patients with type 2 diabetes mellitus: Ristfor is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Ristfor is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct

2010 European Medicines Agency - EPARs

62. Ristaben - sitagliptin

Ristaben - sitagliptin European Medicines Agency Evaluation of Medicines for Human Use 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 70 51 E-mail: mail@ema.europa.eu http://www.ema.europa.eu London, 17 December 2009 Doc.Ref.: EMA/55577/2010 CHMP ASSESSMENT REPORT FOR Ristaben International Nonproprietary Name: sitagliptin Procedure No. EMEA/H/C/001234 Assessment Report as adopted by the CHMP with all information of a commercially confidential (...) plus dual therapy with these agents do not provide adequate glycaemic control. • a PPAR ? agonist and metformin when use of a PPAR ? agonist is appropriate and when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control. Ristaben is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dosage of insulin do not provide adequate glycaemic control. The active substance of Ristaben is sitagliptin phosphate monohydrate

2010 European Medicines Agency - EPARs

63. Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomised, parallel-group, open-label trial. (Abstract)

Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomised, parallel-group, open-label trial. Agonists of the glucagon-like peptide-1 (GLP-1) receptor provide pharmacological levels of GLP-1 activity, whereas dipeptidyl peptidase-4 (DPP-4) inhibitors increase concentrations of endogenous GLP-1 and glucose-dependent insulinotropic polypeptide. We aimed to assess the efficacy and safety of the human GLP-1 (...) analogue liraglutide versus the DPP-4 inhibitor sitagliptin, as adjunct treatments to metformin, in individuals with type 2 diabetes who did not achieve adequate glycaemic control with metformin alone.In this parallel-group, open-label trial, participants (aged 18-80 years) with type 2 diabetes mellitus who had inadequate glycaemic control (glycosylated haemoglobin [HbA(1c)] 7.5-10.0%) on metformin (>or=1500 mg daily for >or=3 months) were enrolled and treated at office-based sites in Europe, the USA

2010 Lancet Controlled trial quality: predicted high

64. Cost-effectiveness analysis: Compared with glyburide, sitagliptin associated with incremental cost-effectiveness ratio of $169 572 per QALY and exenatide with $278 935 per QALY as second-line treatment in adult diabetics in the USA

Cost-effectiveness analysis: Compared with glyburide, sitagliptin associated with incremental cost-effectiveness ratio of $169 572 per QALY and exenatide with $278 935 per QALY as second-line treatment in adult diabetics in the USA Compared with glyburide, sitagliptin associated with incremental cost-effectiveness ratio of $169 572 per QALY and exenatide with $278 935 per QALY as second-line treatment in adult diabetics in the USA | BMJ Evidence-Based Medicine We use cookies to improve our (...) * Password * your user name or password? You are here Compared with glyburide, sitagliptin associated with incremental cost-effectiveness ratio of $169 572 per QALY and exenatide with $278 935 per QALY as second-line treatment in adult diabetics in the USA Article Text Therapeutics Cost-effectiveness analysis Compared with glyburide, sitagliptin associated with incremental cost-effectiveness ratio of $169 572 per QALY and exenatide with $278 935 per QALY as second-line treatment in adult diabetics

2010 Evidence-Based Medicine

65. Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial. (Abstract)

Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial. Most patients with type 2 diabetes begin pharmacotherapy with metformin, but eventually need additional treatment. We assessed the safety and efficacy of once weekly exenatide, a glucagon-like peptide 1 receptor agonist, versus maximum approved doses of the dipeptidyl peptidase-4 inhibitor, sitagliptin (...) oral placebo once daily; 100 mg oral sitagliptin once daily plus injected placebo once weekly; or 45 mg oral pioglitazone once daily plus injected placebo once weekly. Primary endpoint was change in HbA(1c) between baseline and week 26. Analysis was by intention to treat, for all patients who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, number NCT00637273.170 patients were assigned to receive once weekly exenatide, 172 to receive sitagliptin, and 172

2010 Lancet Controlled trial quality: predicted high

66. Impact of sitagliptin on markers of beta-cell function: a meta-analysis

Impact of sitagliptin on markers of beta-cell function: a meta-analysis Untitled Document The CRD Databases will not be available from 08:00 BST on Friday 4th October until 08:00 BST on Monday 7th October for essential maintenance. We apologise for any inconvenience.

2009 DARE.

67. Sitagliptin phosphate - diabetes

Sitagliptin phosphate - diabetes CEDAC FINAL RECOMMENDATION and REASONS for RECOMMENDATION SITAGLIPTIN (Januvia ™ – Merck Frosst Canada Inc.) Description: Sitagliptin is an inhibitor of dipeptidyl peptidase IV, the first of a new class of oral hypoglycemic agents. It is approved for use in combination with metformin in adult patients with Type 2 diabetes mellitus to improve glycemic control when diet and exercise plus metformin do not provide adequate glycemic control. Dosage Forms: 100 mg (...) tablets. The recommended dose is 100 mg daily. Recommendation: The Committee recommends that sitagliptin not be listed. Reasons for the Recommendation: 1. While sitagliptin in combination with metformin reduced blood glucose and hemoglobin A1c (Hb A1c) compared to metformin alone in short term trials, randomized controlled trials (RCTs) have not examined the effect of sitagliptin on any clinically important diabetes-related vascular outcomes. 2. Sitagliptin is not recommended in patients with moderate

2008 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

68. Cost-effectiveness of sitagliptin-based treatment regimens in European patients with type 2 diabetes and haemoglobin A1c above target on metformin monotherapy

Cost-effectiveness of sitagliptin-based treatment regimens in European patients with type 2 diabetes and haemoglobin A1c above target on metformin monotherapy Cost-effectiveness of sitagliptin-based treatment regimens in European patients with type 2 diabetes and haemoglobin A1c above target on metformin monotherapy Cost-effectiveness of sitagliptin-based treatment regimens in European patients with type 2 diabetes and haemoglobin A1c above target on metformin monotherapy Schwarz B, Gouveia M (...) , Chen J, Nocea G, Jameson K, Cook J, Krishnarajah G, Alemao E, Yin D, Sintonen H Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. CRD summary This study examined the cost-effectiveness of adding sitagliptin to treatment for patients with type 2

2008 NHS Economic Evaluation Database.

69. Janumet (Sitagliptin/Metformin Hydrochloride)

Janumet (Sitagliptin/Metformin Hydrochloride) Drug Approval Package: Janumet (Sitagliptin/Metformin Hydrochloride) NDA #022044 Drug Approval Package U.S. Food & Drug Administration Search FDA Drug Approval Package - Janumet (Sitagliptin/Metformin Hydrochloride) Tablets Company: Merck & Co., Inc. Application No.: 022044 Approval Date: 03/30/2007 (PDF) (PDF) Medical Review(s) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) Date created: July 8, 2008 Note: Documents in PDF format

2007 FDA - Drug Approval Package

72. Sitagliptin (MK 0431) for type 2 diabetes - horizon scanning review

Sitagliptin (MK 0431) for type 2 diabetes - horizon scanning review Sitagliptin (MK 0431) for type 2 diabetes - horizon scanning review Sitagliptin (MK 0431) for type 2 diabetes - horizon scanning review NHSC Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation NHSC. Sitagliptin (MK 0431) for type 2 diabetes - horizon scanning review (...) . Birmingham: National Horizon Scanning Centre (NHSC). 2005 Authors' objectives This study aims to assess the effectiveness of sitagliptin (MK 0431) for type 2 diabetes. Authors' conclusions Sitagliptin (MK 0431) belongs to the new class of incretin enhancer drugs that also includes LAF237 (Vildagliptin) and exenatide. Sitagliptin is administered orally and is in clinical trials in addition to, and as a substitute for, current glucose-lowering therapies in patients with type 2 diabetes. Phase II clinical

2005 Health Technology Assessment (HTA) Database.