Latest & greatest articles for sitagliptin

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Top results for sitagliptin

41. Sitagliptin - Benefit assessment according to § 35a Social Code Book V

Sitagliptin - Benefit assessment according to § 35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.8 of the dossier assessment “Sitagliptin – Nutzenbewertung gemäß § 35a SGB V” (Version 1.0; Status: 27 June 2013). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A13-02 Sitagliptin – Benefit assessment according (...) to § 35a Social Code Book V 1 Extract of dossier assessment A13-02 Version 1.0 Sitagliptin – Benefit assessment acc. to § 35a Social Code Book V 27 June 2013 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Sitagliptin – Benefit assessment according to § 35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 27 March 2013 Internal Commission No.: A13-02 Address

Institute for Quality and Efficiency in Healthcare (IQWiG)2013

42. Sitagliptin (Januvia®) 25 and 50 mg tablets

Sitagliptin (Januvia®) 25 and 50 mg tablets Sitagliptin (Januvia®) 25 and 50 mg tablets Sitagliptin (Januvia®) 25 and 50 mg tablets All Wales Medicines Strategy Group (AWMSG) Record Status This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database. Citation All Wales Medicines Strategy Group (AWMSG). Sitagliptin (Januvia®) 25 and 50 mg tablets. Penarth: All Wales Therapeutics and Toxicology (...) Centre (AWTTC), secretariat of the All Wales Medicines Strategy Group (AWMSG). AWMSG Secretariat Assessment Report Advice No. 2912. 2012 Authors' conclusions Sitagliptin (Januvia®) 25 and 50 mg tablets are recommended as an option for use within NHS Wales for the improvement of glycaemic control in type 2 diabetes mellitus patients with moderate renal impairment (CrCl = 30 to < 50 ml/min), severe renal impairment (CrCl < 30 ml/min) or with end-stage renal disease (ESRD) requiring haemodialysis or

Health Technology Assessment (HTA) Database.2012

43. A randomized non-inferiority study comparing the addition of exenatide twice daily to sitagliptin or switching from sitagliptin to exenatide twice daily in patients with Type 2 diabetes experiencing inadequate glycaemic control on metformin and sitaglipti

A randomized non-inferiority study comparing the addition of exenatide twice daily to sitagliptin or switching from sitagliptin to exenatide twice daily in patients with Type 2 diabetes experiencing inadequate glycaemic control on metformin and sitaglipti 22375612 2012 10 08 2013 02 20 2015 11 19 1464-5491 29 11 2012 Nov Diabetic medicine : a journal of the British Diabetic Association Diabet. Med. A randomized non-inferiority study comparing the addition of exenatide twice daily to sitagliptin (...) or switching from sitagliptin to exenatide twice daily in patients with type 2 diabetes experiencing inadequate glycaemic control on metformin and sitagliptin. e417-24 10.1111/j.1464-5491.2012.03624.x To test the hypothesis that glycaemic control achieved when switching sitagliptin to exenatide twice daily plus metformin is non-inferior to adding exenatide twice daily to sitagliptin and metformin. Patients with Type 2 diabetes inadequately controlled with sitagliptin plus metformin were randomly assigned

EvidenceUpdates2012

44. Insulin glargine versus sitagliptin in insulin-naive patients with type 2 diabetes mellitus uncontrolled on metformin (EASIE): a multicentre, randomised open-label trial.

Insulin glargine versus sitagliptin in insulin-naive patients with type 2 diabetes mellitus uncontrolled on metformin (EASIE): a multicentre, randomised open-label trial. BACKGROUND: In people with type 2 diabetes, a dipeptidyl peptidase-4 (DPP-4) inhibitor is one choice as second-line treatment after metformin, with basal insulin recommended as an alternative. We aimed to compare the efficacy, tolerability, and safety of insulin glargine and sitagliptin, a DPP-4 inhibitor, in patients whose (...) plasma glucose of 4·0-5·5 mmol/L) or sitagliptin (oral dose of 100 mg daily). Randomisation (via a central interactive voice response system) was by random sequence generation and was stratified by centre. Patients and investigators were not masked to treatment assignment. The primary outcome was change in HbA(1c) from baseline to study end. Efficacy analysis included all randomly assigned participants who had received at least one dose of study drug and had at least one on-treatment assessment

Lancet2012

45. Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4): a 26-week double-blind study

Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4): a 26-week double-blind study 22210563 2012 01 25 2012 06 12 2016 12 15 1935-5548 35 2 2012 Feb Diabetes care Diabetes Care Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4): a 26-week double-blind study. 252 (...) -8 10.2337/dc11-1107 To test the safety and efficacy of exenatide once weekly (EQW) compared with metformin (MET), pioglitazone (PIO), and sitagliptin (SITA) over 26 weeks, in suboptimally treated (diet and exercise) drug-naive patients with type 2 diabetes. Patients were randomized to subcutaneous (SC) EQW 2.0 mg + oral placebo (n = 248), MET 2,000 mg/day + SC placebo (n = 246), PIO 45 mg/day + SC placebo (n = 163), or SITA 100 mg/day + SC placebo (n = 163) for 26 weeks. MET and PIO therapies

EvidenceUpdates2012 Full Text: Link to full Text with Trip Pro

46. The incidence of hypoglycaemia in Muslim patients with type 2 diabetes treated with sitagliptin or a sulphonylurea during Ramadan: a randomised trial

The incidence of hypoglycaemia in Muslim patients with type 2 diabetes treated with sitagliptin or a sulphonylurea during Ramadan: a randomised trial 21951832 2011 10 14 2012 01 31 2017 02 20 1742-1241 65 11 2011 Nov International journal of clinical practice Int. J. Clin. Pract. The incidence of hypoglycaemia in Muslim patients with type 2 diabetes treated with sitagliptin or a sulphonylurea during Ramadan: a randomised trial. 1132-40 10.1111/j.1742-1241.2011.02797.x To compare the incidence (...) of symptomatic hypoglycaemia in fasting Muslim patients with type 2 diabetes treated with sitagliptin or a sulphonylurea during Ramadan. Patients with type 2 diabetes (age ≥ 18 years) who were treated with a stable dose of a sulphonylurea with or without metformin for at least 3 months prior to screening, who had an HbA(1c) < 10% and who expressed their intention to daytime fast during Ramadan were eligible for this open-label study. Patients were randomised in a 1 : 1 ratio to either switch to sitagliptin

EvidenceUpdates2012 Full Text: Link to full Text with Trip Pro

47. Janumet XR (sitagliptin/metformin hydrochloride extended release)

Janumet XR (sitagliptin/metformin hydrochloride extended release) Drug Approval Package: JANUMET XR (sitagliptin/metformin hydrochloride) NDA #202270 Drug Approval Package U.S. Food & Drug Administration Enter Search terms Drug Approval Package - JANUMET XR (sitagliptin/metformin hydrochloride extended release) fixed-dose combination tablets, 100 mg/1000 mg, 50 mg/500 mg, and 50 mg/1000 mg Company: Merck Sharp & Dohme Corp. Application No.: 202270 Approval Date: 02/02/2012 Persons

FDA - Drug Approval Package2012

48. Efficacy and safety of sitagliptin and the fixed-dose combination of sitagliptin and metformin vs. pioglitazone in drug-naive patients with type 2 diabetes

Efficacy and safety of sitagliptin and the fixed-dose combination of sitagliptin and metformin vs. pioglitazone in drug-naive patients with type 2 diabetes 21849007 2011 08 18 2012 05 07 2015 11 19 1742-1241 65 9 2011 Sep International journal of clinical practice Int. J. Clin. Pract. Efficacy and safety of sitagliptin and the fixed-dose combination of sitagliptin and metformin vs. pioglitazone in drug-naïve patients with type 2 diabetes. 930-8 10.1111/j.1742-1241.2011.02749.x The efficacy (...) and safety of sitagliptin (SITA) monotherapy and SITA/metformin (MET) vs. pioglitazone (PIO) were assessed in patients with type 2 diabetes and moderate-to-severe hyperglycaemia (A1C = 7.5-12.0%). In an initial 12-week phase (Phase A), 492 patients were randomised 1 : 1 in a double-blind fashion to SITA (100 mg qd) or PIO (15 mg qd, up-titrated to 30 mg after 6 weeks). In Phase B (28 additional weeks), the SITA group was switched to SITA/MET (up-titrated to 50/1000 mg bid over 4 weeks) and the PIO group

EvidenceUpdates2011

49. Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and pioglitazone on glycemic control and measures of beta-cell function in patients with type 2 diabetes

Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and pioglitazone on glycemic control and measures of beta-cell function in patients with type 2 diabetes 21235696 2011 01 17 2011 12 22 2015 11 19 1742-1241 65 2 2011 Feb International journal of clinical practice Int. J. Clin. Pract. Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and pioglitazone on glycemic control and measures of β-cell function in patients (...) with type 2 diabetes. 154-64 10.1111/j.1742-1241.2010.02589.x To assess the safety and efficacy of initial combination therapy with sitagliptin and pioglitazone compared with pioglitazone monotherapy in drug-naïve patients with type 2 diabetes. A total of 520 patients were randomised to initial combination therapy with sitagliptin 100 mg q.d. and pioglitazone 30 mg q.d. or pioglitazone 30 mg q.d. monotherapy for 24 weeks. Initial combination therapy with sitagliptin and pioglitazone led to a mean reduction from

EvidenceUpdates2011

50. Efficacy and safety of long-acting glucagon-like peptide-1 receptor agonists compared with exenatide twice daily and sitagliptin in type 2 diabetes mellitus: a systematic review and meta-analysis

Efficacy and safety of long-acting glucagon-like peptide-1 receptor agonists compared with exenatide twice daily and sitagliptin in type 2 diabetes mellitus: a systematic review and meta-analysis Efficacy and safety of long-acting glucagon-like peptide-1 receptor agonists compared with exenatide twice daily and sitagliptin in type 2 diabetes mellitus: a systematic review and meta-analysis Efficacy and safety of long-acting glucagon-like peptide-1 receptor agonists compared with exenatide twice (...) daily and sitagliptin in type 2 diabetes mellitus: a systematic review and meta-analysis Pinelli NR, Hurren KM CRD summary The review concluded that liraglutide and exenatide once weekly resulted in greater improvement in haemoglobin 1C and fasting plasma glucose than exenatide twice daily and sitagliptin. Due to the limited evidence base and potential for publication bias, the authors’ conclusions should be considered tentative. Authors' objectives To compare the efficacy and safety of maximum dose

DARE.2011

56. 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 | Evidence-Based Medicine This site uses cookies. By continuing (...) to browse the site you are agreeing to our use of cookies. Log in using your username and password For personal accounts OR managers of institutional accounts Username * Password * your user name or password? Search for this keyword Search for this keyword Main menu Log in using your username and password For personal accounts OR managers of institutional accounts Username * Password * your user name or password? You are here Compared with glyburide, sitagliptin associated with incremental cost

Evidence-Based Medicine (Requires free registration)2010

57. 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.

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. 20580422 2010 08 09 2010 08 24 2015 11 19 1474-547X 376 9739 2010 Aug 07 Lancet (London, England) Lancet 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. 431-9 10.1016/S0140-6736(10)60590-9 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, or the thiazolidinedione, pioglitazone, in patients treated with metformin. In this 26-week randomised, double-blind, double-dummy, superiority trial, patients with type 2 diabetes who had been treated

Lancet2010

58. 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.

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. 20417856 2010 04 26 2010 05 14 2015 11 19 1474-547X 375 9724 2010 Apr 24 Lancet (London, England) Lancet 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. 1447-56 10.1016/S0140-6736(10 (...) )60307-8 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

Lancet2010

59. 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

European Medicines Agency - EPARs2010

60. 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

European Medicines Agency - EPARs2010