"Saxagliptin"

Saxagliptin + saxagliptin/metformin - Addendum to Commission A16-42 + A16-43 1 Translation of addendum A16-71 Saxagliptin und Saxagliptin/Metformin (Diabetes mellitus Typ 2) – Addendum zu den Aufträgen A16-42 und A16-43 (Version 1.0; Status: 16 November 2016). 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. Addendum 16 November 2016 1.0 Commission: A16-71 Version: Status: IQWiG Reports – Commission No. A16-71 Saxagliptin and saxagliptin/metformin (type 2 diabetes mellitus) – Addendum to Commissions A16-42 and A16-431 Addendum A16-71 Version 1.0

Metformin hydrochloride / saxagliptin / dapagliflozin (Qtrilmet) - type 2 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 , 2019. Reproduction is authorised provided the source is acknowledged. EMA/521799/2019 EMEA/H/C/004910 Qtrilmet (metformin / saxagliptin / dapagliflozin) An overview of Qtrilmet and why it is authorised in the EU What is Qtrilmet and what is it used for? Qtrilmet is a diabetes medicine that contains the active substances metformin, saxagliptin and dapagliflozin. It is used to treat type 2 diabetes

β-Cell Function, Incretin Effect, and Glucose Kinetics in Response to a Mixed Meal in Patients With Type 2 Diabetes Treated With Dapagliflozin Plus Saxagliptin. To explore the complementary effects of a combination of dipeptidyl peptidase 4 and sodium-glucose cotransporter 2 inhibitors added to metformin on hormonal and metabolic responses to meal ingestion. Forty-five patients (age 58 ± 8 years ; HbA1c 58 ± 6 mmol/mol; BMI 30.7 ± 3.2 kg/m2) with type 2 diabetes uncontrolled with metformin were evaluated at baseline and 3 and 28 days after 5 mg saxagliptin (SAXA), 10 mg dapagliflozin (DAPA), or 5 mg saxagliptin plus 10 mg dapagliflozin (SAXA+DAPA) using a mixed-meal tolerance test (MMTT) spiked with dual-tracer glucose to assess glucose metabolism, insulin secretion, and sensitivity. At day 3

Continuous Glucose Monitoring Profiles and Health Outcomes after Dapagliflozin Plus Saxagliptin vs Insulin Glargine. Glycemic variability and hypoglycemia during diabetes treatment may impact therapeutic effectiveness and safety, even when glycated hemoglobin (HbA1c) reduction is comparable between therapies. We employed masked continuous glucose monitoring (CGM) during a randomized trial of dapagliflozin plus saxagliptin (DAPA+SAXA) vs insulin glargine (INS) to compare glucose variability and patient-reported outcomes (PROs). 24-week sub-study of a randomized, open-label, two-arm, parallel-group, phase 3b study. Multicenter study (112 centers in 11 countries). 283 adults with type 2 diabetes (T2D) inadequately controlled with metformin ± sulfonylurea. DAPA+SAXA vs INS. Changes in CGM profiles

Saxagliptin/dapagliflozin is non-inferior to insulin glargine in terms of β-cell function in subjects with latent autoimmune diabetes in adults: A 12-month, randomized, comparator-controlled pilot study. To compare the efficacy and safety of saxagliptin/dapagliflozin and insulin glargine in people with latent autoimmune diabetes in adults (LADA). In this phase 2b multicentre, open-label , comparator-controlled, parallel-group, non-inferiority study, we randomly assigned 33 people with LADA who had a fasting C-peptide concentration ≥0.2 nmol/L (0.6 ng/mL) to receive 1-year daily treatment with either the combination of saxagliptin (5 mg) plus dapagliflozin (10 mg) or insulin glargine (starting dose: 10 IU), both on top of metformin. The primary outcome was the 2-h mixed meal-stimulated C

Efficacy and tolerability of initial triple combination therapy with metformin, dapagliflozin and saxagliptin compared with stepwise add-on therapy in drug-naïve patients with type 2 diabetes (TRIPLE-AXEL study): A multicentre, randomized, 104-week, open To evaluate the efficacy and tolerability of an initial triple combination therapy (TCT) compared with conventional stepwise add-on therapy (SAT) in patients with newly diagnosed type 2 diabetes (T2D). This multicentre, randomized, 104-week, open-label trial randomized 105 patients with drug-naïve T2D (with HbA1c level ≥ 8.0%, < 11.0%) to the TCT (1000 mg of metformin, 10 mg of dapagliflozin and 5 mg of saxagliptin once daily) or SAT (initiated with metformin, followed by glimepiride and sitagliptin) groups. The primary outcome

Safety, Growth and Development After Dapagliflozin or Saxagliptin in Children With Type 2 Diabetes (T2NOW Follow-Up). The T2NOW trial of dapagliflozin or saxagliptin versus placebo in pediatric patients with type 2 diabetes (T2D) demonstrated promising efficacy data for dapagliflozin and did not raise any safety concerns over 52 weeks. Assess long-term effects of prior dapagliflozin/saxagliptin administration on safety, growth and development. Multicenter, randomized, double-blind phase 3 trial (T2NOW). 210 children with T2D aged 10-17 years, followed for up to one year after treatment. Previous treatment with once-daily dapagliflozin (5, 10 mg), saxagliptin (2.5, 5 mg) or placebo as add-on to diet, exercise, metformin and/or insulin for 52 weeks, plus a 52-week non-treatment follow-up period. Change

Qtern (saxagliptin / dapagliflozin) Qtern: Withdrawn application | European Medicines Agency Skip to main content Search Search Menu * Medicines * Human regulatory Human regulatory * Overview * Research and development * Marketing authorisation * Post-authorisation * Herbal products * Veterinary regulatory Veterinary regulatory * Overview to improve control of their blood glucose (sugar) levels. It contains the active substances saxagliptin and dapagliflozin.Qtern is used in patients in whom treatment with a combination of several other diabetes medicines (metformin and/or a sulfonylurea plus either saxagliptin or dapagliflozin) is not working well enough. It is also used to replace saxagliptin and dapagliflozin given as separate

Saxagliptin - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.7 of the dossier assessment Saxagliptin (Diabetes mellitus Typ 2 – Nutzenbewertung gemäß § 35a SGB V (Ablauf Befristung) (Version 1.0; Status: 29 September 2016). 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. A16-42 Saxagliptin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V1 (expiry of the decision) Extract of dossier assessment A16-42 Version 1.0 Saxagliptin (type 2 diabetes mellitus) 29 September 2016 Institute for Quality

Saxagliptin/metformin - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Saxagliptin/Metformin (Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (Ablauf Befristung) ( Version 1.0; Status: 29 September 2016). 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. A16-43 Saxagliptin/metformin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V1 (expiry of the decision) Extract of dossier assessment A16-43 Version 1.0 Saxagliptin/metformin (type 2

Saxagliptin/metformin (type 2 diabetes) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Saxagliptin/Metformin ( Diabetes mellitus Typ 2 ) – Nutzenbewertung gemäß § 35a SGB V ( Version 1.0; Status: 25 October 2017). 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. A17-33 Saxagliptin/metformin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V1 Extract of dossier assessment A17-33 Version 1.0 Saxagliptin/metformin (type 2 diabetes mellitus) 25 October 2017

Saxagliptin + saxagliptin/metformin: Addendum to Commission A16-42 + A16-43 Saxagliptin und Saxagliptin/Metformin (Diabetes mellitus Typ 2): Addendum zu den Aufträgen A16-42 und A16-43; Auftrag A16-71 [Saxagliptin + saxagliptin/metformin: Addendum to Commission A16-42 + A16-43 ] ..

Combination therapy with saxagliptin and vitamin D for the preservation of β-cell function in adult-onset type 1 diabetes: a multi-center, randomized, controlled trial. Disease modifying therapies aiming to preserve β-cell function in patients with adult-onset autoimmune type 1 diabetes are lacking. Here, we conducted a multi-centre, randomized, controlled trial to assess the β-cell preservation effects of saxagliptin alone and saxagliptin combined with vitamin D as adjunctive therapies in adult-onset autoimmune type 1 diabetes. In this 3-arm trial, 301 participants were randomly assigned to a 24-month course of the conventional therapy (metformin with or without insulin) or adjunctive saxagliptin or adjunctive saxagliptin plus vitamin D to the conventional therapy. The primary endpoint

Effects of dapagliflozin and dapagliflozin-saxagliptin on erythropoiesis, iron and inflammation markers in patients with type 2 diabetes and chronic kidney disease: data from the DELIGHT trial. This post-hoc analysis of the DELIGHT trial assessed effects of the SGLT2 inhibitor dapagliflozin on iron metabolism and markers of inflammation. Patients with type 2 diabetes and albuminuria were randomized to dapagliflozin, dapagliflozin and saxagliptin, or placebo. We measured hemoglobin, iron markers (serum iron, transferrin saturation, and ferritin), plasma erythropoietin, and inflammatory markers (urinary MCP-1 and urinary/serum IL-6) at baseline and week 24. 360/461 (78.1%) participants had available biosamples. Dapagliflozin and dapagliflozin-saxagliptin, compared to placebo, increased

Dapagliflozin or Saxagliptin in Pediatric Type 2 Diabetes. Dapagliflozin or Saxagliptin in Pediatric Type 2 DiabetesDapagliflozin (a sodium-glucose co-transporter-2 inhibitor) and saxagliptin (a dipeptidyl peptidase-4 inhibitor) have both been approved by the U.S. Food and Drug Administration for the treatment of type 2 diabetes in adults but not in children. In this randomized trial of 245 pediatric patients (10 to 17 years of age) with uncontrolled type 2 diabetes, dapagliflozin but not saxagliptin significantly reduced A1C compared with placebo.

[Saxagliptin/metformin (type 2 diabetes) - benefit assessment according to õ35a Social Code Book V] Saxagliptin/metformin (Diabetes mellitus typ 2): nutzenbewertung gemäß § 35a SGB V; dossierbewertung; auftrag A17 [Saxagliptin/metformin (type 2 diabetes) - benefit assessment according to §35a Social Code Book V ] ..

Qtern (saxagliptin / dapagliflozin propanediol monohydrate) - 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. 26 May 2016 EMA/428168/2016 Committee for Medicinal Products for Human Use (CHMP) Assessment report Qtern International non-proprietary name: saxagliptin / dapagliflozin Procedure No. EMEA/H/C/004057/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Qtern Assessment report Page 2/91 Table of contents 1. Background

Saxagliptin combined with additional oral antihyperglycemic agents in drug-naive diabetic patients with high glycosylated hemoglobin: a 24-week, multicenter, randomized, open-label, active parallel-controlled group clinical trial in China (SUCCESS). To assess the efficacy and safety of a dipeptidyl peptidase-4 (DPP4) inhibitor combined respectively with 3 oral antihyperglycemic agents in Chinese patients with newly diagnosed type 2 diabetes mellitus (T2DM) with high glycated hemoglobin (HbA ) levels. Between Dec 30, 2014, and Nov 1, 2017, a 24-week, multicenter, parallel-controlled study, a total of 648 drug-naive T2DM patients with 8.0%≤ HbA ≤11.0%, aged 18-80 years, and BMI 19-40 kg/m were randomly assigned 1:1:1 to receive saxagliptin combined with metformin, acarbose, or gliclazide modified

A New Clinical Utility for Tubular Markers to Identify Kidney Responders to Saxagliptin Treatment in Adults With Diabetic Nephropathy. In recent clinical studies, saxagliptin exhibited nephroprotective potential by lowering albuminuria. In this study, we aimed to determine whether these kidney effects of saxagliptin were mediated by changes in markers of kidney tubular damage, including urinary neutrophil gelatinase-associated protein (uNGAL) and liver-type fatty acid-binding protein (uL-FABP). Our study included 80 patients with type 2 diabetes, hypertension and mild to moderate diabetic kidney disease (DKD) with prevalent albuminuria. Patients were either randomly assigned to saxagliptin as add-on therapy or remained unchanged on their stable antidiabetic therapy as a control arm. Saxagliptin

Long-term effects of dapagliflozin plus saxagliptin versus glimepiride on a background of metformin in patients with type 2 diabetes: Results of a 104-week extension to a 52-week randomized, phase 3 study and liver fat MRI substudy. To report the results of a 104-week extension to a 52-week study in which dapagliflozin plus saxagliptin (DAPA+SAXA) improved glycaemic control, liver fat