Dapagliflozin/metformin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V (new scientific findings) Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Dapagliflozin/Metformin (Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 March 2018). 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 A17-66 Dapagliflozin/metformin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V1 (new scientific findings) Extract of dossier assessment A17-66 Version 1.0 Dapagliflozin
Dapagliflozin/metformin (type 2 diabetes mellitus) - Addendum to Commission A19-52 1 Translation of addendum A19-93 Dapagliflozin/Metformin (Diabetes mellitus Typ 2) – Addendum zum Auftrag A19-52 (Version 1.0; Status: 29 November 2019). 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 29 November 2019 1.0 Commission: A19-93 Version: Status: IQWiG Reports – Commission No. A19-93 Dapagliflozin/metformin (type 2 diabetes mellitus) – Addendum to Commission A19-521 Addendum A19-93 Version 1.0 Dapagliflozin/metformin – Addendum to Commission A19-52 29 November 2019 Institute for Quality
Dapagliflozin/metformin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Dapagliflozin/Metformin ( Diabetes mellitus Typ 2) – Nutzenbewertung gemäß § 35a SGB V (neue wissenschaftliche Erkenntnisse) ( Version 1.0; Status: 27 September 2019). 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. A19-52 Dapagliflozin/metformin (type 2 diabetes mellitus) – Benefit assessment according to §35a Social Code Book V1 (new scientific findings) Extract of dossier assessment A19
Pharmacokinetic Variables of Dapagliflozin/Metformin Extended-release Fixed-dose Combination in Healthy Chinese Volunteers and Regional Comparison. A fixed-dose combination (FDC) product combining dapagliflozin and metformin may increase medication adherence in patients with type 2 diabetes mellitus (T2DM) by minimizing pill burden associated with co-administration of individual component (IC ) formulations and, consequently, improve cost-efficiency and compliance. This study evaluated the bioequivalence of the dapagliflozin/metformin FDC product versus IC administration in healthy volunteers from a Chinese population and assessed the safety profile of the FDC product. In addition, pharmacokinetic (PK) and safety comparisons of dapagliflozin and metformin across different regions were conducted
Fed and fasted bioequivalence assessment of two formulations of extended-release fixed-dose combination dapagliflozin/metformin (10/1,000 mg) tablets in healthy subjects. Two open-label, randomized, two-period crossover studies were conducted to investigate the pharmacokinetic (PK) properties, safety, and bioequivalence of the test formulation (KD4004), a new fixed-dose combination (FDC dapagliflozin/metformin XR (10/1,000 mg) FDC formulations under fed and fasting conditions. Safety and tolerability were also evaluated. Part A and Part B were completed by 32 and 37 subjects, respectively. Bioequivalence of the two FDC formulations of dapagliflozin and metformin XR tablets was established in both the fasted and the fed conditions as the 90% confidence interval of the ratios of adjusted
Efficacy and Safety of Evogliptin Add-on Therapy to Dapagliflozin/Metformin Combinations in Patients with Poorly Controlled Type 2 Diabetes Mellitus: A 24-Week Multicenter Randomized Placebo-Controlled Parallel-Design Phase-3 Trial with a 28-Week Extensi This study investigates the long-term efficacy and safety of evogliptin add-on therapy in patients with inadequately controlled type 2 diabetes
Dapagliflozin/metformin - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Dapagliflozin/Metformin – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 12 May 2014). 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. A14-07 Dapagliflozin/metformin – Benefit assessment according to §35a Social Code Book V1 Extract of dossier assessment A14-07 Version 1.0 Dapagliflozin/metformin – Benefit assessment acc. to §35a SGB V 12 May 2014 Institute for Quality and Efficiency in Health Care (IQWiG
Ebymect - dapagliflozin / metformin 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 5520 Send a question via our website www.ema.europa.eu/contact 24 September 2015 EMA/679419/2015 Committee for Medicinal Products for Human Use (CHMP) Assessment report Ebymect International non -proprietary name: dapagliflozin / metformin Procedure No. EMEA/H/C/004162/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Assessment report EMA/679419/2015 Page 2/30 Table of contents 1. Background information on the procedure .............................................. 3 1.1. Submission of the dossier
Xigduo - dapagliflozin / metformin 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7455 E-mail info@ema.europa.eu Website www.ema.europa.eu 21 November 2013 EMA/620505/2013 Committee for Medicinal Products for Human Use (CHMP) Assessment report Xigduo International non -proprietary name: DAPAGLIFLOZIN / METFORMIN Procedure No. EMEA/H/C/002672/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Assessment report EMA/CHMP/620505/2013 Page 2/105 Product information Name of the medicinal product: Xigduo Applicant: Bristol-Myers Squibb/AstraZeneca EEIG Bristol-Myers Squibb House Uxbridge Business
No effects of dapagliflozin, metformin or exercise on plasma glucagon concentrations in individuals with prediabetes: A post hoc analysis from the randomized controlled PRE-D trial. To assess the effects of dapagliflozin, metformin and exercise treatment on changes in plasma glucagon concentrations in individuals with overweight and HbA1c-defined prediabetes. One-hundred and twenty individuals suppression during the OGTT between the groups. In individuals with prediabetes, 13 weeks of treatment with dapagliflozin, metformin or exercise was not associated with changes in fasting or post-OGTT glucagon concentrations.
Dapagliflozin, metformin, monotherapy or both in patients with metabolic syndrome. The present study evaluated the effects of dapagliflozin, a SGLT2 inhibitor, or dapagliflozin plus metformin versus metformin monotherapy in patients with metabolic syndrome. This study included patients who admitted in Jiangxi Provincial People's Hospital from January 1, 2017 to December 31, 2019 and were
The effects of dapagliflozin, metformin or exercise on glycaemic variability in overweight or obese individuals with prediabetes (the PRE-D Trial): a multi-arm, randomised, controlled trial. We aimed to investigate the short-term efficacy and safety of three glucose-lowering interventions in overweight or obese individuals with prediabetes defined by HbA. The PRE-D Trial was a randomised
[Dapagliflozin/metformin: benefit assessment according to § 35a Social Code Book V (dossier assessment)] Dapagliflozin/Metformin – Nutzenbewertung gemäß § 35a SGB V [Dapagliflozin/metformin: benefit assessment according to § 35a Social Code Book V (dossier assessment )] ..
Dapagliflozin + metformin (Xigduo) - in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control
Bioequivalence of Dapagliflozin/Metformin Extended-release Fixed-combination Drug Product and Single-component Dapagliflozin and Metformin Extended-release Tablets in Healthy Russian Subjects. Fixed-combination drug products (FCDPs) combining dapagliflozin and metformin extended release (XR) may provide patients with type 2 diabetes mellitus with an alternative antihyperglycemic treatment, which could improve adherence by reducing tablet burden. This study evaluated the bioequivalence of dapagliflozin/metformin XR FCDP versus the co-administration of the individual monotherapy tablets currently available for use in the Russian Federation. Healthy subjects aged 18 to 45 years were enrolled in this randomized, open-label, 2-period crossover study, conducted in a single Russian center
Efficacy of FDC Regimen of Dapagliflozin/Metformin Compared to Co-administered Dual Therapy on Glycemic Control, Satisfaction and Adherence in Chinese Patients With T2DM Study D1690L00149 is a 24-week, multicentre, randomized, parallel, interventional, non-inferiority, open-label study designed to compare the FDC Regimen of Dapagliflozin/Metformin XR with the Dapagliflozin co-administered
Bioequivalence, Food Effect, and Steady-State Assessment of Dapagliflozin/Metformin Extended-release Fixed-dose Combination Tablets Relative to Single-component Dapagliflozin and Metformin Extended-release Tablets in Healthy Subjects. Simplification of therapeutic regimens for patients with type 2 diabetes mellitus can provide convenience that leads to improved compliance. Dapagliflozin /metformin extended-release (XR) fixed-dose combination (FDC) tablets offer the convenience of once-daily dosing. Two pharmacokinetic (PK) studies were conducted to establish bioequivalence for 2 doses of dapagliflozin/metformin XR FDC versus the same dosage of the individual component (IC) tablets in healthy adults. Two open-label, randomized, 4-period, 4-arm crossover studies were conducted to assess
A Study to Assess the Bioequivalence of Fixed Dose Combination of Dapagliflozin/Metformin XR Relative to Co-administration of the Individual Components in Healthy Chinese Subjects. To assess the bioequivalence between dapagliflozin/metformin XR FDC tablet and co-administration of dapagliflozin and metformin XR tablets. A Single-centre, Parallel-cohort, Randomized, Open-label, Two-period, Cross -over, Bioequivalence Study of the Fixed Dose Combination of Dapagliflozin/Metformin XR Relative to Co-administration of the Individual Components in Two Cohorts of Healthy Chinese Subjects in the Fed State.
Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant This is a Phase II, multicenter, randomized, open-label, active-controlled trial designed to assess the safety and efficacy of the combination of dapagliflozin plus metformin extended release (XR) compared
Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial Combining metformin (XR) with dapagliflozin to initiate pharmacotherapy in patients with type 2 diabetes (T2D) and high baseline HbA1c may be advantageous. We conducted two randomised, double-blind, three-arm 24-week trials in treatment-naïve patients to compare dapagliflozin plus change from baseline; secondary endpoints included change in fasting plasma glucose (FPG) and weight. In both trials, combination therapy led to significantly greater reductions in HbA1c compared with either monotherapy: -2.05 for dapagliflozin + metformin, -1.19 for dapagliflozin, and -1.35 for metformin (p < 0.0001) (Study 1); -1.98 for dapagliflozin + metformin, -1.45 for dapagliflozin and -1.44