Latest & greatest articles for metformin

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Top results for metformin

181. Invokamet (canagliflozin and metformin hydrochloride)

Invokamet (canagliflozin and metformin hydrochloride) Drug Approval Package: Brand Name (Generic Name) NDA # Drug Approval Package U.S. Food & Drug Administration Search FDA Drug Approval Package - Invokamet (canagliflozin and metformin hydrochloride) Tablets Company: Janssen Pharmaceuticals, Inc. Application No.: 204353 Approval Date: 8/08/2014 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. (PDF) (PDF) (PDF) (PDF) (PDF) (PDF

2014 FDA - Drug Approval Package

182. Effect of Metformin on Left Ventricular Function After Acute Myocardial Infarction in Patients Without Diabetes: The GIPS-III Randomized Clinical Trial. (PubMed)

Effect of Metformin on Left Ventricular Function After Acute Myocardial Infarction in Patients Without Diabetes: The GIPS-III Randomized Clinical Trial. Metformin treatment is associated with improved outcome after myocardial infarction in patients with diabetes. In animal experimental studies metformin preserves left ventricular function.To evaluate the effect of metformin treatment on preservation of left ventricular function in patients without diabetes presenting with ST-segment elevation (...) myocardial infarction (STEMI).Double-blind, placebo-controlled study conducted among 380 patients who underwent primary percutaneous coronary intervention (PCI) for STEMI at the University Medical Center Groningen, The Netherlands, between January 1, 2011, and May 26, 2013.Metformin hydrochloride (500 mg) (n = 191) or placebo (n = 189) twice daily for 4 months.The primary efficacy measure was left ventricular ejection fraction (LVEF) after 4 months, assessed by magnetic resonance imaging. A secondary

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2014 JAMA

183. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. (PubMed)

Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Dulaglutide and liraglutide, both glucagon-like peptide-1 (GLP-1) receptor agonists, improve glycaemic control and reduce weight in patients with type 2 diabetes. In a head-to-head trial, we compared the safety and efficacy of once-weekly dulaglutide with that of once-daily liraglutide in metformin-treated patients (...) with uncontrolled type 2 diabetes.We did a phase 3, randomised, open-label, parallel-group study at 62 sites in nine countries between June 20, 2012, and Nov 25, 2013. Patients with inadequately controlled type 2 diabetes receiving metformin (≥1500 mg/day), aged 18 years or older, with glycated haemoglobin (HbA1c) 7·0% or greater (≥53 mmol/mol) and 10·0% or lower (≤86 mmol/mol), and body-mass index 45 kg/m(2) or lower were randomly assigned to receive once-weekly dulaglutide (1·5 mg) or once-daily liraglutide

2014 Lancet

184. Canagliflozin/metformin - Benefit assessment according to §35a Social Code Book V (dossier assessment)

Canagliflozin/metformin - Benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Canagliflozin/Metformin – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 November 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. A14-27 (...) Canagliflozin/metformin – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A14-27 Version 1.0 Canagliflozin/metformin – Benefit assessment acc. to §35a SGB V 13 November 2014 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Canagliflozin/metformin – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

185. Metformin for weight loss in schizophrenia: safe but not a panacea

Metformin for weight loss in schizophrenia: safe but not a panacea Metformin for weight loss in schizophrenia: safe but not a panacea | Evidence-Based Mental Health We use cookies to improve our service and to tailor our content and advertising to you. You can manage your cookie settings via your browser at any time. To learn more about how we use cookies, please see our . 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 Metformin for weight loss in schizophrenia: safe but not a panacea Article Text Pharmacological interventions Metformin for weight loss in schizophrenia: safe but not a panacea Cenk Tek 1 , Lydia Chwastiak 2 Statistics from Altmetric.com What is already

2014 Evidence-Based Mental Health

186. Saxagliptin + metformin (Komboglyze ? AstraZeneca) indication: type 2 diabetes mellitus

Saxagliptin + metformin (Komboglyze ? AstraZeneca) indication: type 2 diabetes mellitus Saxagliptin + metformin (Komboglyze — AstraZeneca) indication: type 2 diabetes mellitus Saxagliptin + metformin (Komboglyze — AstraZeneca) indication: type 2 diabetes mellitus CADTH 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 CADTH. Saxagliptin (...) + metformin (Komboglyze — AstraZeneca) indication: type 2 diabetes mellitus. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH). CDEC Final Recommendation; SR0348. 2014 Authors' conclusions The Canadian Drug Expert Committee (CDEC) recommends that saxagliptin/metformin (Komboglyze) be listed for patients if clinical criterion and conditions are met. Final publication URL Indexing Status Subject indexing assigned by CRD MeSH Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors

2014 Health Technology Assessment (HTA) Database.

187. Observational study: Metformin associated with better cardiovascular outcomes than other glycaemic therapies

Observational study: Metformin associated with better cardiovascular outcomes than other glycaemic therapies Metformin associated with better cardiovascular outcomes than other glycaemic therapies | BMJ Evidence-Based Medicine We use cookies to improve our service and to tailor our content and advertising to you. You can manage your cookie settings via your browser at any time. To learn more about how we use cookies, please see our . 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 Metformin associated with better cardiovascular outcomes than other glycaemic therapies Article Text Therapeutics Observational study Metformin associated with better cardiovascular outcomes than other

2014 Evidence-Based Medicine (Requires free registration)

188. Xigduo - dapagliflozin / metformin

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 Park Uxbridge UB8 1DH UNITED KINGDOM Active substance: METFORMIN / DAPAGLIFLOZIN International Nonproprietary Name/Common Name: DAPAGLIFLOZIN / METFORMIN Pharmaco-therapeutic group (ATC Code): Drugs used in diabetes

2014 European Medicines Agency - EPARs

189. Vokanamet - canagliflozin / metformin

Vokanamet - canagliflozin / 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 7418 8613 E-mail info@ema.europa.eu Website www.ema.europa.eu 20 February 2014 EMA/179391/2014 Committee for Medicinal Products for Human Use (CHMP) Assessment report Vokanamet International non-proprietary name: CANAGLIFLOZIN / METFORMIN Procedure No. EMEA/H/C/002656/0000 Note Assessment report as adopted (...) by the CHMP with all information of a commercially confidential nature deleted. Assessment report EMA/179391/2014 Page 2/130 Product information Name of the medicinal product: Vokanamet Applicant: Janssen-Cilag International N.V. Turnhoutseweg 30 B-2340 Beerse BELGIUM Active substance: CANAGLIFLOZIN / METFORMIN HYDROCHLORIDE International Nonproprietary Name/Common Name: CANAGLIFLOZIN / METFORMIN Pharmaco-therapeutic group (ATC Code): A10BD16 Therapeutic indication(s): Canagliflozin/Metformin is indicated

2014 European Medicines Agency - EPARs

190. Dapagliflozin maintains glycaemic control while reducing weight and body fat mass over 2 years in patients with type 2 diabetes mellitus inadequately controlled on metformin (PubMed)

Dapagliflozin maintains glycaemic control while reducing weight and body fat mass over 2 years in patients with type 2 diabetes mellitus inadequately controlled on metformin Dapagliflozin, a highly selective inhibitor of sodium-glucose cotransporter 2 (SGLT2), reduces hyperglycaemia and weight in patients with type 2 diabetes mellitus (T2DM) by increasing urinary glucose excretion. Long-term glycaemic control, body composition and bone safety were evaluated in patients with T2DM after 102 weeks (...) of dapagliflozin treatment.This randomized, double-blind, placebo-controlled study (NCT00855166) enrolled patients with T2DM [mean: age 60.7 years; HbA1c 7.2%; body mass index (BMI) 31.9 kg/m(2) ; body weight 91.5 kg] inadequately controlled on metformin. Patients (N = 182) were randomly assigned 1 : 1 to receive dapagliflozin 10 mg/day or placebo added to open-label metformin for a 24-week double-blind treatment period followed by a 78-week site- and patient-blinded extension period. At week 102, changes from

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2013 EvidenceUpdates

191. Efficacy and safety of empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, as add-on to metformin in type 2 diabetes with mild hyperglycaemia (PubMed)

Efficacy and safety of empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, as add-on to metformin in type 2 diabetes with mild hyperglycaemia To evaluate the effects of the sodium glucose cotransporter 2 (SGLT2) inhibitor empagliflozin added to metformin for 12 weeks in patients with type 2 diabetes.This dose-ranging, double-blind, placebo-controlled trial randomized 495 participants with type 2 diabetes inadequately controlled on metformin [haemoglobin A1c (HbA1c) >7 to ≤10 (...) %] to receive 1, 5, 10, 25, or 50 mg empagliflozin once daily (QD), or placebo, or open-label sitagliptin (100 mg QD), added to metformin for 12 weeks. The primary endpoint was change in HbA1c from baseline to week 12 (empagliflozin groups versus placebo).Reductions in HbA1c of -0.09 to -0.56% were observed with empagliflozin after 12 weeks, versus an increase of 0.15% with placebo (baseline: 7.8-8.1%). Compared with placebo, empagliflozin doses from 5 to 50 mg resulted in reductions in fasting plasma

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2013 EvidenceUpdates

192. Empagliflozin improves glycaemic and weight control as add-on therapy to pioglitazone or pioglitazone plus metformin in patients with type 2 diabetes: a 24-week, randomized, placebo-controlled trial (PubMed)

Empagliflozin improves glycaemic and weight control as add-on therapy to pioglitazone or pioglitazone plus metformin in patients with type 2 diabetes: a 24-week, randomized, placebo-controlled trial This study investigated the efficacy and tolerability of empagliflozin as add-on to pioglitazone ± metformin in patients with type 2 diabetes (T2DM).Patients with HbA1c ≥7 and ≤10% were randomized and treated with once daily empagliflozin 10 mg (n = 165), empagliflozin 25 mg (n = 168) or placebo (n (...)  = 165) as add-on to pioglitazone ± metformin for 24 weeks. Endpoints included changes from baseline in HbA1c (primary endpoint), fasting plasma glucose (FPG) and body weight at week 24.Adjusted mean ± standard error changes in HbA1c were -0.6 ± 0.07% and -0.7 ± 0.07% with empagliflozin 10 mg and 25 mg, respectively, vs. -0.1 ± 0.07% with placebo (both p < 0.001). More patients with HbA1c ≥7% at baseline achieved HbA1c <7% with empagliflozin 10 mg (23.8%) and 25 mg (30.0%) vs. placebo (7.7%) (both p

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2013 EvidenceUpdates

193. Linagliptin-metformin - Diabetes mellitus

Linagliptin-metformin - Diabetes mellitus Common Drug Review CDEC Meeting – September 18, 2013 Notice of CDEC Final Recommendation – October 17, 2013 Page 1 of 3 © 2013 CADTH CDEC FINAL RECOMMENDATION LINAGLIPTIN / METFORMIN HYDROCHLORIDE (Jentadueto – Boehringer Ingelheim Canada Ltd.) Indication: Type 2 Diabetes Mellitus Recommendation: The Canadian Drug Expert Committee (CDEC) recommends that linagliptin/metformin (Jentadueto) be listed for patients if the following clinical criterion is met (...) : Clinical Criterion: ? Patients for whom insulin is not an option and who are already stabilized on therapy with metformin, a sulfonylurea and linagliptin, to replace the individual components of linagliptin and metformin for these patients. Reason for the Recommendation: At the submitted price, Jentadueto ($vvvvvv per day) is less costly than linagliptin and metformin administered separately ($2.67 to $2.79 per day), and less costly than Janumet (sitagliptin/metformin, $3.20 per day). Background

2013 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

194. linagliptin/metformin (Jentadueto®)

linagliptin/metformin (Jentadueto®) linagliptin/metformin (Jentadueto®) linagliptin/metformin (Jentadueto®) 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). linagliptin/metformin (Jentadueto®) Penarth: All Wales Therapeutics and Toxicology Centre (AWTTC), secretariat of the All (...) Wales Medicines Strategy Group (AWMSG). AWMSG Secretariat Assessment Report Advice No.1113. 2013 Authors' conclusions Linagliptin/metformin (Jentadueto®) is recommended as an option for use within NHS Wales for the treatment of adult patients with type 2 diabetes mellitus: as an adjunct to diet and exercise to improve glycaemic control in adult patients inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of linagliptin

2013 Health Technology Assessment (HTA) Database.

195. Does metformin prevent diabetes in at-risk adults?

Does metformin prevent diabetes in at-risk adults? Does metformin prevent diabetes in at-risk adults? Toggle navigation Shared more. Cited more. Safe forever. Toggle navigation View Item JavaScript is disabled for your browser. Some features of this site may not work without it. Search MOspace This Collection Browse Statistics Does metformin prevent diabetes in at-risk adults? View/ Open Date 2013-08 Format Metadata Abstract Metformin therapy reduces the risk of developing diabetes for adults (...) with one or more risk factors for at least 5 years (strength of recommendation [SOR]: A, consistent meta-analyses) and perhaps as long as 10 years (SOR: B, randomized clinical trial [RCT]). Lifestyle modification with diet and exercise is approximately twice as effective as metformin for preventing diabetes, especially in older patients (SOR: B, RCTs). URI Citation Journal of Family Practice, 62(8) 2013: 436-437. Collections hosted by hosted by

2013 Clinical Inquiries

196. Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU): 52 week results from a randomised, double-blind, phase 3 non-inferiority trial. (PubMed)

Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU): 52 week results from a randomised, double-blind, phase 3 non-inferiority trial. Sodium-glucose cotransporter 2 (SGLT2) inhibitors improve glycaemia in patients with type 2 diabetes by enhancing urinary glucose excretion. We compared the efficacy and safety of canagliflozin, an SGLT2 inhibitor, with glimepiride in patients with type 2 diabetes inadequately (...) controlled with metformin.We undertook this 52 week, randomised, double-blind, active-controlled, phase 3 non-inferiority trial at 157 centres in 19 countries between Aug 28, 2009, and Dec 21, 2011. Patients aged 18-80 years with type 2 diabetes and glycated haemoglobin A1c (HbA1c) of 7·0-9·5% on stable metformin were randomly assigned (1:1:1) by computer-generated random sequence via an interactive voice or web response system to receive canagliflozin 100 mg or 300 mg, or glimepiride (up-titrated to 6

2013 Lancet

197. Empagliflozin As Add-on to Metformin Plus Sulfonylurea in Patients With Type 2 Diabetes: A 24-week, randomized, double-blind, placebo-controlled trial (PubMed)

Empagliflozin As Add-on to Metformin Plus Sulfonylurea in Patients With Type 2 Diabetes: A 24-week, randomized, double-blind, placebo-controlled trial To investigate the efficacy and tolerability of empagliflozin as add-on to metformin and sulfonylurea in patients with type 2 diabetes.Patients inadequately controlled on metformin and sulfonylurea (HbA1c ≥7 to ≤10%) were randomized and treated with once-daily empagliflozin 10 mg (n = 225), empagliflozin 25 mg (n = 216), or placebo (n = 225 (...) : 0.9, 4.5, and 3.9%, respectively; males: 0.9% in each group).Empagliflozin 10 and 25 mg for 24 weeks as add-on to metformin plus sulfonylurea improved glycemic control, weight, and systolic blood pressure and were well tolerated.

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2013 EvidenceUpdates

198. Efficacy and safety of dipeptidyl peptidase-4 inhibitors and metformin as initial combination therapy and as monotherapy in patients with type 2 diabetes mellitus: a meta-analysis (PubMed)

Efficacy and safety of dipeptidyl peptidase-4 inhibitors and metformin as initial combination therapy and as monotherapy in patients with type 2 diabetes mellitus: a meta-analysis This meta-analysis was performed to provide an update on the efficacy and safety of dipeptidyl peptidase-4 (DPP-4) inhibitors and metformin as initial combination therapy and as monotherapy in patients with type 2 diabetes mellitus (T2DM).We conducted a search on MEDLINE, Embase and Cochrane Collaborative database (...) for randomized controlled trials (RCTs) of DPP-4 inhibitors and metformin as initial combination therapy or as monotherapy in patients with T2DM by the end of December 2012, using the key words 'alogliptin', 'dutogliptin', 'linagliptin', 'saxagliptin', 'sitagliptin', 'vildagliptin' and 'metformin'. RCTs were selected for meta-analysis if (1) they were RCTs comparing DPP-4 inhibitors plus metformin as initial combination therapy or DPP-4 inhibitor monotherapy to metformin monotherapy, (2) duration

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2013 EvidenceUpdates

199. Metformin use in adolescents

Metformin use in adolescents Metformin use in adolescents Toggle navigation Shared more. Cited more. Safe forever. Toggle navigation View Item JavaScript is disabled for your browser. Some features of this site may not work without it. Search MOspace This Collection Browse Statistics Metformin use in adolescents View/ Open Date 2013-04 Format Metadata Abstract There are no studies evaluating whether metformin prevents or delays the onset of diabetes in adolescents who are obese. In adults (...) , metformin is as effective as lifestyle interventions in preventing increases in A1C and fasting glucose levels, but it is less effective in preventing or delaying the onset of overt type 2 diabetes. Metformin use reduces body mass index (BMI) for up to six months in adolescents who are obese (Strength of Recommendation [SOR]: C, based on disease-oriented randomized controlled trials [RCTs]) and reduces insulin resistance, the prevalence and severity of steatosis, and nonalcoholic fatty liver disease

2013 Clinical Inquiries

200. Linagliptin/metformin (Jentadueto) - type 2 diabetes mellitus

Linagliptin/metformin (Jentadueto) - type 2 diabetes mellitus All Wales Medicines Strategy Group (AWMSG) - linagliptin/metformin (Jentadueto) | | Appraisal information Search and reports linagliptin/metformin (Jentadueto®) Reference No. 1681 Publication date: 31/07/2013 Last review date: 30/08/2016 Appraisal information linagliptin/metformin (Jentadueto®) 2.5 mg/1000 mg film-coated tablet linagliptin/metformin (Jentadueto®) 2.5 mg/850 mg film-coated tablet Company: Boehringer Ingelheim Ltd BNF (...) category: Endocrine system NMG meeting date: 10/04/2013 AWMSG meeting date: 08/05/2013 Submission Type: Limited Submission Status: Recommended Advice No: 1113 Ratification by Welsh Government: 29/07/2013 Current Progress Submission received NMG meeting AWMSG meeting Ratification by Welsh Government AWMSG advice Linagliptin/metformin (Jentadueto®) is recommended as an option for use within NHS Wales for the treatment of adult patients with type 2 diabetes mellitus: • as an adjunct to diet and exercise

2013 All Wales Medicines Strategy Group