Latest & greatest articles for metformin

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Top results for metformin

161. 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.

162. 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 (Abstract)

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

2013 EvidenceUpdates Controlled trial quality: uncertain

163. 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

164. 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 (Abstract)

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

2013 EvidenceUpdates Controlled trial quality: uncertain

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

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

2013 EvidenceUpdates Controlled trial quality: predicted high

166. 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.

167. 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

168. Empagliflozin As Add-on to Metformin Plus Sulfonylurea in Patients With Type 2 Diabetes: A 24-week, randomized, double-blind, placebo-controlled trial Full Text available with Trip Pro

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.

2013 EvidenceUpdates Controlled trial quality: predicted high

169. 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

170. 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

171. [Addendum to Commission A12-16 Saxagliptin/metformin]

[Addendum to Commission A12-16 Saxagliptin/metformin] Addendum zum Auftrag A12-16 (Saxagliptin/Metformin) [Addendum to Commission A12-16 Saxagliptin/metformin] Addendum zum Auftrag A12-16 (Saxagliptin/Metformin) [Addendum to Commission A12-16 Saxagliptin/metformin] IQWiG 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 IQWiG. Addendum zum (...) Auftrag A12-16 (Saxagliptin/Metformin). [Addendum to Commission A12-16 Saxagliptin/metformin] Cologne: Institut fuer Qualitaet und Wirtschaftlichkeit im Gesundheitswesen (IQWiG). IQWiG-Berichte 161. 2013 Final publication URL Additional data URL Indexing Status Subject indexing assigned by CRD MeSH Adamantane; Dipeptides; Dipeptidyl-Peptidase IV Inhibitors; Drug Combinations; Hypoglycemic Agentss; Metformin Language Published German Country of organisation Germany English summary There is no English

2013 Health Technology Assessment (HTA) Database.

172. [Saxagliptine/metformin (drug combination) - Benefit assessment according to § 35a Social Code Book V (dossier assessment)]

[Saxagliptine/metformin (drug combination) - Benefit assessment according to § 35a Social Code Book V (dossier assessment)] Saxagliptin/Metformin – Nutzenbewertung gemäß § 35a SGB V [Saxagliptine/metformin (drug combination) - Benefit assessment according to § 35a Social Code Book V (dossier assessment)] Saxagliptin/Metformin – Nutzenbewertung gemäß § 35a SGB V [Saxagliptine/metformin (drug combination) - Benefit assessment according to § 35a Social Code Book V (dossier assessment)] IQWiG (...) 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 IQWiG. Saxagliptin/Metformin – Nutzenbewertung gemäß § 35a SGB V. [Saxagliptine/metformin (drug combination) - Benefit assessment according to § 35a Social Code Book V (dossier assessment)] Cologne: Institut fuer Qualitaet und Wirtschaftlichkeit im Gesundheitswesen (IQWiG). IQWiG-Berichte 152

2013 Health Technology Assessment (HTA) Database.

173. Efficacy and Safety of Lixisenatide Once-Daily Morning or Evening Injections in Type 2 Diabetes Inadequately Controlled on Metformin (GetGoal-M) Full Text available with Trip Pro

Efficacy and Safety of Lixisenatide Once-Daily Morning or Evening Injections in Type 2 Diabetes Inadequately Controlled on Metformin (GetGoal-M) To examine the efficacy and safety of lixisenatide (20 μg once daily, administered before the morning or evening meal) as add-on therapy in patients with type 2 diabetes insufficiently controlled with metformin alone.This was a 24-week, randomized, double-blind, placebo-controlled study in 680 patients with inadequately controlled type 2 diabetes (...) . Rates of adverse events were 69.4% in both lixisenatide groups and 60.0% in the placebo group. Rates for nausea and vomiting were 22.7 and 9.4% for lixisenatide morning and 21.2 and 13.3% for lixisenatide evening versus 7.6 and 2.9% for placebo, respectively. Symptomatic hypoglycemia occurred in 6, 13, and 1 patient for lixisenatide morning, evening, and placebo, respectively, with no severe episodes.In patients with type 2 diabetes inadequately controlled on metformin, lixisenatide 20 μg once daily

2013 EvidenceUpdates Controlled trial quality: uncertain

174. Improved glycaemic control with vildagliptin added to insulin, with or without metformin, in patients with type 2 diabetes mellitus (Abstract)

Improved glycaemic control with vildagliptin added to insulin, with or without metformin, in patients with type 2 diabetes mellitus The aim of this study is to assess the efficacy and safety of vildagliptin 50 mg bid as add-on therapy to insulin in type 2 diabetes mellitus (T2DM).This is a multicentre, double-blind, placebo-controlled, parallel group, clinical trial in T2DM patients inadequately controlled by stable insulin therapy, with or without metformin. Patients received treatment (...) with vildagliptin 50 mg bid or placebo for 24 weeks.In all, 449 patients were randomized to vildagliptin (n = 228) or placebo (n = 221). After 24 weeks, the difference in adjusted mean change in haemoglobin A1c (HbA1c) between vildagliptin and placebo was -0.7 ± 0.1% (p < 0.001) in the overall study population, -0.6 ± 0.1% (p < 0.001) in the subgroup also receiving metformin and -0.8 ± 0.2% (p < 0.001) in the subgroup without metformin. Vildagliptin therapy was well tolerated and had a similarly low incidence

2013 EvidenceUpdates Controlled trial quality: uncertain

175. Metformin vs. insulin in gestational diabetes. A randomized study characterizing metformin patients needing additional insulin (Abstract)

Metformin vs. insulin in gestational diabetes. A randomized study characterizing metformin patients needing additional insulin We compared metformin with insulin as treatment of gestational diabetes mellitus (GDM). Furthermore, we aimed to characterize metformin-treated patients needing additional insulin to achieve prespecified glucose targets.We conducted a single centre randomized controlled study with non-inferiority design comparing metformin and insulin in the treatment of 217 GDM (...) patients having birth weight as primary outcome variable.There were no significant differences in mean birth weight expressed in grams [+15 (90% confidence interval (CI): -121 to 89)] or SD units [+0.04 (90% CI: -0.27 to 0.18)] between the metformin and insulin groups. There were no significant differences in neonatal or maternal data between the groups. Only 23 (20.9%) of the 110 patients in the metformin group needed additional insulin. Compared with the patients on metformin only, those needing

2013 EvidenceUpdates Controlled trial quality: uncertain

176. Once-Weekly Exenatide Versus Once- or Twice-Daily Insulin Detemir: Randomized, open-label, clinical trial of efficacy and safety in patients with type 2 diabetes treated with metformin alone or in combination with sulfonylureas Full Text available with Trip Pro

Once-Weekly Exenatide Versus Once- or Twice-Daily Insulin Detemir: Randomized, open-label, clinical trial of efficacy and safety in patients with type 2 diabetes treated with metformin alone or in combination with sulfonylureas This multicenter, open-label, parallel-arm study compared the efficacy and safety of exenatide once weekly (EQW) with titrated insulin detemir in patients with type 2 diabetes inadequately controlled with metformin (with or without sulfonylureas).Patients were randomized

2013 EvidenceUpdates Controlled trial quality: uncertain

177. Effect of antidiabetic agents added to metformin on glycaemic control, hypoglycaemia and weight change in patients with type 2 diabetes: a network meta-analysis

Effect of antidiabetic agents added to metformin on glycaemic control, hypoglycaemia and weight change in patients with type 2 diabetes: a network 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.

2013 DARE.

178. Vipdomet - alogliptin / metformin

Vipdomet - alogliptin / 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 25 July 2013 EMA/CHMP/207158/2013 Committee for Medicinal Products for Human Use (CHMP) CHMP assessment report Vipdomet International non-proprietary name: alogliptin / metformin Procedure No. EMEA/H/C/002654/0000 CHMP assessment report EMA/CHMP/207158 (...) /2013 Page 2/136 Table of contents 1. Background information on the procedure 6 1.1. Submission of the dossier 6 1.2. Manufacturers 7 1.3. Steps taken for the assessment of the product 7 2. Scientific discussion 8 2.1. Introduction 8 2.2. Quality aspects 9 2.2.1. Introduction 9 2.2.2. Active Substance 10 Alogliptin Benzoate 10 Metformin Hydrochloride 12 2.2.3. Finished medicinal product 13 Pharmaceutical Development 13 Adventitious agents 14 Manufacture of the product 14 Product Specification 14

2013 European Medicines Agency - EPARs

179. Kazano (alogliptin and metformin hydrochloride)

Kazano (alogliptin and metformin hydrochloride) Drug Approval Package: Brand Name (Generic Name) NDA # Drug Approval Package U.S. Food & Drug Administration Search FDA Drug Approval Package - Kazano (alogliptin and metformin hydrochloride) Tablets Company: Takeda Pharmaceuticals U.S.A., Inc. Application No.: 203414 Approval Date: 1/25/2013 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF

2013 FDA - Drug Approval Package

180. Polycystic ovary syndrome: metformin in women not planning pregnancy

Polycystic ovary syndrome: metformin in women not planning pregnancy P Poly olycystic o cystic ovary syndrome: metformin in women vary syndrome: metformin in women not planning pregnancy not planning pregnancy Evidence summary Published: 21 February 2013 nice.org.uk/guidance/esuom6 pathways K Ke ey points from the e y points from the evidence vidence The content of this evidence summary was up-to-date in February 2013. See summaries of product characteristics (SPCs), British national formulary (...) (BNF) or the MHRA or NICE websites for up-to-date information. Metformin is licensed in the UK for the control of blood glucose in people with type 2 diabetes. It has also been used to treat polycystic ovary syndrome (PCOS). Metformin is not licensed in the UK for this indication so its use in PCOS is off-label. This evidence summary relates to metformin for PCOS in women who are not planning pregnancy. The use of metformin for treating infertility in women with PCOS is not covered by this evidence

2013 National Institute for Health and Clinical Excellence - Advice