Latest & greatest articles for metformin

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Top results for metformin

61. Metformin in non-diabetic hyperglycaemia: the GLINT feasibility RCT

Metformin in non-diabetic hyperglycaemia: the GLINT feasibility RCT Metformin in non-diabetic hyperglycaemia: the GLINT feasibility RCT Journals Library An error occurred retrieving content to display, please try again. >> >> >> Page Not Found Page not found (404) Sorry - the page you requested could not be found. Please choose a page from the navigation or try a website search above to find the information you need. >> >> >> >> Issue {{metadata .Issue }} Toolkit 1)"> 0)"> 1)"> {{metadata.Title (...) }} {{metadata.Headline}} A large trial comparing the effects of prolonged release metformin and placebo on risk of cardiovascular disease events is potentially feasible. {{author}} {{($index , , , , , , , , , , , , , , , , , , , , & . Simon J Griffin 1, 2, * , M Angelyn Bethel 3 , Rury R Holman 3 , Kamlesh Khunti 4 , Nicholas Wareham 1 , Gwen Brierley 1 , Melanie Davies 4 , Andrew Dymond 1 , Rose Eichenberger 1 , Philip Evans 5 , Alastair Gray 6 , Colin Greaves 5 , Kyla Harrington 4 , Graham Hitman 7 , Greg Irving 2

2018 NIHR HTA programme

62. Ertugliflozin l-pyroglutamic acid / metformin hydrochloride (Segluromet) - Diabetes Mellitus, Type 2

Ertugliflozin l-pyroglutamic acid / metformin hydrochloride (Segluromet) - 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. 25 January 2018 EMA/86928/2018 Committee for Medicinal Products for Human Use (...) (CHMP) Assessment report Segluromet International non-proprietary name: ertugliflozin / metformin hydrochloride Procedure No. EMEA/H/C/004314/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Assessment report EMA/86928/2018 Page 2/159 Table of contents 1. Background information on the procedure 7 1.1. Submission of the dossier 7 1.2. Steps taken for the assessment of the product 8 2. Scientific discussion 9 2.1. Problem statement

2018 European Medicines Agency - EPARs

63. Adequacy of clinical trial evidence of metformin fixed-dose combinations for the treatment of type 2 diabetes mellitus in India (Full text)

Adequacy of clinical trial evidence of metformin fixed-dose combinations for the treatment of type 2 diabetes mellitus in India There is growing national and international concern about the drug regulatory system in India. Parliamentary reports have highlighted the presence of high numbers of unapproved medicines and irrational combinations of both approved and unapproved drugs in the Indian market-place. Fixed-dose combinations (FDCs) are a peculiar feature of the Indian pharmaceutical (...) landscape. Although metformin is a first-line treatment, FDCs for diabetes in India account for two-thirds of all diabetes medicine sales, and some have not been approved by the Central Drugs Standard Control Organization (CDSCO). This study examines the basis of efficacy and safety of top-selling metformin FDCs in India against four WHO criteria from clinical trials guidelines for the approval of FDCs. Data from a commercial drug sales database (PharmaTrac) were combined with searches through published

2018 BMJ global health PubMed

64. Efficacy and Safety of IDegLira Versus Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes Uncontrolled on Metformin and Basal Insulin; DUAL VII Randomized Clinical Trial (Full text)

Efficacy and Safety of IDegLira Versus Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes Uncontrolled on Metformin and Basal Insulin; DUAL VII Randomized Clinical Trial In patients with uncontrolled type 2 diabetes on basal insulin, prandial insulin may be initiated. We assessed the efficacy and safety of initiating insulin degludec/liraglutide fixed-ratio combination (IDegLira) versus basal-bolus insulin.A phase 3b trial examined patients with uncontrolled type 2 diabetes on insulin (...) glargine (IGlar U100) 20-50 units/day and metformin, randomized to IDegLira or IGlar U100 and insulin aspart ≤4 times per day.Glycated hemoglobin (HbA1c) decreased from 8.2% (66 mmol/mol) to 6.7% (50 mmol/mol) with IDegLira and from 8.2% (67 mmol/mol) to 6.7% (50 mmol/mol) with basal-bolus (estimated treatment difference [ETD] -0.02% [95% CI -0.16, 0.12]; -0.2 mmol/mol [95% CI -1.7, 1.3]), confirming IDegLira noninferiority versus basal-bolus (P < 0.0001). The number of severe or blood glucose

2018 EvidenceUpdates PubMed

65. Ertugliflozin - Steglatro, Steglujan (ertugliflozin and sitagliptin), Segluromet (ertugliflozin and metformin hydrochloride) - Type 2 diabetes

Ertugliflozin - Steglatro, Steglujan (ertugliflozin and sitagliptin), Segluromet (ertugliflozin and metformin hydrochloride) - Type 2 diabetes Steglatro (ertugliflozin), Steglujan (ertugliflozin and sitagliptin), Segluromet (ertugliflozin and metformin hydrochloride) Tablets U.S. Department of Health and Human Services Search FDA Submit search Steglatro (ertugliflozin), Steglujan (ertugliflozin and sitagliptin), Segluromet (ertugliflozin and metformin hydrochloride) Tablets Steglatro Company

2018 FDA - Drug Approval Package

66. Different effects of metformin and insulin on primary and secondary chemoprevention of colorectal adenoma in diabetes type 2: Traditional and Bayesian meta-analysis. (Full text)

Different effects of metformin and insulin on primary and secondary chemoprevention of colorectal adenoma in diabetes type 2: Traditional and Bayesian meta-analysis. Metformin and insulin differently affect the risk of colon cancer in type 2 diabetic patients, however their effects on colon adenoma is not clear. PubMed, ISI, Scopus and Cochrane databases were searched for studies reporting. The outcomes were total adenoma; advanced adenoma and recurrent adenoma. Traditional and Bayesian meta (...) and Begg's regression asymmetry tests. Moreover, "trim and fill" procedure was used to assess the possible effect of publication bias. For metformin intake, 11 studies (51991 patients) were included. The results showed that metformin significantly decreased the risk of advance adenoma (OR= 0.51, p< 0.001). The risk of total adenoma was not associated with metformin use (OR= 0.86, p=0.274), and metformin did not affect the risk of adenoma recurrence (OR= 0.89, p=0.137). Five studies (2678 patients) were

2018 EXCLI journal PubMed

67. [Saxagliptin/metformin (type 2 diabetes) - benefit assessment according to õ35a Social Code Book V]

[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] 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] Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen 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 Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen. Saxagliptin/metformin (Diabetes mellitus typ 2): nutzenbewertung gemäß § 35a SGB V; dossierbewertung; auftrag A17. [Saxagliptin/metformin

2018 Health Technology Assessment (HTA) Database.

68. Comparative effectiveness of metformin monotherapy in extended release and immediate release formulations for the treatment of type 2 diabetes in treatment-naive Chinese patients: Analysis of results from the CONSENT trial

Comparative effectiveness of metformin monotherapy in extended release and immediate release formulations for the treatment of type 2 diabetes in treatment-naive Chinese patients: Analysis of results from the CONSENT trial Metformin treatment for type 2 diabetes mellitus (T2DM) can be limited by gastrointestinal (GI) adverse events (AEs), resulting in treatment discontinuation. We investigated whether once-daily metformin extended release (XR) is superior in terms of GI tolerability, with non (...) -inferior efficacy, compared with thrice-daily metformin immediate release (IR) in treatment-naïve Chinese patients with T2DM.This prospective, open-label, randomized, multicentre, phase IV interventional study enrolled Chinese T2DM patients to receive either metformin XR or metformin IR with a 2-week screening period, a 16-week treatment period and a 2-week follow-up period without treatment. Co-primary endpoints were a non-inferiority assessment of metformin XR vs metformin IR in glycated haemoglobin

2018 EvidenceUpdates

69. Ertugliflozin plus sitagliptin versus either individual agent over 52 weeks in patients with type 2 diabetes mellitus inadequately controlled with metformin: The VERTIS FACTORIAL randomized trial (Full text)

Ertugliflozin plus sitagliptin versus either individual agent over 52 weeks in patients with type 2 diabetes mellitus inadequately controlled with metformin: The VERTIS FACTORIAL randomized trial To evaluate the efficacy and safety of ertugliflozin and sitagliptin co-administration vs the individual agents in patients with type 2 diabetes who are inadequately controlled with metformin.In this study (Clinicaltrials.gov NCT02099110), patients with glycated haemoglobin (HbA1c) ≥7.5% and ≤11.0 (...) % (≥58 and ≤97 mmol/mol) with metformin ≥1500 mg/d (n = 1233) were randomized to ertugliflozin 5 (E5) or 15 (E15) mg/d, sitagliptin 100 mg/d (S100) or to co-administration of E5/S100 or E15/S100. The primary endpoint was change from baseline in HbA1c at Week 26.At Week 26, least squares mean HbA1c reductions from baseline were greater with E5/S100 (-1.5%) and E15/S100 (-1.5%) than with individual agents (-1.0%, -1.1% and -1.1% for E5, E15 and S100, respectively; P < .001 for all comparisons). HbA1c

2018 EvidenceUpdates PubMed

70. Doppler analysis of ovarian stromal blood flow changes after treatment with metformin versus ethinyl estradiol-cyproterone acetate in women with polycystic ovarian syndrome: A randomized controlled trial. (PubMed)

Doppler analysis of ovarian stromal blood flow changes after treatment with metformin versus ethinyl estradiol-cyproterone acetate in women with polycystic ovarian syndrome: A randomized controlled trial. To evaluate the effects of oral contraceptive pill (OCP) and metformin at the end of 6 months of treatment on ovarian stromal blood flow by using pulsed and color Doppler in women with PCOS.Women with PCOS (n=101) fulfilling the Rotterdam criteria were enrolled and randomized to receive either (...) OCP or metformin. OCP was administered in cycles of 28 days (21 pills containing 35μg of ethinylestradiol plus 2mg of cyproterone acetate followed by 7 placebo pills) for six cycles and metformin 500mg was administered twice daily for 6 months. Clinical, anthropometric, hormonal and metabolic parameters and resistance index (RI) and pulsatility index (PI) of both ovarian stromal vessels were assessed before and after treatment.OCP resulted in a higher reduction in serum luteinizing hormone (LH

2018 Journal of gynecology obstetrics and human reproduction

71. Saxagliptin add-on therapy in Chinese patients with type 2 diabetes inadequately controlled by insulin with or without metformin: Results from the SUPER study, a randomized, double-blind, placebo-controlled trial

Saxagliptin add-on therapy in Chinese patients with type 2 diabetes inadequately controlled by insulin with or without metformin: Results from the SUPER study, a randomized, double-blind, placebo-controlled trial This prospective, multicentre, phase III study (NCT02104804) evaluated the efficacy and safety of saxagliptin add-on therapy in Chinese patients with type 2 diabetes inadequately controlled by insulin ± metformin. Patients with glycated haemoglobin (HbA1c) 7.5% to 10.5% and fasting (...) plasma glucose (FPG) <15 mmol/L (270 mg/dL) on stable insulin therapy (20-150 U/d) were randomized (1:1) to saxagliptin 5 mg once daily (N = 232) or placebo (N = 230) for 24 weeks, stratified by metformin use. The primary efficacy measure was change in HbA1c. Saxagliptin treatment resulted in a greater adjusted mean change in HbA1c from baseline to week 24 than placebo (-0.58%; P < .001), irrespective of metformin use, and a greater mean change in FPG (0.9 mmol/L [-15.9 mg/dL]; P < .001). More

2018 EvidenceUpdates

72. Segluromet - ertugliflozin and metformin hydrochloride - Diabetes mellitus, Type 2

Segluromet - ertugliflozin and metformin hydrochloride - Diabetes mellitus, Type 2 ertugliflozin and metformin | CADTH.ca Find the information you need ertugliflozin and metformin ertugliflozin and metformin Last Updated: January 25, 2019 Result type: Reports Project Number: SR0566-000 Product Line: Generic Name: ertugliflozin and metformin hydrochloride Brand Name: Segluromet Manufacturer: Merck Canada Inc. Indications: Diabetes mellitus, Type 2 Manufacturer Requested Reimbursement Criteria 1 (...) : Added on to metformin for patients who have inadequate glycemic control on metformin and have a contraindication or intolerance to a sulfonylurea, or To replace the individual components of ertugliflozin and metformin for those patients who are on both therapies Submission Type: New Combination Project Status: Complete Biosimilar: No Companion Diagnostics: No Date Recommendation Issued: January 23, 2019 Recommendation Type: Do not reimburse Fee Schedule: Schedule C The requested reimbursement

2018 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

73. Effect of metformin on the anti-Müllerian hormone level in infertile women with polycystic ovarian syndrome (Full text)

Effect of metformin on the anti-Müllerian hormone level in infertile women with polycystic ovarian syndrome Polycystic ovary syndrome (PCOS) is the major cause of anovulatory infertility in women. The level of serum Anti-Mullerian Hormone (AMH) in patients can be 2-3 times higher than in healthy women. The aim of this study was to assess the effect of metformin on AMH level in PCOS patients suffering from infertility.In this pre and post clinical trial, 30 infertile patients with PCOS were (...) enrolled according to the Rotterdam criteria. The serum AMH level was recorded before and after 8 weeks of treatment with metformin (1500 mg daily). We used SPSS version 17 and paired samples t-test, multiple linear regression and ANCOVA test for data analysis.Serum AMH level was significantly decreased after 8 weeks of treatment with metformin [10±3.75 (ng/ml) versus 7.8±3.7 (ng/ml)] (p=0.008, 95% CI: 0.60-3.75). Also, AMH level change was directly associated to BMI in PCOS patients. In other words

2017 Electronic physician PubMed

74. Insulin-sensitising drugs (metformin, rosiglitazone, pioglitazone, D-chiro-inositol) for women with polycystic ovary syndrome, oligo amenorrhoea and subfertility. (Full text)

Insulin-sensitising drugs (metformin, rosiglitazone, pioglitazone, D-chiro-inositol) for women with polycystic ovary syndrome, oligo amenorrhoea and subfertility. Polycystic ovary syndrome (PCOS) is characterised by infrequent or absent ovulation, and high levels of androgens and insulin (hyperinsulinaemia). Hyperinsulinaemia occurs secondary to insulin resistance and is associated with increased risk of cardiovascular disease and diabetes mellitus. Insulin-sensitising agents such as metformin (...) ). We assessed statistical heterogeneity using the I2 statistic and reported quality of the evidence for primary outcomes using GRADE methodology.We assessed the interventions metformin, clomiphene citrate, metformin plus clomiphene citrate, D-chiro-inositol, rosiglitazone and pioglitazone. We compared these with each other, placebo or no treatment. We included 48 studies (4451 women), 42 of which investigated metformin (4024 women). Evidence quality ranged from very low to moderate. Limitations

2017 Cochrane PubMed

75. Health benefits of late-onset metformin treatment every other week in mice (Full text)

Health benefits of late-onset metformin treatment every other week in mice Chronic 1% metformin treatment is nephrotoxic in mice, but this dose may nonetheless confer health benefits if given intermittently rather than continuously. Here, we examined the effects of 1% metformin given every-other week (EOW) or two consecutive weeks per month (2WM) on survival of 2-year-old male mice fed standard chow. EOW and 2WM mice had comparable life span compared with control mice. A significant reduction (...) in body weight within the first few weeks of metformin treatment was observed without impact on food consumption and energy expenditure. Moreover, there were differences in the action of metformin on metabolic markers between the EOW and 2WM groups, with EOW metformin conferring greater benefits. Age-associated kidney lesions became more pronounced with metformin, although without pathological consequences. In the liver, metformin treatment led to an overall reduction in steatosis and was accompanied

2017 NPJ aging and mechanisms of disease PubMed

76. Efficacy and safety of saxagliptin in combination with metformin as initial therapy in Chinese patients with type 2 diabetes: Results from the START study, a multicentre, randomized, double-blind, active-controlled, phase 3 trial

Efficacy and safety of saxagliptin in combination with metformin as initial therapy in Chinese patients with type 2 diabetes: Results from the START study, a multicentre, randomized, double-blind, active-controlled, phase 3 trial To assess the efficacy and safety of saxagliptin plus metformin over 24 weeks in pharmacotherapy-naïve Chinese patients with type 2 diabetes mellitus and inadequate glycaemic control (HbA1c, 8.0%-12.0%).In this multicentre, double-blind, active-controlled study (...) (The START study: NCT02273050, clinicaltrials.gov), patients were randomized (1:1:1) to saxagliptin 5 mg plus metformin, saxagliptin 5 mg plus placebo or metformin plus placebo. Saxagliptin was taken once daily; metformin was taken once/twice daily and was titrated from 500 mg to a maximum of 2000 mg/d over 8 weeks. The primary end point was change in HbA1c from baseline to Week 24.Data from 630 patients (66.5% men; mean age, 50.1 years; mean body mass index, 26.6 kg/m2 ; mean HbA1c, 9.4%; mean diabetes

2017 EvidenceUpdates

77. Efficacy and safety of the addition of ertugliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin and sitagliptin: The VERTIS SITA2 placebo-controlled randomized study (Full text)

Efficacy and safety of the addition of ertugliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin and sitagliptin: The VERTIS SITA2 placebo-controlled randomized study To assess ertugliflozin in patients with type 2 diabetes who are inadequately controlled by metformin and sitagliptin.In this double-blind randomized study (Clinicaltrials.gov NCT02036515), patients (glycated haemoglobin [HbA1c] 7.0% to 10.5% [53-91 mmol/mol] receiving metformin ≥1500 mg/d (...) of genital mycotic infections was observed in male and female patients receiving ertugliflozin (3.7%-14.1%) vs placebo (0%-1.9%) through Week 52. The incidence of urinary tract infections, symptomatic hypoglycaemia and hypovolaemia adverse events were not meaningfully different across groups.Ertugliflozin added to metformin and sitagliptin was well-tolerated, and provided clinically meaningful, durable glycaemic control, BW and SBP reductions vs placebo over 52 weeks.© 2017 The Authors. Diabetes, Obesity

2017 EvidenceUpdates PubMed

78. Peri-operative continuation of metformin does not improve glycaemic control in patients with type 2 diabetes: A randomized controlled trial

Peri-operative continuation of metformin does not improve glycaemic control in patients with type 2 diabetes: A randomized controlled trial Historically, metformin was withheld before surgery for fear of metformin-associated lactic acidosis. Currently, however, this risk is deemed to be low and guidelines have moved towards the continuation of metformin. We hypothesized that continuing metformin peri-operatively would lower postoperative serum glucose level without an effect on plasma lactate (...) levels. We performed a single-blind multicentre randomized controlled trial in people with type 2 diabetes mellitus scheduled for non-cardiac surgery and continued (MF+ group) or withheld (MF- group) metformin before surgery. The main outcome measures were the differences in peri-operative plasma glucose and lactate levels. We randomized 70 patients (37 MF+ group and 33 MF- group) with type 2 diabetes mellitus. Postoperative glucose levels were similar in the MF+ and the MF- groups (8.2 ± 1.8 vs 8.3

2017 EvidenceUpdates

79. Effect of metformin on maternal and neonatal outcomes in pregnant obese non-diabetic women: A meta-analysis. (Full text)

Effect of metformin on maternal and neonatal outcomes in pregnant obese non-diabetic women: A meta-analysis. Metformin reduces maternal and neonatal weight gain in gestational diabetes mellitus; however, this effect is poorly investigated in non-diabetic women.We performed this meta-analysis to investigate the effect of metformin intake during pregnancy on maternal and neonatal outcomes in obese non-diabetic women.We searched Medline, EMBASE, and Cochrane CENTRAL for eligible randomized (...) controlled trials addressing the efficacy of metformin in pregnant obese non-diabetic women. Data were extracted and analyzed using RevMan software (Version 5.3). Neonatal birth weight was the key outcome. Secondary outcomes included maternal weight gain, the incidence of preeclampsia, and neonatal adverse effects (miscarriage, stillbirth and congenital anomalies).Pooled data from two RCTs (n=843) showed that metformin caused a significant reduction in maternal gestational weight gain (MD-1.35, 95% CI

2017 International journal of reproductive biomedicine (Yazd, Iran) PubMed

80. Metformin for endometrial hyperplasia. (Full text)

Metformin for endometrial hyperplasia. Endometrial cancer is one of the most common gynaecological cancers in the world. Rates of endometrial cancer are rising, in part because of rising obesity rates. Endometrial hyperplasia is a precancerous condition in women that can lead to endometrial cancer if left untreated. Endometrial hyperplasia occurs more commonly than endometrial cancer. Progesterone tablets currently used to treat women with endometrial hyperplasia are associated with adverse (...) effects in up to 84% of women. The levonorgestrel intrauterine device (Mirena Coil, Bayer HealthCare Pharmaceuticals, Inc., Whippany, NJ, USA) may improve compliance, but it is invasive, is not acceptable to all women, and is associated with irregular vaginal bleeding in 82% of cases. Therefore, an alternative treatment for women with endometrial hyperplasia is needed. Metformin, a drug that is often used to treat people with diabetes, has been shown in some human studies to reverse endometrial

2017 Cochrane PubMed