Latest & greatest articles for pioglitazone

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Top results for pioglitazone

21. Vildagliptin and pioglitazone in patients with impaired glucose tolerance after kidney transplantation: a randomized, placebo-controlled clinical trial

Vildagliptin and pioglitazone in patients with impaired glucose tolerance after kidney transplantation: a randomized, placebo-controlled clinical trial 23380864 2013 02 05 2013 06 20 2013 11 21 1534-6080 95 3 2013 Feb 15 Transplantation Transplantation Vildagliptin and pioglitazone in patients with impaired glucose tolerance after kidney transplantation: a randomized, placebo-controlled clinical trial. 456-62 10.1097/TP.0b013e318276a20e New-onset diabetes after transplantation (NODAT) is (...) pioglitazone, or placebo for 3 months in addition to lifestyle counseling. Outcome measures were difference in change in oral glucose tolerance test between the groups and between baseline and end of study as well as change in HbA1c, serum lipids, and renal and hepatic function. In both treatment groups, 2-hr plasma glucose at 3 months was significantly reduced compared with baseline (vildagliptin: -20±24 mg/dL; P=0.002 and pioglitazone: -23±29 mg/dL; P=0.004), and pioglitazone also significantly improved

EvidenceUpdates2013

22. Incresync - alogliptin / pioglitazone

Incresync - alogliptin / pioglitazone 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/208477/2013 Committee for Medicinal Products for Human Use (CHMP) CHMP assessment report Incresync International non-proprietary name: alogliptin / pioglitazone Procedure No. EMEA/H/C/002178/0000 CHMP assessment report EMA/CHMP (...) /208477/2013 Page 2/136 Table of contents 1. Background information on the procedure 7 1.1. Submission of the dossier 7 1.2. Manufacturers 8 1.3. Steps taken for the assessment of the product 8 2. Scientific discussion 9 2.1. Introduction 9 2.2. Quality aspects 10 2.2.1. Introduction 10 2.2.2. Active Substance Pioglitazone 11 2.2.3. Active Substance Alogliptin 12 2.2.4. Finished Medicinal Product 15 2.2.5. Discussion on chemical, pharmaceutical and biological aspects 18 2.2.6. Conclusions

European Medicines Agency - EPARs2013

23. Oseni (alogliptin and pioglitazone)

Oseni (alogliptin and pioglitazone) Drug Approval Package: Brand Name (Generic Name) NDA # Drug Approval Package U.S. Food & Drug Administration Enter Search terms Drug Approval Package - Oseni (alogliptin and pioglitazone) Tablets Company: Takeda Pharmaceuticals Application No.: 022426 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) (PDF) (PDF) (PDF) (PDF) (PDF

FDA - Drug Approval Package2013

24. Effects of Dapagliflozin, a Sodium-Glucose Cotransporter-2 Inhibitor, on Hemoglobin A1c, Body Weight, and Hypoglycemia Risk in Patients With Type 2 Diabetes Inadequately Controlled on Pioglitazone Monotherapy

Effects of Dapagliflozin, a Sodium-Glucose Cotransporter-2 Inhibitor, on Hemoglobin A1c, Body Weight, and Hypoglycemia Risk in Patients With Type 2 Diabetes Inadequately Controlled on Pioglitazone Monotherapy 22446170 2012 06 22 2012 10 23 2016 12 15 1935-5548 35 7 2012 Jul Diabetes care Diabetes Care Effects of dapagliflozin, an SGLT2 inhibitor, on HbA(1c), body weight, and hypoglycemia risk in patients with type 2 diabetes inadequately controlled on pioglitazone monotherapy. 1473-8 10.2337 (...) /dc11-1693 To examine the safety and efficacy of dapagliflozin, a sodium-glucose cotransporter-2 inhibitor, added on to pioglitazone in type 2 diabetes inadequately controlled on pioglitazone. Treatment-naive patients or those receiving metformin, sulfonylurea, or thiazolidinedione entered a 10-week pioglitazone dose-optimization period with only pioglitazone. They were then randomized, along with patients previously receiving pioglitazone ≥30 mg, to 48 weeks of double-blind dapagliflozin 5 (n = 141

EvidenceUpdates2012 Full Text: Link to full Text with Trip Pro

25. Exenatide twice-daily in combination with insulin (Byetta) - as adjunctive therapy to basal insulin with or without metformin and/or pioglitazone in adults with type 2 diabetes

Exenatide twice-daily in combination with insulin (Byetta) - as adjunctive therapy to basal insulin with or without metformin and/or pioglitazone in adults with type 2 diabetes

Scottish Medicines Consortium2012

26. Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4): a 26-week double-blind study

Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4): a 26-week double-blind study 22210563 2012 01 25 2012 06 12 2016 12 15 1935-5548 35 2 2012 Feb Diabetes care Diabetes Care Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4): a 26-week double-blind study. 252 (...) -8 10.2337/dc11-1107 To test the safety and efficacy of exenatide once weekly (EQW) compared with metformin (MET), pioglitazone (PIO), and sitagliptin (SITA) over 26 weeks, in suboptimally treated (diet and exercise) drug-naive patients with type 2 diabetes. Patients were randomized to subcutaneous (SC) EQW 2.0 mg + oral placebo (n = 248), MET 2,000 mg/day + SC placebo (n = 246), PIO 45 mg/day + SC placebo (n = 163), or SITA 100 mg/day + SC placebo (n = 163) for 26 weeks. MET and PIO therapies

EvidenceUpdates2012 Full Text: Link to full Text with Trip Pro

27. Alogliptin as a third oral antidiabetic drug in patients with type 2 diabetes and inadequate glycaemic control on metformin and pioglitazone: a 52-week, randomized, double-blind, active-controlled, parallel-group study

Alogliptin as a third oral antidiabetic drug in patients with type 2 diabetes and inadequate glycaemic control on metformin and pioglitazone: a 52-week, randomized, double-blind, active-controlled, parallel-group study 21733058 2011 10 28 2012 01 16 2013 11 21 1463-1326 13 12 2011 Dec Diabetes, obesity & metabolism Diabetes Obes Metab Alogliptin as a third oral antidiabetic drug in patients with type 2 diabetes and inadequate glycaemic control on metformin and pioglitazone: a 52-week (...) , randomized, double-blind, active-controlled, parallel-group study. 1088-96 10.1111/j.1463-1326.2011.01463.x To assess the efficacy and safety of adding alogliptin versus uptitrating pioglitazone in patients with type 2 diabetes and inadequate glycaemic control on metformin and pioglitazone. In this randomized, double-blind, active-controlled, parallel-group study, patients with type 2 diabetes and A1c ≥7.0 and ≤10.0% on metformin (≥1500 mg or maximum tolerated dose; Met) and pioglitazone 30 mg (Pio30

EvidenceUpdates2012

28. Effects on lipid profile of dipeptidyl peptidase 4 inhibitors, pioglitazone, acarbose, and sulfonylureas: meta-analysis of placebo-controlled trials

Effects on lipid profile of dipeptidyl peptidase 4 inhibitors, pioglitazone, acarbose, and sulfonylureas: meta-analysis of placebo-controlled trials Effects on lipid profile of dipeptidyl peptidase 4 inhibitors, pioglitazone, acarbose, and sulfonylureas: meta-analysis of placebo-controlled trials Effects on lipid profile of dipeptidyl peptidase 4 inhibitors, pioglitazone, acarbose, and sulfonylureas: meta-analysis of placebo-controlled trials Monami M, Vitale V, Ambrosio ML, Bartoli N (...) ) inhibitors, pioglitazone, agents that stimulate insulin secretion (secretagogues), and acarbose on blood lipids, compared with placebo. Searching MEDLINE and The Cochrane Library were searched, for publications in English, up to November 2011. Search terms were reported. Study selection Placebo randomised controlled trials (RCTs) reporting total endpoint cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides, for at least 200 patients

DARE.2012

29. Alogliptin and alogliptin/pioglitazone

Alogliptin and alogliptin/pioglitazone CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022426Orig1s000 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type NDA Complete Response Application Number(s) 22-271 and 22-426 Priority or Standard Standard Submit Date(s) 7-26-12 Received Date(s) 7-26-12 PDUFA Goal Date 1-26-13 Division / Office DMEP/ODEII/OND Reviewer Name(s) Valerie S.W. Pratt, M.D. Review Completion Date 01-17-13 Established Name Alogliptin and alogliptin/pioglitazone FDC (...) ) and (alogliptin/pioglitazone FDC) 3 Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT 12 1.1 Recommendation on Regulatory Action 12 1.2 Risk Benefit Assessment 12 1.3 Recommendations for Postmarket Risk Evaluation and Mitigation Strategies . 15 1.4 Recommendations for Postmarket Requirements and Commitments 15 2 INTRODUCTION AND REGULATORY BACKGROUND 16 2.1 Product Information 16 2.2 Tables of Currently Available Treatments for Proposed Indications 17 2.3 Availability of Proposed Active Ingredient

FDA - Drug Approval Package2012

30. Sepioglin - pioglitazone

Sepioglin - pioglitazone 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8545 E-mail info@ema.europa.eu Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged. London, 19 January 2012 EMA/207581/2012 Committee for Medicinal Products for Human Use (CHMP) Assessment report Sepioglin International nonproprietary name (...) : pioglitazone Procedure No. EMEA/H/C/002021 Assessment Report as adopted by the CHMP with all information of a commercially confidential nature deleted Medicinal product no longer authorisedSepioglin Assessment report EMA/207581/2012 Page 2/23 Table of contents 1 3 Background information on the procedure 1.1 3 Submission of the dossier 1.2 Steps taken for the assessment of the product 4 2 5 Scientific discussion 2.1 5 Introduction 2.2 6 Quality aspects 2.3 10 Non- Clinical aspects 2.4 10 Clinical Aspects

European Medicines Agency - EPARs2012

31. Pioglitazone Actavis

Pioglitazone Actavis 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8545 E-mail info@ema.europa.eu Website www.ema.europa.eu An agency of the European Union European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged. London, 19 January 2012 EMA/210151/2012 Committee for Medicinal Products for Human Use (CHMP) Assessment report Pioglitazone Actavis International nonproprietary name (...) : pioglitazone Procedure No. EMEA/H/C/002324 Assessment Report as adopted by the CHMP with all information of a commercially confidential nature deleted Pioglitazone Actavis Assessment report EMA/210151/2012 Page 2/27 Product information Marketing authorisation application Name of the medicinal product: Pioglitazone Actavis Applicant: Actavis Group PTC ehf Reykjavíkurvegur 76 - 78 IS-220 Hafnarfjörður Iceland Active substance(s): pioglitazone hydrochloride International Nonproprietary Name/Common name

European Medicines Agency - EPARs2012

32. Pioglitazone Krka

Pioglitazone Krka 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail info@ema.europa.eu Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged. London, 19 January 2012 EMA/CHMP/423161/2011 Assessment report Pioglitazone Krka International non proprietary name: pioglitazone Procedure No. EMEA/H/C/2453 Assessment (...) Report as adopted by the CHMP with all information of a commercially confidential nature deleted Pioglitazone Krka Assessment report EMA/183910/2012 Page 2/26 Table of contents 1 3 Background information on the procedure 1.1 3 Submission of the dossier 1.2 4 Steps taken for the assessment of the product 2 5 Scientific discussion 2.1 5 Introduction 2.2 8 Quality aspects 2.3 14 Non- Clinical aspects 2.4 14 Clinical Aspects 2.5 21 Pharmacovigilance 3 22 Benefit-Risk Balance 4 23 Recommendation Appendix

European Medicines Agency - EPARs2012

33. Pioglitazone Accord

Pioglitazone Accord 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8545 E-mail info@ema.europa.eu Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged. 19 January 2012 EMA/CHMP/46573/2012 Assessment report Pioglitazone Accord International non proprietary name: Pioglitazone Procedure No. EMEA/H/C/2277 Assessment Report (...) as adopted by the CHMP with all information of a commercially confidential nature deleted Pioglitazone Accord Assessment report EMA/183905/2012 Page 2/19 Table of contents 1 3 Background information on the procedure 1.1 3 Submission of the dossier 1.2 4 Steps taken for the assessment of the product 2 5 Scientific discussion 2.1 5 Introduction 2.2 6 Quality aspects 2.3 8 Non- Clinical aspects 2.4 9 Clinical Aspects 2.5 13 Pharmacovigilance 3 14 Benefit-Risk Balance 4 16 Recommendation Appendix I 18

European Medicines Agency - EPARs2012

34. Paglitaz - pioglitazone

Paglitaz - pioglitazone 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail info@ema.europa.eu Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged. London, 19 January 2012 EMA/183894/2012 Assessment report Paglitaz International non proprietary name: pioglitazone Procedure No. EMEA/H/C/002309 Assessment Report (...) was agreed upon by the EMA/CHMP on 23 March 2010. The application concerns a generic medicinal product as defined in Article 10(2)(b) of Directive 2001/83/EC and refers to a reference product for which a Marketing Authorisation is or has been granted in the Community on the basis of a complete dossier in accordance with Article 8(3) of Directive 2001/83/EC, as amended. The applicant applied for the following indication: Pioglitazone is indicated as second or third line treatment of type 2 diabetes

European Medicines Agency - EPARs2012

35. Pioglitazone Teva Pharma

Pioglitazone Teva Pharma 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8545 E-mail info@ema.europa.eu Website www.ema.europa.eu An agency of the European Union London, 19 January 2012 EMA/CHMP/844210/2011 Committee for Medicinal Products for Human Use (CHMP) Assessment report Pioglitazone Teva Pharma International nonproprietary name: pioglitazone Procedure No. EMEA/H/C/002410 Assessment Report as adopted by the CHMP (...) with all information of a commercially confidential nature deleted. Pioglitazone Teva Pharma Assessment report EMA/CHMP/844210/2011 Page 2/22 Table of contents 1 3 Background information on the procedure 1.1 3 Submission of the dossier 1.2 4 Steps taken for the assessment of the product 2 6 Scientific discussion 2.1 6 Introduction 2.2 7 Quality aspects 2.2.1 7 Introduction 2.2.2 7 Active Substance 2.2.3 9 Finished Medicinal Product 2.2.4 10 Discussion on chemical, and pharmaceutical aspects 2.2.5 11

European Medicines Agency - EPARs2012

36. Glidipion (previously Pioglitazone Actavis Group)

Glidipion (previously Pioglitazone Actavis Group) 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8545 E-mail info@ema.europa.eu Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged. London 19 January 2012 EMA/207946/2012 Committee for Medicinal Products for Human Use (CHMP) Assessment report Pioglitazone Actavis Group (...) International nonproprietary name: Pioglitazone Procedure No. EMEA/H/C/2558 Assessment Report as adopted by the CHMP with all information of a commercially confidential nature deleted Pioglitazone Actavis Group Assessment report EMA/207946/2012 Page 2/23 Table of contents 1. Background information on the procedure 1. 3 Background information on the procedure 1.1 3 Submission of the dossier 1.2 4 Steps taken for the assessment of the product 2 5 Scientific discussion 2.1 5 Introduction 2.2 6 Quality aspects

European Medicines Agency - EPARs2012

37. Pioglitazone Teva

Pioglitazone Teva 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8545 E-mail info@ema.europa.eu Website www.ema.europa.eu An agency of the European Union London, 19 January 2012 EMEA/CHMP/844031/2011 Committee for Medicinal Products for Human Use (CHMP) Assessment report Pioglitazone Teva International nonproprietary name: pioglitazone Procedure No. EMEA/H/C/002297 Assessment Report as adopted by the CHMP with all (...) information of a commercially confidential nature deleted. Pioglitazone Teva Assessment report EMEA/CHMP/844031/2011 Page 2/22 Table of contents 1 3 Background information on the procedure 1.1 3 Submission of the dossier 1.2 5 Steps taken for the assessment of the product 2 6 Scientific discussion 2.1 6 Introduction 2.2 8 Quality aspects 2.2.1 8 Introduction 2.2.2 8 Active Substance 2.2.3 9 Finished Medicinal Product 2.2.4 11 Discussion on chemical, and pharmaceutical aspects 2.2.5 11 Conclusions

European Medicines Agency - EPARs2012

38. The effect of pioglitazone and resistance training on body composition in older men and women undergoing hypocaloric weight loss

The effect of pioglitazone and resistance training on body composition in older men and women undergoing hypocaloric weight loss 21233810 2011 07 26 2012 01 17 2017 02 20 1930-739X 19 8 2011 Aug Obesity (Silver Spring, Md.) Obesity (Silver Spring) The effect of pioglitazone and resistance training on body composition in older men and women undergoing hypocaloric weight loss. 1636-46 10.1038/oby.2010.327 Age-related increases in ectopic fat accumulation are associated with greater risk (...) for metabolic and cardiovascular diseases, and physical disability. Reducing skeletal muscle fat and preserving lean tissue are associated with improved physical function in older adults. PPARγ-agonist treatment decreases abdominal visceral adipose tissue (VAT) and resistance training preserves lean tissue, but their effect on ectopic fat depots in nondiabetic overweight adults is unclear. We examined the influence of pioglitazone and resistance training on body composition in older (65-79 years

EvidenceUpdates2011 Full Text: Link to full Text with Trip Pro

39. Efficacy and safety of sitagliptin and the fixed-dose combination of sitagliptin and metformin vs. pioglitazone in drug-naive patients with type 2 diabetes

Efficacy and safety of sitagliptin and the fixed-dose combination of sitagliptin and metformin vs. pioglitazone in drug-naive patients with type 2 diabetes 21849007 2011 08 18 2012 05 07 2015 11 19 1742-1241 65 9 2011 Sep International journal of clinical practice Int. J. Clin. Pract. Efficacy and safety of sitagliptin and the fixed-dose combination of sitagliptin and metformin vs. pioglitazone in drug-naïve patients with type 2 diabetes. 930-8 10.1111/j.1742-1241.2011.02749.x The efficacy (...) and safety of sitagliptin (SITA) monotherapy and SITA/metformin (MET) vs. pioglitazone (PIO) were assessed in patients with type 2 diabetes and moderate-to-severe hyperglycaemia (A1C = 7.5-12.0%). In an initial 12-week phase (Phase A), 492 patients were randomised 1 : 1 in a double-blind fashion to SITA (100 mg qd) or PIO (15 mg qd, up-titrated to 30 mg after 6 weeks). In Phase B (28 additional weeks), the SITA group was switched to SITA/MET (up-titrated to 50/1000 mg bid over 4 weeks) and the PIO group

EvidenceUpdates2011