Skip to main content
Top
Published in: Diabetology & Metabolic Syndrome 1/2010

Open Access 01-12-2010 | Short report

Assessment of efficacy and tolerability of once-daily extended release metformin in patients with type 2 diabetes mellitus

Authors: Juliana Levy, Roberta A Cobas, Marília B Gomes

Published in: Diabetology & Metabolic Syndrome | Issue 1/2010

Login to get access

Abstract

Aims

To determine prospectively the efficacy, tolerability and patient satisfaction of an extended release formulation of metformin (metformin XR) in hospital based outpatients with type 2 diabetes mellitus currently treated with standard metformin.

Methods

Patients on immediate release standard metformin either alone or combined with other oral agents were switched to extended release metformin XR 500 mg tablets and titrated to a maximum dose of 2000 mg/day Measurements to include glucose and lipid control, blood pressure, body weight, waist circumference, C-reactive protein, adverse events and patient satisfaction were recorded at baseline, three and six months.

Results

Complete data were obtained for 35 of the 61 patients enrolled to the study. At three and six months no changes were reported for any of the cardiovascular risk factors except for lipids where there was a modest rise in plasma triglycerides. These effects were achieved with a reduced dose of metformin XR compared to pre-study dosing with standard metformin (1500 mg +/- 402 vs 1861 +/- 711 p = 0.004). A total of 77% of patients were free of gastrointestinal side effects and 83% of patients stated a preference for metformin XR at the end of the study. Ghost tablets were reported in the faeces by the majority of the patients (54.1%).

Conclusions

Patients switched to extended release metformin XR derived the same clinical and metabolic benefits as for standard metformin but with reduced dosage, fewer gastrointestinal side effects and a greater sense of well being and satisfaction on medication.
Appendix
Available only for authorised users
Literature
1.
go back to reference American Diabetes Association: Standards of medical care in diabetes. Diabetes Care. 2008, 31: S12-54. 10.2337/dc08-S012.CrossRef American Diabetes Association: Standards of medical care in diabetes. Diabetes Care. 2008, 31: S12-54. 10.2337/dc08-S012.CrossRef
2.
go back to reference Task Force on Diabetes and cardiovascular Diseases of the European Society of Cardiology (ESC) and of the European Association for the study of Diabetes (EASD): Guidelines on diabetes, pre-diabetes, and cardiovascular diseases:executive summary. Eur Heart J. 2007, 28: 88-136. 10.1093/eurheartj/ehl260. Task Force on Diabetes and cardiovascular Diseases of the European Society of Cardiology (ESC) and of the European Association for the study of Diabetes (EASD): Guidelines on diabetes, pre-diabetes, and cardiovascular diseases:executive summary. Eur Heart J. 2007, 28: 88-136. 10.1093/eurheartj/ehl260.
3.
go back to reference Wild S, Roglic G, Green A, Sicree S, King H: Global Prevalence of Diabetes - Estimates for the year 2000 and Projections for 2030. Diabetes Care. 2004, 27: 1047-53. 10.2337/diacare.27.5.1047.CrossRefPubMed Wild S, Roglic G, Green A, Sicree S, King H: Global Prevalence of Diabetes - Estimates for the year 2000 and Projections for 2030. Diabetes Care. 2004, 27: 1047-53. 10.2337/diacare.27.5.1047.CrossRefPubMed
4.
go back to reference Gomes MB, Gianella D, Faria M, Tambascia M, Fonseca R, Rea R, Macedo G, Filho JM, Schimid H, Bittencourt AV, Cvalcanti S, Rassi N, Pedrosa H, Dib SA: Prevalence of patients with diabetes type 2 within the targets of care guidelines in daily clinical practice: A multicenter study of type 2 diabetes in Brazil. The Review of Diabetic Studies. 2006, 3: 73-78. Gomes MB, Gianella D, Faria M, Tambascia M, Fonseca R, Rea R, Macedo G, Filho JM, Schimid H, Bittencourt AV, Cvalcanti S, Rassi N, Pedrosa H, Dib SA: Prevalence of patients with diabetes type 2 within the targets of care guidelines in daily clinical practice: A multicenter study of type 2 diabetes in Brazil. The Review of Diabetic Studies. 2006, 3: 73-78.
5.
go back to reference Alberti KGMM, Zimmet P, Shaw J: International Diabetes Federation: a consensus on type 2 diabetes prevention. Diabet Med. 2007, 24: 451-63. 10.1111/j.1464-5491.2007.02157.x.CrossRefPubMed Alberti KGMM, Zimmet P, Shaw J: International Diabetes Federation: a consensus on type 2 diabetes prevention. Diabet Med. 2007, 24: 451-63. 10.1111/j.1464-5491.2007.02157.x.CrossRefPubMed
6.
go back to reference Nathan DM, Davidson MB, DeFronzo RA, Heine RJ, Henry RR, Prateley R, Zinman B: Impaired fasting glucose and impaired glucose tolerance. Implications for care ADA consensus statement. Diabetes Care. 2007, 30: 753-57. 10.2337/dc07-9920.CrossRefPubMed Nathan DM, Davidson MB, DeFronzo RA, Heine RJ, Henry RR, Prateley R, Zinman B: Impaired fasting glucose and impaired glucose tolerance. Implications for care ADA consensus statement. Diabetes Care. 2007, 30: 753-57. 10.2337/dc07-9920.CrossRefPubMed
7.
go back to reference IDF Clinical Guidelines Task Force: Global guideline for type 2 diabetes: recommendations for standard, comprehensive, and minimal care. Diabet Med. 2006, 23: 579-593. 10.1111/j.1464-5491.2006.01918.x.CrossRef IDF Clinical Guidelines Task Force: Global guideline for type 2 diabetes: recommendations for standard, comprehensive, and minimal care. Diabet Med. 2006, 23: 579-593. 10.1111/j.1464-5491.2006.01918.x.CrossRef
8.
go back to reference Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B: Medical management of hyperglycaemia in type 2 diabetes: A consensus algorithm for the initiation and adjustment of therapy. Consensus statement of the American Diabetes Association and the European Association for the study of diabetes. Diabetes Care. 2009, 32: 193-203. 10.2337/dc08-9025.PubMedCentralCrossRefPubMed Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B: Medical management of hyperglycaemia in type 2 diabetes: A consensus algorithm for the initiation and adjustment of therapy. Consensus statement of the American Diabetes Association and the European Association for the study of diabetes. Diabetes Care. 2009, 32: 193-203. 10.2337/dc08-9025.PubMedCentralCrossRefPubMed
9.
go back to reference Gaede P, Lund-Andersen H, Parving HH, Pedersen O: Effect of a multifactorial intervention on mortality in type 2 diabetes. N Engl J Med. 2008, 358: 580-91. 10.1056/NEJMoa0706245.CrossRefPubMed Gaede P, Lund-Andersen H, Parving HH, Pedersen O: Effect of a multifactorial intervention on mortality in type 2 diabetes. N Engl J Med. 2008, 358: 580-91. 10.1056/NEJMoa0706245.CrossRefPubMed
10.
go back to reference Bailey CJ, Campbell IW, Chan JCN, Davidson JA, Howlett HCS, Ritz P: Metformin the gold standard -a scientific handbook. 2007, Published by John Wiley & Sons ltd Chichester, UK Bailey CJ, Campbell IW, Chan JCN, Davidson JA, Howlett HCS, Ritz P: Metformin the gold standard -a scientific handbook. 2007, Published by John Wiley & Sons ltd Chichester, UK
11.
go back to reference UK Prospective Diabetes Study (UKPDS) Group: Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes. Lancet. 1998, 352: 854-865. 10.1016/S0140-6736(98)07037-8.CrossRef UK Prospective Diabetes Study (UKPDS) Group: Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes. Lancet. 1998, 352: 854-865. 10.1016/S0140-6736(98)07037-8.CrossRef
12.
go back to reference Holman RR, Paul SK, Angelyn-Bethel M, Matthews DR, Neil AW: 10 year Follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008, 359: 1577-89. 10.1056/NEJMoa0806470.CrossRefPubMed Holman RR, Paul SK, Angelyn-Bethel M, Matthews DR, Neil AW: 10 year Follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008, 359: 1577-89. 10.1056/NEJMoa0806470.CrossRefPubMed
13.
14.
go back to reference Garber AJ, Duncan TG, Goodman AM et al.: Efficacy of metformin in type II diabetes: results of a double-blind placebo-controlled dose response trial. Am J Med. 1997, 102: 491-7. 10.1016/S0002-9343(97)00254-4.CrossRef Garber AJ, Duncan TG, Goodman AM et al.: Efficacy of metformin in type II diabetes: results of a double-blind placebo-controlled dose response trial. Am J Med. 1997, 102: 491-7. 10.1016/S0002-9343(97)00254-4.CrossRef
15.
go back to reference Wu Jy, Leung WY, Chang S, Lee B, Zee B, Tong Pc, Chan JC: Effectiveness of counselling in reducing mortality in patients receiving polypharmacy: randomized controlled study. BMJ. 2006, 333: 522-5. 10.1136/bmj.38905.447118.2F.PubMedCentralCrossRefPubMed Wu Jy, Leung WY, Chang S, Lee B, Zee B, Tong Pc, Chan JC: Effectiveness of counselling in reducing mortality in patients receiving polypharmacy: randomized controlled study. BMJ. 2006, 333: 522-5. 10.1136/bmj.38905.447118.2F.PubMedCentralCrossRefPubMed
16.
go back to reference Cramer JA: A systematic review of adherence with medications for diabetes. Diabetes Care. 2004, 27: 1218-1224. 10.2337/diacare.27.5.1218.CrossRefPubMed Cramer JA: A systematic review of adherence with medications for diabetes. Diabetes Care. 2004, 27: 1218-1224. 10.2337/diacare.27.5.1218.CrossRefPubMed
17.
go back to reference Donnan PT, MacDonald TM, Morris AD: Adherence to prescribed oral hypoglycaemic medication in a population of patients with Type 2 diabetes: a retrospective cohort study. Diabet Med. 2002, 19: 279-284. 10.1046/j.1464-5491.2002.00689.x.CrossRefPubMed Donnan PT, MacDonald TM, Morris AD: Adherence to prescribed oral hypoglycaemic medication in a population of patients with Type 2 diabetes: a retrospective cohort study. Diabet Med. 2002, 19: 279-284. 10.1046/j.1464-5491.2002.00689.x.CrossRefPubMed
18.
go back to reference Scarpello JHB: Optimal dosing strategies for maximising the clinical response to metformin in type 2 diabetes. Br J Diabetes Vasc Dis. 2001, 1: 28-36. 10.1177/14746514010010010501.CrossRef Scarpello JHB: Optimal dosing strategies for maximising the clinical response to metformin in type 2 diabetes. Br J Diabetes Vasc Dis. 2001, 1: 28-36. 10.1177/14746514010010010501.CrossRef
19.
go back to reference Menzies DG, Campbell IW, McBain A, Brown IRF: Metformin efficacy and tolerance in obese non-insulin dependent diabetics: a comparison of two dosage schedules. Curr Med Res Opin. 1989, 11: 273-78.CrossRefPubMed Menzies DG, Campbell IW, McBain A, Brown IRF: Metformin efficacy and tolerance in obese non-insulin dependent diabetics: a comparison of two dosage schedules. Curr Med Res Opin. 1989, 11: 273-78.CrossRefPubMed
20.
go back to reference Blonde L, Dailey GE, Jabbour SA, Reasner CA, Mills DJ: Gastrointestinal tolerability of extended-release metformin tablets compared to immediate-release metformin tablets: results of a retrospective cohort study. Curr Med Res Opin. 2004, 20: 565-72. 10.1185/030079904125003278.CrossRefPubMed Blonde L, Dailey GE, Jabbour SA, Reasner CA, Mills DJ: Gastrointestinal tolerability of extended-release metformin tablets compared to immediate-release metformin tablets: results of a retrospective cohort study. Curr Med Res Opin. 2004, 20: 565-72. 10.1185/030079904125003278.CrossRefPubMed
21.
go back to reference Feher MD, Al-Mrayat M, Brake J, Leong KS: Tolerability of prolonged-release metformin (Glucophage SR) in individuals intolerant to standard metformin-results from four UK centres. Br J Diabetes Vasc Dis. 2007, 7: 225-8. 10.1177/14746514070070050501.CrossRef Feher MD, Al-Mrayat M, Brake J, Leong KS: Tolerability of prolonged-release metformin (Glucophage SR) in individuals intolerant to standard metformin-results from four UK centres. Br J Diabetes Vasc Dis. 2007, 7: 225-8. 10.1177/14746514070070050501.CrossRef
22.
go back to reference Timmins P, Donahue S, Meeker J, Marathe P: Steady-state pharmacokinetics of a novel extended-release metformin formulation. Clin Pharmacokinet. 2005, 44: 721-729. 10.2165/00003088-200544070-00004.CrossRefPubMed Timmins P, Donahue S, Meeker J, Marathe P: Steady-state pharmacokinetics of a novel extended-release metformin formulation. Clin Pharmacokinet. 2005, 44: 721-729. 10.2165/00003088-200544070-00004.CrossRefPubMed
23.
go back to reference Davidson J, Howlett H: New prolonged-release metformin improves gastrointestinal tolerability. Br J Diabetes Vasc Dis. 2004, 4: 273-7. 10.1177/14746514040040041101.CrossRef Davidson J, Howlett H: New prolonged-release metformin improves gastrointestinal tolerability. Br J Diabetes Vasc Dis. 2004, 4: 273-7. 10.1177/14746514040040041101.CrossRef
24.
go back to reference Donnelly LA, Morris AD, Pearson ER: Adherence in patients transferred from immediate release metformin to a sustained release formulation: a population-based study. Diabetes Obesity and Metabolism. 2009, 11: 338-342. 10.1111/j.1463-1326.2008.00973.x.CrossRef Donnelly LA, Morris AD, Pearson ER: Adherence in patients transferred from immediate release metformin to a sustained release formulation: a population-based study. Diabetes Obesity and Metabolism. 2009, 11: 338-342. 10.1111/j.1463-1326.2008.00973.x.CrossRef
25.
go back to reference UK Prospective Diabetes Study (UKPDS) Group: Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2005, 321: 405-12. 10.1136/bmj.321.7258.405. UK Prospective Diabetes Study (UKPDS) Group: Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2005, 321: 405-12. 10.1136/bmj.321.7258.405.
26.
go back to reference Fujioka K, Pans M, Joyal S: Glycemic control in patients with type 2 diabetes mellitus switched from twice-daily immediate release metformin to a once-daily extended-release formulation. Clin Ther. 2003, 25: 515-29. 10.1016/S0149-2918(03)80093-0.CrossRefPubMed Fujioka K, Pans M, Joyal S: Glycemic control in patients with type 2 diabetes mellitus switched from twice-daily immediate release metformin to a once-daily extended-release formulation. Clin Ther. 2003, 25: 515-29. 10.1016/S0149-2918(03)80093-0.CrossRefPubMed
27.
go back to reference Fujioka K, Brazg RL, Raz I, Bruce S, Joyal S, Swanink R, Pans M: Efficacy, dose-response relationship and safety of once-daily extended-release metformin (Glucophage XR) in type 2 diabetic patients with inadequate glycaemic control despite prior treatment with diet and exercise: results from two-double-blind, placebo-controlled studies. Diabetes Obesity and Metabolism. 2005, 7: 28-39. 10.1111/j.1463-1326.2004.00369.x.CrossRef Fujioka K, Brazg RL, Raz I, Bruce S, Joyal S, Swanink R, Pans M: Efficacy, dose-response relationship and safety of once-daily extended-release metformin (Glucophage XR) in type 2 diabetic patients with inadequate glycaemic control despite prior treatment with diet and exercise: results from two-double-blind, placebo-controlled studies. Diabetes Obesity and Metabolism. 2005, 7: 28-39. 10.1111/j.1463-1326.2004.00369.x.CrossRef
28.
go back to reference Marchetti P, Benzi L, Cerri M, Cecchetti P, Giannarelli R, Giannecchini M, Cianni GD, Cristofani R, Miccoli RC, Bertolotto A, Zapella A, Navalesi R: Effect of plasma metformin concentratrions on serum lipid levels in type II diabetic patients. Acta Diabetol Lat. 1988, 55: 55-62. 10.1007/BF02581246.CrossRef Marchetti P, Benzi L, Cerri M, Cecchetti P, Giannarelli R, Giannecchini M, Cianni GD, Cristofani R, Miccoli RC, Bertolotto A, Zapella A, Navalesi R: Effect of plasma metformin concentratrions on serum lipid levels in type II diabetic patients. Acta Diabetol Lat. 1988, 55: 55-62. 10.1007/BF02581246.CrossRef
29.
go back to reference Caballero AE, Delgado A, Aguilar-Salinas CA: The differential effects of metformin on markers of endothelial activation and inflammation in subjects with impaired glucose tolearance. J Clin Endocrinol Metab. 2004, 89: 3943-48. 10.1210/jc.2004-0019.CrossRefPubMed Caballero AE, Delgado A, Aguilar-Salinas CA: The differential effects of metformin on markers of endothelial activation and inflammation in subjects with impaired glucose tolearance. J Clin Endocrinol Metab. 2004, 89: 3943-48. 10.1210/jc.2004-0019.CrossRefPubMed
30.
go back to reference Haffner S, Temprosa M, Crandall J, Diabetes Prevention Program Research Group: Intensive lifestyle intervention or metformin on inflammation and coagulation in participants with impaired glucose tolerance. Diabetes. 2005, 54: 1566-72. 10.2337/diabetes.54.5.1566.CrossRefPubMed Haffner S, Temprosa M, Crandall J, Diabetes Prevention Program Research Group: Intensive lifestyle intervention or metformin on inflammation and coagulation in participants with impaired glucose tolerance. Diabetes. 2005, 54: 1566-72. 10.2337/diabetes.54.5.1566.CrossRefPubMed
31.
go back to reference Pradhan AD, Everett BM, Cook NR: Effects of initiating insulin and metformin on glycaemic control and inflammatory biomarkers among patients with type 2 diabetes: The Lancet randomised trial. JAMA. 2009, 302: 1186-1194. 10.1001/jama.2009.1347.CrossRefPubMed Pradhan AD, Everett BM, Cook NR: Effects of initiating insulin and metformin on glycaemic control and inflammatory biomarkers among patients with type 2 diabetes: The Lancet randomised trial. JAMA. 2009, 302: 1186-1194. 10.1001/jama.2009.1347.CrossRefPubMed
32.
go back to reference Ting RZW, Szeto CC, Chan MHM, Ma KK, Chow KM: Risk factors of vitamin B12 deficiency in patients receiving metformin. Arch Intern Med. 2006, 166: 1975-1979. 10.1001/archinte.166.18.1975.CrossRefPubMed Ting RZW, Szeto CC, Chan MHM, Ma KK, Chow KM: Risk factors of vitamin B12 deficiency in patients receiving metformin. Arch Intern Med. 2006, 166: 1975-1979. 10.1001/archinte.166.18.1975.CrossRefPubMed
Metadata
Title
Assessment of efficacy and tolerability of once-daily extended release metformin in patients with type 2 diabetes mellitus
Authors
Juliana Levy
Roberta A Cobas
Marília B Gomes
Publication date
01-12-2010
Publisher
BioMed Central
Published in
Diabetology & Metabolic Syndrome / Issue 1/2010
Electronic ISSN: 1758-5996
DOI
https://doi.org/10.1186/1758-5996-2-16

Other articles of this Issue 1/2010

Diabetology & Metabolic Syndrome 1/2010 Go to the issue
Live Webinar | 27-06-2024 | 18:00 (CEST)

Keynote webinar | Spotlight on medication adherence

Live: Thursday 27th June 2024, 18:00-19:30 (CEST)

WHO estimates that half of all patients worldwide are non-adherent to their prescribed medication. The consequences of poor adherence can be catastrophic, on both the individual and population level.

Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.

Prof. Kevin Dolgin
Prof. Florian Limbourg
Prof. Anoop Chauhan
Developed by: Springer Medicine
Obesity Clinical Trial Summary

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine

Highlights from the ACC 2024 Congress

Year in Review: Pediatric cardiology

Watch Dr. Anne Marie Valente present the last year's highlights in pediatric and congenital heart disease in the official ACC.24 Year in Review session.

Year in Review: Pulmonary vascular disease

The last year's highlights in pulmonary vascular disease are presented by Dr. Jane Leopold in this official video from ACC.24.

Year in Review: Valvular heart disease

Watch Prof. William Zoghbi present the last year's highlights in valvular heart disease from the official ACC.24 Year in Review session.

Year in Review: Heart failure and cardiomyopathies

Watch this official video from ACC.24. Dr. Biykem Bozkurt discusses last year's major advances in heart failure and cardiomyopathies.