Clinical development of metformin extended-release tablets for type 2 diabetes: An overview

Expert Opinion on Drug Metabolism and Toxicology

Volumn 4, Issue 9, 2008, Pages 1235-1243

  Schwartz, Sherwin L ^a   Gordi, Toufigh ^b   Hou, Eddie ^b   Cramer, Marilou ^b   Heritier, Michelle ^b   Cowles, Verne E ^b  

^a Diabetes and Glandular Disease Clinic   (United States)

^b Pharmacokinetics Depomed Inc   (United States)

Author keywords

Drug interaction; Efficacy; Gastric retention; Pharmacokinetics; Tolerability

Indexed keywords

GLIBENCLAMIDE; GLUCOSE; HEMOGLOBIN A1C; METFORMIN; SULFONYLUREA;

ABDOMINAL DISTENSION; AREA UNDER THE CURVE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; DIARRHEA; DIET RESTRICTION; DOSAGE SCHEDULE COMPARISON; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CONTRAINDICATION; DRUG DELIVERY SYSTEM; DRUG DOSAGE FORM COMPARISON; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG ELIMINATION; DRUG FORMULATION; DRUG HALF LIFE; DRUG MEGADOSE; DRUG RELEASE; DRUG SAFETY; DRUG TOLERABILITY; EVENING DOSAGE; FOOD DRUG INTERACTION; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HUMAN; HYPOGLYCEMIA; KIDNEY DISEASE; KIDNEY FUNCTION; LOW DRUG DOSE; MAXIMUM PLASMA CONCENTRATION; MONOTHERAPY; MORNING DOSAGE; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; RECOMMENDED DRUG DOSE; REVIEW; SCINTIGRAPHY; SINGLE DRUG DOSE; SUSTAINED RELEASE PREPARATION; TABLET; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT DURATION;

BIOLOGICAL AVAILABILITY; CLINICAL TRIALS AS TOPIC; DELAYED-ACTION PREPARATIONS; DIABETES MELLITUS, TYPE 2; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG INTERACTIONS; FOOD-DRUG INTERACTIONS; HUMANS; HYPOGLYCEMIC AGENTS; METFORMIN; RENAL INSUFFICIENCY;

SUS;

EID: 52649147609     PISSN: 17425255     EISSN: None     Source Type: Journal    
DOI: 10.1517/17425255.4.9.1235     Document Type: Review

References (18)

1. National Diabetes Fact Sheet. United States, 2005. Available from: http://www.ndep.nih.gov/diabetes/pubs/ 2005_National_Diabetes_Fact_Sheet.pdf
2. Bolen S, Feldman L, Vassy J, et al. Systematic review: comparative effectiveness and safety of oral medications for type 2 diabetes mellitus. Ann Intern Med 2007;147:386-99
3. Nathan DM, Buse JB, Davidson MB, et al. Management of hyperglycaemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy. A consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia 2006;49:1711-21
4. Kirpichnikov D, McFarlane SI, Sowers JR. Metformin: an update. Ann Intern Med 2002;137:25-33
5. Howlett HC, Bailey CJ. A risk-benefit assessment of metformin in type 2 diabetes mellitus. Drug Saf 1999;20:489-503
6. Bristol-Myers Squibb Company J2. Glucophage Prescribing information. 2006. Available from: http://packageinserts.bms.com/pi/pi_glucophage.pdf
7. Dunn CJ, Peters DH. Metformin. A review of its pharmacological properties and therapeutic use in non-insulin-dependent diabetes mellitus. Drugs 1995;49:721-49
8. 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;103:491-7
9. Noel M. Kinetic study of normal and sustained dosage of metformin in normal subjects. J Inter Biomed Info Data 1980;1:9-20
10. Karttunen P, Uusitupa M, Lamminsivu U. The pharmacokinetics of metformin: a comparison of the properties of a rapid-release and a sustained-release preparation. Int J Clin Pharmacol Ther Toxicol 1983;21:31-6
11. Pentikainen PJ. Bioavailability of metformin. Comparison of solution, rapidly dissolving tablet, and three sustained release products. Int J Clin Pharmacol Ther Toxicol 1986;24:213-20
12. Tucker GT, Casey C, Phillips PJ, et al. Metformin kinetics in healthy subjects and in patients with diabetes mellitus. Br J Clin Pharmacol 1981;12:235-46
13. Berner B, Cowles VE. Case studies in swelling polymeric gastric retentive tablets. Expert Opin Drug Deliv 2006;3:541-8
14. Hou SY, Cowles VE, Berner B. Gastric retentive dosage forms: a review. Crit Rev Ther Drug Carrier Syst 2003;20:459-97
15. Schwartz S, Fonseca V, Berner B, et al. Efficacy, tolerability, and safety of a novel once-daily extended-release metformin in patients with type 2 diabetes. Diabetes Care 2006;29:759-64
16. Glumetza prescribing information. 2006. Available from: http://www.glumetzaxr.com/pdf/current_PI_PW2.pdf
17. Fujioka K, Brazg RL, Raz I, et al. 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 Obes Metab 2005;7:28-39
18. Lewin A, Lipetz R, Wu J, Schwartz S. Comparison of extended-release metformin in combination with a sulfonylurea (glyburide) to sulfonylurea monotherapy in adult patients with type 2 diabetes: a multicenter, double-blind, randomized, controfled, phase III study. Clin Ther 2007;29:844-55