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Diabetes Care. 2003 Dec;26(12):3273-9.
The combined effect of triple therapy with rosiglitazone, metformin, and insulin aspart in type 2 diabetic patients.

Poulsen MK, Henriksen JE, Hother-Nielsen O, Beck-Nielsen H.

Diabetes Research Center, Odense University Hospital, Odense, Denmark.

OBJECTIVE: Type 2 diabetes is caused by reduced insulin secretion and insulin resistance in skeletal muscle and liver. We tested the combination therapy with insulin aspart, rosiglitazone, and metformin with the purpose of treating all three defects in order to test the hypothesis that this "triple therapy" will normalize glucose metabolism. RESEARCH DESIGN AND METHODS: Sixteen obese type 2 diabetic outpatients on human NPH or MIX (regular + NPH insulin) insulin twice daily were randomized to either triple therapy, i.e., insulin aspart (a rapid-acting insulin analog) at meals, metformin (which improves hepatic insulin sensitivity), and rosiglitazone (which improves peripheral insulin sensitivity), or to continue their NPH or MIX insulin twice daily for 6 months. Insulin doses were adjusted in both groups based on algorithms. HbA(1c), insulin dose, hypoglycemic episodes, insulin sensitivity (clamp), hepatic glucose production (tracer), and diurnal profiles of plasma glucose and insulin were used in evaluating treatment. RESULTS: In the triple therapy group, HbA(1c) declined from 8.8 to 6.8% (P < 0.01) without inducing severe hypoglycemic events. Postprandial hyperglycemia was generally avoided, and the diurnal profile of serum insulin showed fast and high peaks without any need to increase insulin dose. In the control group, the insulin dose was increased by 50%, but nevertheless both HbA(1c) and 24-h blood glucose profiles remained unchanged. Insulin sensitivity improved in both skeletal muscle and the liver in the triple therapy group, whereas no change was observed in the control group. CONCLUSIONS: We conclude that treatment of the three major pathophysiological defects in type 2 diabetic subjects by triple therapy significantly improved glucose metabolism in obese type 2 diabetic subjects.

online pharmacy ref source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=14633813&dopt=Abstract [PubMed - in process]




J Chromatogr B Analyt Technol Biomed Life Sci. 2003 Dec 25;798(2):203-9.
Determination of metformin in plasma using a new ion pair solid phase extraction technique and ion pair liquid chromatography.

AbuRuz S, Millership J, McElnay J.

Clinical and Practice Research Group, School of Pharmacy, Queen's University Belfast, Belfast BT9 7BL, UK.

This article describes the development of the first ion pair solid phase extraction technique (IPSPE), which has been applied to the extraction of metformin from plasma samples. In addition an ion pair chromatographic method was developed for the specific HPLC determination of metformin. Several extraction and HPLC methods have been described previously for metformin, however, most of them did not solve the problems associated with the high polarity of this drug. Drug recovery in the developed method was found to be more than 98%. The limit of detection and limit of quantification was 3 and 5 ng/ml, respectively. The intraday and interday precision (measured by coefficient of variation, CV%) was always less than 9%. The accuracy (measured by relative error, R.E.%) was always less than 6.9%. Stability analysis showed that metformin is stable for at least 3 months when stored at -70 degrees C. The method has been applied to 150 patient samples as part of a medication adherence study.

online pharmacy ref source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=14643498&dopt=Abstract [PubMed - in process]




J Anal Toxicol. 2003 Nov-Dec;27(8):592-4.
Analysis of metformin in antemortem serum and postmortem specimens by a novel HPLC method and application to an intoxication case.

Moore KA, Levine B, Titus JM, Fowler DR.

Office of the Chief Medical Examiner, State of Maryland, 111 Penn Street, Baltimore, Maryland 21201, USA.

A case of intoxication from the oral hypoglycemic drug metformin is presented. A number of published liquid chromatographic methods were combined to enable a simplified analysis of metformin in both antemortem and postmortem specimens. The method involved direct injection of a protein-free filtrate into the liquid chromatograph. The method was sufficiently sensitive to detect therapeutic use of metformin; no common therapeutic or abused drugs interfered with the assay. In the presented case, the hospital admission serum metformin concentration was 141 mg/L, or approximately two orders of magnitude above therapeutic concentrations. The medical examiner concluded that the cause of death in this case was metformin intoxication, and the manner of death was suicide.

online pharmacy ref source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=14670139&dopt=Abstract [PubMed - in process]





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