TITLE

Glycemic Variability in Patients with Type 2 Diabetes on Basal Insulin and Fixed Combination Oral Antidiabetic Treatment - Results of a Pilot Study

AUTHOR(S)
De Mattia, Giancarlo; Laurenti, Oriana; Moretti, Arianna; Mollica, Maria R.
PUB. DATE
June 2007
SOURCE
Diabetes;Jun2007 Supplement 1, Vol. 56, pA148
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
Type 2 diabetes (T2DM) is a progressive disease, which may eventually require insulin therapy when glycemic control fails using oral antidiabetic drugs (OADs) alone. Once-daily glargine ensures a 24-hr basal insulin replacement in T2DM patients, which can allow lower glycemic fluctuations during the day. This randomized, single-center, crossover study, compared glargine+OADs (fixed combination of glibenclamide 2.5 mg + metformin 400 mg) with NPH insulin+OADs in T2DM patients (HbA[sub 1c] >8-≤11%). The study assessed the coefficient of variability (CV) of fasting blood glucose (FBG) (calculated via self monitoring blood glucose [BG] values) and post-meal BG (measured either by iv blood sample at times: 0, 30, 60, 120 min or continuous glucose monitoring system [CGMS]). Patients with T2DM (n=20) on OADs were treated with NPH insulin (at bedtime) or glargine (at dinnertime) for 12 weeks of each crossover treatment period; OADs were continued. The decrease in values (mean±CV) of FBG (baseline=203.6±28.6 mg/dL) were significant for both therapies; glargine=103.7±16.7 mg/dL vs NPH insulin=103.2±15.2 mg/dL (p<0.01 for both). The total daily dose at endpoint was 28.8 vs 34.7 U for glargine and NPH insulin, respectively. A standard meal test with a 350 kcal mixed meal (55% carbohydrates, 26% lipids, 19% proteins) was performed at 1.00 PM the day after NPH insulin or glargine injection. Area under the curve for BG determined by iv blood samples showed a better postprandial BG (PPBG) value for glargine (146.4±6.7 mg/dL) vs NPH insulin (171.2±24.7 mg/dL), with a significant difference between treatment (-24.7 mg/dL, p=0.02). According to CGMS records, glargine vs NPH insulin achieved a better PPBG profile during the first 5 hrs after the standard meal test and extended a statistically significant better PPBG profile up to 8 hrs after the end of the test. The incidence of hypoglycemia (BG <72 mg/dL) was lower with glargine vs NPH insulin (1.02 vs 2.12 episodes/patient/month). The results suggest that glargine added to existing OADs is more effective in reducing PPBG fluctuations during the day, compared with NPH insulin+OADs.
ACCESSION #
25820867

 

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