Titre du document / Document title

NIDDM: New once-daily intervention for type 2 diabetes mellitus: Diaprel MR

Auteur(s) / Author(s)

IONESCU-TIRGOVISTE C. ; GAVRILA L. ; BRADESCU O. M. ; GUJA C. ;

Résumé / Abstract

Pharmacological treatment of hyperglycemia should address to both abnormalities in T2DM treatment, that is reduction of insulin resistance and restoration of normal insulin secretion. Gliclazide is a sulfonylurea compoundoral hypoglycemic drug that has a unique feature of restoring the first-phase insulin secretion, which is lost in T2DM being one of the early features of disease. Material and method: Laboratoires Servier conducted in Romania a an open non randomized surveillance on the efficacy and safety of Diaprel MR in type 2 diabetic patients. 199 patients in 14 treatment centers were enrolled. Eligibility criteria were as it follows: men and women with diabetes, previously on diet alone and not treated with other OAD, over 35 years old with FPG (mg/dl) at enrolment between 126 and 180. The clinical trial lasted for 16 weeks. During this period the doctors examined the patients 6 times. First visits were at a 2 weeks interval and the last two visits at a 4 weeks interval. At each visit the doctor renewed the prescription for the subsequent period according to the following protocol: the starting dose was 30 mg Diaprel MR /day, if the FPG (mg/dl) was over 140 (at the next visit) the dosage was increased with 30 mg Diaprel MR /day, if the FPG (mg/dl) was under 140 the dosage remained the same as the previous dosage. The maximum dosage was 120 mg Diaprel MR /day. The following parameters were measured on first and last (seventh) visit: blood pressure (systolic and diastolic), heart rate (bpm), body mass index-BMI (kg/m₂), fasting plasma glucose FPG (mg/dl and mmol/l), glycated hemoglobin HbAlc (%) and Hb-Hct (mg/dl-%), creatinine (mg/dl), SGPT (UI/I), cholesterol (mg/dl) and triglycerides (mg/dl). Blood pressure (systolic and diastolic), heart rate, BMI and FPG were measured from the second to sixth visit also. On each visit there was registered other data such as: associated illnesses, concomitant medication and adverse events. Results: Primary end points. The average values of end points HbAlc (%) and PFG (mg/dl) registered a significant decrease during the 16 weeks of medication, from the enrolment moment (SO) to the last week (S 16). The decrease was significant on the total sample of the main analysis group but also on subsamples of age, gender and BMI. HbAlc (%) average values decreased in the main analysis group (S16 compared to S0): with 22% on the total sample (from 7.7 to 6.0); p < 0.05. FPG (mg/dl) average values decreased in the main analysis group (S16 compared to S0): with 21% on the total sample (from 159 to 126); p < 0.05. Secondary end points. There were no significant changes registered in the average level of cholesterol and triglycerides, BMI, diastolic blood pressure, heart rate, creatinine, SGPT. A significant decline of the average systolic blood pressure was registered Conclusion: Diaprel MR can be used safety in diabetic patients newly diagnosed, uncontrolled on diet or other oral antidiabetic drugs, overweight, safety in those with cardio-vascular disease, or in patients with creatinine clearance 50-80 ml/min.

Revue / Journal Title

Romanian Journal of Internal Medicine   ISSN 1582-3296 

Source / Source

2004, vol. 42, n^o2, pp. 431-440 [10 page(s) (article)]

Langue / Language

Anglais

Editeur / Publisher

Editura Academiei Române, Bucureşti,   (1999) (Revue)

Localisation / Location

INIST-CNRS, Cote INIST : 11624, 35400011426336.0200