Five thousand five hundred seventy-two newly diagnosed
non-insulin-dependent diabetes mellitus (
NIDDM) patients (3,225 men and 2,347 women; mean age, 58.5 years) were recruited through the General Practitioners (GPs) network in France. All had persistent
hyperglycemia after a preliminary 3-month period with dietary and life-style modification.
Gliclazide (80 to 320 mg/d) was then prescribed as diabetic
pharmacotherapy for 2 years. Additional
therapy for
hypertension and
dyslipidemia was started if necessary. The aim of the study was mainly to determine the feasibility of a GP-directed protocol for the monitoring and treatment of newly diagnosed
NIDDM patients, and to assess the effectiveness of diabetic
therapy in this cohort. Diabetes was diagnosed in 78% of the cohort during routine screening. Among the women, 6.5% had a history of
gestational diabetes. Eighteen percent of the patients had a parental history of diabetes, and the dominant maternal role in the genesis of
NIDDM was confirmed.
High blood pressure (Joint National Committee V criteria) was found at inclusion in 38.8% of the whole cohort.
Hyperlipidemia was known in 44.6%. A history of
stroke was present in 1.6% of the patients, and
coronary heart disease (CHD) in 6.3%. These data support the relationship between the atherogenic state and development of
NIDDM. Microalbuminuria defined as urinary
albumin excretion (UAE) of at least 20 mg/L was found in 29.6% of the patients, and retinopathy in 9.8%. Among the included patients, 23% did not complete the study and were excluded from the efficacy analysis. Of these, 14% (808 patients) had only baseline evaluation data and 9% (499 patients) withdrew later. Comparison of mean baseline and final results in study completers uncovered a significant improvement in fasting
blood glucose ([FBG] 182 +/- 48 v 137 +/- 40 mg/dL), post prandial
blood glucose ([PPBG] 209 +/- 68 v 162 +/- 52 mg/dL), and
hemoglobin A1c ([HbA1c] 8.7% +/- 2.5% v 7.3% +/- 2.0%). A slight improvement in total
cholesterol (228 +/- 44 v 222 +/- 41 mg/dL), body mass index ([BMI] 28.5 +/- 4.7 v 27.9 +/- 4.5 kg/m2), and waist to hip ratio (0.99 +/- 0.1 v 0.98 +/- 0.1) was observed. There was a decrease in the percentage of patients with
high blood pressure (38.5% v 30.7%). A mild increase in the prevalence of retinopathy (10.2% v 11.8%) was noted during the study, while the incidence of microalbuminuria remained unchanged (30.2% v 29.5%). In conclusion, the data indicate that the GPs involved in this study were able to successfully monitor and manage
NIDDM patients in accordance with a standardized protocol.
Gliclazide appeared to be an effective and well-tolerated treatment. The high prevalence of chronic
diabetic complications at diagnosis emphasizes the delay encountered in reaching the diagnosis of
NIDDM and the problems associated with this delay. In addition to the classic risk factors for
NIDDM exhibited in this patient cohort, we have identified CHD and a maternal genetic component as further potential predicting factors.