The efficacy of repaglinide monotherapy and in combination with metformin in Indonesian type 2 diabetes mellitus patients.
OBJECTIVE
To investigate the efficacy and safety of repaglinide alone and in combination with metformin therapy.


METHODS
Seventy-two type 2 diabetes patients who were oral anti-diabetic drugs (OAD)-naive or currently on OAD for </=36 months with HbA1c </=9% and fasting plasma glucose (FPG) pound 13 mmol/L were recruited. Patients were titrated for 6 weeks to a dose level which maintained fasting blood glucose at 4.4-7.0 mmol/L and continued treatment for 8 weeks. Dose regimen started with 0.5 mg repaglinide each main meal, progressing to 1.0 mg repaglinide, 1.0 mg repaglinide + metformin 500 mg b.i.d. and 1.0 mg repaglinide + metformin 500 mg t.i.d., depending on patients' glycaemic status. Patients' glycaemic control (HbA(1c) and FPG), body weight and other safety parameters were evaluated.


RESULTS
Thirty-seven patients completed the trial. Patients were overweight (mean BMI 25.5 +/- 4.1 kg/m(2)) with mean age 52.5 +/- 8.8 years and mean diabetes duration of 2.4 +/- 3.8 years. Mean HbA1c (2.26 +/- 0.22%, [p <0.05]) and FPG (3.31 +/- 0.47 mmol/L, [p <0.05]) decreased significantly from baseline. Body weight did not change significantly (0.85 +/-0.45 kg, p=0.068). Of the 33 patients who had baseline FPG >7.0 mmol/L, it appeared that repaglinide alone at doses 0.5 or 1.0 mg achieved FBG <7.0 mmol/L in 67% of patients. The majority of the treatment emergent adverse events were mild and unlikely related to trial product. Episodes of symptomatic hypoglycaemia were low (9.3%) in frequency. The changes in haematology, clinical biochemistry and urinalysis were mostly minor or remained unchanged. Vital signs and the results of physical examination also remained unchanged. Three of the four withdrawals were due to adverse events but were unlikely related to trial product.


CONCLUSIONS
treatment with repaglinide alone and in combination with metformin was efficacious in glycaemic control in OAD-naive or previous users. Most of the patients appeared to achieve good control with repaglinide alone. The treatment regimens were safe (317 words).
Soegondo
Sidartawan
S
Division of Metabolic Endocrinology, Department of Internal Medicine, Faculty of Medicine, University of Indonesia-Dr. Cipto Mangunkusumo National Central General Hospital, Jakarta.
Subekti
Imam
I
Luthariana
Lies
L
D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis / Q000187:drug effects; D002219:Carbamates / Q000627:therapeutic use*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis / Q000187:drug effects; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007214:Indonesia; D008297:Male; D008687:Metformin / Q000627:therapeutic use*; D008875:Middle Aged; D010880:Piperidines / Q000627:therapeutic use*; D016896:Treatment Outcome
D001786:Blood Glucose; D002219:Carbamates; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D010880:Piperidines; C072379:repaglinide