Safety and efficacy of repaglinide in combination with metformin and bedtime NPH insulin as an insulin treatment regimen in type 2 diabetes.
OBJECTIVE
To evaluate the efficacy and safety of the association of repaglinide, metformin and bedtime NPH insulin compared to two classic regimens: metformin plus NPH and two doses of NPH in patients with poorly controlled type 2 diabetes despite two or more oral antidiabetic drugs (OADs).


METHODS
Random, parallel and open study of 24 weeks with 37 patients randomized into three therapeutic groups: group A (n=12) (repaglinide/metformin/NPH), group B (n=12) (metformin/NPH) and group C (n=13) (NPH/NPH). The insulin was adjusted in the visits to obtain a basal blood glucose <110 mg/dl. The endpoint criteria included HbA1c, blood glucose profile, hypoglycemias and body weight.


RESULTS
At the end of the study, group A presented HbA1c (mean+/-standard deviation) 7.2+/-0.7%, which was significantly less than B (8.8+/-0.1%) and C (8.4+/-1.2%). In terms of absolute reduction, there were only differences (p=0.01) between group A (-2.4+/-1.1%) and B (-0.7+/-1.2%). Group A presented lower postprandial blood glucose values (p<0.01). Nor were there any significant differences in weight gain and incidence of hypoglycemia.


CONCLUSIONS
The combination of repaglinide, metformin and bedtime NPH is safe and effective and it provides better postprandial blood glucose control. The association of metformin and a dose of NPH does not obtain suitable control in patients with a long evolution who have already received two or more OADs.
Civera
Miguel
M
Unidad de Diabetes, Servicio de Medicina Interna, Hospital Lluís Alcanyís (Xàtiva), Carretera de Xàtiva a Silla Km 2, 46800 Xàtiva, Valencia, Spain. mi.civeraa@comv.es
Merchante
Angel
A
Salvador
María
M
Sanz
Javier
J
Martínez
Isidoro
I
D000368:Aged; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D001794:Blood Pressure; D015992:Body Mass Index; D002219:Carbamates / Q000627:therapeutic use*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000503:physiopathology; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects / Q000378:metabolism; D006801:Humans; D007336:Insulin, Isophane / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000627:therapeutic use*; D008875:Middle Aged; D010880:Piperidines / Q000627:therapeutic use*; D011446:Prospective Studies; D012449:Safety; D015430:Weight Gain / Q000187:drug effects
D001786:Blood Glucose; D002219:Carbamates; D006442:Glycated Hemoglobin; D007336:Insulin, Isophane; D008687:Metformin; D010880:Piperidines; C072379:repaglinide