Repaglinide in type 2 diabetes: a 24-week, fixed-dose efficacy and safety study.
In this 24-week multicenter, double-blind, randomized, fixed-dose trial, 361 patients having type 2 diabetes received daily preprandial treatment with placebo (n = 75), repaglinide 1 mg (n = 140), or repaglinide 4 mg (n = 146). By a last-observation carried-forward calculation, repaglinide 1 mg or 4 mg treatment decreased mean fasting plasma glucose (FPG) values (by -47 mg/dL or -49 mg/dL) while the placebo group had increased FPG values (by 19 mg/dL). For the repaglinide treatment groups at the end of the study, changes in HbA1c from baseline values ranged from 1.8 to 1.9 percentage points lower than the placebo group. There were no events of severe hypoglycemia. Nearly all hypoglycemic symptom episodes had blood glucose levels above 45 mg/dL. Repaglinide was well tolerated in a preprandial fixed-dose regimen of 1 mg or 4 mg, assigned without adjustment for clinical parameters.
Jovanovic
L
L
Sansum Medical Research Institute, Santa Barbara, California 93105, USA.
Dailey
G
G
Huang
W C
WC
Strange
P
P
Goldstein
B J
BJ
D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000187:drug effects*; D002219:Carbamates / Q000008:administration & dosage* / Q000009:adverse effects*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005215:Fasting; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010352:Patient Dropouts; D010880:Piperidines / Q000008:administration & dosage* / Q000009:adverse effects*; D013997:Time Factors; D016896:Treatment Outcome
D001786:Blood Glucose; D002219:Carbamates; D007004:Hypoglycemic Agents; D010880:Piperidines; C072379:repaglinide