Nateglinide alone or with metformin safely improves glycaemia to target in patients up to an age of 84.
OBJECTIVE
To assess the effect of nateglinide on efficacy [fasting plasma glucose (FPG), postprandial plasma glucose (PPG) plasma glucose and HbA1c], tolerability and safety in patients with type 2 diabetes mellitus (T2Dm) on diet alone or on metformin in subjects up to an age of 84.


METHODS
In an open-labelled 12-week, parallel study of 358 patients, aged 35-84 years with T2Dm, nateglinide was given as either monotherapy in patients previously on diet alone or low-dose sulfonylureas, which required washout before the study (group 1), or as an addition therapy in patients on steady dose of metformin (group 2). Nateglinide 120 mg was given before main meals. HbA1c, FPG and PPG values were taken at the time of breakfast at the beginning and the end of the study.


RESULTS
HbA1c fell by a mean of 0.83%, 95% confidence interval (CI) (-0.97, -0.69) (p < 0.001) in group 1, and 0.67%, 95% CI (-0.77, -0.58) (p < 0.001) in group 2. There was a significant improvement in PPG in group 1 by a mean reduction of -3.47 mmol/l, 95% CI (-4.08, -2.87) (p < 0.0001) and in group 2 of -2.41 mmol/l, 95% CI (-2.84, -1.99) (p < 0.0001). There was an improvement in FPG of -1.2 mmol/l, 95% CI (-1.49, -0.81) (p < 0.0001) and -0.8 mmol/l, 95% CI -(1.07, -0.53) (p < 0.0001) in group 1 and 2 respectively. 44% of patients in group 1 and 34% in group 2 achieved target of HbA1c < 7.0 and 66% in group 1 and 59% in group 2 achieved of HbA1c < 7.5%. Only one subject on nateglinide and metformin was withdrawn due to the side effect of hypoglycaemia. No patient required third-party assistance nor was admitted to hospital due to hypoglycaemia.


CONCLUSIONS
These data demonstrate that nateglinide is a safe and effective agent in treatment to target in patients with T2Dm up to an age of 84 years.
Weaver
J U
JU
Queen Elizabeth Hospital, University of Newcastle-upon-Tyne, Tyne and Wear, UK. j.u.weaver@ncl.ac.uk
Robertson
D
D
Atkin
S L
SL
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000032:analysis; D003510:Cyclohexanes / Q000627:therapeutic use*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000627:therapeutic use*; D008875:Middle Aged; D000077715:Nateglinide; D010649:Phenylalanine / Q000031:analogs & derivatives / Q000627:therapeutic use*; D019518:Postprandial Period; D011446:Prospective Studies; D012044:Regression Analysis
D001786:Blood Glucose; D003510:Cyclohexanes; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D000077715:Nateglinide; D010649:Phenylalanine