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Nateglinide combination therapy with basal insulin and metformin in patients with Type 2 diabetes
Author(s) -
Juurinen L.,
Tiikkainen M.,
Saltevo J.,
Nikkilä K.,
Lanki H.,
Leppävuori E.,
Kock T.,
TeikariMyyrä T.,
KauppinenMäkelin R.,
Kotronen A.,
YkiJärvinen H.
Publication year - 2009
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1111/j.1464-5491.2009.02691.x
Subject(s) - nateglinide , medicine , postprandial , metformin , placebo , endocrinology , insulin , type 2 diabetes , diabetes mellitus , basal (medicine) , body mass index , alternative medicine , pathology
Aims To compare the effect of adding nateglinide or placebo on postprandial glucose excursions (PPGEs), glycated haemoglobin (HbA 1c ), diurnal glucose profiles and hypoglycaemia in patients with Type 2 diabetes treated with the combination of basal insulin and metformin. Research design and methods This was an investigator‐initiated, double‐blind, randomized, parallel‐group, study in five centres. Patients with Type 2 diabetes ( n = 88, age 56.0 ± 0.9 years, duration of diabetes 9.4 ± 0.5 years, HbA 1c 7.8 ± 0.1%, body mass index 32.4 ± 0.5 kg/m 2 ) treated with basal insulin and metformin entered a 24‐week period, during which basal insulin was titrated to optimize glucose control. Thereafter, the patients were randomized to receive either nateglinide (120 mg three times daily) or placebo before their main meals for 24 weeks. Results During the optimization period, HbA 1c decreased by −0.3 ± 0.1 and −0.4 ± 0.2% (NS) and insulin doses increased by 10.0 IU (2.0–32.0) [0.09 IU/kg (0.02–0.34)] and 10.0 IU (0.0–19.0) [0.11 IU/kg (0.0–0.25)] (NS) in the nateglinide and placebo groups. Mean postprandial glucose during weeks 20–24 averaged 9.0 ± 0.3 and 10.0 ± 0.3 mmol/l in the nateglinide and placebo groups ( P = 0.025) and mean PPGE averaged 2.4 ± 0.2 and 3.1 ± 0.2 mmol/l, respectively ( P = 0.019). At 24 weeks as compared with 0 weeks, mean HbA 1c had decreased by 0.41 ± 0.12% in the nateglinide group and by 0.04 ± 0.12% in the placebo group ( P = 0.023). The frequency of confirmed, symptomatic hypoglycaemia was 7.7 episodes/patient‐year vs. 4.7 episodes/patient‐year in the nateglinide and placebo groups ( P = 0.031). Conclusions Addition of a short‐acting insulin secretagogue at main meals improves postprandial hyperglycaemia during combination therapy with basal insulin and metformin, but increases the frequency of hypolycaemia.