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Journal Article
Multicenter Study
Randomized Controlled Trial
Remission of hyperglycemia after withdrawal of oral antidiabetic drugs in Japanese patients with early-stage type 2 diabetes.
Journal of Diabetes Investigation 2018 September
AIMS/INTRODUCTION: To assess whether intervention with oral antidiabetic drug in Japanese patients with the early stage of type 2 diabetes could provide a significant remission of the disease process.
MATERIALS AND METHODS: Patients with diabetes duration <5 years were randomized to the lifestyle modification (LFS), pioglitazone (PIO) or sulfonylurea (SU) treatment group. In phase 1 as the on-treatment period and in phase 2 as the off-treatment period, the duration that glycated hemoglobin (HbA1c) was maintained at less than the target was compared among groups.
RESULTS: A total of 278 patients were assigned to LFS (n = 84), PIO (n = 101) and SU (n = 93), and 212 patients completed phase 1. The number of patients that dropped out because of HbA1c elevation was larger in the LFS group, and the duration of HbA1c being maintained at <7.9% was longer in the SU group than the other groups. The duration of HbA1c being maintained at <7.4% in phase 2 was significantly shorter in the SU group than in the other groups. The proportion of patients who achieved HbA1c <6.9% or 6.2% at the end of phase 1 was obviously less in the LFS group than other groups. The duration of HbA1c being maintained at <6.2% in phase 2 was longer in the PIO group than other groups, although not significant statistically. An increase in serum adiponectin and decreases in high-sensitivity C-reactive protein and homeostatic model assessment of insulin resistance were shown in patients treated with PIO, but not LFS and SU, in phase 1, but were canceled in the drug-off phase 2 period.
CONCLUSIONS: PIO treatment provided a prolonged remission of hyperglycemia after stopping the dosage in patients with the early stage of type 2 diabetes.
MATERIALS AND METHODS: Patients with diabetes duration <5 years were randomized to the lifestyle modification (LFS), pioglitazone (PIO) or sulfonylurea (SU) treatment group. In phase 1 as the on-treatment period and in phase 2 as the off-treatment period, the duration that glycated hemoglobin (HbA1c) was maintained at less than the target was compared among groups.
RESULTS: A total of 278 patients were assigned to LFS (n = 84), PIO (n = 101) and SU (n = 93), and 212 patients completed phase 1. The number of patients that dropped out because of HbA1c elevation was larger in the LFS group, and the duration of HbA1c being maintained at <7.9% was longer in the SU group than the other groups. The duration of HbA1c being maintained at <7.4% in phase 2 was significantly shorter in the SU group than in the other groups. The proportion of patients who achieved HbA1c <6.9% or 6.2% at the end of phase 1 was obviously less in the LFS group than other groups. The duration of HbA1c being maintained at <6.2% in phase 2 was longer in the PIO group than other groups, although not significant statistically. An increase in serum adiponectin and decreases in high-sensitivity C-reactive protein and homeostatic model assessment of insulin resistance were shown in patients treated with PIO, but not LFS and SU, in phase 1, but were canceled in the drug-off phase 2 period.
CONCLUSIONS: PIO treatment provided a prolonged remission of hyperglycemia after stopping the dosage in patients with the early stage of type 2 diabetes.
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