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Remission of hyperglycemia after withdrawal of oral antidiabetic drugs in Japanese patients with early-stage type 2 diabetes.

ABSTRACT: 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.

SUBMITTER: Hirukawa H

PROVIDER: S-EPMC6123043 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Remission of hyperglycemia after withdrawal of oral antidiabetic drugs in Japanese patients with early-stage type 2 diabetes.

Hirukawa Hidenori H Hashiramoto Mitsuru M Tanizawa Yukio Y Kaku Kohei K

Journal of diabetes investigation 20180313 5

<h4>Aims/introduction</h4>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.<h4>Materials and methods</h4>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 hem ...[more]

PMID: 29406607

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Project description:IntroductionTwo studies were carried out to investigate the efficacy and safety of luseogliflozin added to existing oral antidiabetic drugs (OADs) in Japanese type 2 diabetic patients inadequately controlled with OAD monotherapy.Materials and methodsIn the trial involving add-on to sulfonylureas (study 03-1), patients were randomly assigned to receive luseogliflozin 2.5 mg or a placebo for a 24-week double-blind period, followed by a 28-week open-label period. In the open-label trial involving add-on to other OADs; that is, biguanides, dipeptidyl peptidase-4 inhibitors, thiazolidinediones, glinides and ?-glucosidase inhibitors (study 03-2), patients received luseogliflozin for 52 weeks.ResultsIn study 03-1, luseogliflozin significantly decreased glycated hemoglobin at the end of the 24-week double-blind period compared with the placebo (-0.88%, P < 0.001), and glycated hemoglobin reduction from baseline at week 52 was -0.63%. In study 03-2, luseogliflozin added to other OADs significantly decreased glycated hemoglobin from baseline at week 52 (-0.52 to -0.68%, P < 0.001 for all OADs). Bodyweight reduction was observed in all add-on therapies, even with agents associated with weight gain, such as sulfonylureas and thiazolidinediones. Most adverse events were mild in severity. When added to a sulfonylurea, incidences of hypoglycemia during the double-blind period were 8.7% and 4.2% for luseogliflozin and placebo, respectively, but no major hypoglycemic episodes occurred. The frequency and incidences of adverse events of special interest for sodium glucose cotransporter 2 inhibitors and adverse events associated with combined OADs were acceptable.ConclusionsAdd-on therapies of luseogliflozin to existing OADs improved glycemic control, reduced bodyweight and were well tolerated in Japanese type 2 diabetic patients. These trials were registered with the Japan Pharmaceutical Information Center (add on to sulfonylurea: JapicCTI-111507; add on to other OADs: JapicCTI-111508).

Project description:IntroductionAlthough metformin is recommended as a first-line treatment for patients with type 2 diabetes (T2D) in Western countries, no specific treatment is recommended in Japan, and various agents are used. Metformin has long been used at low doses in Japan, and information regarding its effect at the maximum maintenance dose is lacking. Here, we compared the efficacy and safety of metformin at 1500 mg/day with those of the other oral anti-diabetic drugs (OADs) approved in Japan.MethodsRandomized controlled trials comparing a change in hemoglobin A1c (HbA1c) from baseline at 12 weeks or later (ΔHbA1c) among OADs (including placebo) as a first-line treatment in adult patients with T2D were selected by systematic review with comprehensive searching of CENTRAL, MEDLINE, Ichushi Web, and EMBASE and manual searching of clinical trial registries. The ΔHbA1c and incidence of hypoglycemia were compared among OAD treatments using Bayesian network meta-analysis (NMA). The relative risk (RR) of the incidence of hypoglycemia was determined relative to that of placebo.ResultsForty-six randomized controlled trials were identified in the systematic review, and 37 studies, comprising 38 different types of treatments, including placebos, were selected for the NMA of ΔHbA1c. Compared with metformin 1500 mg/day, 20 OAD treatments were significantly less effective in reducing HbA1c from baseline (differences from metformin 1500 mg/day: 0.40-0.96%). Two treatments (glimepiride 2 mg/day and pioglitazone 45 mg/day) showed greater mean reductions in HbA1c from baseline than metformin 1500 mg/day (- 0.38% and - 0.03%), although these differences were not significant. Regarding the incidence of hypoglycemia, only pioglitazone 30 mg/day among 31 treatments showed a lower RR (< - 0.01), whereas 23 treatments showed a significantly higher RR (1.02-66.71) than metformin 1500 mg/day.ConclusionThe NMA suggested a preferable efficacy and safety profile of metformin 1500 mg/day compared with the other OADs approved in Japan.

Dataset Information

Remission of hyperglycemia after withdrawal of oral antidiabetic drugs in Japanese patients with early-stage type 2 diabetes.

Publications

Remission of hyperglycemia after withdrawal of oral antidiabetic drugs in Japanese patients with early-stage type 2 diabetes.

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