National Variations in Comorbidities, Glycosylated Hemoglobin Reduction, and Insulin Dosage in Asian Patients with Type 2 Diabetes: The FINE-Asia Registry

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Abstract

Introduction

The First Basal Insulin Evaluation (FINE) Asia study was a prospective, observational registry evaluating basal insulin initiation in Asian patients with type 2 diabetes mellitus inadequately controlled by oral antihyperglycemic agents.

Methods

The objective of this post hoc analysis was to observe and report the findings from individual participating countries. The primary endpoint was change in glycosylated hemoglobin (HbA _1c) from baseline to month 6 after basal insulin initiation. Secondary endpoints included change in fasting blood glucose (FBG), percent of patients achieving target HbA _1c and FBG levels, average insulin doses, and hypoglycemic events.

Results

The study included 2921 patients from 11 Asian countries at baseline, 2679 (92%) of whom had evaluable data. Following initiation of basal insulin (neutral protamine Hagedorn insulin, glargine, or detemir), there was a significant ( P < 0.001) difference in HbA _1c reduction and proportions of patients meeting HbA _1c and FBG targets (<7% and <110 mg/dL, respectively) across all country cohorts by month 6. Glycemic control also varied greatly, with 7.4% (Taiwan) to 71.5% (China) of patients reaching target HbA _1c <7% levels. Mean (±standard deviation) insulin dose increases over the 6-month period ranged from 0.5 ± 3.1 U (Pakistan) to 6.0 ± 8.6 U (Thailand). Hypoglycemia rates also varied, with 7.1% (India) to 27.3% (China) of patients experiencing one or more events.

Conclusions

Data from the FINE-Asia registry study show widely varying degrees of baseline comorbidities and glycemic control in patients among the country cohorts observed. Countries with >9 years of diabetes prior to insulin initiation had the lowest reductions in HbA _1c and proportions of patients achieving HbA _1c and FBG targets, suggesting that earlier basal insulin initiation may afford better glycemic control in these patients.

Funding

This study was funded by Sanofi.

Electronic supplementary material

The online version of this article (doi:10.1007/s13300-015-0137-8) contains supplementary material, which is available to authorized users.

Related collections

Most cited references 24

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Effect of intensive insulin therapy on beta-cell function and glycaemic control in patients with newly diagnosed type 2 diabetes: a multicentre randomised parallel-group trial.

Jianping Weng, Yanbing Li, Wen Xu … (2008)

Early intensive insulin therapy in patients with newly diagnosed type 2 diabetes might improve beta-cell function and result in extended glycaemic remissions. We did a multicentre, randomised trial to compare the effects of transient intensive insulin therapy (continuous subcutaneous insulin infusion [CSII] or multiple daily insulin injections [MDI]) with oral hypoglycaemic agents on beta-cell function and diabetes remission rate. 382 patients, aged 25-70 years, were enrolled from nine centres in China between September, 2004, and October, 2006. The patients, with fasting plasma glucose of 7.0-16.7 mmol/L, were randomly assigned to therapy with insulin (CSII or MDI) or oral hypoglycaemic agents for initial rapid correction of hyperglycaemia. Treatment was stopped after normoglycaemia was maintained for 2 weeks. Patients were then followed-up on diet and exercise alone. Intravenous glucose tolerance tests were done and blood glucose, insulin, and proinsulin were measured before and after therapy withdrawal and at 1-year follow-up. Primary endpoint was time of glycaemic remission and remission rate at 1 year after short-term intensive therapy. Analysis was per protocol. This study was registered with ClinicalTrials.gov, number NCT00147836. More patients achieved target glycaemic control in the insulin groups (97.1% [133 of 137] in CSII and 95.2% [118 of 124] in MDI) in less time (4.0 days [SD 2.5] in CSII and 5.6 days [SD 3.8] in MDI) than those treated with oral hypoglycaemic agents (83.5% [101 of 121] and 9.3 days [SD 5.3]). Remission rates after 1 year were significantly higher in the insulin groups (51.1% in CSII and 44.9% in MDI) than in the oral hypoglycaemic agents group (26.7%; p=0.0012). beta-cell function represented by HOMA B and acute insulin response improved significantly after intensive interventions. The increase in acute insulin response was sustained in the insulin groups but significantly declined in the oral hypoglycaemic agents group at 1 year in all patients in the remission group. Early intensive insulin therapy in patients with newly diagnosed type 2 diabetes has favourable outcomes on recovery and maintenance of beta-cell function and protracted glycaemic remission compared with treatment with oral hypoglycaemic agents.