Abstract
Aims Basal insulin plus oral hypoglycemic agents (OHAs) has not been investigated for early intensive antihyperglycemic treatment in people with newly diagnosed type 2 diabetes. This study is aimed at comparing the short-term (over a period of 12 days) effects of basal insulin glargine plus OHAs and continuous subcutaneous insulin infusion (CSII) on glycemic control and beta-cell function in this setting. Methods An open-label parallel-group study. Newly diagnosed hospitalized patients with type 2 diabetes and fasting plasma glucose (FPG) ≥11.1 mmol/L or glycated hemoglobin (HbA1c) ≥9% (75 mmol/mol) were randomized to CSII or insulin glargine in combination with metformin and gliclazide. The primary outcome measure was the mean amplitude of glycemic excursions (MAGE), and secondary endpoints included time to reach glycemic control target (FPG < 7 mmol/L and 2-hour postprandial plasma glucose < 10 mmol/L), markers of β-cell function, and hypoglycemia. Results Subjects in the CSII (n = 35) and basal insulin plus OHA (n = 33) groups had a similar significant reduction from baseline to end of treatment in glycated albumin (−6.44 ± 3.23% and− 6.42 ± 3.56%, P = 0.970). Groups A and B have comparable time to glycemic control (3.6 ± 1.2 days and 4.0 ± 1.4 days), MAGE (3.40 ± 1.40 mmol/L vs. 3.16 ± 1.38 mmol/L; p = 0.484), and 24-hour mean blood glucose (7.49 ± 0.96 mmol/L vs. 7.02 ± 1.03 mmol/L). Changes in the C-peptide reactivity index, the secretory unit of islet in transplantation index, and insulin secretion-sensitivity index-2 indicated a greater β-cell function improvement with basal insulin plus OHAs versus CSII. Conclusions Short-term insulin glargine plus OHAs may be an alternative to CSII for initial intensive therapy in people with newly diagnosed type 2 diabetes.
Highlights
The progressive nature of type 2 diabetes mellitus is ascribed to a vicious cycle of increasing insulin resistance and progressive pancreatic islet β-cell dysfunction [1, 2], caused by the toxic effects of hyperglycemia and gluco-lipotoxicity [3]
No differences were observed between baseline values of glucose assessment parameters (HbA1c, glycated albumin, fasting plasma glucose (FPG), and PPG), proinsulin to immunoreactive insulin (PI/IRI), or indices of β-cell secretion (CPI, secretory unit of islet in transplantation (SUIT), △INS0.5h/△GLU0.5h, and insulin secretion-sensitivity index2 (ISSI-2)) (Tables 1 and 2)
To the authors’ knowledge, this is the first randomized trial to compare the effect of short-term intensive therapy with basal insulin plus oral hypoglycemic agents (OHAs) versus continuous subcutaneous insulin infusion (CSII) in people with newly diagnosed type 2 diabetes mellitus
Summary
The progressive nature of type 2 diabetes mellitus is ascribed to a vicious cycle of increasing insulin resistance and progressive pancreatic islet β-cell dysfunction [1, 2], caused by the toxic effects of hyperglycemia and gluco-lipotoxicity [3]. Recent studies have suggested that early intensive glucose-lowering therapies are effective for managing blood glucose levels and sustaining β-cell function and have the long-term benefit of reducing the development of both micro- and macrovascular complications [5,6,7]. Of these intensive regimens, insulin-based protocols, such as continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI), are highly effective at reducing hyperglycemia in patients with poorly controlled type 2 diabetes [8,9,10,11]. Two to five weeks of CSII can reduce glucotoxicity, ameliorate insulin resistance, and promote recovery of β-cell function in subjects with newly diagnosed type 2 diabetes [13, 14]
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