Effects of a combination of oral anti-diabetes drugs with basal insulin therapy on β-cell function and glycaemic control in patients with newly diagnosed type 2 diabetes

Background Oral anti-diabetes drugs plus basal insulin (OAD+ insulin) therapy in patients with newly diagnosed type 2 diabetes might improve beta-cell function and result in extended glycaemic remission. This randomised trial compared the effect on beta-cell function and diabetes remission rate between oral drug alone or with addition of basal insulin. Methods One hundred and twenty-nine patients, aged 35-50 years, were enrolled between June 2005 and June 2009. For initial correction of hyperglycaemia, patients with fasting plasma glucose >= 9.0 mmol/L and HbA(1c) >= 9.0%, were randomly assigned to therapy with oral drugs+ insulin or oral drugs alone. Treatment was stopped after normoglycaemia was maintained for 3 months. Patients were then followed-up with diet and physical exercise. Blood glucose, HbA(1c) and insulin were measured prior to treatment and at 1-year follow-up. Results More patients achieved target glycaemic control in the oral drugs+ insulin group [98.3% (58 of 59)] in less time [(10.4 +/- 2.5) days] than those in the oral drug group [95.7% (67 of 70) and (12.4 +/- 3.4) days]. At 1-year follow-up, more patients maintained target glycaemia without any drugs in the oral drug+ insulin group than in the oral drug group [37.9% (22 of 58) vs 20.9% (14 of 67)]. Both treatments improved homeostasis model assessment-beta (HOMA-beta) and homeostasis model assessment-insulin resistance (HOMA-IR) significantly. They had similar effects on insulin resistance [lg(HOMA-IR): (0.50 +/- 0.09) vs (0.48 +/- 0.09), p= 0.23]. However, oral drugs+ insulin could recover beta-cell function much more than OAD alone could [lg(HOMA-beta): (2.17 +/- 0.14) vs (2.11 +/- 0.13), p= 0.03]. Conclusion In newly diagnosed type 2 diabetes, therapywith oral drugs+ insulin has had favourable outcomes on recovery and maintenance of beta-cell function and protracted glycaemic remission compared with treatment with oral drugs alone. Copyright c 2011 John Wiley & Sons, Ltd.