Abstract
BackgroundThe large clinical trials proved that Basal-Bolus (BB) insulin therapy was effective in the prevention of diabetic complications and their progression. However, BB therapy needs multiple insulin injections per a day. In this regard, a biphasic insulin analogue needs only twice-daily injections, and is able to correct postprandial hyperglycemia. Therefore it may achieve the blood glucose control as same as that of BB therapy and prevent the diabetic complications including macroangiopathy.MethodsIn PROBE (Prospective, Randomized, Open, Blinded-Endpoint) design, forty-two type 2 diabetic patients (male: 73.8%, median(inter quartile range) age: 64.5(56.8~71.0)years) with secondary failure of sulfonylurea (SU) were randomly assigned to BB therapy with a thrice-daily insulin aspart and once-daily basal insulin (BB group) or to conventional therapy with a twice-daily biphasic insulin analogue (30 Mix group), and were followed up for 6 months to compare changes in HbA1c, daily glycemic profile, intima-media thickness (IMT) of carotid artery, adiponectin levels, amounts of insulin used, and QOL between the two groups.ResultsAfter 6 months, HbA1c was significantly reduced in both groups compared to baseline (30 Mix; 9.3(8.1~11.3) → 7.4(6.9~8.7)%, p < 0.01, vs BB;8.9(7.7~10.0) → 6.9(6.2~7.3)%, p < 0.01), with no significant difference between the groups in percentage change in HbA1c (30 Mix; -14.7(-32.5~-7.5)% vs BB -17.8(-30.1~-11.1)%, p = 0.32). There was a significant decrease in daily glycemic profile at all points except dinner time in both groups compared to baseline. There was a significant increase in the amount of insulin used in the 30 Mix group after treatment compared to baseline (30 Mix;0.30(0.17~0.44) → 0.39(0.31~0.42) IU/kg, p = 0.01). There was no significant difference in IMT, BMI, QOL or adiponectin levels in either group compared to baseline.ConclusionBoth BB and 30 mix group produced comparable reductions in HbA1c in type 2 diabetic patients with secondary failure. There was no significant change in IMT as an indicator of early atherosclerotic changes between the two groups. The basal-bolus insulin therapy may not be necessarily needed if the type 2 diabetic patients have become secondary failure.Trial registrationCurrent Controlled Trials number, NCT00348231
Highlights
The large clinical trials proved that Basal-Bolus (BB) insulin therapy was effective in the prevention of diabetic complications and their progression
Insulin regimens currently in use include conventional once- or twice-daily insulin injection therapy, and intensive insulin therapy with a rapidacting insulin analogue administered three times daily before meals to reproduce the physiologic insulin secretion dynamics seen in healthy individuals complemented by Neutral Protamine Hargedorn (NPH) or long-acting insulin analogue injections administered at night on an on-demand basis
There was a significant decrease in daily glycemic profile at all time points except dinner following initiation of insulin therapy in both groups compared to baseline, with no significant difference noted in percentage change in glucose levels between the groups (Figure 3)
Summary
The large clinical trials proved that Basal-Bolus (BB) insulin therapy was effective in the prevention of diabetic complications and their progression. BB therapy needs multiple insulin injections per a day. In this regard, a biphasic insulin analogue needs only twice-daily injections, and is able to correct postprandial hyperglycemia. A biphasic insulin analogue needs only twice-daily injections, and is able to correct postprandial hyperglycemia It may achieve the blood glucose control as same as that of BB therapy and prevent the diabetic complications including macroangiopathy. The goal of diabetes management consists in the prevention of diabetic complications, as well as their progression, by achieving favorable control over glycemic and other risk factors [1]. Insulin regimens currently in use include conventional once- or twice-daily insulin injection therapy, and intensive insulin therapy with a rapidacting insulin analogue administered three times daily before meals to reproduce the physiologic insulin secretion dynamics seen in healthy individuals complemented by Neutral Protamine Hargedorn (NPH) or long-acting insulin analogue injections administered at night on an on-demand basis
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