Randomized study comparing basal bolus with basal + correction insulin regimen for hospital management of patients with type 2 diabetes: Basal Plus Trial

Umpierrez GE, Smiley D, Hermayer K, et al. Randomized study comparing a basal bolus with a basal plus correction insulin regimen for the hospital management of medical and surgical patients with type 2 diabetes: Basal Plus Trial. Diabetes Care. 2013;36(8):2169-2174.

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Background 

Glycemic improvement in critically ill patients can reduce hospital complications, hospital stay, and mortality. A basal bolus regimen shows better mean daily blood glucose (BG) and a higher amount of BG within target range vs sliding-scale insulin (SSI) for hospitalized patients with type 2 diabetes.

Basal bolus is the preferred insulin regimen for patients with diabetes not in the intensive care unit per clinical guidelines. But, use is limited due to the complexity of the regimen and fear of hypoglycemia. 

In this study, Umpierrez and colleagues explored the hypothesis that a single daily dose of basal insulin plus one other corrective dose of glulisine as needed with a meal might result in similar glycemic control and a lower rate of hypoglycemia than a basal bolus regimen. (Click here for slide) 

Design  

A total of 375 subjects (aged 18 to 80 years) with type 2 diabetes treated with diet, oral antidiabetic agents (OADs), or low-dose insulin (≤4 units/kg/day) were enrolled. Prior to randomization, BG was between 140 and 400 mg/dL; subjects were recruited when BG was >140 mg/dL. OADs were stopped at admission.

Randomization was in a 2:2:1 ratio:

  • Basal bolus: glargine once daily, glulisine before meals, corrective doses of glulisine by sliding scale for BG >140 mg/dL
  • Basal plus: glargine once daily, corrective glulisine given by sliding scale before meals for BG >140 mg/dL
  • Regular SSI (no basal insulin): for BG >140 mg/dL

The goal of insulin therapy was maintenance of fasting and premeal glucose levels between 100 and 140 mg/dL. Mean glucose level at admission was 204 ± 84 mg/dL for all groups. The primary outcome was between-group difference in glycemic control, measured by mean daily BG. (Click here for slide) 

Results  

All treatment regimens yielded prompt, sustained improvement in mean daily BG during hospital stay. The basal bolus and basal plus regimens showed similar improvements in daily BG after day 1 of treatment (P=0.16) and better glycemic control vs SSI (P=0.04). (Click here for slide) 

The percentage of glucose readings within the 70-140 mg/dL target range was highest with the basal plus regimen (42%) compared with the basal bolus (37%) and the SSI (32%) regimens (P=0.04). The percentage of glucose readings >180 mg/dL was lower in the basal bolus group (27%) compared with the basal plus (32%) and SSI (38%) regimens (P=0.11).  (Click here for slide) 

Treatment failure was defined as mean daily blood glucose >240 mg/dL or 2 consecutive values >240 mg/dL. In the SSI group, 19% of subjects had treatment failure, vs 0% in the basal bolus group and 2% in the basal plus group (P<0.0001).

There were no differences in the frequency of hypoglycemic events between the basal bolus and basal plus regimens: 16% of subjects in the basal bolus group had BG <70 mg/dL, vs 13% in the basal plus group and 3% in the SSI group (P=0.009). No between-group differences in the rate of severe hypoglycemia (<40 mg/dL) were seen (P=0.76). (Click here for slide)   

 

 

The pharmacologic agents discussed are approved for use in the United States by the U.S. Food and Drug Administration (FDA) unless otherwise noted. Consult individual prescribing information for approved uses outside of the United States. 

April 2013 

This overview was created by KnowledgePoint360 Group, LLC, and was not associated with funding via an educational grant or a promotional/commercial interest.  

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Last Modified: 3/23/2015