Combination therapy for NIDDM with biosynthetic human insulin and glyburide.

ABSTRACT

OBJECTIVE: TO investigate the effects of the addition of glyburide to the regimen of insulin-treated non-insulin-dependent diabetes mellitus (NIDDM) patients with regard to their overall insulin requirement and dosage schedule and to assess persistence of these effects. RESEARCH DESIGN AND METHODS: A double-blind randomized parallel-groupo, placebo-controlled, 20-wk outpatient trial at the Clinical Research Unit (CRU) at St. Luke's/Roosevelt Hospital (New York). Subjects were 20 insulin-dependent NIDDM patients previously managed on insulin alone. After a baseline period of satisfactory diabetes control on biosynthetic human insulin alone, insulin dosage was halved, and patients were placed on a combination with either glyburide or placebo. Diabetes control equivalent to baseline was reestablished by adjusting insulin as required on subsequent visits to the CRU. RESULTS: Insulin requirements in the glyburide group decreased by 29 U at 14 wk compared with 9 U in the placebo group (P less than 0.05). At 20 wk, the decreases remained significant (25 vs. 11 U, respectively; P less than 0.05). The mean +/- SD reduction in insulin requirement in the glyburide group was relatively constant (25 +/- 10 U) and was not related to premedication insulin requirement. Successful response to glyburide was inversely correlated with initial serum alkaline phosphatase level. CONCLUSIONS: Glyburide reduces insulin requirements for 20 wk of combination therapy in NIDDM patients. Patients whose initial insulin requirement is less than or equal to 25 U have a 50% chance of achieving equivalent glycemic control on glyburide alone.