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Combination insulin/glyburide therapy in type II diabetes mellitus

1985; Elsevier BV; Volume: 79; Issue: 3 Linguagem: Inglês

10.1016/s0002-9343(85)80014-0

1555-7162

James M. Falko, Kwame Osei,

Diabetes Treatment and Management

A randomized double-blind, placebo-controlled trial of insulin plus glyburide was carried out in 22 insulin-treated patients with poorly controlled type II diabetes mellitus. Glycemic control and lipoprotein responses were assessed for 16 weeks. Oral glucose tolerance testing was performed at weeks 0, 4, and 16. Clinical characteristics and glycemic control were similar at week 0 in the placebo/insulin group (n=12) and the glyburide/insulin group (n=10). Throughout the study, the dose of insulin was fixed. The placebo group had no change in any metabolic parameter throughout the protocol period. After four weeks, glyburide significantly lowered fasting blood glucose and integrated glucose areas (p<0.01) after oral glucose testing compared with week 0 (fasting blood glucose 225±20 mg/dl versus 286±27 mg/dl, p<0.02). Associated with this were mean fasting, stimulated, and integrated C-peptide levels that were significantly higher (p<0.02) at week 4 versus week 0. After 16 weeks, mean fasting blood glucose remained significantly lower compared with baseline values (252±25 mg/dl versus 286±27 mg/dl, p<0.05). Glycosylated hemoglobin (hemoglobin A1c) levels decreased significantly (p<0.05) at weeks 4 to 16 compared with the baseline value. Although integrated areas were no different after oral glucose, fasting and stimulated C-peptide levels were significantly higher (p<0.05) at week 16 versus week 0. Total cholesterol, triglycerides, low-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol did not change during the study. After the code was broken, comparisons were made between those with response to combination therapy (reduction of fasting blood glucose by at least 50 mg/dl or fasting blood glucose of 140 mg/dl or less at the end of the first week of treatment that persisted for four consecutive weeks) and those without response. Baseline clinical and laboratory characteristics were identical in both groups. Mean fasting and stimulated serum C-peptide levels after oral glucose, however, were significantly higher in the patients with response at week 4 compared with the patients without response. The mean maximal incremental C-peptide level was 1.50±0.19 ng/ml at week 0 in the patients with response compared with 0.67±0.28 ng/ml in the patients without response (p<0.01). Lipoproteins were not different in the two groups. In summary, concomitant insulin and glyburide treatment may produce useful improvement of diabetic control in insulin-treated type II diabetic patients who secrete some endogenous insulin. Long-term prospective studies with combination therapy are needed to further define its role in the future management of type II diabetic patients. A randomized double-blind, placebo-controlled trial of insulin plus glyburide was carried out in 22 insulin-treated patients with poorly controlled type II diabetes mellitus. Glycemic control and lipoprotein responses were assessed for 16 weeks. Oral glucose tolerance testing was performed at weeks 0, 4, and 16. Clinical characteristics and glycemic control were similar at week 0 in the placebo/insulin group (n=12) and the glyburide/insulin group (n=10). Throughout the study, the dose of insulin was fixed. The placebo group had no change in any metabolic parameter throughout the protocol period. After four weeks, glyburide significantly lowered fasting blood glucose and integrated glucose areas (p<0.01) after oral glucose testing compared with week 0 (fasting blood glucose 225±20 mg/dl versus 286±27 mg/dl, p<0.02). Associated with this were mean fasting, stimulated, and integrated C-peptide levels that were significantly higher (p<0.02) at week 4 versus week 0. After 16 weeks, mean fasting blood glucose remained significantly lower compared with baseline values (252±25 mg/dl versus 286±27 mg/dl, p<0.05). Glycosylated hemoglobin (hemoglobin A1c) levels decreased significantly (p<0.05) at weeks 4 to 16 compared with the baseline value. Although integrated areas were no different after oral glucose, fasting and stimulated C-peptide levels were significantly higher (p<0.05) at week 16 versus week 0. Total cholesterol, triglycerides, low-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol did not change during the study. After the code was broken, comparisons were made between those with response to combination therapy (reduction of fasting blood glucose by at least 50 mg/dl or fasting blood glucose of 140 mg/dl or less at the end of the first week of treatment that persisted for four consecutive weeks) and those without response. Baseline clinical and laboratory characteristics were identical in both groups. Mean fasting and stimulated serum C-peptide levels after oral glucose, however, were significantly higher in the patients with response at week 4 compared with the patients without response. The mean maximal incremental C-peptide level was 1.50±0.19 ng/ml at week 0 in the patients with response compared with 0.67±0.28 ng/ml in the patients without response (p<0.01). Lipoproteins were not different in the two groups. In summary, concomitant insulin and glyburide treatment may produce useful improvement of diabetic control in insulin-treated type II diabetic patients who secrete some endogenous insulin. Long-term prospective studies with combination therapy are needed to further define its role in the future management of type II diabetic patients.