Effect of GlucoNorm vs Glyburide on Post-Prandial Hyperglycemia in Elderly Subjects With Type 2 Diabetes

The results from the DECODE Study have shown that postprandial hyperglycemia is more common in elderly people with diabetes than younger people and is the best predictor of mortality and morbidity. Studies in younger people with diabetes have shown that in response to a meal, insulin profiles are more physiologic and glucose levels are lower with GlucoNorm than with Glyburide. There is no data available that demonstrates this in elderly people with type 2 diabetes.

This is a randomized, open-label, cross-over study. Subjects will undergo 2 Standard Meal Tests with Ensure 325 ml separated by 15 - 30 days. Group 1 will receive GlucoNorm 1 mg during the 1st Standard Meal Test and Glyburide 2.5 mg during the 2nd Standard Meal Test. Group 2 will receive Glyburide 2.5 mg during the 1st Standard Meal Test and GlucoNorm 1mg during the 2nd Standard Meal Test.

Inclusion criteria

• Type 2 diabetes > 3 months duration
• Male or female
• Over 65 years of age
• Diet controlled only
• HgbA1C < 8.5%

Exclusion criteria

• Treatment with oral hypoglycemic agents or insulin or the likelihood of requiring treatment with these during the study.
• Anemia - hgb below 130 g/L (males) and below 120 g/L (females).
• Taking medications that known to interfere with glucose metabolism eg systemic corticosteriods, non-selective beta blockers.
• Known or suspected allergy to glyburide, sulfa drugs or GlucoNorm impaired liver function, as shown by but not limited to AST and/or ALT > 2x the upper limit of normal.
• Impaired renal function, as shown by but not limited to serum creatinine > 133 µmol/L (males) or 124 µmol/L (females).
• Participated in another clinical trial within the past 30 days.