A Study to Evaluate the Efficacy and Safety of BRL 49653C in Non-insulin Dependent Diabetes
Status:
Completed
Trial end date:
2000-04-01
Target enrollment:
Participant gender:
Summary
At least 30% of patients initially treated with sulphonylureas for NIDOM will have a poor
response, and in the remaining 70% the subsequent failure rate is approximately 4% to 5% per
year. BRL 49653C has a different mechanism of action to the sulphonylureas, and therefore the
effects on fasting plasma glucose and Hb A1c are expected to be additive. Since circulatory
insulin levels should decrease, and plasma glucose should be regulated, these combinations
are also anticipated to slow both the progression of diabetic complications and delay the
need for exogenous insulin.
The proposed study is intended primarily to determine the effectiveness of BRL 49653C by
measure of glucose homeostasis as determined by Hb A1c and fasting plasma glucose, when added
to sulphonylurea therapy (sulphonylureas are limited to: glibenclamide, glipazide and
gliclazide). In addition, the clinical safety of BRL 49653C will be assessed in this patient
population. The starting doses have been selected based on dose response studies examining
safety, tolerability and efficacy in the U.S.A.