The Benefits of Intensive Glycemic Control in Elderly Patients With Type 2 Diabetes
Status:
Unknown status
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
Summary
Aims/hypothesis:
Populations worldwide are aging and type 2 diabetes is common in individuals aged >80 years.
The important issue that needs to be considered is whether tight glycemic control is benefits
for elderly patients with type 2 diabetes. The benefits of intensive glucose control remain
uncertain for the heterogeneous population of older diabetic patients due to a lack of
clinical trial data evaluating the benefits of long-term intensive glucose control in older
patients. This study is designed to provide reliable evidence on the balance of benefits and
risks conferred by intensive glucose control in elderly patients with type 2 diabetes
Methods: This is a prospective, randomized, open-labeled, controlled design to assess the
benefits of treating elderly patients with type 2 diabetes. The study will include 208
elderly patients with type 2 diabetes and follow-up for 5 years. Eligible patients are
randomized to receive intensive (A1C <7.0%) or conservative (A1C around 8.0%) glycemic
control. The primary study outcomes are a composite of macrovascular events and a composite
of microvascular events, considered both jointly and separately. The secondary outcomes are
death from any cause, death from cardiovascular causes, total coronary events, total
cerebrovascular events, heart failure, peripheral vascular events, all cardiovascular events,
and hospitalization for 24 hours or more.
Expected results: This study is designed to provide reliable evidence on the balance of
benefits and risks conferred by intensive and conservative glucose control in elderly
patients with type 2 diabetes. Once completed, this trial will clearly influence the
management of elderly patients with type 2 diabetes, regardless of the results.