Type 2 Diabetes Clinical Trial
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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