The Benefits of Intensive Glycemic Control in Elderly Patients With Type 2 Diabetes

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Intensive glycemic control; Drug: Conservative glycemic control

• Study Type: Interventional
• Enrollment (Anticipated): 208
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 11217
    • Recruiting
    • Chen-Hsen Lee
    • Contact: Harn-Shen Chen, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 80 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men or women aged ≥80 years at time of randomization.There is no upper age limit.
• Be able to walk by themselves
• They had their first diagnosis of type 2 diabetes mellitus at age 30 years or older.

Exclusion Criteria:

• Known advanced diabetic complications (such as proliferative retinopathy, chronic kidney disease stage IV or above).
• Overt clinical congestive heart failure (CHF) requiring treatment with a diuretic or ACE inhibitor.
• Previous documented cerebral or subarachnoid haemorrhage in the last 6 months
• Condition expected to severely limit survival
• Clinical diagnosis of dementia
• Resident in a nursing home

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Fasting plasma glucose (mg/dL) 90 to 130 Glycated hemoglobin (%) 6.0 to 7.0	Drug: Intensive glycemic control; Intensive glycemic control
Active Comparator: 2; Fasting plasma glucose (mg/dL) 90 to 180 Glycated hemoglobin (%) 7.0 to 9.0	Drug: Conservative glycemic control; OADs and insulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary study outcomes are a composite of macrovascular events and a composite of microvascular events, considered both jointly and separately.	Every 6 months and up to 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
The secondary outcomes are death from any cause, disability from any cause, total coronary events, total cerebrovascular events, heart failure, peripheral vascular events, all cardiovascular events, and hospitalization for 24 hours or more.	Every 6 months and upto 5 years

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: February 23, 2009
• First Submitted That Met QC Criteria: February 24, 2009
• First Posted (Estimate): February 25, 2009

Study Record Updates

• Last Update Posted (Estimate): July 26, 2010
• Last Update Submitted That Met QC Criteria: July 23, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: Type 2 diabetes; Glycemic control; Elder patients; Men or women aged ≥80 years at time of randomization. There is no upper age limit.; Be able to walk by themselves; They had their first diagnosis of type 2 diabetes mellitus at age 30 years or older.
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: VGHIRB 97-12-04