The Benefits of Intensive Glycemic Control in Elderly Patients With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Intensive glycemic control
Conservative glycemic control
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 diabetes, Elder patients, Glycemic control, 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.
Eligibility Criteria
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
Sites / Locations
- Chen-Hsen LeeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Fasting plasma glucose (mg/dL) 90 to 130 Glycated hemoglobin (%) 6.0 to 7.0
Fasting plasma glucose (mg/dL) 90 to 180 Glycated hemoglobin (%) 7.0 to 9.0
Outcomes
Primary Outcome Measures
The primary study outcomes are a composite of macrovascular events and a composite of microvascular events, considered both jointly and separately.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00850798
First Posted
February 23, 2009
Last Updated
July 23, 2010
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT00850798
Brief Title
The Benefits of Intensive Glycemic Control in Elderly Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 diabetes, Elder patients, Glycemic control, 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.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
208 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Fasting plasma glucose (mg/dL) 90 to 130 Glycated hemoglobin (%) 6.0 to 7.0
Arm Title
2
Arm Type
Active Comparator
Arm Description
Fasting plasma glucose (mg/dL) 90 to 180 Glycated hemoglobin (%) 7.0 to 9.0
Intervention Type
Drug
Intervention Name(s)
Intensive glycemic control
Intervention Description
Intensive glycemic control
Intervention Type
Drug
Intervention Name(s)
Conservative glycemic control
Intervention Description
OADs and insulin
Primary Outcome Measure Information:
Title
The primary study outcomes are a composite of macrovascular events and a composite of microvascular events, considered both jointly and separately.
Time Frame
Every 6 months and up to 5 years
Secondary Outcome Measure Information:
Title
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.
Time Frame
Every 6 months and upto 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Harn-Shen Chen, MD, PhD
Phone
886-2-28757515
Email
chenhs@vghtpe.gov.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Hong-Da Lin, MD.
Phone
886-2-28757012
Email
hdlin@vghtpe.gov.tw
Facility Information:
Facility Name
Chen-Hsen Lee
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harn-Shen Chen, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
The Benefits of Intensive Glycemic Control in Elderly Patients With Type 2 Diabetes
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