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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2010 by Taipei Veterans General Hospital, Taiwan
Sponsor:
Information provided by:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT00850798
First received: February 23, 2009
Last updated: July 23, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Drug: Intensive glycemic control
Drug: Conservative glycemic control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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. [ Time Frame: Every 6 months and upto 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 208
Study Start Date: February 2009
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   80 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00850798

Contacts
Contact: Harn-Shen Chen, MD, PhD 886-2-28757515 chenhs@vghtpe.gov.tw
Contact: Hong-Da Lin, MD. 886-2-28757012 hdlin@vghtpe.gov.tw

Locations
Taiwan
Chen-Hsen Lee Recruiting
Taipei, Taiwan, 11217
Contact: Harn-Shen Chen, MD, PhD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
  More Information

No publications provided

Responsible Party: Chen-Hsen Lee, Chairman, Institutional Review Board, Taipei Veterans General Hospital,Taiwan
ClinicalTrials.gov Identifier: NCT00850798     History of Changes
Other Study ID Numbers: VGHIRB 97-12-04
Study First Received: February 23, 2009
Last Updated: July 23, 2010
Health Authority: Institutional Review Board, Taipei Veterans General Hospital: Taiwan, ROC

Keywords provided by Taipei Veterans General Hospital, Taiwan:
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.

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 20, 2014