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

NCT00850798 | Unknown DMC

• 1 other identifier: VGHIRB 97-12-04
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

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.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

Fasting plasma glucose (mg/dL) 90 to 130 Glycated hemoglobin (%) 6.0 to 7.0

Drug: Intensive glycemic control

2

ACTIVE COMPARATOR

Fasting plasma glucose (mg/dL) 90 to 180 Glycated hemoglobin (%) 7.0 to 9.0

Drug: Conservative glycemic control

Interventions

Intensive glycemic control DRUG

Intensive glycemic control

1

Conservative glycemic control DRUG

OADs and insulin

2

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Chen-Hsen Lee

Taipei, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Harn-Shen Chen, MD, PhD

CONTACT

886-2-28757515; chenhs@vghtpe.gov.tw

Hong-Da Lin, MD.

CONTACT

886-2-28757012; hdlin@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: February 23, 2009
• First Posted: February 25, 2009
• Study Start: February 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2020
• Last Updated: July 26, 2010

Record last verified: 2010-06

Locations

TW (1)