The Benefits of Intensive Glycemic Control in Elderly Pat... | NCT00850798

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

NCT00850798

Sponsor

Taipei Veterans General Hospital, Taiwan

Status

Unknown status

Last Update Posted

Jul 26, 2010Estimated

Enrollment

208Estimated

Phase

Not Applicable

Conditions

Type 2 Diabetes

Interventions

Intensive glycemic control
Conservative glycemic control

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Feb 23, 2009

First Submission Date that Met QC Criteria

Feb 24, 2009

First Posted Date

Feb 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2010

Last Update Posted Date

Jul 26, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Taipei Veterans General Hospital, TaiwanOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Conditions Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

208Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Intensive glycemic control	Drug	Intensive glycemic control	1
Conservative glycemic control

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

80 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chen-Hsen Lee	Recruiting	Taipei		11217	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D018761	Multiple Endocrine Neoplasia Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided