Type 2 DiabetesNCT00850798
The Benefits of Intensive Glycemic Control in Elderly Patients With Type 2 Diabetes
A study of Type 2 Diabetes, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Type 2 Diabetes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2009to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chen-Hsen Lee
Taipei, 11217
Harn-Shen Chen, MD, PhD
About this study
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
- Being tested
- Intensive glycemic control, Conservative glycemic control
- 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.
- Medical subject headings
- Diabetes Mellitus, Type 2, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive glycemic controlDrug
Intensive glycemic control
Conservative glycemic controlDrug
OADs and insulin
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Fasting plasma glucose (mg/dL) 90 to 130 Glycated hemoglobin (%) 6.0 to 7.0 Receives: Drug: Intensive glycemic control |
| 2 | Active comparator | Fasting plasma glucose (mg/dL) 90 to 180 Glycated hemoglobin (%) 7.0 to 9.0 Receives: Drug: Conservative glycemic control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary study outcomes are a composite of macrovascular events and a composite of microvascular events, considered both jointly and separately.
Measured: 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.
Measured: Every 6 months and upto 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2014 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850798
- Sponsor's protocol ID
- VGHIRB 97-12-04
- Status last verified
- Jun 2010
- First submitted
- 23 Feb 2009
- Last updated
- 26 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yang JH, Yeh YK, Chen HS. Intensive glycemic control in adults aged 80 years and older: A randomized trial evaluating diabetes complications and competing mortality. Diabetes Res Clin Pract. 2026 Aug 3:113483. doi: 10.1016/j.diabres.2026.113483. Online ahead of print.
PubMed 42546974
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefits of Intensive Glycemic Control in Elderly Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00850798
- Acronym / sponsor ID
- VGHIRB 97-12-04
- 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.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Feb 2009
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 25 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Intensive glycemic controlFasting plasma glucose (mg/dL) 90 to 130 Glycated hemoglobin (%) 6.0 to 7.0 |
| 2 | Active comparator | Drug: Conservative glycemic controlFasting plasma glucose (mg/dL) 90 to 180 Glycated hemoglobin (%) 7.0 to 9.0 |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive glycemic controlIntensive glycemic control | Drug | 1 |
| Conservative glycemic controlOADs and insulin | Drug | 2 |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2010.
- Derived from this study: PubMed 42546974Yang JH, Yeh YK, Chen HS. Intensive glycemic control in adults aged 80 years and older: A randomized trial evaluating diabetes complications and competing mortality. Diabetes Res Clin Pract. 2026 Aug 3:113483. doi: 10.1016/j.diabres.2026.113483. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Type 2 Diabetes, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Harn-Shen Chen, MD, PhD (886-2-28757515, chenhs@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00850798, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2010.