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

Study Overview
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Brief Summary
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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
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Intensive glycemic control
* Drug: Conservative glycemic control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Fasting plasma glucose (mg/dL) 90 to 130 Glycated hemoglobin (%) 6.0 to 7.0 | Drug: Intensive glycemic control<br>* Intensive glycemic control<br>|
| Active Comparator: 2<br>Fasting plasma glucose (mg/dL) 90 to 180 Glycated hemoglobin (%) 7.0 to 9.0 | Drug: Conservative glycemic control<br>* OADs and insulin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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.