Insulin Effects on Metabolism and Cardiovascular Function in Type 2 Diabetes

Study Overview
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Brief Summary
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Compared to human insulins analogue insulins offer the option of optimizing metabolism also in type 2 diabetes. Especially, fast acting insulin analogues lower postprandial glucose levels more effectively than human regular insulin. However, it is not known whether therapy with analogue insulins can also improve the subclinically impaired myocardial function in type 2 diabetes. This prospective, randomized, open long term study compared the effects of a basal-bolus insulin therapy with analogue insulins versus human insulins on metabolic control and systolic and diastolic myocardial function, testing the hypothesis that optimized postprandial glucose control improves cardiac function and cardiovascular risk.

Detailed Description
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This is a single centre, long term (24-48 months), therapy controlled and randomised study with blinded analysis of the ultrasound data in 120 patients with type 2 diabetes mellitus and with previous insulin therapy. After recruitment and informed consent, patients are randomized to two treatment arms according to a randomisation protocol which takes into account age and absence or presence of cardiovascular events in each patient's history. In one treatment arm, the intensive insulin therapy is based on human insulin (insulin NPH and regular human insulin) while in the other arm, the intensive insulin therapy is based on analogue insulin (insulin detemir and insulin aspart). Both treatment arms will be titrated to identical glycemic goals (fasting blood glucose <110 mg/dL and post prandial blood glucose <150 mg/dL). All patients will be updated in their skills of self medication by the departmental diabetic teaching programme und will receive life style instructions during each visit. Furthermore, they are encouraged to keep records of any episode of hypoglycemia throughout the study. Outpatient visits for metabolic control are every 3 months and ultrasound and blood tests every 6 months.

Official Title
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Randomized, Long-Term Study About the Effects of Analogue Versus Human Insulin Based Regimens (Insulin Detemir and Aspart Versus NPH- and Regular Human Insulin) on Metabolic Control and Myocardial Function in People With Type 2 Diabetes.

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: insulin aspart and detemir (NovoRapid, Levemir)
* Drug: human regular insulin and NPH insulin (Actrapid, Protaphne)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 2 diabetes, insulin therapy Exclusion Criteria: type 1 diabetes, BMI >40, pregnancy,

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hum<br>use of human regular insulin and NPH insulin | Drug: human regular insulin and NPH insulin (Actrapid, Protaphne)<br>* basal-bolus therapy with human regular and NPH insulin<br>* Other names: Insulin Actrapid, Insulin Protaphne;|
| Active Comparator: Ana<br>use of insulin aspart and insulin detemir | Drug: insulin aspart and detemir (NovoRapid, Levemir)<br>* use of basal-bolus therapy with insulin aspart and detemir<br>* Other names: Insulin NovoRapid, Insulin Levemir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postprandial blood glucose at the end of the study and its change from baseline. |  | 24-48 months treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diastolic myocardial function |  | 24-48 months treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postprandial glucose, diastolic function, analogue insulins