Comparison of Two Biphasic Insulin Regimens

Study Overview
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Brief Summary
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Comparison of Two Biphasic Insulin Regimens in Well-controlled Patients With the Use of Continuous Glucose Monitoring and New Glycemic Control Indices

Detailed Description
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A cross-over study of 36 well controlled people with type 2 Diabetes Mellitus who underwent 7-day Continuous Glucose Monitoring with Premixed Human Insulin 30/70 and subsequently with Biphasic Aspart 30.

Official Title
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Comparison of Two Biphasic Insulin Regimens in Well-controlled Patients With the Use of Continuous Glucose Monitoring and New Glycemic Control Indices

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Premixed Human Isophane Insulin Suspension + Human Insulin Injection
* Drug: Premixed Insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: regular attendees of Outpatient Clinic of the Diabetes Centre of the 1st Department of Internal Medicine of University Hospital in Thessaloniki Greece The patients were on Premixed Human Insulin 30/70 twice daily with or without metformin baseline HbA1c<7% Exclusion Criteria: the presence of type 1 Diabetes Mellitus stage 4 Chronic Kidney Disease use of antidiabetic medications other than insulin and metformin major cardiovascular event during the last six months acute illness and hospitalization during the last two weeks pregnancy absence of good metabolic control assessed with self-monitoring of blood glucose during the week before entering the study (>20% of the measurements <80mg/dl or >130mg/dl) inability of the patients to understand the study procedures and sign the consent form

Ages Eligible for Study
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Minimum Age: 18 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: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Cross-over
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Premixed Insulin<br>Premixed Human Insulin | Drug: Premixed Human Isophane Insulin Suspension + Human Insulin Injection<br>* premixed human insulin<br>* Other names: premixed human insulin;Drug: Premixed Insulin<br>* Premixed Insulin Analog Biphasic Aspart 30<br>* Other names: Biphasic Aspart 30;|
| Active Comparator: Premixed insulin<br>Premixed Insulin Analog | Drug: Premixed Human Isophane Insulin Suspension + Human Insulin Injection<br>* premixed human insulin<br>* Other names: premixed human insulin;Drug: Premixed Insulin<br>* Premixed Insulin Analog Biphasic Aspart 30<br>* Other names: Biphasic Aspart 30;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in average blood glucose | average blood glucose (mg/dl) from continuous glucose monitoring | 7 days | 
| Glycated Albumin | levels of glycated albumin (%) in serum | 7 days | 
| Fructosamine | levels of fructosamine (μmol/L) in serum | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Insulin requirements | change in total daily dose of insulin (u) | 7 days | 
| nocturnal average blood glucose | change in nocturnal average blood glucose | 7 days | 
| Time in range | change in time in range (% and minutes) from continuous glucose monitoring | 7 days | 
| time above 180 | change in time above 180 (% and minutes) from continuous glucose monitoring | 7 days | 
| time below 70 | change in time below 70 (% and minutes) from continuous glucose monitoring | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus type 2, glycemic control, glycated albumin, continuous glucose monitoring, fructosamine, glycated hemoglobin, insulin, premixed human insulin, premixed insulin analog