Comparison of Two Biphasic Insulin Regimens

Aristotle University Of Thessaloniki

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Premixed Human Isophane Insulin Suspension + Human Insulin Injection; Drug: Premixed Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT04726657

2279

Details and patient eligibility

About

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

Full description

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Premixed Insulin

Active Comparator group

Description:

Premixed Human Insulin

Treatment:

Drug: Premixed Insulin

Drug: Premixed Human Isophane Insulin Suspension + Human Insulin Injection

Premixed insulin

Active Comparator group

Description:

Premixed Insulin Analog

Treatment:

Drug: Premixed Insulin

Drug: Premixed Human Isophane Insulin Suspension + Human Insulin Injection