Status:
COMPLETED
Comparison of Two Biphasic Insulin Regimens
Lead Sponsor:
Aristotle University Of Thessaloniki
Collaborating Sponsors:
University Hospital Tuebingen
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Comparison of Two Biphasic Insulin Regimens in Well-controlled Patients With the Use of Continuous Glucose Monitoring and New Glycemic Control Indices
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 18 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2020
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04726657
Start Date
January 18 2016
End Date
February 3 2020
Last Update
January 27 2021
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