Comparison of Two Biphasic Insulin Regimens

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04726657
• Other study ID #: 2279
• Status: Completed
• Phase: N/A
• Start date: January 18, 2016
• Est. completion date: February 3, 2020

Study information

• Verified date: January 2021
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 3, 2020
• Est. primary completion date: February 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Premixed Human Isophane Insulin Suspension + Human Insulin Injection
premixed human insulin
• Premixed Insulin
Premixed Insulin Analog Biphasic Aspart 30

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki	University Hospital Tuebingen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in average blood glucose	average blood glucose (mg/dl) from continuous glucose monitoring	7 days
Primary	Glycated Albumin	levels of glycated albumin (%) in serum	7 days
Primary	Fructosamine	levels of fructosamine (µmol/L) in serum	7 days
Secondary	Daily Insulin requirements	change in total daily dose of insulin (u)	7 days
Secondary	nocturnal average blood glucose	change in nocturnal average blood glucose	7 days
Secondary	Time in range	change in time in range (% and minutes) from continuous glucose monitoring	7 days
Secondary	time above 180	change in time above 180 (% and minutes) from continuous glucose monitoring	7 days
Secondary	time below 70	change in time below 70 (% and minutes) from continuous glucose monitoring	7 days