Comparison of Two Biphasic Insulin Regimens

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Premixed Human Isophane Insulin Suspension + Human Insulin Injection; Drug: Premixed Insulin

• Registration Number: NCT04726657
• Lead Sponsor: Aristotle University Of Thessaloniki

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 30.

Study Timeline

• Study Start: 2016-01-18
• Primary Completion: 2020-02-03
• Study Completion: 2020-02-03
• Status Verified: 2021-01
• Study First Submitted: 2021-01-23
• Study First Submitted QC: 2021-01-23
• Last Update Submitted: 2021-01-23
• Study First Posted: 2021-01-27
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Premixed insulin	Premixed Insulin	Premixed Insulin Analog
Premixed Insulin	Premixed Insulin	Premixed Human Insulin
Premixed Insulin	Premixed Human Isophane Insulin Suspension + Human Insulin Injection	Premixed Human Insulin
Premixed insulin	Premixed Human Isophane Insulin Suspension + Human Insulin Injection	Premixed Insulin Analog

Primary Outcome Measures

Name	Time	Method
Change in average blood glucose	7 days	average blood glucose (mg/dl) from continuous glucose monitoring
Glycated Albumin	7 days	levels of glycated albumin (%) in serum
Fructosamine	7 days	levels of fructosamine (μmol/L) in serum

Secondary Outcome Measures

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