Comparison of Two Biphasic Insulin Regimens

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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Premixed Human Isophane Insulin Suspension + Human Insulin Injection; Drug: Premixed Insulin

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Premixed Insulin; Premixed Human Insulin	Drug: Premixed Human Isophane Insulin Suspension + Human Insulin Injection; premixed human insulin; Other Names: premixed human insulin; Drug: Premixed Insulin; Premixed Insulin Analog Biphasic Aspart 30; Other Names: Biphasic Aspart 30
ACTIVE_COMPARATOR: Premixed insulin; Premixed Insulin Analog	Drug: Premixed Human Isophane Insulin Suspension + Human Insulin Injection; premixed human insulin; Other Names: premixed human insulin; Drug: Premixed Insulin; Premixed Insulin Analog Biphasic Aspart 30; Other Names: Biphasic Aspart 30

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Collaborators: University Hospital Tuebingen
• Investigators: Principal Investigator: Triantafyllos Didangelos, Assoc. Prof., AHEPA Hospital Aristotle University Of Thessaloniki

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 18, 2016
• Primary Completion (ACTUAL): February 3, 2020
• Study Completion (ACTUAL): February 3, 2020

Study Registration Dates

• First Submitted: January 23, 2021
• First Submitted That Met QC Criteria: January 23, 2021
• First Posted (ACTUAL): January 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 23, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: insulin; diabetes mellitus type 2; continuous glucose monitoring; glycated hemoglobin; glycemic control; premixed insulin analog; fructosamine; glycated albumin; premixed human insulin
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef
• Other Study ID Numbers: 2279

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No