NCT04726657

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable diabetes-mellitus-type-2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

4 years

First QC Date

January 23, 2021

Last Update Submit

January 23, 2021

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetes mellitus type 2glycemic controlglycated albumincontinuous glucose monitoringfructosamineglycated hemoglobininsulinpremixed human insulinpremixed insulin analog

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • Daily Insulin requirements

    7 days

  • nocturnal average blood glucose

    7 days

  • Time in range

    7 days

  • time above 180

    7 days

  • time below 70

    7 days

Study Arms (2)

Premixed Insulin

ACTIVE COMPARATOR

Premixed Human Insulin

Drug: Premixed Human Isophane Insulin Suspension + Human Insulin InjectionDrug: Premixed Insulin

Premixed insulin

ACTIVE COMPARATOR

Premixed Insulin Analog

Drug: Premixed Human Isophane Insulin Suspension + Human Insulin InjectionDrug: Premixed Insulin

Interventions

Premixed Human Isophane Insulin Suspension + Human Insulin InjectionDRUG

premixed human insulin

Also known as: premixed human insulin
Premixed InsulinPremixed insulin
Premixed InsulinDRUG

Premixed Insulin Analog Biphasic Aspart 30

Also known as: Biphasic Aspart 30
Premixed InsulinPremixed insulin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Interventions

Insulininsulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Triantafyllos Didangelos, Assoc. Prof.

    AHEPA Hospital Aristotle University Of Thessaloniki

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Cross-over
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Internal Medicine-Diabetology

Study Record Dates

First Submitted

January 23, 2021

First Posted

January 27, 2021

Study Start

January 18, 2016

Primary Completion

February 3, 2020

Study Completion

February 3, 2020

Last Updated

January 27, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Upon request