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CompletedNCT04726657Updated Jan 27, 2021

Comparison of Two Biphasic Insulin Regimens

An interventional study of Premixed Human Isophane Insulin Suspension + Human Insulin Injection and Premixed Insulin in Diabetes Mellitus, Type 2, sponsored by Aristotle University Of Thessaloniki. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-27.

Sponsored by Aristotle University Of Thessaloniki · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years after the study started (first participant enrolled Jan 2016, registered Jan 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • diabetes mellitus type 2
  • glycemic control
  • glycated albumin
  • continuous glucose monitoring
  • fructosamine
  • glycated hemoglobin
  • insulin
  • premixed human insulin
  • premixed insulin analog
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 36 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Aristotle University Of Thessaloniki is the lead sponsor of 274 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Active comparator
    Premixed Insulin

    Premixed Human Insulin

    Drug: Premixed Human Isophane Insulin Suspension + Human Insulin Injection · Drug: Premixed Insulin

  • Active comparator
    Premixed insulin

    Premixed Insulin Analog

    Drug: Premixed Human Isophane Insulin Suspension + Human Insulin Injection · Drug: Premixed Insulin

Interventions

  • DrugPremixed Human Isophane Insulin Suspension + Human Insulin Injection

    premixed human insulin

    Also known as: premixed human insulin

  • DrugPremixed Insulin

    Premixed Insulin Analog Biphasic Aspart 30

    Also known as: Biphasic Aspart 30

06

What researchers measure

Primary outcomes

  1. Change in average blood glucose

    average blood glucose (mg/dl) from continuous glucose monitoring

    Time frame: 7 days

  2. Glycated Albumin

    levels of glycated albumin (%) in serum

    Time frame: 7 days

  3. Fructosamine

    levels of fructosamine (μmol/L) in serum

    Time frame: 7 days

Secondary outcomes

  1. Daily Insulin requirements

    change in total daily dose of insulin (u)

    Time frame: 7 days

  2. nocturnal average blood glucose

    change in nocturnal average blood glucose

    Time frame: 7 days

  3. Time in range

    change in time in range (% and minutes) from continuous glucose monitoring

    Time frame: 7 days

  4. time above 180

    change in time above 180 (% and minutes) from continuous glucose monitoring

    Time frame: 7 days

  5. time below 70

    change in time below 70 (% and minutes) from continuous glucose monitoring

    Time frame: 7 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Upon request

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04726657
Lead sponsor
Aristotle University Of Thessaloniki
Collaborators
University Hospital Tuebingen
Responsible party
Prof. Triantafyllos Didangelos (Associate Professor of Internal Medicine-Diabetology, Aristotle University Of Thessaloniki) — Principal investigator
First posted
Jan 27, 2021
Start date
Jan 18, 2016
Primary completion
Feb 3, 2020
Completion
Feb 3, 2020
Last update
Jan 27, 2021

Study contacts

Triantafyllos Didangelos, Assoc. Prof.
principal investigator · AHEPA Hospital Aristotle University Of Thessaloniki

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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