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Completed

NCT Number: NCT04726657

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Premixed Human Isophane Insulin Suspension + Human Insulin Injection

Drug

premixed human insulin

Other names: premixed human insulin

PREMIXED INSULIN

Drug

Premixed Insulin Analog Biphasic Aspart 30

Other names: Biphasic Aspart 30

Primary outcomes

  1. Change in average blood glucose

    Time frame: 7 days

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

  2. Glycated Albumin

    Time frame: 7 days

    levels of glycated albumin (%) in serum

  3. Fructosamine

    Time frame: 7 days

    levels of fructosamine (μmol/L) in serum

Secondary outcomes

  1. Daily Insulin requirements

    Time frame: 7 days

    change in total daily dose of insulin (u)

  2. nocturnal average blood glucose

    Time frame: 7 days

    change in nocturnal average blood glucose

  3. Time in range

    Time frame: 7 days

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

  4. time above 180

    Time frame: 7 days

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

  5. time below 70

    Time frame: 7 days

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

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Collaborators

  • University Hospital Tuebingen

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jan 27, 2021
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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