Comparison of Two Biphasic Insulin Regimens

NCT ID: NCT04726657

Last Updated: 2021-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-18

Study Completion Date

2020-02-03

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Cross-over
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Premixed Insulin

Premixed Human Insulin

Group Type ACTIVE_COMPARATOR

Premixed Human Isophane Insulin Suspension + Human Insulin Injection

Intervention Type DRUG

premixed human insulin

Premixed Insulin

Intervention Type DRUG

Premixed Insulin Analog Biphasic Aspart 30

Premixed insulin

Premixed Insulin Analog

Group Type ACTIVE_COMPARATOR

Premixed Human Isophane Insulin Suspension + Human Insulin Injection

Intervention Type DRUG

premixed human insulin

Premixed Insulin

Intervention Type DRUG

Premixed Insulin Analog Biphasic Aspart 30

Interventions

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Premixed Human Isophane Insulin Suspension + Human Insulin Injection

premixed human insulin

Intervention Type DRUG

Premixed Insulin

Premixed Insulin Analog Biphasic Aspart 30

Intervention Type DRUG

Other Intervention Names

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premixed human insulin Biphasic Aspart 30

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role collaborator

Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Prof. Triantafyllos Didangelos

Associate Professor of Internal Medicine-Diabetology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Triantafyllos Didangelos, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

AHEPA Hospital Aristotle University Of Thessaloniki

Other Identifiers

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2279

Identifier Type: -

Identifier Source: org_study_id

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