Completed

Biphasic Insulin Aspart 30 and Insulin Aspart Treatment Efficiency in Glycemic Control for Type 2 Diabetes

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Study Aim

This study aims to evaluate the efficiency of Biphasic Insulin Aspart 30 and Insulin Aspart in maintaining glycemic control, as measured by HbA1c levels, in individuals with Type 2 Diabetes.

What is being tested

biphasic insulin aspart 30

+ biphasic insulin aspart 30

+ insulin aspart

Drug
Who is being recruted

Endocrine System Diseases+3

+ Metabolic Diseases

+ Nutritional and Metabolic Diseases

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: July 2002
See protocol details

Summary

Principal SponsorNovo Nordisk A/S
Last updated: February 24, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: July 22, 2002

Actual date on which the first participant was enrolled.

This this trial is conducted in Europe. The aim of this trial is to compare glycaemic control of biphasic insulin aspart 30 (BIAsp 30) alone or combined with insulin aspart(IAsp) in patients previously treated with conventional Biphasic Human Insulin 30/70.

NCT01697631
Principal SponsorNovo Nordisk A/S
Last updated: February 24, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

131 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDiabetes MellitusDiabetes Mellitus, Type 2

Criteria

4 inclusion criteria required to participate
Current treatment with conventional biphasic human insulin 30/70 b.i.d. (twice daily) for at least 3 months
HbA1c (glycosylated haemoglobin) equal to or below 12%
Type 2 diabetes
Willing and able to perform self blood glucose monitoring (SMBG)
5 exclusion criteria prevent from participating
History of drug or alcohol dependence
Known or suspected allergy to trial products or related products
Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
Previous participation in this trial
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 12 locations

Novo Nordisk Investigational Site

Bialystok, PolandOpen Novo Nordisk Investigational Site in Google Maps

Novo Nordisk Investigational Site

Bytom, Poland

Novo Nordisk Investigational Site

Kamieniec Ząbkowicki, Poland

Novo Nordisk Investigational Site

Katowice, Poland
Completed12 Study Centers