Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Subjects With Type 2 Diabetes

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

543 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-03

Study Completion Date

2017-06-19

Brief Summary

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This trial is conducted in Asia. The aim of this trial is to compare efficacy and safety of insulin degludec/insulin aspart and BIAsp 30 in subjects with type 2 diabetes.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IDegAsp BID

Group Type EXPERIMENTAL

insulin degludec/insulin aspart

Intervention Type DRUG

Twice daily subcutaneous (sc, under the skin) injection.

BIAsp 30 BID

Group Type ACTIVE_COMPARATOR

biphasic insulin aspart

Intervention Type DRUG

Twice daily subcutaneous (sc, under the skin) injection.

Interventions

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insulin degludec/insulin aspart

Twice daily subcutaneous (sc, under the skin) injection.

Intervention Type DRUG

biphasic insulin aspart

Twice daily subcutaneous (sc, under the skin) injection.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Male or female at least 18 years of age
* Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
* Insulin treated subjects on current treatment: basal insulin, premixed insulin or a self-mixed insulin regimen, all administered once daily (OD) or BID with or without metformin. The treatment regimen should have remained unchanged for at least 8 weeks prior to randomisation
* HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
* Body mass index (BMI) equal or below 40.0 kg/m\^2

Exclusion Criteria

* Treatment with sulphonylureas, meglitinides, DPP-4 inhibitors, alpha-glycosidase inhibitors within 8 weeks prior to screening (Visit 1) or thiazolidinediones (TZDs) or GLP-1 receptor agonists within 12 weeks prior to screening (Visit 1)
* Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers and monoamine oxidase (MAO) inhibitors
* Anticipated significant lifestyle changes during the trial according to the discretion of the investigator, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits
* Cardiovascular disease, within the last 6 months prior to screening (Visit 1), defined as: stroke; decompensated heart failure NYHA1 class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
* Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes, which in the investigator's opinion could interfere with the results of the trial
* Previous participation in this trial. Participation is defined as screened.
* Known or suspected hypersensitivity to trial products or related products

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Hefei, Anhui, China

Site Status