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Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Type 2 Diabetes

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
biphasic insulin aspart
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects must have been correctly included in and completed BIAsp-1234

Exclusion Criteria:

  • Persistent non-compliance with study medication, visit schedules or other trial specific procedures during the preceding trial
  • Fulfilment of any withdrawal criteria prior to and including the final visit of the BIAsp-1234.
  • Females only: breast feeding, intention of becoming pregnant, or judged to be using inadequate contraceptive measures (adequate contraceptive methods are sterilisation,IUD (Intra Uterine Device), oral contraceptives or barrier methods)
  • Known or suspected allergy to trial product or related products
  • Development since entry into the previous trial of late diabetic micro or macro vascular complications, which in the opinion of the Investigator indicates a progressed state of disease

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

Occurrence of adverse events
Frequency of hypoglycaemic episodes

Secondary Outcome Measures

HbA1c (glycosylated haemoglobin)

Full Information

First Posted
November 4, 2011
Last Updated
February 22, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01467375
Brief Title
Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Type 2 Diabetes
Official Title
An Open Label, Non Comparative, Multicentre Extension Trial to Assess the Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Who Have Completed BIAsp-1234
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 8, 2001 (Actual)
Primary Completion Date
October 22, 2004 (Actual)
Study Completion Date
October 22, 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is conducted in Oceania and North America. The aim of this trial is to assess the long term safety and efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes who have completed the BIAsp-1234 trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart
Intervention Description
Individually adjusted dose, injected s.c. (under the skin) before breakfast and dinner
Primary Outcome Measure Information:
Title
Occurrence of adverse events
Title
Frequency of hypoglycaemic episodes
Secondary Outcome Measure Information:
Title
HbA1c (glycosylated haemoglobin)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must have been correctly included in and completed BIAsp-1234 Exclusion Criteria: Persistent non-compliance with study medication, visit schedules or other trial specific procedures during the preceding trial Fulfilment of any withdrawal criteria prior to and including the final visit of the BIAsp-1234. Females only: breast feeding, intention of becoming pregnant, or judged to be using inadequate contraceptive measures (adequate contraceptive methods are sterilisation,IUD (Intra Uterine Device), oral contraceptives or barrier methods) Known or suspected allergy to trial product or related products Development since entry into the previous trial of late diabetic micro or macro vascular complications, which in the opinion of the Investigator indicates a progressed state of disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Broadmeadow
State/Province
New South Wales
ZIP/Postal Code
2292
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Ashford
ZIP/Postal Code
5035
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Auchenflower
ZIP/Postal Code
4066
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Launceston
ZIP/Postal Code
7250
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Nowra
ZIP/Postal Code
2540
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Ringwood
ZIP/Postal Code
3134
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Rooty Hill
ZIP/Postal Code
2766
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Hull
ZIP/Postal Code
J8Y 1W1
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
London
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Saskatoon
ZIP/Postal Code
S7N 0W8
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Type 2 Diabetes

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