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Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or 2 Diabetes

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

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

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Type 1 or 2 diabetes for at least 3 months
  • Stabilised on current treatment with premixed human insulin for at least 4 weeks
  • Body mass index (BMI) between 18-40 kg/m2
  • HbA1c below 13.0%
  • Able and willing to perform self-blood glucose monitoring

Exclusion Criteria:

  • The receipt of any investigational drug within the last three months prior to this trial
  • Has a history of drug abuse or alcohol dependence within the last 5 years
  • Active proliferative retinopathy requiring laser or surgical intervention within the last year
  • Recurrent major hypoglycaemia as judged by the Investigator
  • Known or suspected allergy to trial product or related product

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

Outcomes

Primary Outcome Measures

2-hr postprandial plasma glucose (PPPG) excursion

Secondary Outcome Measures

HbA1c
Fasting plasma glucose

Full Information

First Posted
February 6, 2008
Last Updated
February 22, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00617565
Brief Title
Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or 2 Diabetes
Official Title
A Multi-centre, Randomised, Parallel, Open Labelled Study to Compare the Efficacy and Safety Profile of Biphasic Insulin Aspart 30 (BIAsp 30) and Biphasic Human Insulin 30/70 (BHI 30/70) in Chinese Type 1 and 2 Diabetics
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 8, 2003 (Actual)
Primary Completion Date
November 26, 2003 (Actual)
Study Completion Date
November 26, 2003 (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 Asia. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on postprandial glycaemic control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
219 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart
Other Intervention Name(s)
BIASP
Intervention Type
Drug
Intervention Name(s)
biphasic human insulin
Primary Outcome Measure Information:
Title
2-hr postprandial plasma glucose (PPPG) excursion
Time Frame
after 12 weeks of treatment
Secondary Outcome Measure Information:
Title
HbA1c
Title
Fasting plasma glucose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 1 or 2 diabetes for at least 3 months Stabilised on current treatment with premixed human insulin for at least 4 weeks Body mass index (BMI) between 18-40 kg/m2 HbA1c below 13.0% Able and willing to perform self-blood glucose monitoring Exclusion Criteria: The receipt of any investigational drug within the last three months prior to this trial Has a history of drug abuse or alcohol dependence within the last 5 years Active proliferative retinopathy requiring laser or surgical intervention within the last year Recurrent major hypoglycaemia as judged by the Investigator Known or suspected allergy to trial product or related product
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
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Beijing
ZIP/Postal Code
100029
Country
China

12. IPD Sharing Statement

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

Learn more about this trial

Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or 2 Diabetes

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