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CompletedNCT00184561Updated Jan 6, 2017

Effectiveness and Safety of Biphasic Insulin Aspart 70/30 in Subjects With Type 2 Diabetes

A Phase 4 interventional study of biphasic insulin aspart in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 8 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-01-06.

Sponsored by Novo Nordisk A/S · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
321
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This trial is conducted in Asia. This is a clinical trial investigating the effectiveness of using Biphasic Insulin Aspart 70/30 in two different treatment regiments for 6 months in subjects with type 2 diabetes, not well controlled on their current oral anti-diabetic drug therapy.

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 321 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Type 2 diabetes
  • HbA1C = 7.5%
  • Insulin naïve
  • Current treatment by Oral Anti-diabetic Drugs

Exclusion criteria

Exclusion Criteria:

  • Severe medical conditions
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
321 participants (actual)

Interventions

  • Drugbiphasic insulin aspart
06

What researchers measure

Primary outcomes

  1. Change in HbA1c

    Time frame: After 24 weeks of treatment

Secondary outcomes

  1. Adverse events

  2. Weight change

  3. Fasting blood glucose

  4. Hypoglycaemic episodes

  5. 2-hour postprandial blood glucose

  6. after 24 weeks of treatment.

07

Study locations

8 sites
  • Novo Nordisk Investigational Site
    Beijing, Beijing 100029, China
  • Novo Nordisk Investigational Site
    Beijing, Beijing 100730, China
  • Novo Nordisk Investigational Site
    Guangzhou, Guangdong 510120, China
  • Novo Nordisk Investigational Site
    Wuhan, Hubei 430022, China
  • Novo Nordisk Investigational Site
    Nanjing, Jiangsu 210008, China
  • Novo Nordisk Investigational Site
    Xi'an, Shaanxi 710032, China
  • Novo Nordisk Investigational Site
    Shanghai, Shanghai 200003, China
  • Novo Nordisk Investigational Site
    Tianjin, Tianjin 300070, China
08

References and documents

Publications

  • Yang W, Ji Q, Zhu D, Yang J, Chen L, Liu Z, Yu D, Yan L. Biphasic insulin aspart 30 three times daily is more effective than a twice-daily regimen, without increasing hypoglycemia, in Chinese subjects with type 2 diabetes inadequately controlled on oral antidiabetes drugs. Diabetes Care. 2008 May;31(5):852-6. doi: 10.2337/dc07-1992. Epub 2008 Feb 11. PubMed 18268073 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00184561
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Sep 16, 2005
Start date
Jul 2005
Primary completion
Jul 2006
Completion
Jul 2006
Last update
Jan 6, 2017

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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