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CompletedNCT00282451Updated Oct 31, 2016

Effect of Biphasic Insulin Compared to Biphasic Insulin Combined With Insulin Aspart, With or Without Metformin in Type 2 Diabetes

A Phase 4 interventional study of biphasic insulin aspart and insulin aspart in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 4 sites in 2 countries. Open to participants aged 18 Years to 18 Years. Per ClinicalTrials.gov, last updated 2016-10-31.

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

Phase
Phase 4
Study type
Interventional
Enrollment
79
Allocation
Randomized
Ages
18 Years to 18 Years
Sex
All
01

Study summary

This trial is conducted in Africa and Middle East. The objective of the study is to compare glycemic control of Biphasic insulin Aspart 30 twice daily with Biphasic insulin Aspart 30 twice daily plus Insulin Aspart, both insulin treatments with or without metformin, in subjects with type 2 diabetes, previously treated with Biphasic Human Insulin 30/70.

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 79 is close to 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 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Type 2 diabetic subjects
  • Current treatment with Biphasic Human Insulin 30/70 twice daily alone or in combination with any oral hypoglycaemic agent for at least 3 months prior to entering the trial
  • HbA1c at least 12%
  • Willing and able to perform self blood glucose monitoring (SMBG)

Exclusion criteria

Exclusion Criteria:

  • History of drug or alcohol dependence
  • Receipt of any investigational drug within the last month prior to this trial
  • Anticipated change in dose of prescription medication, which may influence glucose regulation (Mono Amino Oxidase-inhibitors, non selective beta-adrenergic agents, anabolic steroids and systemic glucocorticoids)
  • Severe uncontrolled hypertension
  • Recurrent severe hypoglycemia as judged by investigator
  • Any disease or condition, which the Investigator feels, would interfere with the trial
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Study design

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

Interventions

  • Drugbiphasic insulin aspart
  • Druginsulin aspart
06

What researchers measure

Primary outcomes

  1. HbA1c

    Time frame: At Visit 6 (14 weeks)

Secondary outcomes

  1. Postprandial glucose concentration increments (calculated based on 7-point blood glucose profiles)

07

Study locations

4 sites
  • Novo Nordisk Investigational Site
    Aghakhan, Egypt
  • Novo Nordisk Investigational Site
    Giza, Egypt
  • Novo Nordisk Investigational Site
    Jeddah, 80215, Saudi Arabia
  • Novo Nordisk Investigational Site
    Riyadh, 245, Saudi Arabia
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00282451
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Jan 26, 2006
Start date
Feb 2006
Primary completion
Aug 2006
Completion
Aug 2006
Last update
Oct 31, 2016

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 Oct 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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