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TerminatedNCT00267683Updated Nov 2, 2023

Efficacy and Safety of Insulin Aspart Versus Glibenclamide in Type 2 Diabetes

A Phase 3 interventional study of insulin aspart and glibenclamide in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Terminated. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-11-02.

Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment

Why this study was terminated
This trial was terminated due to low recruitment
Phase
Phase 3
Study type
Interventional
Enrollment
9
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

This trial is conducted in Japan. This is a clinical trial to study the efficacy and safety of thrice daily Insulin Aspart compared to Glibenclamide in type 2 diabetic patients.

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 9 is below the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,400 studies on the registry; 102 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 98 (48%) have results posted.

Browse Novo Nordisk A/S studies →

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

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Type 2 diabetes
  • Diet therapy for at least 12 weeks, or diet therapy and oral hypoglycaemic agent(s) other than SU agents for at least 12 weeks
  • No previous treatment with insulin and/or SU agents
  • HbA1c between 7.5% and 10.0%
  • Body Mass Index (BMI) below 30.0 kg/m2

Exclusion criteria

Exclusion Criteria:

  • Proliferative retinopathy or maculopathy requiring acute treatment
  • Impaired hepatic function
  • Impaired renal function
  • Cardiac diseases
  • Uncontrolled hypertension
  • Known hypoglycaemia unawareness or recurrent major hypoglycaemia
  • Current treatment with systemic corticosteroids
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
9 participants (actual)

Interventions

06

What researchers measure

Primary outcomes

  1. HbA1c

    Time frame: after 24 weeks of treatment

Secondary outcomes

  1. Plasma glucose levels

  2. Percentage of subjects achieving the treatment target of HbA1c value < 6.5%

07

Study locations

No study locations are listed for this record.

08

References and documents

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2005, a primary completion of Apr 2006 and a completion of Apr 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 20, 2005
First posted
Dec 21, 2005
Start
Dec 2005
Primary completionActual
Apr 2006
CompletionActual
Apr 2006
Last update
Nov 2, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00267683
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Dec 21, 2005
Start date
Dec 2005
Primary completion
Apr 2006
Completion
Apr 2006
Last update
Nov 2, 2023

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 terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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