NCT00267683

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_3 diabetes

Timeline
Completed

Started Dec 2005

Shorter than P25 for phase_3 diabetes

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

December 20, 2005

Last Update Submit

October 31, 2023

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    after 24 weeks of treatment

Secondary Outcomes (2)

  • Plasma glucose levels

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

Interventions

insulin aspartDRUG
glibenclamideDRUG

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Insulin AspartGlyburide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsSulfonylurea CompoundsUreaAmidesOrganic ChemicalsSulfonesSulfur Compounds

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2005

First Posted

December 21, 2005

Study Start

December 1, 2005

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

November 2, 2023

Record last verified: 2023-10