NCT00184626

Brief Summary

This trial is conducted in Asia. The aim of the trial is to compare the glycaemic control of Insulin glargine versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in combination with metformin in subjects with Type 2 Diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P25-P50 for phase_4 diabetes

Timeline
Completed

Started Sep 2004

Geographic Reach
1 country

1 active site

Status
completed

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

September 10, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2005

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

1.1 years

First QC Date

September 12, 2005

Last Update Submit

February 22, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    Measured at end of treatment (26 weeks)

Secondary Outcomes (3)

  • safety variables

  • other glycemic variables

  • Fasting plasma glucose value

Interventions

biphasic insulin aspartDRUG
insulin glargineDRUG
metforminDRUG

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • Body mass index equal to or lesser than 35.0 kg/m2
  • Currently treated with oral hypoglycaemic drug

You may not qualify if:

  • Known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the Investigator
  • Any condition that the Investigator and/or the Sponsor feel would interfere with trial participation or evaluation of results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Istanbul, 111, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70Insulin GlargineMetformin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsBiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

September 10, 2004

Primary Completion

October 24, 2005

Study Completion

October 24, 2005

Last Updated

February 24, 2017

Record last verified: 2017-02

Locations

TU(1)