NCT00521690

Brief Summary

The trial is conducted in Asia. The aim of the trial is to evaluate the effect of insulin detemir on blood glucose control in Taiwanese patients with type 2 diabetes failing on OAD with/without once-daily NPH Insulin treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_4 diabetes

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_4 diabetes

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

December 1, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2007

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

8 months

First QC Date

August 27, 2007

Last Update Submit

October 31, 2023

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Incidence of serious adverse events, including major hypoglycaemic events

    during 16 weeks of insulin detemir therapy

Secondary Outcomes (4)

  • Change in HbA1C

    after 16 weeks

  • Change in weight

  • Change in fasting plasma glucose (FPG)

  • Incidence of hypoglycaemic episodes

Interventions

insulin detemirDRUG

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • HbA1C: 7.0-11.0%
  • Previous diabetes treatment for at least 6 months
  • BMI max. 35 kg/m2
  • Treatment with an oral anti-diabetic drug (OAD)

You may not qualify if:

  • Type 1 diabetes
  • Receipt of any investigational drug within the last three months prior to this trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Taipei, 100, Taiwan

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Insulin Detemir

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 Proteins

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 27, 2007

First Posted

August 28, 2007

Study Start

December 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

November 2, 2023

Record last verified: 2023-10

Locations

TW(1)