NCT00383877

Brief Summary

This trial is conducted in China. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of insulin detemir or NPH-insulin given once daily at bedtime as add-on to oral anti-diabetic drug(s).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
263

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_3 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

September 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2006

Completed
10 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
Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

11 months

First QC Date

October 3, 2006

Last Update Submit

December 29, 2023

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    after 20 weeks of treatment

Secondary Outcomes (4)

  • FBG

    after 20 weeks of treatment

  • Safety profile

    during 20 weeks treatment

  • Proportion of subjects achieving HbA1c less than or equal to 7.0%

    after 20 weeks of treatment

  • Within-subject variation of self measured blood glucose (SMBG) before breakfast during the trial at the end of the trial

    before breakfast during the trial at the end of the trial

Interventions

insulin detemirDRUG
insulin NPHDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • HbA1C greater than 7.5% and less than or equal to 11.0%
  • Currently on any oral antidiabetic drug (OAD) more than or equal to 3 months

You may not qualify if:

  • Previous acute treatment with insulin for more than 7 days.
  • Treatment with OAD(s) which does not adhere to the approval labeling.
  • Proliferate retinopathy or maculopathy that has required acute treatment within the last year.
  • Known hypoglycaemia unawareness or recurrent major hypoglycaemia, that may interfere with study participation as judged by the Investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Beijing, China

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Insulin DetemirInsulin, Isophane

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

Study Record Dates

First Submitted

October 3, 2006

First Posted

October 4, 2006

Study Start

September 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

January 2, 2024

Record last verified: 2023-12

Locations

CN(1)