NCT00494988

Brief Summary

This trial is conducted in Asia. The aim of this trial is evaluate the remission rate in newly diagnosed subjects with type 2 diabetes after short-term intensive treatment with insulin aspart and insulin NPH.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at below P25 for phase_4 diabetes

Timeline
Completed

Started Dec 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

December 1, 2004

Completed
1.3 years 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
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2007

Completed
Last Updated

March 4, 2016

Status Verified

March 1, 2016

Enrollment Period

1.3 years

First QC Date

June 29, 2007

Last Update Submit

March 3, 2016

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Remission rate

    after 24 weeks

Secondary Outcomes (2)

  • blood glucose profiles

  • HbA1c

Interventions

insulin aspartDRUG
insulin NPHDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Type 2 diabetes newly diagnosed within 6-12 months
  • FBG: 11.1-17.0 mmol/L
  • Body mass index (BMI) larger than 25.0 kg/m2

You may not qualify if:

  • Known or suspected allergy to trial product(s) or related products
  • Recurrent major hypoglycaemia as judged by the Investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Beijing, 100029, China

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Insulin AspartInsulin, Isophane

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 ProteinsInsulin, Long-Acting

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

June 29, 2007

First Posted

July 2, 2007

Study Start

December 1, 2004

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

March 4, 2016

Record last verified: 2016-03

Locations

CN(1)