NCT00184639

Brief Summary

This trial is conducted in Europe. A 32-week efficacy and safety comparison of insulin detemir and insulin semilente MC in children between 6 and 21 years with type 1 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at below P25 for phase_3 diabetes

Timeline
Completed

Started Aug 2004

Geographic Reach
1 country

2 active sites

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

August 16, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2005

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

1.3 years

First QC Date

September 13, 2005

Last Update Submit

February 22, 2017

Conditions

DiabetesDiabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • Fasting plasma glucose

    after 16 and 32 weeks, respectively

Secondary Outcomes (5)

  • Adverse events

  • HbA1c results at the end of each treatment period

  • Blood glucose

  • Standard Laboratory Safety Parameters

  • Hypoglycaemia

Interventions

insulin detemirDRUG

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Type 1 diabetes
  • Current intensified insulin treatment
  • Injection of insulin Semilente®MC at bedtime for at least 6 weeks
  • BMI maximum 32 kg/m\^2
  • HbA1c \> 5.5 % and \< 12.0 %

You may not qualify if:

  • Current treatment with premixed insulin(s)
  • Impaired hepatic or renal function
  • Recurrent major hypoglycaemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novo Nordisk Investigational Site

Berlin, 13353, Germany

Location

Novo Nordisk Investigational Site

Hanover, 30173, Germany

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1

Interventions

Insulin Detemir

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune 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
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

August 16, 2004

Primary Completion

November 22, 2005

Study Completion

November 22, 2005

Last Updated

February 24, 2017

Record last verified: 2017-02

Locations

DE(2)