NCT01709929

Brief Summary

This trial is conducted in North America. The aim of this trial is to evaluate the safety of insulin detemir for the treatment of diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,287

participants targeted

Target at P75+ for phase_3 diabetes

Timeline
Completed

Started Oct 2005

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

October 1, 2005

Completed
6 months 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
6.5 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2012

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2016

Enrollment Period

6 months

First QC Date

October 16, 2012

Last Update Submit

March 2, 2016

Conditions

DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemic events

Secondary Outcomes (5)

  • Number of adverse events (all and serious)

  • Number of all hypoglycaemic events

  • Change in weight

  • HbA1c (glycosylated haemoglobin)

  • Treatment satisfaction as assessed by Insulin Treatment Satisfaction Questionnaire (ITSQ-22)

Study Arms (1)

Insulin detemir

EXPERIMENTAL
Drug: insulin detemir

Interventions

insulin detemirDRUG

Administered subcutaneously (s.c., under the skin). Dose individually adjusted.

Insulin detemir

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with type 1 or type 2 diabetes
  • Using a basal/bolus insulin regimen

You may not qualify if:

  • Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
  • Subjects who previously enrolled in this study
  • Subjects with a hypersensitivity to insulin detemir or to any of the excipients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Mississauga, L4W 4XI, Canada

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2012

First Posted

October 18, 2012

Study Start

October 1, 2005

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

March 3, 2016

Record last verified: 2016-03

Locations

CA(1)