NCT00771680

Brief Summary

This study is conducted in Europe and Asia. The aim of this observational study is to evaluate the effectiveness and the incidence of serious adverse reactions while using Levemir®, NovoMix® and/or NovoRapid® in subjects with type 2 diabetes that have not used insulin previously under normal clinical practice conditions.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
10,408

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2008

Geographic Reach
2 countries

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

October 1, 2008

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 13, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

1.7 years

First QC Date

October 9, 2008

Last Update Submit

October 26, 2016

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

  • HbA1c

    at baseline visit and during 3, 6, 9 and 12 months

  • Serious adverse drug reactions including major hypoglycaemic events

    during 12 months of treatment

Secondary Outcomes (7)

  • Number of serious adverse drug reactions

    during 12 months of treatment

  • Number of all major (daytime and nocturnal) hypoglycaemic events

    during 12 months of treatment

  • Number of all minor (daytime and nocturnal) hypoglycaemic events

    During 4 weeks prior to each study visit

  • Weight (BMI) change

    At 6 and 12 months

  • Variability in fasting blood glucose values and average (mean) fasting blood glucose level

    At baseline visit and after 6 and 12 months treatment

  • +2 more secondary outcomes

Study Arms (1)

A

Drug: insulin detemirDrug: biphasic insulin aspart 30Drug: insulin aspart

Interventions

insulin detemirDRUG

Start dose and frequency at the discretion of the physician following clinical practice

A
biphasic insulin aspart 30DRUG

Start dose and frequency at the discretion of the physician following clinical practice

A
insulin aspartDRUG

Start dose and frequency at the discretion of the physician following clinical practice

A

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of both genders who, in practice settings, have been deemed appropriate to receive Levemir®, NovoMix® 30 or and/or NovoRapid® as new treatment and as part of routine out-patient care by the prescribing physician.

You may qualify if:

  • Any insulin näive type 2 diabetic patient that able to use the drug as judged by the investigator

You may not qualify if:

  • In accordance with approved label

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novo Nordisk Investigational Site

Moscow, 119330, Russia

Location

Novo Nordisk Investigational Site

Kiev, 252030, Ukraine

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Insulin Detemirinsulin aspart, insulin aspart protamine drug combination 30:70Insulin Aspart

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 ProteinsInsulin, Short-Acting

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2008

First Posted

October 13, 2008

Study Start

October 1, 2008

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

October 28, 2016

Record last verified: 2016-10

Locations

UA(1)RU(1)