NCT00698269

Brief Summary

This study is conducted in Asia. The aim of this observational study is to evaluate the safety and efficacy of modern insulins after switch from any other anti-diabetic treatment under normal clinical conditions in the Gulf countries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,926

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2008

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

February 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

1.5 years

First QC Date

June 13, 2008

Last Update Submit

October 26, 2016

Conditions

DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

  • Incidence of major hypoglycaemic events reported

    during 24 weeks of treatment

  • Change in HbA1c

    during 24 weeks of treatment

Secondary Outcomes (7)

  • Percentage of subjects achieving HbA1c below 7.0%

    at 12 & 24 weeks

  • Change in FPG

    at 12 & 24 weeks

  • Change in PPG

    at 12 & 24 weeks

  • Body weight

    at 12 & 24 weeks

  • Change in number of hypoglycaemic events in the last 4 weeks before routine visits

    at 12 & 24 weeks

  • +2 more secondary outcomes

Study Arms (3)

A

Drug: insulin detemir

B

Drug: biphasic insulin aspart 30

C

Drug: insulin aspart

Interventions

insulin detemirDRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Also known as: Levemir®
A
biphasic insulin aspart 30DRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

B
insulin aspartDRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

C

Eligibility Criteria

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

A non-randomized sample of Type 1 or Type 2 diabetics

You may qualify if:

  • Type 1 or type 2 diabetes
  • Treatment with any diabetes treatment other than NovoMix® 30, Levemir® and/or NovoRapid®
  • Selection will be at the discretion of the individual physician

You may not qualify if:

  • Current treatment with Levemir®, NovoMix® 30 and/or NovoRapid®
  • Previous enrolled in this study
  • Hypersensitivity to Levemir®, NovoMix® 30 and/or NovoRapid® or to any of the excipients
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Riyadh, 3542, Saudi Arabia

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes 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 DiseasesAutoimmune DiseasesImmune 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
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2008

First Posted

June 17, 2008

Study Start

February 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

October 28, 2016

Record last verified: 2016-10

Locations

SA(1)