NCT00709683

Brief Summary

This study is conducted in Africa. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 30 FlexPen® under normal clinical practice conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2008

Shorter than P25 for all trials

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

May 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

March 7, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

July 1, 2008

Last Update Submit

March 4, 2016

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Incidence of major hypoglycaemic events reported as serious adverse drug reactions

    during 26 weeks of treatment

Secondary Outcomes (9)

  • Number of serious adverse drug reactions

    during 26 weeks of treatment

  • Number of serious adverse events

    during 26 weeks of treatment

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

    during 26 weeks of treatment

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

    during 26 weeks of treatment

  • Weight (BMI) change from baseline

    At the end of the study

  • +4 more secondary outcomes

Study Arms (1)

A

Drug: biphasic insulin aspart 30

Interventions

biphasic insulin aspart 30DRUG

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

Also known as: NovoMix® 30
A

Eligibility Criteria

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

Type 2 diabetic patients

You may qualify if:

  • Type 2 diabetes having failed on basal insulin with or without OAD
  • HbA1c greater than 7.0%

You may not qualify if:

  • Subjects being unlikely to comply with protocol requirements
  • Subjects who previously enrolled in this study
  • Subjects with hypersensitivity to biphasic insulin aspart or any of the excipients
  • Women who are pregnant, breast feeding and women in child bearing capacity who are not using reliable contraceptive method

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tunisia, 1053, Tunisia

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

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

July 1, 2008

First Posted

July 3, 2008

Study Start

May 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

March 7, 2016

Record last verified: 2016-03

Locations

TU(1)