NCT00696163

Brief Summary

This study is conducted in Asia. The aim of this observational study is to evaluate the quality of life and clinical outcomes in subjects using NovoMix® 30 (biphasic insulin aspart 30) for the treatment of diabetes mellitus under normal clinical practice conditions in India.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24,975

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 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

April 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

11 months

First QC Date

June 10, 2008

Last Update Submit

October 27, 2016

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Change in Quality of Life from baseline (using QoLD questionnaire)

    From baseline to 26 weeks of treatment

Secondary Outcomes (2)

  • Safety

    After 26 weeks

  • Efficacy

    After 26 weeks

Study Arms (1)

A

Drug: biphasic insulin aspart 30

Interventions

biphasic insulin aspart 30DRUG

Being an observational study, dose of NovoMix 30 will be according to treating physician's discretion

Also known as: NovoMix® 30, BIAsp30
A

Eligibility Criteria

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

Type 2 diabetes

You may qualify if:

  • Type 2 diabetes, including newly-diagnosed who have never received insulin or an insulin analogue before, at the discretion of the physician.

You may not qualify if:

  • Currently treated with NovoMix® 30
  • Subjects who are unlikely to comply with protocol requirements
  • Previously enrolled in this study
  • Hypersensitivity to biphasic insulin aspart or to any of the excipients
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Bangalore, 560001, India

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
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2008

First Posted

June 12, 2008

Study Start

April 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

October 31, 2016

Record last verified: 2016-10

Locations

IN(1)