NCT01536600

Brief Summary

This study is conducted in Africa, Asia and Europe. The aim of this study is to investigate biphasic insulin aspart 30 (NovoMix® 30) alone or in combination with oral hypoglycaemic agent (OHA) for type 2 diabetes management in routine clinical practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33,010

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2004

Typical duration 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

September 1, 2004

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 22, 2012

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

2.2 years

First QC Date

February 16, 2012

Last Update Submit

January 5, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c (glycosylated haemoglobin)

Secondary Outcomes (5)

  • Change in post prandial glucose (PPG)

  • Change in fasting glucose (FG)

  • Difference in prandial glucose increment (PGI)

  • Incidence of hypoglycaemic episodes

  • Adverse drug reactions (ADR)

Study Arms (1)

BIAsp 30 users

Drug: biphasic insulin aspart 30

Interventions

biphasic insulin aspart 30DRUG

The insulin dose and regimen was individualised at the physician's discretion

BIAsp 30 users

Eligibility Criteria

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

Patients with type 2 diabetes who were not adequately controlled on their current therapy and who were prescribed biphasic insulin aspart 30 (NovoMix® 30)

You may qualify if:

  • Subjects with type 2 diabetes whose glycaemia was not optimally controlled with current therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Seoul, 137-920, South Korea

Location

Related Publications (5)

  • Guler S, Sharma SK, Almustafa M, Kim CH, Azar S, Danciulescu R, Shestakova M, Khutsoane D, Bech OM. Improved Glycaemic Control with Biphasic Insulin Aspart 30 in Type 2 Diabetes Patients Failing Oral Antidiabetic Drugs: PRESENT Study Results. Arch Drug Inf. 2009 Jun;2(2):23-33. doi: 10.1111/j.1753-5174.2008.00015.x.

    PMID: 19684847RESULT

  • Khutsoane D, Sharma SK, Almustafa M, Jang HC, Azar ST, Danciulescu R, Shestakova M, Ayad NM, Guler S, Bech OM; PRESENT Study Group. Biphasic insulin aspart 30 treatment improves glycaemic control in patients with type 2 diabetes in a clinical practice setting: experience from the PRESENT study. Diabetes Obes Metab. 2008 Mar;10(3):212-22. doi: 10.1111/j.1463-1326.2007.00826.x.

    PMID: 18269636RESULT

  • Shestakova M, Sharma SK, Almustafa M, Min KW, Ayad N, Azar ST, Danciulescu R, Khutsoane D, Guler S. Transferring type 2 diabetes patients with uncontrolled glycaemia from biphasic human insulin to biphasic insulin aspart 30: experiences from the PRESENT study. Curr Med Res Opin. 2007 Dec;23(12):3209-14. doi: 10.1185/030079907X253636.

    PMID: 18005503RESULT

  • Gao Y, Guo XH, Vaz JA; PRESENT Study Group. Biphasic insulin aspart 30 treatment improves glycaemic control in patients with type 2 diabetes in a clinical practice setting: Chinese PRESENT study. Diabetes Obes Metab. 2009 Jan;11(1):33-40. doi: 10.1111/j.1463-1326.2008.00904.x. Epub 2008 May 20.

    PMID: 18494806RESULT

  • Jang HC, Guler S, Shestakova M; PRESENT Study Group. When glycaemic targets can no longer be achieved with basal insulin in type 2 diabetes, can simple intensification with a modern premixed insulin help? Results from a subanalysis of the PRESENT study. Int J Clin Pract. 2008 Jul;62(7):1013-8. doi: 10.1111/j.1742-1241.2008.01792.x. Epub 2008 May 9.

    PMID: 18479365RESULT

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

February 16, 2012

First Posted

February 22, 2012

Study Start

September 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

January 6, 2017

Record last verified: 2017-01

Locations

KR(1)