Observational Study of Biphasic Insulin Aspart 30 Alone or in Combination With Oral Hypoglycaemic Agents in Subjects With Type 2 Diabetes

A Multi-center, Prospective, Non-interventional Evaluation of Efficacy, Safety and Convenience of Using NovoMix 30 as Monotherapy, or in Combination With OHAs, in the Treatment of Type 2 Diabetic Patients in Routine Clinical Practice

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01536600

Acronym

PRESENT

Enrollment

33010

Registered

2012-02-22

Start date

2004-09-30

Completion date

2006-12-31

Last updated

2017-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

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.

Interventions

DRUGbiphasic insulin aspart 30

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Change in HbA1c (glycosylated haemoglobin)	—

Secondary

Measure	Time frame
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)	—

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026