Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen® in Insulin Naive Subjects With Type 2 Diabetes

Efficacy and Safety of Biphasic Insulin Aspart 30 in Insulin Naive Type 2 Diabetic Patients With Secondary OHA Failure

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00600366

Enrollment

Registered

2008-01-25

Start date

2004-03-31

Completion date

2005-01-31

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 trial is conducted in Europe. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on blood glucose control in insulin naive type 2 diabetes failing on secondary oral hypoglycaemic agent (OHA).

Interventions

DRUGbiphasic insulin aspart

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to No maximum

Healthy volunteers

Inclusion criteria

* Type 2 diabetes * Insulin naive diabetes * Current treatment with OHA, secondary failure * Body mass index (BMI) below 40 kg/m2 * HbA1c over 8.5% * Willing and able to start with insulin therapy and to perform self-blood glucose monitoring

Exclusion criteria

* History of drug or alcohol abuse * Receipt of the investigational drug within the last month prior to this trial * Known or suspected allergy to trial products or related products * Severe uncontrolled hypertension * Any disease or condition, which the Investigator feels, would interfere with the trial

Design outcomes

Primary

Measure	Time frame
HbA1c	after 12 weeks of treatment

Secondary

Measure	Time frame
Blood glucose profiles	—
Incidence of hypoglycaemic episodes	—
Incidence of adverse events	—

Countries

Serbia and Montenegro

Outcome results

None listed

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