Comparison of Biphasic Insulin Aspart 70/30, 50/50, and 30/70 in Subjects With Type 2 Diabetes

Comparison of the Effect on Glycemic Control of Biphasic Insulin Aspart 70/30, Biphasic Insulin Aspart 50/50, and Biphasic Insulin Aspart 30/70 All in Combination With Metformin in Subjects With Type 2 Diabetes (the INTENSIMIX Trial).

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00184574

Enrollment

603

Registered

2005-09-16

Start date

2005-04-30

Completion date

2006-03-31

Last updated

2017-01-05

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. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of three different premixed insulin analogues given in combination with an oral anti-diabetic drug.

Interventions

DRUGbiphasic insulin aspart

DRUGmetformin

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Type 2 diabetes * Currently treated with insulin * Currently treated with Metformin * HbA1c: 7.5-12.0%

Exclusion criteria

* Body Mass Index (BMI) \< 25.0 or \> 40.0 kg/m2 * Metformin contraindications according to local practice * TZDs within 6 months prior to randomisation

Design outcomes

Primary

Measure	Time frame
HbA1c	after 36 weeks

Secondary

Measure	Time frame
8-point plasma glucose profiles	—
Safety variables	—
Other glycemic variables	—

Countries

Austria, Belgium, Bulgaria, Czechia, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Romania, Russia, Slovenia, Spain, Switzerland, Turkey (Türkiye), United Kingdom

Outcome results

None listed

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