Skip to main content
OpenTrials
Completed

NCT Number: NCT00184574

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Bregenz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biphasic insulin aspart

Drug

metformin

Drug

Primary outcomes

  1. HbA1c

    Time frame: after 36 weeks

Secondary outcomes

  1. 8-point plasma glucose profiles

  2. Safety variables

  3. Other glycemic variables

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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).

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 16, 2005
Registry last updated
Jan 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.