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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00184574
First received: September 12, 2005
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart
Drug: metformin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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).

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 36 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 8-point plasma glucose profiles [ Designated as safety issue: No ]
  • Safety variables [ Designated as safety issue: No ]
  • Other glycemic variables [ Designated as safety issue: No ]

Enrollment: 603
Study Start Date: April 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184574

  Show 18 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Malene B. Krüger Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00184574     History of Changes
Other Study ID Numbers: BIASP-1440
Study First Received: September 12, 2005
Last Updated: October 18, 2013
Health Authority: Bulgaria: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
Russia: Pharmacological Committee, Ministry of Health
Turkey: Ministry of Health Drug and Pharmaceutical Department
Denmark: Danish Medicines Agency
Poland: Ministry of Health
Romania: National Medicines Agency
Hungary: National Institute of Pharmacy
Netherlands: Dutch Health Care Inspectorate
Czech Republic: State Institute for Drug Control
Austria: Federal Ministry for Health and Women
Italy: The Italian Medicines Agency
Slovenia: Agency for Medicinal Products - Ministry of Health
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014