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
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 April 16, 2014