Basal Bolus of Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00600626
First received: January 14, 2008
Last updated: June 15, 2012
Last verified: June 2012
  Purpose

This trial is conducted in Europe and Asia. The aim of this trial is to compare basal bolus treatment with insulin aspart and insulin NPH to biphasic insulin aspart treatment on blood glucose control in type 2 diabetes.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart
Drug: insulin NPH
Drug: insulin aspart
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Basal Bolus Treatment With Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes Mellitus

Resource links provided by NLM:


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

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 4 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 8-point blood glucose profile [ Designated as safety issue: No ]
  • incidence of hypoglycaemic episodes [ Designated as safety issue: No ]
  • safety profiles [ Designated as safety issue: No ]
  • changes in body weight and vital signs [ Designated as safety issue: No ]

Enrollment: 394
Study Start Date: January 2004
Study Completion Date: July 2004
Primary Completion Date: July 2004 (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 human insulin or insulin analogues for at least 3 months, with or without combination with OADs
  • HbA1c between 8.0-10.5%
  • Body mass index (BMI) below 35.0 kg/m2
  • Able and willing to perform self-monitoring of blood glucose

Exclusion Criteria:

  • Total daily insulin dose of 1.80 IU/kg or more
  • Known or suspected allergy to trial product or related products
  • Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures
  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: NCT00600626

Locations
Croatia
Zagreb, Croatia, 10 000
France
Lille, France, 59037
Germany
Neuss, Germany, 41460
Hong Kong
Hong Kong, Hong Kong
Malaysia
Cheras, Malaysia, 56000
Netherlands
Beverwijk, Netherlands, 1942 LE
Poland
Lodz, Poland, 90-030
Romania
Timisoara, Romania, 300736
Russian Federation
Saint-Petersburg, Russian Federation, 194354
Singapore
Singapore, Singapore, 119074
Spain
Sevilla, Spain, 41009
Sweden
Lund, Sweden, 221 85
United Kingdom
York, United Kingdom, YO3 7HE
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Plamen Kozlovski Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00600626     History of Changes
Other Study ID Numbers: BIASP-1486
Study First Received: January 14, 2008
Last Updated: June 15, 2012
Health Authority: Croatia: Ministry of Health and Social Care
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department of Health
Malaysia: Ministry of Health
Netherlands: Dutch Health Care Inspectorate
Poland: The Office for Registration of Medicinal Products, Medical Devices; and Biocides, Central Evidence of Clinical Trials
Romania: State Institute for Drug Control
Russia: Federal Service for Control of Health Care and Social Development
Singapore: Health Sciences Authority
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Biphasic Insulins
Insulin
Insulin Aspart
Insulin, Globin Zinc
Insulin, Isophane
Isophane insulin, beef
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014