Comparison of Two Biphasic Insulin Aspart Treatments in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01520753
First received: January 25, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
  Purpose

This trial is conducted in Europe. The aim of this trial is to compare two different active treatment regimens of biphasic insulin aspart in subjects with type 2 diabetes.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart 70
Drug: biphasic insulin aspart 50
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, 4-week, Crossover Trial on Two Treatment Regimens With Biphasic Insulin Aspart 70 and 50 in Patients With Type 2 Diabetes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Fasting serum glucose [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 24-hour serum glucose profiles [ Designated as safety issue: No ]
  • 24-hour insulin profiles [ Designated as safety issue: No ]
  • Incidence of hypoglycaemic episodes [ Designated as safety issue: No ]
  • Incidence of adverse events [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: March 1999
Study Completion Date: June 1999
Primary Completion Date: June 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIAsp 70 Drug: biphasic insulin aspart 70
Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner
Experimental: BIAsp 70 + BIAsp 50 Drug: biphasic insulin aspart 70
Administered subcutaneously (s.c., under the skin) at breakfast and lunch
Drug: biphasic insulin aspart 50
Administered subcutaneously (s.c., under the skin) at dinner

  Eligibility

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

Inclusion Criteria:

  • Type 2 diabetes
  • Duration of diabetes for longer than 12 months
  • Body mass index (BMI) below 35.0 kg/m^2
  • HbA1c below 11.0 %
  • Treatment with BHI (biphasic human insulin) 20 or 30 twice daily for at least three months and in the last month as sole anti-diabetic treatment (i.e., no additional oral hypoglycaemic medication or daily use of short-acting insulin supplement)

Exclusion Criteria:

  • Current treatment with agents affecting glucose metabolism
  • History of drug or alcohol dependence
  • Impaired hepatic function
  • Impaired renal function
  • Cardiac disease
  • Proliferative retinopathy
  • Recurrent severe hypoglycaemia or advanced neuropathy
  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: NCT01520753

Locations
Denmark
Århus C, Denmark, 8000
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Lone Mordhorst 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: NCT01520753     History of Changes
Other Study ID Numbers: BIASP-1074
Study First Received: January 25, 2012
Last Updated: January 25, 2012
Health Authority: Denmark: Danish Medicines Agency

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

ClinicalTrials.gov processed this record on October 19, 2014