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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01520753
Recruitment Status : Completed
First Posted : January 30, 2012
Last Update Posted : January 4, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart 70 Drug: biphasic insulin aspart 50 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : March 1999
Actual Primary Completion Date : June 1999
Actual Study Completion Date : June 1999

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Fasting serum glucose

Secondary Outcome Measures :
  1. 24-hour serum glucose profiles
  2. 24-hour insulin profiles
  3. Incidence of hypoglycaemic episodes
  4. Incidence of adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01520753

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Novo Nordisk Investigational Site
Århus C, Denmark, 8000
Sponsors and Collaborators
Novo Nordisk A/S
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Study Director: Global Clinical Registry (GCR,1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S Identifier: NCT01520753     History of Changes
Other Study ID Numbers: BIASP-1074
First Posted: January 30, 2012    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs