Working… Menu

Glycemic Control of Biphasic Insulin Aspart 30 in 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: NCT01697631
Recruitment Status : Completed
First Posted : October 2, 2012
Last Update Posted : February 24, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This this trial is conducted in Europe. The aim of this trial is to compare glycaemic control of biphasic insulin aspart 30 (BIAsp 30) alone or combined with insulin aspart(IAsp) in patients previously treated with conventional Biphasic Human Insulin 30/70.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart 30 Drug: insulin aspart Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Biphasic Insulin Aspart 30 Twice Daily and Biphasic Insulin Aspart 30 Twice Daily Plus Lunchtime Injection of Insulin Aspart Treatment Efficiency in Overall Glycemic Control and Postprandial Glycemic Excursions. A Multi-center, Randomized, Open-label, Two-armed Parallel Group Trial in Subjects With Type 2 Diabetes Previously Treated With Conventional Biphasic Human Insulin 30/70
Actual Study Start Date : July 22, 2002
Actual Primary Completion Date : April 24, 2003
Actual Study Completion Date : April 24, 2003

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BIAsp Drug: biphasic insulin aspart 30
Administrated subcutaneously (s.c., under the skin) at breakfast and evening main meals

Experimental: Insulin aspart Drug: biphasic insulin aspart 30
Administrated subcutaneously (s.c., under the skin) at breakfast and evening main meals

Drug: insulin aspart
Administrated subcutaneously (s.c., under the skin) before lunch

Primary Outcome Measures :
  1. HbA1c (glycosylated haemoglobin)

Secondary Outcome Measures :
  1. 7-point blood glucose profile
  2. Correlation of endpoint HbA1c with baseline BMI (body mass index) and HbA1c with treatment mode stratification
  3. Incidence of adverse events
  4. Hypoglycaemic episodes (minor, major or nocturnal)

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
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
  • Current treatment with conventional biphasic human insulin 30/70 b.i.d. (twice daily) for at least 3 months
  • HbA1c (glycosylated haemoglobin) equal to or below 12%
  • Willing and able to perform self blood glucose monitoring (SMBG)

Exclusion Criteria:

  • History of drug or alcohol dependence
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
  • Previous participation in this trial
  • Receipt of any investigational drug within the last month prior to this trial
  • Known or suspected allergy to trial products or related products

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): NCT01697631

Layout table for location information
Novo Nordisk Investigational Site
Bialystok, Poland, 15-276
Novo Nordisk Investigational Site
Bytom, Poland, 41-902
Novo Nordisk Investigational Site
Kamieniec Zabkowicki, Poland, 57-230
Novo Nordisk Investigational Site
Katowice, Poland, 40-053
Novo Nordisk Investigational Site
Krakow, Poland, 31-261
Novo Nordisk Investigational Site
Nysa, Poland, 48-300
Novo Nordisk Investigational Site
Otwock, Poland, 05-400
Novo Nordisk Investigational Site
Radom, Poland, 26-600
Novo Nordisk Investigational Site
Ruda Slaska, Poland, 41-700
Novo Nordisk Investigational Site
Sosnowiec, Poland, 41-200
Novo Nordisk Investigational Site
Warsaw, Poland, 01-877
Novo Nordisk Investigational Site
Wroclaw, Poland, 50-306
Sponsors and Collaborators
Novo Nordisk A/S
Layout table for investigator information
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Layout table for additonal information
Responsible Party: Novo Nordisk A/S Identifier: NCT01697631     History of Changes
Other Study ID Numbers: BIASP-1409
First Posted: October 2, 2012    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Biphasic Insulins
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin, Isophane
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs