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Glycemic Control of Biphasic Insulin Aspart 30 in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01697631
First received: September 28, 2012
Last updated: February 22, 2017
Last verified: February 2017
  Purpose
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 Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart 30
Drug: insulin aspart
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • HbA1c (glycosylated haemoglobin)

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

Enrollment: 131
Actual Study Start Date: July 22, 2002
Study Completion Date: April 24, 2003
Primary Completion Date: April 24, 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
  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: NCT01697631

Locations
Poland
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
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01697631     History of Changes
Other Study ID Numbers: BIASP-1409
Study First Received: September 28, 2012
Last Updated: February 22, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin degludec, insulin aspart drug combination
Insulin
Insulin, Isophane
Biphasic Insulins
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 28, 2017