Glycemic Control of Biphasic Insulin Aspart 30 in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01697631
First received: September 28, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 7-point blood glucose profile [ Designated as safety issue: No ]
  • Correlation of endpoint HbA1c with baseline BMI (body mass index) and HbA1c with treatment mode stratification [ Designated as safety issue: No ]
  • Incidence of adverse events [ Designated as safety issue: No ]
  • Hypoglycaemic episodes (minor, major or nocturnal) [ Designated as safety issue: No ]

Enrollment: 131
Study Start Date: July 2002
Study Completion Date: April 2003
Primary Completion Date: April 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
Genders Eligible for Study:   Both
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
Sosnowiec, Poland, 41-200
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Irek Otulski Novo Nordisk RONAG
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, 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: September 28, 2012
Health Authority: Poland: Ministry of Health and Social Security

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
Insulin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014