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Completed

NCT Number: NCT01697631

Glycemic Control of Biphasic Insulin Aspart 30 in Type 2 Diabetes

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site, Bialystok, Poland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biphasic insulin aspart 30

Drug

Administrated subcutaneously (s.c., under the skin) at breakfast and evening main meals

insulin aspart

Drug

Administrated subcutaneously (s.c., under the skin) before lunch

Primary outcomes

  1. HbA1c (glycosylated haemoglobin)

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Oct 2, 2012
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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