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OpenTrials
Completed

NCT Number: NCT01526980

Glycaemic Control of Biphasic Insulin Aspart 70 and 30 in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control of biphasic insulin aspart 70 + biphasic insulin aspart 30 with biphasic human insulin 30 in subjects with type 2 diabetes.

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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 2

Primary location

Novo Nordisk Investigational Site

Newcastle, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with Type 2 diabetes
  • Treatment with BHI (biphasic human insulin) 30 twice daily for at least three months
  • HbA1c maximum 10.0%
  • BMI (Body Mass Index) maximum 35.0 kg/m2
  • Able and willing to perform self-blood glucose monitoring (SBGM)

Exclusion criteria

  • The receipt of any investigational drug within the last 30 days prior to this trial
  • Total daily insulin dose minimum 2.0 U/(kg·day)
  • A history of drug abuse or alcohol dependence within the last 5 years
  • Impaired hepatic function
  • Impaired renal function
  • Cardiac disease
  • Severe, uncontrolled hypertension

Treatment and study plan

biphasic insulin aspart 30

Drug

Administrated subcutaneously (s.c., under the skin) once daily before dinner for 30 days in each treatment period

biphasic insulin aspart 70

Drug

Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and lunch for 30 days in each treatment period

biphasic human insulin 30

Drug

Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and dinner for 30 days in each treatment period

Primary outcomes

  1. Glucose average in 24-hour blood glucose profiles

Secondary outcomes

  1. Pre-meal glucose level

  2. Post-meal excursion of glucose (0-4 hours)

  3. Cmax, maximum concentration of total insulin

  4. tmax, time of maximum concentration of total insulin

  5. The area under the 24-hour total insulin concentration time curve

  6. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Single-Centre, Randomised, Open-Labelled, Two-Period, Crossover Trial In Subjects With Type 2 Diabetes Comparing the Glycaemic Control of Two Treatment Regimens: A Thrice Daily Regimen With Biphasic Insulin Aspart 70 and - 30 and a Twice Daily Regimen With Biphasic Human Insulin 30

Important dates

Study start
2002
Primary completion
2002
Study completion
2002
First posted
Feb 6, 2012
Registry last updated
Jan 5, 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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