Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01467323
First received: November 4, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted
  Purpose

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart 30 in subjects with type 1 or type 2 diabetes.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart
Drug: biphasic human insulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-labelled, Randomised, Parallel Group, Multicentre, Multinational Efficacy and Safety Comparison of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30/70 as Meal Related Insulin in a Twice Daily Regimen in Type 1 and Type 2 Diabetic Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • HbA1c (glycosylated haemoglobin A1c) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 8-point blood glucose profiles [ Designated as safety issue: No ]
  • Incidence of hypoglycaemic episodes [ Designated as safety issue: No ]
  • Occurrence of adverse events [ Designated as safety issue: No ]

Enrollment: 303
Study Start Date: April 1998
Study Completion Date: September 1998
Primary Completion Date: September 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: biphasic insulin aspart
Injected subcutaneously (under the skin) twice daily
Active Comparator: B Drug: biphasic human insulin
Injected subcutaneously (under the skin) twice daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with insulin requiring type 1 or type 2 diabetes for at least 24 months
  • Current treatment with human insulin (either premix of short and long/intermediate acting insulin) in a twice daily treatment regimen preparation and/or self-mix for at least 12 months
  • Body mass index (BMI) below or equal to 35.0 kg/m^2
  • HbA1c below or equal to 11.0%

Exclusion Criteria:

  • Total daily insulin dose at least 1.4 IU/kg
  • Treatment with oral hypoglycaemic agents within the month prior to inclusion
  • Recurrent severe hypoglycaemia (as judged by the investigator)
  • Active proliferative retinopathy
  • Impaired renal function with creatinine at least 150 mcmol/l (1.7 mg/dl)
  • History of pancreatitis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01467323

Locations
Austria
Wien, Austria, A 1080
Germany
Leipzig, Germany, 04177
Ireland
Dublin, Ireland, DUBLIN 8
United Kingdom
Bolton, United Kingdom, BL1 4QS
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Helle Kastberg Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01467323     History of Changes
Other Study ID Numbers: ANA/DCD/038
Study First Received: November 4, 2011
Last Updated: November 4, 2011
Health Authority: Austria: The Austrian Agency for Health and Food Safety (AGES)
Germany: Federal Institute for Drugs and Medical Devices
Ireland: Irish Medicines Board
United Kingdom: Medicines and Healthcare Regulatory Authority (MHRA)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin aspart
Insulin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014