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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01467323
First received: November 4, 2011
Last updated: January 3, 2017
Last verified: January 2017
  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
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)

Secondary Outcome Measures:
  • 8-point blood glucose profiles
  • Incidence of hypoglycaemic episodes
  • Occurrence of adverse events

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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: NCT01467323

Locations
Austria
Novo Nordisk Investigational Site
Graz, Austria, 8036
Novo Nordisk Investigational Site
Wien, Austria, A 1080
Germany
Novo Nordisk Investigational Site
Anklam, Germany, 17389
Novo Nordisk Investigational Site
Berlin, Germany, 10559
Novo Nordisk Investigational Site
Berlin, Germany, 14089
Novo Nordisk Investigational Site
Cottbus, Germany, 03048
Novo Nordisk Investigational Site
Erkner, Germany, 15537
Novo Nordisk Investigational Site
Hamburg, Germany, 20251
Novo Nordisk Investigational Site
Jena, Germany, 07743
Novo Nordisk Investigational Site
Leipzig, Germany, 04177
Novo Nordisk Investigational Site
München, Germany, 80804
Novo Nordisk Investigational Site
Neunkirchen, Germany, 66538
Novo Nordisk Investigational Site
Quakenbrück, Germany, 49610
Novo Nordisk Investigational Site
Rostock, Germany, 18057
Novo Nordisk Investigational Site
Saarlouis, Germany, 66740
Novo Nordisk Investigational Site
Schwedt, Germany, 16303
Novo Nordisk Investigational Site
Ulm, Germany, 89081
Novo Nordisk Investigational Site
Würzburg, Germany, 97080
Ireland
Novo Nordisk Investigational Site
Cork, Ireland
Novo Nordisk Investigational Site
Dublin 9, Ireland
Novo Nordisk Investigational Site
Dublin, Ireland, DUBLIN 8
Switzerland
Novo Nordisk Investigational Site
Bern, Switzerland, 3010
United Kingdom
Novo Nordisk Investigational Site
Ayr, United Kingdom, KA6 6DX
Novo Nordisk Investigational Site
Bath, United Kingdom, BA1 3NG
Novo Nordisk Investigational Site
Birmingham, United Kingdom, B9 5SS
Novo Nordisk Investigational Site
Blackburn, United Kingdom, BB3 3LR
Novo Nordisk Investigational Site
Bolton, United Kingdom, BL1 4QS
Novo Nordisk Investigational Site
Bristol, United Kingdom, BS2 8HW
Novo Nordisk Investigational Site
Kettering, United Kingdom, NN16 8UZ
Novo Nordisk Investigational Site
Leicester, United Kingdom, LE1 5WW
Novo Nordisk Investigational Site
Livingstone, United Kingdom, EH54 6PP
Novo Nordisk Investigational Site
Newcastle, United Kingdom, NE7 7DN
Novo Nordisk Investigational Site
Northampton, United Kingdom, NN1 5BD
Novo Nordisk Investigational Site
Nottingham, United Kingdom, NG7 2UH
Novo Nordisk Investigational Site
Paisley, United Kingdom, PA2 9PL
Novo Nordisk Investigational Site
Watford, United Kingdom, WD18 0HB
Novo Nordisk Investigational Site
Whiston, United Kingdom, L35 5DR
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR,1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: 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: January 3, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Insulin Aspart
Insulin, Long-Acting
Insulin, Isophane
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 27, 2017