Clinical Trials Logo
  1. Home
  2. Diabetes Mellitus, Type 2
  3. NCT00604656
  4. Details
NCT00604656 Clinical Trial

Comparison of Insulin Aspart Produced by the NN2000 Process to the Current Process in Type 1 Diabetes

Diabetes Clinical Trial

Official title:
A Six Months, Multi-centre, Open, Randomised, Parallel Safety and Efficacy Comparison of NovoRapid® Produced by the Current Process and Insulin Aspart With the Same Formulation as NovoRapid®, Produced by the NN2000 Process in Subjects With Type 1 Diabetes on a Basal/Bolus Regimen

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00604656
Other study ID # NN2000-1542
Secondary ID
Status Completed
Phase Phase 3
First received January 17, 2008
Last updated February 28, 2017
Start date May 5, 2003
Est. completion date January 29, 2004

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of this trial is to investigate the safety and efficacy of insulin aspart produced by current process compared to that of insulin aspart produced by NN2000 process in subjects with type 2 diabetes.

Recruitment information / eligibility
Status Completed
Enrollment 241
Est. completion date January 29, 2004
Est. primary completion date January 29, 2004
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subjects with type 1 diabetes

- Duration of diabetes for at least 12 months

- Treatment with insulin aspart for at least 3 months before trial start

- Body Mass Index (BMI) below 35.0 kg/m2

- HbA1c below 12.0%

Exclusion Criteria:

- Total insulin dosage more than 1.4 IU/kg/day

- Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the investigator)

- Known hypoglycaemia unawareness as judged by the investigator

- Known hypersensitivity or allergy

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• insulin aspart

Locations
Country Name City State
Czech Republic Novo Nordisk Investigational Site Hradec Králové
Czech Republic Novo Nordisk Investigational Site Praha 5
Germany Novo Nordisk Investigational Site Bad Kreuznach
Germany Novo Nordisk Investigational Site Bad Neuenahr-Ahrweiler
Germany Novo Nordisk Investigational Site Diez
Germany Novo Nordisk Investigational Site Frankfurt
Germany Novo Nordisk Investigational Site Friedrichsthal
Germany Novo Nordisk Investigational Site Karlsruhe
Germany Novo Nordisk Investigational Site Marktheidenfeld
Germany Novo Nordisk Investigational Site Marl
Germany Novo Nordisk Investigational Site Oberursel
Germany Novo Nordisk Investigational Site Rehlingen-Siersburg
Germany Novo Nordisk Investigational Site Saarbrücken
Germany Novo Nordisk Investigational Site Simmern
Germany Novo Nordisk Investigational Site Speyer
Germany Novo Nordisk Investigational Site St. Ingbert
Germany Novo Nordisk Investigational Site Würzburg
Hungary Novo Nordisk Investigational Site Budapest
Hungary Novo Nordisk Investigational Site Nyíregyháza
Italy Novo Nordisk Investigational Site Cagliari
Italy Novo Nordisk Investigational Site Chiavari
Italy Novo Nordisk Investigational Site Citta' Di Castello
Italy Novo Nordisk Investigational Site Lucca
Italy Novo Nordisk Investigational Site Orvieto
Italy Novo Nordisk Investigational Site Parma
Italy Novo Nordisk Investigational Site Perugia
Italy Novo Nordisk Investigational Site Rimini
Italy Novo Nordisk Investigational Site Roma
Italy Novo Nordisk Investigational Site Roma
Poland Novo Nordisk Investigational Site Bytom
Poland Novo Nordisk Investigational Site Mazowieckie
Poland Novo Nordisk Investigational Site Radom
Poland Novo Nordisk Investigational Site Warsaw
Poland Novo Nordisk Investigational Site Wroclaw

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Czech Republic,  Germany,  Hungary,  Italy,  Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Insulin aspart antibodies After 6 months treatment
Secondary Occurrence of adverse events
Secondary Incidence of hypoglycaemic episodes
Secondary HbA1c
See also
  Status Clinical Trial Phase
Completed NCT05594446 - Morphometric Study of the Legs and Feet of Diabetic Patients in Order to Collect Data Intended to be Used to Measure by Dynamometry the Pressures Exerted by Several Medical Compression Socks at the Level of the Forefoot
Completed NCT03975309 - DHS MIND Metabolomics
Completed NCT01855399 - Technologically Enhanced Coaching: A Program to Improve Diabetes Outcomes N/A
Completed NCT01819129 - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes Phase 3
Recruiting NCT04984226 - Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD Phase 2
Recruiting NCT05007990 - Caregiving Networks Across Disease Context and the Life Course
Active, not recruiting NCT04420936 - Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program N/A
Recruiting NCT03549559 - Imaging Histone Deacetylase in the Heart N/A
Completed NCT04903496 - Clinical Characteristics and Disease Burden of Diabetic Patients Based on Tianjin Regional Database
Completed NCT01437592 - Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects Phase 1
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Completed NCT04082585 - Total Health Improvement Program Research Project
Completed NCT03390179 - Hyperglycemic Response and Steroid Administration After Surgery (DexGlySurgery)
Not yet recruiting NCT05029804 - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes N/A
Recruiting NCT05294822 - Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes N/A
Completed NCT04427982 - Dance and Diabetes/Prediabetes Self-Management N/A
Completed NCT02356848 - STEP UP to Avert Amputation in Diabetes N/A
Completed NCT03292185 - A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects Phase 1
Active, not recruiting NCT05477368 - Examining the Feasibility of Prolonged Ketone Supplement Drink Consumption in Adults With Type 2 Diabetes N/A
Completed NCT04496401 - PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus Phase 4

External Links