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Basal Bolus of Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
biphasic insulin aspart
insulin NPH
insulin aspart
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Type 2 diabetes
  • Currently treated with human insulin or insulin analogues for at least 3 months, with or without combination with OADs
  • HbA1c between 8.0-10.5%
  • Body mass index (BMI) below 35.0 kg/m2
  • Able and willing to perform self-monitoring of blood glucose

Exclusion Criteria:

  • Total daily insulin dose of 1.80 IU/kg or more
  • Known or suspected allergy to trial product or related products
  • Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
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  • Novo Nordisk Investigational Site
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  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
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  • Novo Nordisk Investigational Site
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  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Outcomes

Primary Outcome Measures

HbA1c

Secondary Outcome Measures

8-point blood glucose profile
incidence of hypoglycaemic episodes
safety profiles
changes in body weight and vital signs

Full Information

First Posted
January 14, 2008
Last Updated
January 5, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00600626
Brief Title
Basal Bolus of Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes
Official Title
Comparison of Basal Bolus Treatment With Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
July 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is conducted in Europe and Asia. The aim of this trial is to compare basal bolus treatment with insulin aspart and insulin NPH to biphasic insulin aspart treatment on blood glucose control in type 2 diabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
394 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart
Intervention Type
Drug
Intervention Name(s)
insulin NPH
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Primary Outcome Measure Information:
Title
HbA1c
Time Frame
after 4 months of treatment
Secondary Outcome Measure Information:
Title
8-point blood glucose profile
Title
incidence of hypoglycaemic episodes
Title
safety profiles
Title
changes in body weight and vital signs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes Currently treated with human insulin or insulin analogues for at least 3 months, with or without combination with OADs HbA1c between 8.0-10.5% Body mass index (BMI) below 35.0 kg/m2 Able and willing to perform self-monitoring of blood glucose Exclusion Criteria: Total daily insulin dose of 1.80 IU/kg or more Known or suspected allergy to trial product or related products Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Zagreb
ZIP/Postal Code
10 000
Country
Croatia
Facility Name
Novo Nordisk Investigational Site
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Novo Nordisk Investigational Site
City
NEVERS cedex
ZIP/Postal Code
58033
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Rennes
ZIP/Postal Code
35056
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Venissieux
ZIP/Postal Code
69200
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Bad Heilbrunn
ZIP/Postal Code
83670
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Neuss
ZIP/Postal Code
41460
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Schaafheim
ZIP/Postal Code
64850
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Schwedt
ZIP/Postal Code
16303
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
St. Ingbert
ZIP/Postal Code
66386
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Völklingen
ZIP/Postal Code
66333
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Wiesbaden
ZIP/Postal Code
65183
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Würzburg
ZIP/Postal Code
97072
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Shatin, New Territories
Country
Hong Kong
Facility Name
Novo Nordisk Investigational Site
City
Cheras
ZIP/Postal Code
56000
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Kota Bharu, Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Beverwijk
ZIP/Postal Code
1942 LE
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Delft
ZIP/Postal Code
2625 AD
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Eindhoven
ZIP/Postal Code
5631 BM
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Rotterdam
ZIP/Postal Code
3011 TD
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Lodz
ZIP/Postal Code
90-030
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Szczecin
ZIP/Postal Code
71-455
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Warszawa
ZIP/Postal Code
03-242
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Cluj Napoca
State/Province
Cluj
ZIP/Postal Code
400006
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Constanta
ZIP/Postal Code
900591
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Iasi
ZIP/Postal Code
700111
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
117036
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
119435
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Novo Nordisk Investigational Site
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Orihuela
ZIP/Postal Code
03300
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Valladolid
ZIP/Postal Code
47011
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Falun
ZIP/Postal Code
791 82
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Göteborg
ZIP/Postal Code
416 85
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Mölndal
ZIP/Postal Code
431 80
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Coventry
ZIP/Postal Code
CV6 2FL
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Glasgow
ZIP/Postal Code
G42 9TY
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Northampton
ZIP/Postal Code
NN1 5BD
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Plymouth
ZIP/Postal Code
PL8 8DQ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
York
ZIP/Postal Code
YO3 7HE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
17115349
Citation
Ligthelm RJ, Mouritzen U, Lynggaard H, Landin-Olsson M, Fox C, le Devehat C, Romero E, Liebl A. Biphasic insulin aspart given thrice daily is as efficacious as a basal-bolus insulin regimen with four daily injections: a randomised open-label parallel group four months comparison in patients with type 2 diabetes. Exp Clin Endocrinol Diabetes. 2006 Oct;114(9):511-9. doi: 10.1055/s-2006-924424.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Basal Bolus of Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes

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