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Comparison of Insulin Detemir Plus Insulin Aspart With Insulin NPH Plus Human Soluble Insulin in Subjects With Type 1 Diabetes

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
insulin detemir
insulin aspart
insulin NPH
human soluble insulin
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
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 1 diabetes for at least 12 months
  • Current treatment with any basal/bolus regimen or any biphasic insulin treatment for at least 6 months
  • BMI below or equal to 35 kg/m^2
  • HbA1c below or equal to 12%

Exclusion Criteria:

  • Proliferative retinopathy or maculopathy requiring acute treatment
  • Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the Investigator)
  • Subjects with known hypoglycaemic unawareness as judged by the Investigator

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Basal/bolus regimen 1

Basal/bolus regimen 2

Arm Description

Outcomes

Primary Outcome Measures

HbA1c (glycosylated haemoglobin)

Secondary Outcome Measures

Intra-subject variation in home measured blood glucose (3-point blood glucose profiles)
8-point blood glucose profiles
Incidence of self-recorded hypoglycaemic episodes
Incidence of adverse events

Full Information

First Posted
December 5, 2011
Last Updated
January 26, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01486940
Brief Title
Comparison of Insulin Detemir Plus Insulin Aspart With Insulin NPH Plus Human Soluble Insulin in Subjects With Type 1 Diabetes
Official Title
A Multi-centre, Multinational, Open-labelled, Randomised, Parallel-Group Comparison of Insulin Detemir Plus Insulin Aspart With NPH Insulin Plus Human Soluble Insulin in Subjects With Type 1 Diabetes on a Basal-Bolus Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
October 2002 (Actual)
Study Completion Date
October 2002 (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 South America. The aim of this trial is to compare the glycaemic control of insulin detemir plus insulin aspart with that of insulin NPH plus human soluble insulin in subjects with type 1 diabetes on a basal/bolus regimen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Basal/bolus regimen 1
Arm Type
Experimental
Arm Title
Basal/bolus regimen 2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
insulin detemir
Intervention Description
Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals
Intervention Type
Drug
Intervention Name(s)
insulin NPH
Intervention Description
Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily
Intervention Type
Drug
Intervention Name(s)
human soluble insulin
Intervention Description
Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals
Primary Outcome Measure Information:
Title
HbA1c (glycosylated haemoglobin)
Secondary Outcome Measure Information:
Title
Intra-subject variation in home measured blood glucose (3-point blood glucose profiles)
Title
8-point blood glucose profiles
Title
Incidence of self-recorded hypoglycaemic episodes
Title
Incidence of adverse events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 1 diabetes for at least 12 months Current treatment with any basal/bolus regimen or any biphasic insulin treatment for at least 6 months BMI below or equal to 35 kg/m^2 HbA1c below or equal to 12% Exclusion Criteria: Proliferative retinopathy or maculopathy requiring acute treatment Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the Investigator) Subjects with known hypoglycaemic unawareness as judged by the Investigator
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
Junin
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Moron
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Varazdin
ZIP/Postal Code
42 000
Country
Croatia
Facility Name
Novo Nordisk Investigational Site
City
Hradec Kralove
ZIP/Postal Code
50036
Country
Czech Republic
Facility Name
Novo Nordisk Investigational Site
City
Liberec
ZIP/Postal Code
46001
Country
Czech Republic
Facility Name
Novo Nordisk Investigational Site
City
Plzen - Lochotin
ZIP/Postal Code
30460
Country
Czech Republic
Facility Name
Novo Nordisk Investigational Site
City
Praha 10
ZIP/Postal Code
10034
Country
Czech Republic
Facility Name
Novo Nordisk Investigational Site
City
Praha 2
ZIP/Postal Code
12000
Country
Czech Republic
Facility Name
Novo Nordisk Investigational Site
City
Praha 4
ZIP/Postal Code
140 00
Country
Czech Republic
Facility Name
Novo Nordisk Investigational Site
City
Praha 5
ZIP/Postal Code
150 18
Country
Czech Republic
Facility Name
Novo Nordisk Investigational Site
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Hjørring
ZIP/Postal Code
9800
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Holbæk
ZIP/Postal Code
4300
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
København
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Køge
ZIP/Postal Code
4600
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Slagelse
ZIP/Postal Code
4200
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Svendborg
ZIP/Postal Code
5700
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Århus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Kemi
ZIP/Postal Code
94100
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Kokkola
ZIP/Postal Code
67200
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Oulu
ZIP/Postal Code
FI-90220
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Pärnu
ZIP/Postal Code
80010
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Rovaniemi
ZIP/Postal Code
96400
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Viljandi
ZIP/Postal Code
71024
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Angers
Country
France
Facility Name
Novo Nordisk Investigational Site
City
GRENOBLE cedex
ZIP/Postal Code
38043
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Lorient
ZIP/Postal Code
56322
Country
France
Facility Name
Novo Nordisk Investigational Site
City
MONTPELLIER cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Mougins
ZIP/Postal Code
06250
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Narbonne
ZIP/Postal Code
11108
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Paris
ZIP/Postal Code
75877
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
GR-10552
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
GR-115 27
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
GR-11527
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Alessandria
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Asti
ZIP/Postal Code
14100
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Bari
ZIP/Postal Code
70100
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Catania
ZIP/Postal Code
95126
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Lucca
ZIP/Postal Code
55100
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Padova
ZIP/Postal Code
35143
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Prato
ZIP/Postal Code
59100
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Skopje
ZIP/Postal Code
1000
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
Novo Nordisk Investigational Site
City
Arendal
ZIP/Postal Code
4841
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Gjettum
ZIP/Postal Code
1346
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Gjøvik
ZIP/Postal Code
NO-2819
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Kongsberg
ZIP/Postal Code
NO-3602
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Kongsvinger
ZIP/Postal Code
2212
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Kristiansand S
ZIP/Postal Code
4604
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Rådal
ZIP/Postal Code
5235
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-094
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-822
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
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
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
125315
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Kosice
ZIP/Postal Code
043 80
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Moldava nad Bodvou
ZIP/Postal Code
045 01
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Falun
ZIP/Postal Code
791 82
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
15298338
Citation
Hermansen K, Fontaine P, Kukolja KK, Peterkova V, Leth G, Gall MA. Insulin analogues (insulin detemir and insulin aspart) versus traditional human insulins (NPH insulin and regular human insulin) in basal-bolus therapy for patients with type 1 diabetes. Diabetologia. 2004 Apr;47(4):622-9. doi: 10.1007/s00125-004-1365-z.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Comparison of Insulin Detemir Plus Insulin Aspart With Insulin NPH Plus Human Soluble Insulin in Subjects With Type 1 Diabetes

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