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Safety and Efficacy of Insulin Aspart 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 aspart
human soluble insulin
insulin NPH
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:

  • The subject must have completed the six month controlled treatment period in trial ANA/DCD/035

Sites / Locations

  • Novo Nordisk Investigational Site
  • 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

insulin aspart

human insulin

Arm Description

Outcomes

Primary Outcome Measures

Number of hypoglycaemic events

Secondary Outcome Measures

Occurrence of adverse events
Incidence of hypoglycaemic episodes
Standard safety parameters: Haematology and biochemistry
HbA1c (glycosylated haemoglobin)

Full Information

First Posted
October 10, 2012
Last Updated
January 3, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01707134
Brief Title
Safety and Efficacy of Insulin Aspart in Subjects With Type 1 Diabetes
Official Title
An Open-labelled, Controlled, Multicentre, Multinational, Extension Study Assessing Safety and Efficacy of the Human Insulin Analogue Insulin Aspart (X14) and Human Soluble Insulin as Meal Related Insulin in a Multiple Injection Regimen in Type 1 Diabetic Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 1997 (undefined)
Primary Completion Date
May 2000 (Actual)
Study Completion Date
May 2000 (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. The aim of this trial is to evaluate the safety profile of insulin aspart in subjects with type 1 diabetes having participated in trial ANA/DCD/035.

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
753 (Actual)

8. Arms, Groups, and Interventions

Arm Title
insulin aspart
Arm Type
Experimental
Arm Title
human insulin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
Injected subcutaneously (s.c, under the skin) as meal time insulin
Intervention Type
Drug
Intervention Name(s)
human soluble insulin
Intervention Description
Injected subcutaneously (s.c, under the skin) as meal time insulin
Intervention Type
Drug
Intervention Name(s)
insulin NPH
Intervention Description
Will be administrated subcutaneously (s.c, under the skin) once or twice daily as basal insulin
Primary Outcome Measure Information:
Title
Number of hypoglycaemic events
Secondary Outcome Measure Information:
Title
Occurrence of adverse events
Title
Incidence of hypoglycaemic episodes
Title
Standard safety parameters: Haematology and biochemistry
Title
HbA1c (glycosylated haemoglobin)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject must have completed the six month controlled treatment period in trial ANA/DCD/035
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
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Wien
ZIP/Postal Code
1030
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Gentofte
ZIP/Postal Code
2820
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Kolding
ZIP/Postal Code
6000
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
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Kotka
ZIP/Postal Code
48210
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Vantaa
ZIP/Postal Code
01400
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Bad Neuenahr-Ahrweiler
ZIP/Postal Code
53474
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Bad Oeynhausen
ZIP/Postal Code
32454
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Essen
ZIP/Postal Code
45131
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Essen
ZIP/Postal Code
45138
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Flensburg
ZIP/Postal Code
24939
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Friedrichsthal
ZIP/Postal Code
66299
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Giessen
ZIP/Postal Code
35385
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Haan
ZIP/Postal Code
42781
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Kiel
ZIP/Postal Code
24103
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Magdeburg
ZIP/Postal Code
39124
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Mainz
ZIP/Postal Code
55116
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Mönchengladbach
ZIP/Postal Code
41061
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
München
ZIP/Postal Code
81925
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Oberhausen
ZIP/Postal Code
46145
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Ostercappeln
ZIP/Postal Code
49179
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Saarlouis
ZIP/Postal Code
66740
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Schwerin
ZIP/Postal Code
19049
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Stuttgart
ZIP/Postal Code
70184
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Stuttgart
ZIP/Postal Code
70191
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Wuppertal
ZIP/Postal Code
42117
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Würzburg
ZIP/Postal Code
97070
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Haugesund
ZIP/Postal Code
5500
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Oslo
ZIP/Postal Code
0407
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Falun
ZIP/Postal Code
791 82
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Karlstad
ZIP/Postal Code
651 85
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Zürich
ZIP/Postal Code
8032
Country
Switzerland
Facility Name
Novo Nordisk Investigational Site
City
Airdrie
ZIP/Postal Code
ML6 0JS
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Blackburn
ZIP/Postal Code
BB3 3LR
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Bolton
ZIP/Postal Code
BL1 4QS
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Church Village
ZIP/Postal Code
CF38 1AB
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Cosham
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Coventry
ZIP/Postal Code
CV1 4FH
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
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Exeter
ZIP/Postal Code
EX2 5AX
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Gillingham
ZIP/Postal Code
ME7 5NY
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Inverness
ZIP/Postal Code
IV2 3UJ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Middlesbrough
ZIP/Postal Code
TS5 5AZ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Newcastle
ZIP/Postal Code
NE7 7DN
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
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Penarth
ZIP/Postal Code
CF64 2XX
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
Reading
ZIP/Postal Code
RG51 5BS
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Rugby
ZIP/Postal Code
CV22 5PX
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Salisbury
ZIP/Postal Code
SP2 8BJ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Southampton
ZIP/Postal Code
SO14 OYG
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Stevenage
ZIP/Postal Code
SG1 4AB
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Stirling
ZIP/Postal Code
FK8 2AU
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Watford
ZIP/Postal Code
WD18 0HB
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Whiston
ZIP/Postal Code
L35 5DR
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
16054266
Citation
Home PD, Hallgren P, Usadel KH, Sane T, Faber J, Grill V, Friberg HH. Pre-meal insulin aspart compared with pre-meal soluble human insulin in type 1 diabetes. Diabetes Res Clin Pract. 2006 Feb;71(2):131-9. doi: 10.1016/j.diabres.2005.05.015. Epub 2005 Jul 27.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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Safety and Efficacy of Insulin Aspart in Subjects With Type 1 Diabetes

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