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Comparison of Biphasic Human Insulin 30 With Biphasic Insulin Aspart in Subjects With Diabetes

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
biphasic insulin aspart 50
biphasic insulin aspart 70
biphasic human insulin 30
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 or Type 2 diabetes
  • Current treatment with BHI 30 twice daily as the only insulin therapy for at least 3 months, with or without combination with oral hypoglycaemic agents
  • Body mass index (BMI) maximum 40.0 kg/m^2

Exclusion Criteria:

  • History of drug or alcohol dependence
  • Impaired hepatic function
  • Impaired renal function
  • Cardiac disease
  • Proliferative retinopathy
  • Total daily insulin dose at least 1.80 IU/kg

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

BIAsp 50 or 70

BHI 30

Arm Description

Outcomes

Primary Outcome Measures

HbA1c (glycosylated haemoglobin A1c)

Secondary Outcome Measures

Blood glucose profiles
Adverse events
Hypoglycaemic episodes
Quality of Life (QoL) assessed via World Health Organization Diabetes Treatment Satisfaction Questionnaire (WHO DTSQ)
Quality of Life (QoL) assessed via Diabetes Health Profile (DHP-2)

Full Information

First Posted
January 25, 2012
Last Updated
January 3, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01520818
Brief Title
Comparison of Biphasic Human Insulin 30 With Biphasic Insulin Aspart in Subjects With Diabetes
Official Title
A Multinational, Randomised, Open-labelled, Parallel Group Four Months Comparison of Twice Daily Biphasic Human Insulin 30 and Thrice Daily Biphasic Insulin Aspart 50 and 70 in Subjects With Type 1 or Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
April 2001 (Actual)
Study Completion Date
April 2001 (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 compare the glycaemic control of biphasic insulin aspart (BIAsp) 70 and/or BIAsp 50 with biphasic human insulin (BHI) 30 treatment.

6. Conditions and Keywords

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

8. Arms, Groups, and Interventions

Arm Title
BIAsp 50 or 70
Arm Type
Experimental
Arm Title
BHI 30
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart 50
Intervention Description
Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner. Randomised subjects being obese with a body mass index (BMI) exceeding 30 kg/m^2 will receive BIAsp 50
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart 70
Intervention Description
Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner. Randomised subjects being lean and overweight with a body mass index (BMI) of maximum 30 kg/m^2 will receive BIAsp 70
Intervention Type
Drug
Intervention Name(s)
biphasic human insulin 30
Intervention Description
Administered subcutaneously (s.c., under the skin), twice a day
Primary Outcome Measure Information:
Title
HbA1c (glycosylated haemoglobin A1c)
Secondary Outcome Measure Information:
Title
Blood glucose profiles
Title
Adverse events
Title
Hypoglycaemic episodes
Title
Quality of Life (QoL) assessed via World Health Organization Diabetes Treatment Satisfaction Questionnaire (WHO DTSQ)
Title
Quality of Life (QoL) assessed via Diabetes Health Profile (DHP-2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 1 or Type 2 diabetes Current treatment with BHI 30 twice daily as the only insulin therapy for at least 3 months, with or without combination with oral hypoglycaemic agents Body mass index (BMI) maximum 40.0 kg/m^2 Exclusion Criteria: History of drug or alcohol dependence Impaired hepatic function Impaired renal function Cardiac disease Proliferative retinopathy Total daily insulin dose at least 1.80 IU/kg
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
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Jumet
ZIP/Postal Code
6040
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Amiens
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Avignon
ZIP/Postal Code
84902
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Bagnols-sur-ceze
ZIP/Postal Code
30200
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
Novo Nordisk Investigational Site
City
DIJON cedex
ZIP/Postal Code
21079
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Dommartin Les Toul
ZIP/Postal Code
54201
Country
France
Facility Name
Novo Nordisk Investigational Site
City
GRENOBLE cedex
ZIP/Postal Code
38043
Country
France
Facility Name
Novo Nordisk Investigational Site
City
LA ROCHELLE cedex
ZIP/Postal Code
17019
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Le Creusot
ZIP/Postal Code
71200
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Lorient
ZIP/Postal Code
56322
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Macon
ZIP/Postal Code
71000
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Nanterre
ZIP/Postal Code
92014
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Narbonne
ZIP/Postal Code
11108
Country
France
Facility Name
Novo Nordisk Investigational Site
City
NEVERS cedex
ZIP/Postal Code
58033
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Nimes
ZIP/Postal Code
30006
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Orleans
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Paris
ZIP/Postal Code
75007
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Reims
ZIP/Postal Code
51056
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Roubaix
ZIP/Postal Code
59056
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Saint Etienne
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Novo Nordisk Investigational Site
City
TOULOUSE cedex
ZIP/Postal Code
31054
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Dublin
ZIP/Postal Code
DUBLIN 15
Country
Ireland
Facility Name
Novo Nordisk Investigational Site
City
Dublin
ZIP/Postal Code
DUBLIN 7
Country
Ireland
Facility Name
Novo Nordisk Investigational Site
City
Dublin
Country
Ireland
Facility Name
Novo Nordisk Investigational Site
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Amersfoort
ZIP/Postal Code
3816 CP
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Arnhem
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Beverwijk
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Delft
ZIP/Postal Code
2625 AD
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Den Bosch
ZIP/Postal Code
5223 GV
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Den Haag
ZIP/Postal Code
2597 AX
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Einhoven
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Hengelo
ZIP/Postal Code
7555 DL
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Rotterdam
ZIP/Postal Code
3011 TD
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Rotterdam
ZIP/Postal Code
3021 HC
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Ayrsh
ZIP/Postal Code
KA2 0BE
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Ayr
ZIP/Postal Code
KA6 6DX
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
Birmingham
ZIP/Postal Code
B9 5SS
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
CV1 4FH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Edgware
ZIP/Postal Code
HA8 0AD
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
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Haywards Heath
ZIP/Postal Code
RH16 4EX
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Ipswich
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Leeds
ZIP/Postal Code
LS9 7TF
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
E11 1NR
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
London
ZIP/Postal Code
N19 3UA
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Manchester
ZIP/Postal Code
M13 0JE
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Manchester
ZIP/Postal Code
M8 5RB
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
Paisley
ZIP/Postal Code
PA2 9PL
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Poole
ZIP/Postal Code
BH15 2JB
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
Scunthorpe
ZIP/Postal Code
DN15 7BH
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
Sunderland
ZIP/Postal Code
SR4 7TP
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

12. IPD Sharing Statement

Citations:
PubMed Identifier
18269638
Citation
Clements MR, Tits J, Kinsley BT, Rastam J, Friberg HH, Ligthelm RJ. Improved glycaemic control of thrice-daily biphasic insulin aspart compared with twice-daily biphasic human insulin; a randomized, open-label trial in patients with type 1 or type 2 diabetes. Diabetes Obes Metab. 2008 Mar;10(3):229-37. doi: 10.1111/j.1463-1326.2006.00687.x.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Comparison of Biphasic Human Insulin 30 With Biphasic Insulin Aspart in Subjects With Diabetes

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