search
Back to results

Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or Type 2 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
biphasic human 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:

  • Subjects with insulin requiring type 1 or type 2 diabetes for at least 24 months
  • Current treatment with human insulin (either premix of short and long/intermediate acting insulin) in a twice daily treatment regimen preparation and/or self-mix for at least 12 months
  • Body mass index (BMI) below or equal to 35.0 kg/m^2
  • HbA1c below or equal to 11.0%

Exclusion Criteria:

  • Total daily insulin dose at least 1.4 IU/kg
  • Treatment with oral hypoglycaemic agents within the month prior to inclusion
  • Recurrent severe hypoglycaemia (as judged by the investigator)
  • Active proliferative retinopathy
  • Impaired renal function with creatinine at least 150 mcmol/l (1.7 mg/dl)
  • History of pancreatitis

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

HbA1c (glycosylated haemoglobin A1c)

Secondary Outcome Measures

8-point blood glucose profiles
Incidence of hypoglycaemic episodes
Occurrence of adverse events

Full Information

First Posted
November 4, 2011
Last Updated
January 3, 2017
Sponsor
Novo Nordisk A/S
search

1. Study Identification

Unique Protocol Identification Number
NCT01467323
Brief Title
Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or Type 2 Diabetes
Official Title
An Open-labelled, Randomised, Parallel Group, Multicentre, Multinational Efficacy and Safety Comparison of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30/70 as Meal Related Insulin in a Twice Daily Regimen in Type 1 and Type 2 Diabetic Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 1998 (undefined)
Primary Completion Date
September 1998 (Actual)
Study Completion Date
September 1998 (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 efficacy and safety of biphasic insulin aspart 30 in subjects with type 1 or 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 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
303 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart
Intervention Description
Injected subcutaneously (under the skin) twice daily
Intervention Type
Drug
Intervention Name(s)
biphasic human insulin
Intervention Description
Injected subcutaneously (under the skin) twice daily
Primary Outcome Measure Information:
Title
HbA1c (glycosylated haemoglobin A1c)
Secondary Outcome Measure Information:
Title
8-point blood glucose profiles
Title
Incidence of hypoglycaemic episodes
Title
Occurrence of adverse events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with insulin requiring type 1 or type 2 diabetes for at least 24 months Current treatment with human insulin (either premix of short and long/intermediate acting insulin) in a twice daily treatment regimen preparation and/or self-mix for at least 12 months Body mass index (BMI) below or equal to 35.0 kg/m^2 HbA1c below or equal to 11.0% Exclusion Criteria: Total daily insulin dose at least 1.4 IU/kg Treatment with oral hypoglycaemic agents within the month prior to inclusion Recurrent severe hypoglycaemia (as judged by the investigator) Active proliferative retinopathy Impaired renal function with creatinine at least 150 mcmol/l (1.7 mg/dl) History of pancreatitis
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
A 1080
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Anklam
ZIP/Postal Code
17389
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
10559
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
14089
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Cottbus
ZIP/Postal Code
03048
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Erkner
ZIP/Postal Code
15537
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Jena
ZIP/Postal Code
07743
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Leipzig
ZIP/Postal Code
04177
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
München
ZIP/Postal Code
80804
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Neunkirchen
ZIP/Postal Code
66538
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Quakenbrück
ZIP/Postal Code
49610
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Saarlouis
ZIP/Postal Code
66740
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Schwedt
ZIP/Postal Code
16303
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Cork
Country
Ireland
Facility Name
Novo Nordisk Investigational Site
City
Dublin 9
Country
Ireland
Facility Name
Novo Nordisk Investigational Site
City
Dublin
ZIP/Postal Code
DUBLIN 8
Country
Ireland
Facility Name
Novo Nordisk Investigational Site
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
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
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
Bristol
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Kettering
ZIP/Postal Code
NN16 8UZ
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
Livingstone
ZIP/Postal Code
EH54 6PP
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
Paisley
ZIP/Postal Code
PA2 9PL
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
12027927
Citation
Boehm BO, Home PD, Behrend C, Kamp NM, Lindholm A. Premixed insulin aspart 30 vs. premixed human insulin 30/70 twice daily: a randomized trial in Type 1 and Type 2 diabetic patients. Diabet Med. 2002 May;19(5):393-9. doi: 10.1046/j.1464-5491.2002.00733.x. Erratum In: Diabet Med. 2002 Sep;19(9):797.
Results Reference
result
PubMed Identifier
11978684
Citation
Lindholm A, Jensen LB, Home PD, Raskin P, Boehm BO, Rastam J. Immune responses to insulin aspart and biphasic insulin aspart in people with type 1 and type 2 diabetes. Diabetes Care. 2002 May;25(5):876-82. doi: 10.2337/diacare.25.5.876.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or Type 2 Diabetes

We'll reach out to this number within 24 hrs