Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or Type 2 Diabetes
Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT01467323
Collaborator
(none)
303
37
2
5
8.2
1.6
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
303 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date
:
Apr 1, 1998
Actual Primary Completion Date
:
Sep 1, 1998
Actual Study Completion Date
:
Sep 1, 1998
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: A
|
Drug: biphasic insulin aspart
Injected subcutaneously (under the skin) twice daily
|
| Active Comparator: B
|
Drug: biphasic human insulin
Injected subcutaneously (under the skin) twice daily
|
Outcome Measures
Primary Outcome Measures
- HbA1c (glycosylated haemoglobin A1c) []
Secondary Outcome Measures
- 8-point blood glucose profiles []
- Incidence of hypoglycaemic episodes []
- Occurrence of adverse events []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Graz | Austria | 8036 | |
| 2 | Novo Nordisk Investigational Site | Wien | Austria | A 1080 | |
| 3 | Novo Nordisk Investigational Site | Anklam | Germany | 17389 | |
| 4 | Novo Nordisk Investigational Site | Berlin | Germany | 10559 | |
| 5 | Novo Nordisk Investigational Site | Berlin | Germany | 14089 | |
| 6 | Novo Nordisk Investigational Site | Cottbus | Germany | 03048 | |
| 7 | Novo Nordisk Investigational Site | Erkner | Germany | 15537 | |
| 8 | Novo Nordisk Investigational Site | Hamburg | Germany | 20251 | |
| 9 | Novo Nordisk Investigational Site | Jena | Germany | 07743 | |
| 10 | Novo Nordisk Investigational Site | Leipzig | Germany | 04177 | |
| 11 | Novo Nordisk Investigational Site | München | Germany | 80804 | |
| 12 | Novo Nordisk Investigational Site | Neunkirchen | Germany | 66538 | |
| 13 | Novo Nordisk Investigational Site | Quakenbrück | Germany | 49610 | |
| 14 | Novo Nordisk Investigational Site | Rostock | Germany | 18057 | |
| 15 | Novo Nordisk Investigational Site | Saarlouis | Germany | 66740 | |
| 16 | Novo Nordisk Investigational Site | Schwedt | Germany | 16303 | |
| 17 | Novo Nordisk Investigational Site | Ulm | Germany | 89081 | |
| 18 | Novo Nordisk Investigational Site | Würzburg | Germany | 97080 | |
| 19 | Novo Nordisk Investigational Site | Cork | Ireland | ||
| 20 | Novo Nordisk Investigational Site | Dublin 9 | Ireland | ||
| 21 | Novo Nordisk Investigational Site | Dublin | Ireland | DUBLIN 8 | |
| 22 | Novo Nordisk Investigational Site | Bern | Switzerland | 3010 | |
| 23 | Novo Nordisk Investigational Site | Ayr | United Kingdom | KA6 6DX | |
| 24 | Novo Nordisk Investigational Site | Bath | United Kingdom | BA1 3NG | |
| 25 | Novo Nordisk Investigational Site | Birmingham | United Kingdom | B9 5SS | |
| 26 | Novo Nordisk Investigational Site | Blackburn | United Kingdom | BB3 3LR | |
| 27 | Novo Nordisk Investigational Site | Bolton | United Kingdom | BL1 4QS | |
| 28 | Novo Nordisk Investigational Site | Bristol | United Kingdom | BS2 8HW | |
| 29 | Novo Nordisk Investigational Site | Kettering | United Kingdom | NN16 8UZ | |
| 30 | Novo Nordisk Investigational Site | Leicester | United Kingdom | LE1 5WW | |
| 31 | Novo Nordisk Investigational Site | Livingstone | United Kingdom | EH54 6PP | |
| 32 | Novo Nordisk Investigational Site | Newcastle | United Kingdom | NE7 7DN | |
| 33 | Novo Nordisk Investigational Site | Northampton | United Kingdom | NN1 5BD | |
| 34 | Novo Nordisk Investigational Site | Nottingham | United Kingdom | NG7 2UH | |
| 35 | Novo Nordisk Investigational Site | Paisley | United Kingdom | PA2 9PL | |
| 36 | Novo Nordisk Investigational Site | Watford | United Kingdom | WD18 0HB | |
| 37 | Novo Nordisk Investigational Site | Whiston | United Kingdom | L35 5DR |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Global Clinical Registry (GCR,1452), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01467323
Other Study ID Numbers:
- ANA/DCD/038
First Posted:
Nov 8, 2011
Last Update Posted:
Jan 4, 2017
Last Verified:
Jan 1, 2017
Additional relevant MeSH terms: