Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Multi-National, Multi-Centre, Open-Labelled Extension Study Assessing the Long-Term Safety of Biphasic Insulin Aspart 30 in NovoMix®30 FlexPen™ in Type 2 Diabetic Patients Previously Treated in BIAsp-1236
| Verified date | February 2017 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This trial is conducted in Europe. The aim of this trial investigate the the long-term safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.
| Status | Completed |
| Enrollment | 89 |
| Est. completion date | March 14, 2003 |
| Est. primary completion date | March 14, 2003 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Signed informed consent obtained before any trial-related activities - Completed the trial BIAsp-1236 Exclusion Criteria: - Planned changes in use of any prescription medication that may interfere with glucose regulation - Known or suspected allergy to trial products or related products - Women who are having the intention of becoming pregnant, or are judged not to be using adequate contraceptive measures - Any other significant condition or concomitant disease or any condition that would interfere with participation as judged by the Investigator |
| Country | Name | City | State |
|---|---|---|---|
| Finland | Novo Nordisk Investigational Site | Kotka | |
| Finland | Novo Nordisk Investigational Site | Kuopio | |
| Finland | Novo Nordisk Investigational Site | Lahti | |
| Norway | Novo Nordisk Investigational Site | Gjøvik | |
| Norway | Novo Nordisk Investigational Site | Horten | |
| Norway | Novo Nordisk Investigational Site | Kirkenær | |
| Norway | Novo Nordisk Investigational Site | Kongsvinger | |
| Norway | Novo Nordisk Investigational Site | Notodden | |
| Sweden | Novo Nordisk Investigational Site | Falun | |
| Sweden | Novo Nordisk Investigational Site | Helsingborg | |
| Sweden | Novo Nordisk Investigational Site | Motala | |
| United Kingdom | Novo Nordisk Investigational Site | Derby | |
| United Kingdom | Novo Nordisk Investigational Site | Edinburgh | |
| United Kingdom | Novo Nordisk Investigational Site | Hull | |
| United Kingdom | Novo Nordisk Investigational Site | Liverpool | |
| United Kingdom | Novo Nordisk Investigational Site | Scarborough | |
| United Kingdom | Novo Nordisk Investigational Site | Wirral, Merseyside |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Finland, Norway, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Hypoglycaemic episodes | |||
| Primary | Occurrence of adverse events | |||
| Secondary | HbA1c (glycosylated haemoglobin) | |||
| Secondary | Prandial increment in blood glucose | |||
| Secondary | 7-point blood glucose profile |
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