Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Comparison of Biphasic Insulin Aspart 30 Twice Daily and Biphasic Insulin Aspart 30 Twice Daily Plus Lunchtime Injection of Insulin Aspart Treatment Efficiency in Overall Glycemic Control and Postprandial Glycemic Excursions. A Multi-center, Randomized, Open-label, Two-armed Parallel Group Trial in Subjects With Type 2 Diabetes Previously Treated With Conventional Biphasic Human Insulin 30/70
| Verified date | February 2017 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This this trial is conducted in Europe. The aim of this trial is to compare glycaemic control of biphasic insulin aspart 30 (BIAsp 30) alone or combined with insulin aspart(IAsp) in patients previously treated with conventional Biphasic Human Insulin 30/70.
| Status | Completed |
| Enrollment | 131 |
| Est. completion date | April 24, 2003 |
| Est. primary completion date | April 24, 2003 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Type 2 diabetes - Current treatment with conventional biphasic human insulin 30/70 b.i.d. (twice daily) for at least 3 months - HbA1c (glycosylated haemoglobin) equal to or below 12% - Willing and able to perform self blood glucose monitoring (SMBG) Exclusion Criteria: - History of drug or alcohol dependence - Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation - Previous participation in this trial - Receipt of any investigational drug within the last month prior to this trial - Known or suspected allergy to trial products or related products |
| Country | Name | City | State |
|---|---|---|---|
| Poland | Novo Nordisk Investigational Site | Bialystok | |
| Poland | Novo Nordisk Investigational Site | Bytom | |
| Poland | Novo Nordisk Investigational Site | Kamieniec Zabkowicki | |
| Poland | Novo Nordisk Investigational Site | Katowice | |
| Poland | Novo Nordisk Investigational Site | Krakow | |
| Poland | Novo Nordisk Investigational Site | Nysa | |
| Poland | Novo Nordisk Investigational Site | Otwock | |
| Poland | Novo Nordisk Investigational Site | Radom | |
| Poland | Novo Nordisk Investigational Site | Ruda Slaska | |
| Poland | Novo Nordisk Investigational Site | Sosnowiec | |
| Poland | Novo Nordisk Investigational Site | Warsaw | |
| Poland | Novo Nordisk Investigational Site | Wroclaw |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Poland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1c (glycosylated haemoglobin) | |||
| Secondary | 7-point blood glucose profile | |||
| Secondary | Correlation of endpoint HbA1c with baseline BMI (body mass index) and HbA1c with treatment mode stratification | |||
| Secondary | Incidence of adverse events | |||
| Secondary | Hypoglycaemic episodes (minor, major or nocturnal) |
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