NCT00600366
Completed
Phase 4
Efficacy and Safety of Biphasic Insulin Aspart 30 in Insulin Naive Type 2 Diabetic Patients With Secondary OHA Failure
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- HbA1c
Overview
Brief Summary
This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on blood glucose control in insulin naive type 2 diabetes failing on secondary oral hypoglycaemic agent (OHA).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type 2 diabetes
- •Insulin naive diabetes
- •Current treatment with OHA, secondary failure
- •Body mass index (BMI) below 40 kg/m2
- •HbA1c over 8.5%
- •Willing and able to start with insulin therapy and to perform self-blood glucose monitoring
Exclusion Criteria
- •History of drug or alcohol abuse
- •Receipt of the investigational drug within the last month prior to this trial
- •Known or suspected allergy to trial products or related products
- •Severe uncontrolled hypertension
- •Any disease or condition, which the Investigator feels, would interfere with the trial
Outcomes
Primary Outcomes
HbA1c
Time Frame: after 12 weeks of treatment
Secondary Outcomes
- Blood glucose profiles
- Incidence of hypoglycaemic episodes
- Incidence of adverse events
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 4
Glycemic Control of Biphasic Insulin Aspart 30 in Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT01697631Novo Nordisk A/S131
Completed
Phase 3
Safety and Effect of Biphasic Insulin Aspart 50 in Patients With Type 2 Diabetes Mellitus.DiabetesDiabetes Mellitus, Type 2NCT00476437Novo Nordisk A/S81
Completed
Phase 4
Efficacy and Safety of a Fixed or a Flexible Supplementary Insulin Therapy in Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT00274274Novo Nordisk A/S373
Completed
Phase 4
Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal InsulinDiabetesDiabetes Mellitus, Type 2NCT00669864Novo Nordisk A/S293
Completed
Phase 1
Comparison of Two Biphasic Insulin Aspart 30 Formulations (Current and New Formulation) in Healthy VolunteersDiabetesHealthyNCT01487811Novo Nordisk A/S50