NCT01697631
Completed
Phase 4
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
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 131
- Locations
- 1
- Primary Endpoint
- HbA1c (glycosylated haemoglobin)
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
BIAsp
Experimental
Intervention: biphasic insulin aspart 30 (Drug)
Insulin aspart
Experimental
Intervention: biphasic insulin aspart 30 (Drug)
Insulin aspart
Experimental
Intervention: insulin aspart (Drug)
Outcomes
Primary Outcomes
HbA1c (glycosylated haemoglobin)
Secondary Outcomes
- 7-point blood glucose profile
- Correlation of endpoint HbA1c with baseline BMI (body mass index) and HbA1c with treatment mode stratification
- Incidence of adverse events
- Hypoglycaemic episodes (minor, major or nocturnal)
Investigators
Study Sites (1)
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