Comparison of Biphasic Insulin Aspart 70/30, 50/50, and 30/70 in Subjects With Type 2 Diabetes
Phase 3
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 2
- Registration Number
- NCT00184574
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of three different premixed insulin analogues given in combination with an oral anti-diabetic drug.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 603
Inclusion Criteria
- Type 2 diabetes
- Currently treated with insulin
- Currently treated with Metformin
- HbA1c: 7.5-12.0%
Exclusion Criteria
- Body Mass Index (BMI) < 25.0 or > 40.0 kg/m2
- Metformin contraindications according to local practice
- TZDs within 6 months prior to randomisation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method HbA1c after 36 weeks
- Secondary Outcome Measures
Name Time Method 8-point plasma glucose profiles Safety variables Other glycemic variables
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which biphasic insulin aspart mixtures improve glycemic control in type 2 diabetes?
How does the efficacy of biphasic insulin aspart 70/30 compare to standard-of-care insulin regimens in type 2 diabetes patients on metformin?
Which biomarkers correlate with differential response to biphasic insulin aspart 30/70 versus 50/50 mixtures in combination with metformin?
What are the most common adverse events associated with biphasic insulin aspart formulations in type 2 diabetes management?
How do biphasic insulin aspart mixtures compare to other premixed insulin analogs like biphasic insulin lispro in terms of HbA1c reduction and hypoglycemia risk?
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇬🇧Watford, United Kingdom
Novo Nordisk Investigational Site🇬🇧Watford, United Kingdom