Frequency of Episodes of Hypoglycaemia During Treatment With Biphasic Insulin Aspart 30 in Type 2 Diabetes
Phase 4
Completed
- Conditions
- Diabetes Mellitus, Type 2Diabetes
- Interventions
- Drug: biphasic human insulin 30
- Registration Number
- NCT01487798
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. The aim of this trial is to investigate the difference in frequency of episodes of hypoglycaemia during treatment with biphasic insulin aspart 30 compared to biphasic human insulin 30 in subjects with well controlled type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 170
Inclusion Criteria
- Type 2 diabetes
- Treated with insulin 1-3 injections daily for at least 6 months
- Body Mass Index (BMI) below 40 kg/m^2
- HbA1c (glycosylated haemoglobin A1c) below 9.5% at screening
Exclusion Criteria
- Total insulin dosage more than 1.8 IU/kg
- Impaired hepatic or renal function or significant cardiac problems
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment period 1 biphasic insulin aspart 30 - Treatment period 2 biphasic insulin aspart 30 - Treatment period 1 biphasic human insulin 30 - Treatment period 2 biphasic human insulin 30 -
- Primary Outcome Measures
Name Time Method Frequency of hypoglycaemic episodes
- Secondary Outcome Measures
Name Time Method HbA1c (glycosylated haemoglobin A1c) Overall frequency of nocturnal hypoglycaemia Diabetes Treatment Satisfaction Questionaire Frequency of reported severe hypoglycaemic episodes
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 molecular mechanisms differentiate biphasic insulin aspart 30 from biphasic human insulin 30 in type 2 diabetes management?
How does biphasic insulin aspart 30 compare to standard human insulin mixtures in reducing hypoglycemic episodes in well-controlled type 2 diabetes?
Are there specific biomarkers that identify type 2 diabetes patients most likely to benefit from biphasic insulin aspart 30 over conventional insulin therapies?
What are the long-term adverse event profiles of biphasic insulin aspart 30 versus biphasic human insulin 30 in phase 4 studies for type 2 diabetes?
How do Novo Nordisk's rapid-acting insulin analogs compare to other pharmaceutical companies' formulations in managing postprandial glucose in type 2 diabetes?
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇬🇧York, United Kingdom
Novo Nordisk Investigational Site🇬🇧York, United Kingdom