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 30Drug: biphasic insulin aspart 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
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Exclusion Criteria
- Total insulin dosage more than 1.8 IU/kg
- Impaired hepatic or renal function or significant cardiac problems
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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 Frequency of reported severe hypoglycaemic episodes HbA1c (glycosylated haemoglobin A1c) Overall frequency of nocturnal hypoglycaemia Diabetes Treatment Satisfaction Questionaire
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇬🇧York, United Kingdom