Comparison of Biphasic Human Insulin 30 With Biphasic Insulin Aspart in Subjects With Diabetes
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2Diabetes Mellitus, Type 1Diabetes
- Interventions
- Drug: biphasic insulin aspart 50Drug: biphasic human insulin 30Drug: biphasic insulin aspart 70
- Registration Number
- NCT01520818
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control of biphasic insulin aspart (BIAsp) 70 and/or BIAsp 50 with biphasic human insulin (BHI) 30 treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 666
Inclusion Criteria
- Type 1 or Type 2 diabetes
- Current treatment with BHI 30 twice daily as the only insulin therapy for at least 3 months, with or without combination with oral hypoglycaemic agents
- Body mass index (BMI) maximum 40.0 kg/m^2
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Exclusion Criteria
- History of drug or alcohol dependence
- Impaired hepatic function
- Impaired renal function
- Cardiac disease
- Proliferative retinopathy
- Total daily insulin dose at least 1.80 IU/kg
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BIAsp 50 or 70 biphasic insulin aspart 50 - BHI 30 biphasic human insulin 30 - BIAsp 50 or 70 biphasic insulin aspart 70 -
- Primary Outcome Measures
Name Time Method HbA1c (glycosylated haemoglobin A1c)
- Secondary Outcome Measures
Name Time Method Blood glucose profiles Adverse events Hypoglycaemic episodes Quality of Life (QoL) assessed via World Health Organization Diabetes Treatment Satisfaction Questionnaire (WHO DTSQ) Quality of Life (QoL) assessed via Diabetes Health Profile (DHP-2)
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇬🇧Whiston, United Kingdom