NCT01520753
Completed
Phase 3
A Randomised, Double-blind, 4-week, Crossover Trial on Two Treatment Regimens With Biphasic Insulin Aspart 70 and 50 in Patients With Type 2 Diabetes
Overview
- Phase
- Phase 3
- Intervention
- biphasic insulin aspart 50
- Conditions
- Diabetes
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Fasting serum glucose
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This trial is conducted in Europe. The aim of this trial is to compare two different active treatment regimens of biphasic insulin aspart in subjects with type 2 diabetes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Type 2 diabetes
- •Duration of diabetes for longer than 12 months
- •Body mass index (BMI) below 35.0 kg/m\^2
- •HbA1c below 11.0 %
- •Treatment with BHI (biphasic human insulin) 20 or 30 twice daily for at least three months and in the last month as sole anti-diabetic treatment (i.e., no additional oral hypoglycaemic medication or daily use of short-acting insulin supplement)
Exclusion Criteria
- •Current treatment with agents affecting glucose metabolism
- •History of drug or alcohol dependence
- •Impaired hepatic function
- •Impaired renal function
- •Cardiac disease
- •Proliferative retinopathy
- •Recurrent severe hypoglycaemia or advanced neuropathy
Arms & Interventions
BIAsp 70 + BIAsp 50
Intervention: biphasic insulin aspart 50
BIAsp 70
Intervention: biphasic insulin aspart 70
BIAsp 70 + BIAsp 50
Intervention: biphasic insulin aspart 70
Outcomes
Primary Outcomes
Fasting serum glucose
Secondary Outcomes
- 24-hour serum glucose profiles
- Incidence of hypoglycaemic episodes
- 24-hour insulin profiles
- Incidence of adverse events
Study Sites (1)
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