NCT01650129CompletedPhase 3
An Open-labelled, Randomised, Parallel Group, Multicentre, Safety and Efficacy Study of NN-X14Mix50 (BIAsp50) in a Twice Daily Regimen in Type 2 Diabetic Subjects
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 83
- Locations
- 1
- Primary Endpoint
- Glycosylated haemoglobin A1c (HbA1c)
Study Overview
Brief Summary
This trial is conducted in Japan. The aim of this trial is to investigate the safety and efficacy of biphasic insulin aspart (BIAsp) 50 (NN-X14Mix50) compared with biphasic human insulin (BHI) 50 in subjects with type 2 diabetes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects with type 2 diabetes
- •Subjects with insulin treated for at least 24 weeks
- •HbA1c maximum 11.0%
- •Body mass index (BMI) below 30.0 kg/m^2
- •Patients who have the skill of self-injection of insulin, and are able and willing to perform self-monitoring blood glucose (SMBG) and are able to take measures against hypoglycaemic episodes
Exclusion Criteria
- •Recurrent severe hypoglycaemia
- •Subjects with proliferative retinopathy or preproliferative retinopathy diagnosed within the last 12 weeks, or receiving photocoagulation therapy within the last one year
- •Impaired hepatic function
- •Impaired renal function
- •Cardiac diseases
- •Uncontrolled hypertension
- •Subjects with history of severe allergic or severe hypersensitive reactions
- •Total daily insulin dose at least 100 IU
- •Treatment with oral hypoglycaemic agentsvwithin the last 4 weeks
Arms & Interventions
BIAsp
Experimental
Intervention: biphasic insulin aspart 50 (Drug)
BHI
Experimental
Intervention: biphasic human insulin 50 (Drug)
Outcomes
Primary Outcomes
Glycosylated haemoglobin A1c (HbA1c)
Secondary Outcomes
- Blood glucose
- Change from baseline in insulin antibodies
- Incidence of hypoglycaemic episodes
- Occurrence of adverse event(s)
- Insulin doses
Investigators
Study Sites (1)
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