Safety and Efficacy of Biphasic Insulin Aspart 50 in Subjects With Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Interventions: Drug: biphasic human insulin 50; Drug: biphasic insulin aspart 50

• Registration Number: NCT01650129
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-12-13
• Primary Completion: 2001-10-18
• Study Completion: 2001-10-18
• Study First Submitted: 2012-07-24
• Study First Submitted QC: 2012-07-24
• Study First Posted: 2012-07-26
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BHI	biphasic human insulin 50	-
BIAsp	biphasic insulin aspart 50	-

Primary Outcome Measures

Name	Time	Method
Glycosylated haemoglobin A1c (HbA1c)

Secondary Outcome Measures

Name	Time	Method
Insulin doses
Blood glucose
Change from baseline in insulin antibodies
Incidence of hypoglycaemic episodes
Occurrence of adverse event(s)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇯🇵 Tokyo, Japan