Skip to main content
MedPathMedPath Home
Clinical Trials/NCT00476437
NCT00476437
Completed
Phase 3

Safety and Effect of Biphasic Insulin Aspart 50 Compared to Biphasic Human Insulin 50 in Patients With Type 2 Diabetes Mellitus.

Novo Nordisk A/S0 sites81 target enrollmentStarted: April 2007Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsDiabetesDiabetes Mellitus, Type 2
Drugsbiphasic insulin aspartbiphasic human insulin

Overview

Phase
Phase 3
Status
Completed
Enrollment
81
Primary Endpoint
Incidence of hypoglycaemic episodes
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

This trial is conducted in Japan. The purpose of this trial is to investigate the safety and the effect of biphasic insulin aspart 50 compared to biphasic human insulin 50 in patients with type 2 diabetes mellitus.

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

  • •Type 2 diabetes mellitus
  • •Current treatment with pre-mixed human insulin preparation or biphasic/pre-mixed insulin analogue in twice daily treatment for at least 8 weeks.
  • •HbA1C: less than 11.0%
  • •BMI: less than 30.0 kg/m2

Exclusion Criteria

  • •Total daily insulin dose: 100 IU/U and more
  • •Treatment with oral hypoglycaemic agents within the last 4 weeks.
  • •Treatment with insulin sensitizer within the last 12 weeks
  • •A lifestyle that is considered unsuitable for this trial (frequent or routine night shift workers etc.)

Outcomes

Primary Outcomes

Incidence of hypoglycaemic episodes

Time Frame: During 16 weeks of treatment

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Similar Trials

Completed
Phase 4
Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen® in Insulin Naive Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2
NCT00600366Novo Nordisk A/S71
Completed
Phase 3
Effect of Biphasic Insulin Aspart 50 on Blood Glucose Control in Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2
NCT00627445Novo Nordisk A/S441
Completed
Phase 1
Insulin Profile of Biphasic Insulin Aspart 70 to That of Biphasic Insulin Aspart 30 in Healthy VolunteersDiabetesDiabetes Mellitus, Type 2
NCT01538511Novo Nordisk A/S59
Completed
Phase 4
Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal InsulinDiabetesDiabetes Mellitus, Type 2
NCT00669864Novo Nordisk A/S293
Completed
Phase 4
Efficacy and Safety of a Fixed or a Flexible Supplementary Insulin Therapy in Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2
NCT00274274Novo Nordisk A/S373