Efficacy and Safety of Three Times a Day BIAsp-70 Compared to Two Times a Day BIAsp-30 in Subjects With Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2

• Registration Number: NCT00318786
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Japan. This a clinical trial to study the efficacy and safety of three times a day BIAsp-70 compared to two times a day BIAsp-30 in subjects with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-04-26
• Study First Submitted QC: 2006-04-26
• Study First Posted: 2006-04-27
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-05
• Last Update Posted: 2017-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 289

Inclusion Criteria

• Subjects with type 2 diabetes
• Current treatment using intermediate-acting, long-acting insulin (including long-acting insulin analogue) or pre-mixed human insulin for at least 24 weeks
• HbA1c at least 7.5% and below 10.0%

Exclusion Criteria

• Proliferative retinopathy or maculopathy requiring acute treatment
• Impaired hepatic and/or renal function
• Cardiac diseases
• Uncontrolled hypertension
• Known hypoglycemia unawareness or recurrent major hypoglycemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1C (HbA1C)	After 16 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
HbA1C, after 28 weeks of treatment; Plasma glucose levels

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇯🇵 Tokyo, Japan