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

Trial to Investigate the Efficacy and the Safety of Thrice-Daily NN2000-Mix70 (NovoRapid 70 Mix) Compared to Twice-Daily NN-X14Mix30 (NovoRapid 30 Mix) in Subjects With Type 2 Diabetes Mellitus

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00318786

Enrollment

289

Registered

2006-04-27

Start date

2006-04-30

Completion date

2007-06-30

Last updated

2017-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

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.

Interventions

DRUGbiphasic insulin aspart

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Hemoglobin A1C (HbA1C)	After 16 weeks of treatment

Secondary

Measure	Time frame
HbA1C, after 28 weeks of treatment; Plasma glucose levels	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026