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NCT00318786 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00318786
Other study ID # BIASP-1598
Secondary ID JapicCTI-060241
Status Completed
Phase Phase 3
First received April 26, 2006
Last updated January 5, 2017
Start date April 2006
Est. completion date June 2007

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 289
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• biphasic insulin aspart

Locations
Country Name City State
Japan Novo Nordisk Investigational Site Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Kadowaki T, Nishida T, Kaku K. 28-week, randomized, multicenter, open-label, parallel-group phase III trial to investigate the efficacy and safety of biphasic insulin aspart 70 thrice-daily injections vs twice-daily injections of biphasic insulin aspart 3 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Hemoglobin A1C (HbA1C) After 16 weeks of treatment No
Secondary HbA1C, after 28 weeks of treatment; Plasma glucose levels No
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