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Effectiveness and Safety of Biphasic Insulin Aspart 70/30 in Subjects With Type 2 Diabetes

Change in HbA1c With Biphasic Insulin Aspart 70/30 in Two Different Treatment Regiments in Subjects With Type 2 Diabetes Inadequately Controlled With Oral Anti-diabetic Drug Therapy.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00184561
Enrollment
321
Registered
2005-09-16
Start date
2005-07-31
Completion date
2006-07-31
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 Asia. This is a clinical trial investigating the effectiveness of using Biphasic Insulin Aspart 70/30 in two different treatment regiments for 6 months in subjects with type 2 diabetes, not well controlled on their current oral anti-diabetic drug therapy.

Interventions

DRUGbiphasic insulin aspart

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Type 2 diabetes * HbA1C = 7.5% * Insulin naïve * Current treatment by Oral Anti-diabetic Drugs

Exclusion criteria

* Severe medical conditions

Design outcomes

Primary

MeasureTime frame
Change in HbA1cAfter 24 weeks of treatment

Secondary

MeasureTime frame
Weight change
Fasting blood glucose
Adverse events
2-hour postprandial blood glucose
after 24 weeks of treatment.
Hypoglycaemic episodes

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026