The Step-Up-Trial by biphasic insulin analogues

The Step-Up-Trial by biphasic insulin analogues - High-Mix Study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004246

Enrollment

Registered

2010-10-01

Start date

2010-10-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Type 2 diabetes

Interventions

Insulin aspart-70 three times daily injection for 28 weeks Insulin aspart-50 three times daily injection for 28 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. A written consent form for participating in this study is submitted 2. Type 2 diabetic patients whose ages are more than 20 years old 3. Type 2 diabetic patients treated with three times daily (TID) insulin regimen (i.e. fast acting or biphasic insulin including fast acting) for 12 weeks or more 4. HbA1c >= 7.5% 5. BMI <=30kg/m2 6. Subjects who can conduct SMBG

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetic patients 2. Patients who are pregnant or likely to become pregnant 3. Patients with severe complications 4. Patients having difficulty with the drug compliance 5. Other patients determined to be inappropriate for participating in this study by the physician

Design outcomes

Primary

Measure	Time frame
HbA1c levels after 16 and 28 weeks from the beginning of treatment.	—

Countries

Japan

Contacts

Public ContactTeiji Takeda

Shinshu University Graduate School Department of Aging Medicine and Geriatrics

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026