A randomized, multi-center trial to compare the efficacy of once-daily insulin detemir and biphasic insulin aspart-30 in Japanese type 2 diabetes patients with oral hypoglycaemic agents therapy.

A randomized, multi-center trial to compare the efficacy of once-daily insulin detemir and biphasic insulin aspart-30 in Japanese type 2 diabetes patients with oral hypoglycaemic agents therapy. - Once-J Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004396

Enrollment

100

Registered

2010-10-16

Start date

2010-04-01

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 DM

Interventions

Once-daily insulin detemir Once-daily biphasic insulin aspart-30

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Consent of the participation to this study by a document. More than three months since subjects were diagnosed as Type 2 diabetes mellitus. Not having insulin treatment within six months. HbA1c>8.0%,<10% BMI<30kg/m2 Monotherapy or combination therapy with oral hypoglycaemic agents (Sulfonylureas,Thiazolidinediones,Biguanides).

Exclusion criteria

Exclusion criteria: Hypoglycemia Insulin allergy having participated in this study in the past amount of medicine for usage out of an authorized use Severe retinopathy Pregnancy Nursing Past using Alpha-GIs or Glinides within two months In addition, Medical attendants judged not to be appropriate as a subject of this study

Design outcomes

Primary

Measure	Time frame
24 hour glycemic variations using CGM Change of HbA1c value Frequency of hypoglycemia during an observation period	—

Countries

Japan

Contacts

Public ContactDaisuke Tsujino

The Jikei University School of Medicine Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine

dtsujino7777@gmail.com03-3433-1111(3243)

Outcome results

None listed

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