Comparative study of the usefulness of a novel insulin therapy in Japanese patients with Type 2 diabetes for concomitant use of an oral antidiabetic agent with twice-daily dosing either of insulin aspart, biphasic insulin aspart-30, or insulin detemir.

Comparative study of the usefulness of a novel insulin therapy in Japanese patients with Type 2 diabetes for concomitant use of an oral antidiabetic agent with twice-daily dosing either of insulin aspart, biphasic insulin aspart-30, or insulin detemir. - Two times Insulin injection Combined with oral therapy Efficacy Study (TWICE study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003537

Enrollment

100

Registered

2010-05-01

Start date

2010-05-01

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

Twice a day (before breakfast and dinner) insulin aspart+SU agent Twice a day (before breakfast and dinner) biphasic insulin aspart-30 Twice a day (before breakfast and dinner) insulin detemir + glini

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes who meet the following conditions (1)Patients younger than 75 years old (2)Patients with 7.5%<HbA1c<10.0% immediately before study entry (3)Patients administered an oral antidiabetic agent for three months or more (except for DPP4 inhibitory drugs) (4)Patients with ability to consent from whom written consent can be obtained (5)Patients with recent HbA1c 10.0%< but judged as eligible by their doctor in charge

Exclusion criteria

Exclusion criteria: A patient who falls under any of the following conditions shall be excluded: (1)Already under insulin treatment on outpatient basis (2)A patient with BMI higher than 35 (3)A patient with severe proteinuria (4)A patient with decompensated liver cirrhosis or renal failure (5)A patient with unstable proliferative diabetic retinopathy (6)A patient with severe neurologic disorder (7)A patient administered steroid drugs (8)A patient who is pregnant or is likely to become pregnant in the near future (9) A patient engaged in night shift work or keeping irregular hours (10) Other patients determined to be inappropriate by the doctor

Design outcomes

Primary

Measure	Time frame
Achievement rate of HbA1c < 7.0%	—

Secondary

Measure	Time frame
Safety (frequency of adverse events/hypoglycemia, etc.) Dose Changes in casual blood sugar level Changes in and mean values of blood glucose level before breakfast, blood glucose level 2 hours after breakfast, blood glucose level before dinner, and blood glucose level after dinner Comprehensive efficacy evaluation by the doctor Changes in body weight	—

Countries

Japan

Contacts

Public ContactMitsuyasu Itoh

Fujita Health University Hospital Department of Internal Medicine, Division of Endocrinology & Metabolism

endolabo@fujita-hu.ac.jp0562-93-9242

Outcome results

None listed

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