Study on insulin treatment for type 2 diabetes performed by general practitioners

Study on insulin treatment for type 2 diabetes performed by general practitioners - Study on insulin treatment for type 2 diabetes performed by general practitioners (Simple-i)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000011287

Enrollment

100

Registered

2013-07-26

Start date

2013-07-09

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 mellitus

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Type 2 diabetes patients aged 20 years or more who are willing to undergo insulin therapy with the study drug are eligible for the present study. Voluntary consent for participation in the study must be obtained in writing from the eligible patients.

Exclusion criteria

Exclusion criteria: Females during pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Changes in HbA1c from baseline at the specified measurement times (every four weeks)	—

Secondary

Measure	Time frame
- Changes in HbA1c from baseline (Week 0) at the specified measurement times (every four weeks) in patients undergoing insulin therapy with the study drug - Changes from baseline in self-measurement of blood glucose (SMBG) (wake up time, SMBG for five days of the week before or/and after the specified day) at specified measurement times (every four weeks) - Changes in the dose of the study drug at specified measurement times (every four weeks) - Changes from baseline (Week 0) in early-morning fasting blood glucose level and BMI at study completion (Week 12) - Changes from baseline (Week 0) in liver function, renal function, and lipid test values at study completion (Week 12) - Information on onset of hypoglycemia	—

Measure

Time frame

- Changes in HbA1c from baseline (Week 0) at the specified measurement times (every four weeks) in patients undergoing insulin therapy with the study drug - Changes from baseline in self-measurement of blood glucose (SMBG) (wake up time, SMBG for five days of the week before or/and after the specified day) at specified measurement times (every four weeks) - Changes in the dose of the study drug at specified measurement times (every four weeks) - Changes from baseline (Week 0) in early-morning fasting blood glucose level and BMI at study completion (Week 12) - Changes from baseline (Week 0) in liver function, renal function, and lipid test values at study completion (Week 12) - Information on onset of hypoglycemia

—

Countries

Japan

Outcome results